Handbook of Aseptic

Processing and Packaging

SECOND EDITION
 Handbook of Aseptic
Processing and Packaging
SECOND EDITION

Jairus R.D. David

Ralph H. Graves
Thomas Szemplenski

Boca Raton London New York

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 Dedication
In memory of
V.R. (Bob) Carlson
Dr. Walter Dunkley
Robert Graves
David R. Dass, Priscilla Juliet Dass, and Rufus David
Lynn Joel Zylstra
Contents
Foreword......................................................................................................... xvii
Preface................................................................................................................xix
Acknowledgments...........................................................................................xxi
Authors........................................................................................................... xxiii
Contributing Authors.................................................................................. xxvii

Chapter 1 Aseptic processing and packaging:

Past, present, and future............................................................. 1
Jairus R.D. David
1.1 Framework and current state.................................................................. 1
1.2 Departures from optima and challenges.............................................. 3
1.3 Current and future opportunities for optimization............................ 4
References............................................................................................................ 8

Chapter 2 United States history and evolution........................................ 9

Ralph H. Graves
2.1 Early pioneers............................................................................................ 9
2.2 The Graves era......................................................................................... 11
2.3 Jack Stambaugh....................................................................................... 12
2.4 The first commercial aseptic plant....................................................... 13
2.5 The real fresh company......................................................................... 13
2.6 The first aseptic form–fill–seal packages............................................ 13
2.7 Early aseptic packers.............................................................................. 14
2.8 Restrictions for growth.......................................................................... 15
2.9 Trends for the future.............................................................................. 16
References.......................................................................................................... 17

Chapter 3 The U.S. markets for aseptic packaging................................ 19

Thomas Szemplenski
3.1 Development........................................................................................... 19
3.2 Aseptic metal can market...................................................................... 20
3.3 Aseptic bag-in-box.................................................................................. 21
3.4 Aseptic paperboard market.................................................................. 25

vii
viii Contents

3.5 Aseptic plastic cup market.................................................................... 28

3.6 Aseptic pouch market............................................................................ 29
3.7 Aseptic plastic bottle market................................................................ 31

Chapter 4 Aseptic processing equipment and systems........................ 33

Thomas Szemplenski
4.1 Introduction............................................................................................. 33
4.2 Aseptic processing equipment............................................................. 34
4.2.1 Basic requirements of aseptic processing equipment......... 34
4.2.2 Blending vessel, balance surge, formulation of product..... 35
4.2.3 Timing pump............................................................................ 36
4.2.3.1 Pumping of foods containing particulates.......... 37
4.2.4 Heat exchangers........................................................................ 39
4.2.4.1 Heating: Sterilization of the products................... 39
4.2.4.2 Steam injection or infusion heaters....................... 39
4.2.4.3 Plate heat exchangers.............................................. 41
4.2.4.4 Tubular heat exchangers......................................... 42
4.2.4.5 Regeneration............................................................. 44
4.2.4.6 Scraped surface heat exchangers........................... 47
4.2.4.7 Ohmic heating.......................................................... 48
4.2.4.8 Microwave heating.................................................. 49
4.2.5 Continuous holding tubes....................................................... 51
4.2.6 Deaerator.................................................................................... 51
4.2.7 Controls...................................................................................... 52
4.2.8 Aseptic surge tanks, barrier seals, and automatic air-
operated valves......................................................................... 54
4.2.8.1 Aseptic surge tanks................................................. 54
4.2.8.2 Barrier seals.............................................................. 55
4.2.8.3 Valves......................................................................... 55
4.2.9 Homogenizers........................................................................... 57
4.2.10 Ingredients................................................................................. 58
4.2.11 Clean-in-place (CIP).................................................................. 59
4.2.11.1 Clean-in-place solutions.......................................... 59
4.3 Plant layout considerations................................................................... 61
4.3.1 Preparation and processing equipment and systems......... 61
4.3.2 Packaging system area (bacteriological conditions)............ 61
4.4 Utilities..................................................................................................... 63
4.4.1 System sterilization water....................................................... 63
4.4.2 Preparation water..................................................................... 64
4.4.3 Heating/cooling water............................................................. 65
4.4.4 Refrigerated water.................................................................... 66
4.4.5 Steam.......................................................................................... 67
4.4.6 Air............................................................................................... 68
Contents ix

4.5 Filters........................................................................................................ 69
4.5.1 Gases........................................................................................... 69
4.5.2 Liquids........................................................................................ 71
4.5.3 HEPA filters............................................................................... 71
4.5.4 General information on filtration........................................... 72
4.6 Chemicals used as sterilizing agents (equipment)............................ 72
4.6.1 Chlorine and iodine................................................................. 73
4.6.2 Oxonia........................................................................................ 74
4.6.3 Food acids.................................................................................. 74
4.6.4 Ozone.......................................................................................... 75
4.6.5 Hydrogen peroxide................................................................... 75
4.6.6 Ultraviolet.................................................................................. 75
References.......................................................................................................... 76

Chapter 5 Aseptic filling and packaging equipment............................ 77

Thomas Szemplenski
5.1 Development of aseptic packaging...................................................... 77
5.2 Dole aseptic canning system................................................................. 79
5.2.1 Can sterilizing unit.................................................................. 79
5.2.2 The filling section..................................................................... 80
5.2.3 Lid sterilizer.............................................................................. 80
5.2.4 The sealer................................................................................... 81
5.3 Aseptic bag-in-box.................................................................................. 81
5.4 Aseptic paperboard fillers..................................................................... 85
5.4.1 Tetra Pak..................................................................................... 85
5.4.2 SIG Combibloc........................................................................... 88
5.5 Aseptic plastic cups................................................................................ 88
5.5.1 Bosch and Erca.......................................................................... 88
5.5.2 OYSTAR Hassia, Erca, Gasti, and Hamba............................. 89
5.5.3 Ampack Ammann, Benco, and Metal Box............................ 89
5.6 Coffee creamers...................................................................................... 91
5.7 Aseptic pouches...................................................................................... 91
5.7.1 Bosch........................................................................................... 92
5.7.2 DuPont/Liqui-Box and Inpaco............................................... 92
5.7.3 Fres-co........................................................................................ 93
5.7.4 OYSTAR Hassia......................................................................... 93
5.7.5 Cryovac...................................................................................... 93
5.8 Aseptic plastic bottle fillers................................................................... 94
5.8.1 Ampack Ammann.................................................................... 95
5.8.2 Bosch........................................................................................... 95
5.8.3 Krones........................................................................................ 95
5.8.4 OYSTAR Hamba....................................................................... 95
5.8.5 Procomac.................................................................................... 97
5.8.6 Serac............................................................................................ 98
x Contents

5.8.7 Shibuya Kogyo.......................................................................... 99

5.8.8 Sidel/Tetra Laval....................................................................... 99
5.9 Stork........................................................................................................ 101

Chapter 6 Aseptic packaging materials and sterilants....................... 103

Robert Fox
6.1 Product requirements.......................................................................... 103
6.2 Materials................................................................................................ 103
6.2.1 Nonbarrier sheeting............................................................... 105
6.2.2 Barrier sheeting....................................................................... 105
6.3 Sterilizing Agents................................................................................. 105
6.3.1 Heat........................................................................................... 106
6.3.2 Hot water................................................................................. 106
6.3.3 Neutral aseptic system (NAS)............................................... 106
6.3.4 Chemical sterilants................................................................. 109
6.3.5 Radiation.................................................................................. 109
6.4 Packaging systems.................................................................................110
6.4.1 Dole aseptic canning...............................................................110
6.4.2 Preformed thermoformed containers...................................110
6.4.3 Form–fill–seal (FFS).................................................................110
6.5 Environmental considerations.............................................................115

Chapter 7 Aseptic bulk packaging.......................................................... 119

Thomas Szemplenski
7.1 Aseptic bag-in-box.................................................................................119
7.2 Aseptic bulk container......................................................................... 121
7.3 Aseptic bulk storage............................................................................. 122
7.4 Aseptic ocean liner transportation and storage............................... 125

Chapter 8 Regulations for aseptic processing and

packaging of food.................................................................... 129
Ralph H. Graves
8.1 U.S. Food and Drug Administration requirements
and approval..................................................................................... 129
8.1.1 European versus U.S. approach............................................ 129
8.1.2 U.S. Food and Drug Administration
and U.S. Department of Agriculture................................... 129
8.1.3 Pasteurized milk ordinance.................................................. 130
8.1.4 State regulations..................................................................... 130
8.1.5 Hazard analysis critical control point approach................ 130
8.2 Code of Federal Regulations (CFR).................................................... 131
8.3 Low-acid food regulations and definitions...................................... 131
8.4 U.S. Food and Drug Administration: Specific concerns................. 133
Contents xi

8.5 Other requirements.............................................................................. 135

References........................................................................................................ 137

Chapter 9 Validation and establishment of aseptic processing

and packaging operations...................................................... 139
Jairus R.D. David and V.R. (Bob) Carlson
9.1 Some considerations............................................................................. 139
9.2 Decision process................................................................................... 140
9.3 Equipment selection............................................................................. 140
9.4 Process schematic and process and instrument
diagrams (P&IDs)..................................................................................141
9.4.1 Process schematic....................................................................141
9.4.2 P&ID schematic........................................................................141
9.5 Preinstallation review.......................................................................... 142
9.5.1 Sterilization, operation, clean-in-place,
and maintenance................................................................... 143
9.5.2 Interlocks.................................................................................. 144
9.5.3 Hold tube................................................................................. 144
9.5.4 Timing pump.......................................................................... 145
9.5.5 Controls.................................................................................... 145
9.6 Postinstallation review........................................................................ 146
9.7 Equipment testing and validation...................................................... 146
9.7.1 Aseptic processing system.................................................... 147
9.7.2 Aseptic surge tank.................................................................. 148
9.7.3 Aseptic packaging system..................................................... 150
9.7.3.1 Filler and filler bowl sterilization tests and
sterile gas lines and fiber sterilization tests....... 150
9.7.3.2 Aseptic zone sterilization tests............................ 151
9.7.3.3 Container and lid sterilization tests.................... 152
9.7.3.4 Conveyor chain sterilization tests....................... 152
9.8 Thermal process design for products containing particles
(principles applicable to homogenous fluid foods).......................... 153
9.8.1 Scraped surface heat exchangers with straight
hold tubes................................................................................ 153
9.8.2 Microbiological validation.................................................... 154
9.8.2.1 Microbiological aspects......................................... 154
9.8.2.2 Quality and optimization considerations.......... 155
9.8.3 Process filing........................................................................... 155
9.9 Factors other than temperature contributing to nonsterility......... 156
9.10 Summary............................................................................................... 157
Acknowledgments.......................................................................................... 158
References........................................................................................................ 158
xii Contents

Chapter 10 Aseptic processing operations.............................................. 161

Thomas Szemplenski
10.1 Introduction............................................................................................161
10.2 Presterilization of the processing system..........................................162
10.3 Loss of sterility...................................................................................... 163
10.4 Water-to-product separation............................................................... 163
10.5 Product-to-water separation................................................................ 164
10.6 Cleaning................................................................................................. 165
10.7 Control.................................................................................................... 165

Chapter 11 Thermal processing and optimization................................ 167

Jairus R.D. David
11.1 Thermal processing and optimization...............................................167
11.1.1 Introduction..............................................................................167
11.1.2 Principles of thermal process calculations..........................167
11.1.3 Thermal process design and commercial sterility............ 170
11.1.4 Economic spoilage.................................................................. 170
11.1.5 Thermal destruction of enzymes, nutrients, and
quality factors.......................................................................... 171
11.1.6 Optimization of thermal processes for nutrients and
quality retention..................................................................... 172
11.1.6.1 Agitated retort........................................................ 172
11.1.6.2 The “Flash 18” process.......................................... 172
11.1.6.3 Ultra-high temperature (UHT) processing
and aseptic packaging........................................... 173
11.2 Comparison of conventional canning and aseptic processing
and packaging of foods........................................................................174
11.2.1 ................................................................................................
Comparison of conventional canning and aseptic
processing and packaging of foods......................................174
11.2.2 Some advantages of aseptic processing and
packaging of foods................................................................. 175
11.2.2.1 Nutritional quality................................................. 175
11.2.2.2 Sensory quality...................................................... 175
11.2.2.3 Microwaveability................................................... 175
11.3 Comparison of processing methods.................................................. 178
11.3.1 Pasteurization.......................................................................... 178
11.3.2 Ultra-pasteurization............................................................... 179
11.3.3 Conventional canning............................................................ 179
11.3.4 Refrigerated aseptic products............................................... 180
11.3.5 Comparison of continuous processing methods based
on optimization hierarchy..................................................... 180
Contents xiii

11.4 Definitions............................................................................................. 183

11.5 Nomenclature........................................................................................ 185
References........................................................................................................ 186

Chapter 12 Quality assurance and food protection for

aseptically processed and packaged food........................... 187
Jairus R.D. David
12.1 Introduction and concepts.................................................................. 187
12.1.1 Quality control........................................................................ 188
12.1.2 Quality assurance................................................................... 188
12.2 Quality assurance for aseptically processed and packaged food..... 188
12.2.1 Preprocess assurance............................................................. 189
12.2.1.1 Raw materials......................................................... 189
12.2.2 In-process assurance.............................................................. 190
12.2.2.1 Batch preparation................................................... 190
12.2.2.2 Thermal processing operations........................... 191
12.2.2.3 Aseptic filling and packaging operations.......... 193
12.2.3 Postprocess assurance............................................................ 196
12.2.3.1 Incubated product evaluation.............................. 197
12.2.3.2 Microbiological testing for sterility and
sample size consideration..................................... 197
12.2.3.3 Distribution, handling, and storage.................... 198
12.2.3.4 ASTM drop test...................................................... 198
12.2.3.5 Cumulative assurance and product release....... 199
12.3 Hazard analysis critical control point (HACCP) program............. 199
12.3.1 Principles of HACCP.............................................................. 199
12.3.2 Categories of hazards............................................................. 200
12.4 Others..................................................................................................... 200
12.4.1 Consumer complaints............................................................ 200
12.4.2 Recalls and spoilage............................................................... 201
References........................................................................................................ 201

Chapter 13 Failure mode and effect analysis, and spoilage

troubleshooting........................................................................ 203
Jairus R.D. David
13.1 Failure mode and effect analysis........................................................ 203
13.2 Failure mode and effect analysis, and troubleshooting.................. 203
13.2.1 Systems analysis and bioburden.......................................... 204
13.2.1.1 Canning or retorting............................................. 204
13.2.1.2 Aseptic processing and packaging..................... 204
13.2.2 Failure modes, analysis of their effects, and controls....... 207
13.2.2.1 Type 1: Incoming raw ingredients, handling,
storage, and batching............................................ 207
xiv Contents

13.2.2.2 Type 2: Equipment preparation and setup......... 208

13.2.2.3 Type 3: Thermal process design and
delivery—Heat cycle.............................................. 209
13.2.2.4 Type 4: Thermal process design and
delivery—Cool cycle............................................. 210
13.2.2.5 Type 5: Incoming packaging material and its
sterilization............................................................. 210
13.2.2.6 Type 6: Aseptic zone integrity and
environmental load................................................211
13.2.2.7 Type 7: Package seal integrity.............................. 213
13.2.3 Cause-and-effect relationships............................................. 213
13.2.3.1 Microbiological and package integrity
testing for troubleshooting................................... 213
13.2.4 Summary..................................................................................214
13.3 Nomenclature........................................................................................ 215
Acknowledgments...........................................................................................216
References.........................................................................................................216

Chapter 14 Aseptic processing of particulate foods.............................. 217

Pablo M. Coronel, Josip Simunovic, and Kenneth R. Swartzel
14.1 Introduction........................................................................................... 217
14.2 Considerations for equipment design............................................... 221
14.2.1 Heat exchangers...................................................................... 221
14.2.2 Novel heating technologies................................................... 223
14.2.3 Transport of liquids with particulates................................. 227
14.3 Validation of aseptic processes with particulates............................ 229
14.3.1 Available technologies and alternatives for validation......233
14.3.2 Practical considerations for validation of continuous
flow sterilization treatments of particulate foods
based on conservatively designed fabricated carrier
particles and residence time and thermosensitive
implants................................................................................... 238
14.3.3 Fabricated carrier particles: Selection, design, and
relevant property adjustments............................................. 238
14.3.4 Achieving conservative thermal characteristics of
carrier particle enclosures..................................................... 240
14.3.5 Experimental confirmation and adjustment of
conservative thermal properties.......................................... 244
14.3.6 Thermal property adjustments for advanced heating
applications.............................................................................. 244
14.3.7 Tags and implants used within the carrier particle
cavities for residence time and time–temperature
history measurements............................................................ 249
Contents xv

14.3.8 Insertion, unobstructed flow, and retrieval of

fabricated tag and implant-carrying particles.................... 254
14.4 Concluding remarks............................................................................. 259
References........................................................................................................ 260

Chapter 15 Industry research and development, and

management needs and challenges...................................... 263
Jairus R.D. David
15.1 Introduction........................................................................................... 263
15.2 Research and development needs and challenges.......................... 265
15.2.1 Raw product............................................................................ 265
15.2.1.1 Raw food quality.................................................... 265
15.2.1.2 Thermization.......................................................... 266
15.2.1.3 Enzyme blockers and biotechnology.................. 266
15.2.1.4 Economic spoilage and control............................ 266
15.2.2 Processing................................................................................ 267
15.2.2.1 12D “Bot Cook” for milk....................................... 267
15.2.2.2 Lethality credit for come-up time....................... 267
15.2.2.3 Control of hold time and temperature................ 268
15.2.2.4 Heat exchangers and product quality................ 269
15.2.2.5 Holding tubes......................................................... 269
15.2.2.6 Cooling cycle and leak detection......................... 271
15.2.2.7 Surge tank............................................................... 271
15.2.2.8 Aseptic processing of low-acid particulate
foods........................................................................ 271
15.2.2.9 Ohmic heating........................................................ 273
15.2.2.10 Microwave heating.................................................274
15.2.2.11 Other nonthermal processes.................................274
15.2.2.12 Additive and synergistic processes......................274
15.2.3 Aseptic filling and packaging................................................274
15.2.3.1 Line speed................................................................274
15.2.3.2 At-line and on-line measurements...................... 275
15.2.3.3 Packaging issues.................................................... 275
15.2.3.4 Bulk packaging....................................................... 276
15.2.3.5 Pulsed light technology........................................ 276
15.2.3.6 Seal integrity........................................................... 277
15.2.3.7 Aseptic filler or sterile work zone integrity
and validation........................................................277
15.2.3.8 Cleanup and extended run................................... 279
15.2.3.9 Defect rate or sterility assurance level (SAL)..... 279
15.2.4 Finished product and package............................................. 281
15.2.4.1 Flavor problems..................................................... 281
15.2.4.2 Gelation and other physical defects.................... 281
xvi Contents

15.2.4.3 Rapid microbiological methods........................... 281

15.2.4.4 Consumer education............................................. 282
15.2.4.5 “Aseptic” versus quality fresh............................. 282
15.2.4.6 Product development............................................ 283
15.3 Management and administrative challenges................................... 283
15.3.1 Capital cost.............................................................................. 283
15.3.2 Complexity.............................................................................. 283
15.3.3 Reliability................................................................................. 284
15.3.4 Repair and maintenance........................................................ 284
15.4 Future..................................................................................................... 285
15.5 Summary............................................................................................... 286
Acknowledgment............................................................................................ 287
References........................................................................................................ 287

Appendices Contract manufacturing for aseptic processing

and packaging......................................................................... 289
Thomas Szemplenski
Appendix A: Aseptic filler profiles.............................................................. 291
Appendix B: Aseptic contract packers in the United States..................... 349
Foreword
This book is a good resource for people who currently aseptically package
and process foods, as well as for people who might wish to get involved
in aseptic packaging and processing of foods. The book is based upon the
extensive experience and knowledge of the authors in the aseptic food
processing and equipment industry. The authors have a wide range of
experience encompassing production, quality assurance, research and
development, and sales in the aseptic packaging and processing indus-
tries. The information provided is very practical and can be used as a
guide to develop or review current day-to-day procedures for a number
of different aseptic processing and packaging applications.
This book is an updated and reorganized version of the previous
book Aseptic Processing and Packaging of Food: A Food Industry Perspective
(CRC Press, 1996). Chapters on aseptic packaging materials and steril-
ants, aseptic bulk packaging, aseptic processing operations, failure mode
effect analysis and spoilage troubleshooting, aseptic processing of par-
ticulate foods, and contract manufacturing have been added. These chap-
ters encompass current information and practical applications so that
those in need have a valuable useful resource. The appendices have a
list of aseptic packaging equipment including those currently accepted
by the U.S. Food and Drug Administration (FDA) and a list of manu-
facturers that do contract packaging. The chapter on aseptic packaging
of particulate foods (Chapter 14) has current information on the use of
microwave to heat particulate foods as well as the most recent technol-
ogy available to monitor and develop processes for this special category
of foods. Chapter 13 on failure mode analysis provides some examples
of failure modes and their effects on food safety. Chapter 10 on asep-
tic processing operations discusses the totality of the operation includ-
ing the processing of the product, including the operation of the aseptic
packaging system. Chapter 7 on aseptic bulk packaging, provides not
only a historical perspective but also an update on the state of bulk pack-
aging in container sizes of several gallons to several millions of gallons
of product. The chapter on aseptic packaging materials and sterilants

xvii
xviii Foreword

(Chapter 6) consolidates information on these subjects into one chapter

and provides up-to-date information.
This book is simple to use and understand with clear chapter head-
ings. The chapters are well organized and follow a logical sequence so
that topics are easy to locate. Once found, the information is understand-
able and can be put to immediate use. The information is current to the
time (2012) it was written and has been provided from the perspective of
individuals with experience in the subject.
The book provides an excellent update on the status of aseptic pro-
cessing and packaging and deserves a space in the library of anyone with
an interest in aseptic processing and packaging of foods.

Keith A. Ito
Laboratory for Research in Food Preservation
Food Science and Technology
University of California, Davis
Preface
This book provides a comprehensive treatment of aseptic processing and
packaging for people interested in the food and beverage processing indus-
try. It is based primarily on the extensive experience of the authors in
processing, marketing, business, quality assurance, and research and devel-
opment related to aseptically processed and packaged foods and beverages.
There have been dynamic changes that have occurred in the food
industry since the publication of our previous book in 1996 (David,
Graves, and Carlson). Our objective was to assemble in one volume the
large amount of information that has been published and to update
changes in food packaging, especially aseptic filling into plastic bottles,
one of the fastest growing areas in the retail sector, and bulk packaging of
value-added commodity products such as juice, concentrate, and puree.
Opportunities for the application of existing and novel food processing
methods and sensor technologies are also discussed in various chapters.
The three coauthors and the contributing authors have more than 150
years of combined food industry experience in aseptic processing and
packaging of foods, which is reflected in the 15 chapters and appendices.
We realize that there may be some duplication and overlap between chap-
ters but we think that readers can read and analyze specific chapters, and
obtain the information desired rather than having to read the entire book.
For many years, researchers recognized that the use of high tempera-
tures for short times had potential advantages over conventional thermal
processes at lower temperatures for longer times, but there were difficul-
ties in taking advantage of this information. Heat causes reactions in food,
some of which are undesirable; the rate of reaction approximately doubles
for every increase in temperature of 10C° (18F°). In contrast, typical rates
of destruction of bacteria and spores increase tenfold for the same temper-
ature increase. Therefore, processes using higher temperatures for shorter
times can achieve commercial sterility with improvements in quality with
respect to flavor, color, vitamin retention, and physical properties, as com-
pared to the quality of products from conventional heat processes.
Application of this principle was limited by the availability of processes
and equipment to apply it in commercial practice. Rapid heat transfer for

xix
xx Preface

heating and cooling is readily achieved in liquid foods but not in solid
foods, which depends on conduction heat transfer rather than convection.
Therefore, early work focused on liquid foods, especially milk and its prod-
ucts. Specialized equipment was developed for applying ultra-high temper-
ature (UHT) treatments using tubular or other heat exchangers, or steam
injection or infusion devices, which were usually coupled with vacuum
coolers. Commercial use of such equipment necessitated aseptic packaging
after sterilization, which proved to be the most serious limitation.
Early successes with milk and its products increased interest in adapt-
ing aseptic processing and packaging to other liquid foods. The book out-
lines progress with products such as soups, juices, and purees, and current
research and development directed toward the challenging problems with
foods containing solid particles. Introduction of new aseptic processing
and packaging technologies necessitated the evolution of a new body of
food laws and regulations, and new or expanded agencies to enforce them.
Innovations in the United States have been delayed by the industry’s justifi-
able cautious approach in developing validation procedures for compliance
with its own quality and safety standards, and those of regulatory agen-
cies. Collaboration among industry, industry organizations, public officials,
and agencies has been excellent in guiding the development of a rapidly
expanding industry based on aseptic processing and packaging.
The organization of the book permits readers to selectively choose
those sections in which they have the greatest interest. The sections
written by the different authors reflect their personal styles and areas
of expertise. The book provides a comprehensive update on this rapidly
developing technology for the food processing industry.
We wish to express our sincere appreciation to the four contributing
authors Dr. Robert Fox, Dr. Pablo Coronel, Dr. Josip Simunovic, and Dr. Kenneth
Swartzel, who, by giving freely of their expertise, have made this book pos-
sible. Many thanks are due to Steve Zollo, senior editor, Taylor & Francis/CRC
Press, Boca Raton, Florida, for his professionalism and unstinting support in
bringing this book to publication. Our appreciation to David Fausel and Linda
Leggio at Taylor & Francis/CRC Press for expediting the final stage of printing.
Jairus R.D. David
Omaha, Nebraska
Ralph H. Graves
Visalia, California
Thomas Szemplenski
San Diego, California
Note: References to commercial products and trade names are made with
the understanding that no discrimination and/or no endorsement by
the authors or the organizations that they are involved with are implied.
Acknowledgments
I would like to express my thanks to the following: my wife, Shelley, for
her loving encouragement of this work, and to our children, Adriana,
Brennan, and Blake, for “daring” me to write “another book.”
Dr. Al Bolles, Senior Executive Vice President of Research, Quality,
and Innovation (RQI), and Dr. Corey Berends, Vice President, Innovation,
RQI, for their visionary leadership and encouragement of this work.
Dr. Richard McArdle, Vice President, RQI, for espousing the value of
“Leader Level 5,” and active listening. Dr. Athula Ekanayake, Research
Fellow, at the Procter & Gamble Company, for introducing me to the
Minto pyramid principle and logic, and to the world of natural antimicro-
bials and delivery systems.
Dr. Kailash Purohit, President and CEO of Process Tek, Prospect
Heights, Illinois, who single-handedly coined and articulated the terms
“aseptic sterile work zone,” “maintenance sterility,” and “passive or
dynamic decontamination” in both the pharmaceutical and food indus-
tries. His review of Chapters 9, 11, 12, 13, and 15, and useful discussions
are acknowledged.

Jairus R.D. David

My family for their constructive criticism.

Jody and Robert Graves for their good memories and expertise.
My fellow authors—Jairus David and Thomas Szemplenski.

Ralph H. Graves

I would like to express my special appreciation to the following people:

Dr. Philip Nelson of Purdue University for giving me the opportunity
to participate in the development of aseptic bag-in-box and bulk storage,
and his mentoring over the course of my career.
Dr. Dilip Chandarana for being a very special friend and source of
aseptic and other food technology over the years.

xxi
xxii Acknowledgments

Darryl Wernimont, Director of the Haskell Co., for his longtime

friendship.
Malcom Knight, Vice President of Pom Wonderful, for his support
of me to facilitate his company’s aseptic processing and packaging
objectives, and experience hands-on installation of an aseptic rotary
bottle filler.

Thomas Szemplenski
Authors
Jairus R.D. David, M.Sc., Ph.D., is Senior Principal Research Scientist,
Innovation—Breakthrough Science, Research, Quality, and Innovation
(RQI), ConAgra Foods headquartered in Omaha, Nebraska. David’s
responsibilities include science leadership and development of inter-
vention technologies for food protection, and process and quality
optimization.
David is a Fellow of the Institute of Food Technologists (IFT), 2008,
and is the recipient of IFT’s prestigious Industrial Scientist Award, 2006.
He is recognized for developing and influencing public health food safety
policy on the use of honey in cereals and bakery products for the preven-
tion of infant botulism in infants under 12 months of age. Currently, all
honey and honey-containing food products in commerce carry a warning
label “Do not feed honey to infants less than one year of age.”
David has 20-plus years of food industry management and leadership
experience in the areas of food safety, thermal processing, aseptic technol-
ogy, quality assurance, and risk analysis. Prior to this, he worked at Real
Fresh Aseptic Operations in Visalia, California, and Gerber Baby Foods in
Fremont, Michigan.
David earned his Ph.D. in microbiology with emphasis in thermal pro-
cessing from the University of California at Davis, under the tutelage of
Dr. Richard Larry Merson. He is a Certified Quality Manager (CQM) and
Certified Quality Engineer (CQE), American Society for Quality. David has
participated in the leadership development program at the Kellogg School
of Management, Dr. Stephen Covey Leadership Center, Massachusetts
Institute of Technology, and Center for Creative Leadership.

Ralph H. Graves held the position of Senior Vice President for Real Fresh,
Inc., a company involved in the processing and sale of aseptically pack-
aged foods. His responsibilities included the research and development
of processing techniques, quality control, engineering, and maintenance
and warehousing of aseptically packaged dairy products. Prior to his
employment with Real Fresh, Graves was involved in the startup of several

xxiii
xxiv Authors

ultra-high temperature (UHT) milk processing plants for International

Milk Processors, Inc., one of the first U.S. companies devoted entirely to
aseptic packaging. He majored in animal science and dairy production at
Valparaiso and Michigan State universities. His interest in aseptic packag-
ing came from his father, who was one of the pioneers in the field of UHT
sterilization, holding several patents related to the process.
Graves’ career has taken him around the world, from working as
President of Graves Farm, Inc., in Maryland, to overseeing the produc-
tion and distribution of aseptically packaged foods overseas. Milestones
include assisting in the startup of a joint venture between Real Fresh and
the Murray Goldburn Dairy Cooperative in Australia, and overseeing the
distribution of Real Fresh milk for the first Saudi Arabian school lunch
program. Although now officially retired, he continues his work in this
field as a consultant for Real Fresh and other firms.
Graves’ involvement in professional organizations includes: Chair
of the Aseptic Packaging Committee of the National Food Processors
Association (now Grocery Manufacturers Association [GMA]); Past
President of the California Creamery Operators Association; Director
and Secretary–Treasurer of the California Dairy Institute; member of the
Scientific Affairs Committee of the National Food Processors Association;
President of Visalia Kiwanis Club; President of California Backcountry
Horsemen; and Treasurer and Director of Visalia, California Chamber
of Commerce.

Thomas Szemplenski is currently the owner of Aseptic Resources, Inc., a

consulting company dedicated to assisting food processors and equipment
manufacturers with aseptic processing techniques. He has more than four
decades of food processing and packaging experience. The vast majority
of those years have been dedicated to aseptic processing and packaging
techniques, commercial application, and marketplace dynamics.
Prior to starting Aseptic Resources in 1987, Szemplenski initially
worked for a frozen food manufacturer and after attending the University
of Nebraska, he went on to hold senior marketing positions with several
leading manufacturers of food processing equipment, affording world-
wide exposure to many different aseptic processing and packaging alter-
natives. In addition, while in these marketing positions, Szemplenski
was very fortunate to work and learn from Dr. Phil Nelson of Purdue
University and William Scholle with the initial development of aseptic
packaging of food products into bag-in-box. Subsequently, he has actively
participated in many commercial aseptic processing and packaging sys-
tems using bag-in-box fillers.
Authors xxv

A number of years ago, while continuing Aseptic Resources,

Szemplenski concurrently was a part owner of an aseptic processing facil-
ity located in the Midwest. This facility aseptically contract packaged both
high- and low-acid food products under FDA validation.
Szemplenski has published numerous papers during his professional
career primarily dealing with aseptic processing and packaging tech-
niques, and he has been invited to teach aseptic processing techniques
at several leading universities and major food processors. Additionally,
Szemplenski holds several patents centered on aseptic technology.
Contributing Authors
Pablo M. Coronel, Ph.D. Josip Simunovic, Ph.D.
R&D Department of Food Bioprocessing
Aseptia, Inc.   and Nutrition Sciences
Raleigh, North Carolina North Carolina State University at
  Raleigh
Robert Fox, Ph.D. Raleigh, North Carolina
Synergy Packaging, LLC
Williamsburg, Virginia Kenneth R. Swartzel, Ph.D.
William Neal Reynolds
  Distinguished Professor Emeritus
North Carolina State University at
  Raleigh
Raleigh, North Carolina

xxvii
chapter 1

Aseptic processing and packaging:

Past, present, and future

Jairus R.D. David

Marketing, industrial, and regulatory frameworks based on principles

of aseptic processing and packaging are available, and continue to be of
interest to the food processors of ambient, shelf-stable foods in retail pack-
ages and bulk containers.
Aseptic processing and packaging of foods consist of filling sterilized
and cooled food into presterilized containers, followed by hermetic seal-
ing with a presterilized closure in a presterilized and continuously decon-
taminated tunnel or aseptic work zone.
It is axiomatic to consider aseptic processing and packaging as
the benchmark in optimization, for manufacture of sterile, shelf-stable
canned food. Contrasted with retorting or in-container sterilization, in
aseptic processing, the product and package are independently sterilized
by optimal processes, wherein microbial inactivation and quality factor
degradation are also co-optimized given first-order kinetics. Aseptic sys-
tems permit sterilizing the product and container separately and appro-
priately, without the rate-limiting heat transfer modes, or the attendant
thermal and pressure stress to the container closure and seal integrity,
and permitting high-temperature, short-time (HTST) or ultra-high tem-
perature (UHT) processing of very heat-labile products without excessive
quality and nutritional degradation, while achieving requisite commer-
cial sterility (see Figure 1.1).

1.1  Framework and current state

Aseptic processing is a commercially successful and robust technology.
It is approximately 70 years old, and began with the invention of the first
aseptic line of the Heat/hold–Fill/hold–Cool (HFC) system by Dr. C. Olin
Ball (1936). Aseptic technology became a commercial reality with the
installation of Dr. W.M. Martin’s Dole (1951) aseptic canner in the 1950s.

1
2 Handbook of aseptic processing and packaging

Aseptic Product Filler and Packaging Commercially

UHT Bulk Aseptic Balance * Sterile work zone Sterile Shelf-
Raw Product Bulk Cool
Sterilize Tank * Package and seal integrity Stable Filled
* Interfaces Containers

Figure 1.1  A schematic diagram of an ultra-high temperature (UHT) processing

and aseptic filling and packaging system.

Martin recognized that the production of nutritionally superior and

“home-style” baby foods, heat-sensitive infant formula, and milk prod-
ucts would be possible through the use of short-time, high-temperature
sterilization together with aseptic canning.
In the United States before 1981, the Martin–Dole aseptic canning
system was the only aseptic filling and packaging system of commercial
importance for milk and milk-based low-acid products in metal cans. This
core technology was correctly designated as UHT-sterilized and asepti-
cally packaged process. The pre-1981 market drivers were better quality,
low-acid, heat-sensitive products, compared to retorted versions. It was a
formidable marketing and research and development challenge to educate
consumers to appreciate aseptic technology and differentiate products in
Martin–Dole aseptic metal containers from that of classical canning or
retorting. Also in commercial use were 55-gallon metal drums invented
in the 1970s by Fran Rica for bulk packaging of tomato products.
In 1981, the U.S. Food and Drug Administration (FDA) approval of the
food additive petition for use of hydrogen peroxide as a sterilant for food
contact surfaces provided the impetus for introduction of various aseptic
filling and packaging systems into the U.S. markets. The market was pri-
marily driven by “juice box” technology, which involved high-acid food
pasteurization at HTST followed by aseptic filling and packaging. The post-
1981 market drivers were use of alternate flexible and semirigid packages,
consumer convenience, reduced package weight, cost reduction, superior
quality and nutrition, and package sterilization by optimal methods.
Aseptic processing and packaging is one of the most dynamic and
profitable sectors in the U.S. food and beverage market. The major asep-
tic packaging segments are cans, plastic bottles, plastic cups, bag-in-box,
paper board, and pouches. In addition, the aseptic processing industry
is going through another period of specific growth via plastic, primar-
ily polyethylene and polyethylene terepthalate (PET) containers to the
world market. These packages have been in commercial use for several
years for packaging high-acid products (such as fruit juices and spaghetti
sauces) and refrigerated low-acid products (such as fruit smoothies, and
white and flavored milk beverages), but are being used with increasing
frequency for low-acid shelf-stable fluid products (such as coffee and
protein-fortified nutritional beverages, and energy and sports drinks) to
Chapter 1:  Aseptic processing and packaging: Past, present, and future 3

meet consumers’ modern lifestyle and demand for ergonomic and envi-
ronmentally sustainable containers.
Today, there are more than 34 manufacturers of aseptic filling equip-
ment worldwide (Appendix A) and more than 600 aseptic systems for
manufacture of retail package and bulk containers in the United States.
Contract manufacturers play a crucial role in the introduction of inno-
vative and consumer-convenient new products to the market in a timely
and cost-effective manner (Appendix B). Contract manufacturers facilitate
rapid prototyping, product sensory and specifications development, and
go/no-go business decisions.

1.2  Departures from optima and challenges

Even though the aseptic technology is considered the benchmark in opti-
mization for manufacture of sterile, shelf-stable canned food, there are
several departures from optima or gaps that should be closed in order
to leverage the full benefits of quality, nutrition, safety, and convenience.
Some of the gaps include potential compromises to sterile work zone
and seal integrity leading to microbial recontamination, overdelivery of
designed thermal process, inadequate or slow cooling, and special han-
dling of sensitive ingredients known to contain and protect thermoduric
and thermophilic spores during heating.
Aseptic systems that process and package shelf-stable foods are
indeed well suited to be hierarchically co-optimized, as there are many
competing priorities and numerous critical parameters that must be
validated and controlled. But most important, the numerous vectors of
recontamination must be recognized for their capacity to cause failure.
Although sophisticated control systems do help, there is no substitute for
training, environmental control, and system validation for defect preven-
tion and food protection.
The aseptic zone is undoubtedly the heart of the aseptic system and
is crucial to the delivery of a sterile product. Although it can be presteril-
ized and validated to be sterile to a sterility assurance level of 10−6, proce-
dures and practices to maintain or monitor its sterility are unavailable. It
is assumed to be sterile by virtue of presterilization and the use of sterile,
high-efficiency particulate air (HEPA), or laminar flow air. Thus the work
zone is at best, sterile or passive, and not sterilizing or active, and thus not
able to overcome recontamination. The vectors of recontamination include
filter failures, grow through, and nonsterile air aspiration by the work zone
due to loss of laminarity, eddy currents at interfaces or leaks, and the dis-
charge of finished containers from the zone (K. Purohit, Process Tek, per-
sonal communication, 2008).
It should be reemphasized that despite subsystem validation to 10−6,
overall sterility assurance is governed by the aseptic work zone, wherein
4 Handbook of aseptic processing and packaging

maintenance of sterility cannot be assured and monitored, and any recon-

tamination cannot be detected, removed, or inactivated. An exception is
the active or sterilizing work zone (using superheated steam), which is
an integral part of the very first aseptic system—the Martin–Dole aseptic
canner. However, it is important to note that the Dole aseptic system is
somewhat vulnerable, when superheated cans are “tempered down” prior
to filling to avoid product contact burn-on.
The terminal retort process in canning is a de facto seal integrity
tester, and marginal seals usually do not survive the time, temperature,
and pressure of the retort scheduled process. In aseptics, not only are the
product and package decoupled but also the final seal, made in a sterile
work zone, is not trauma tested, ever. In aseptics, the reliability of seal
inspections, mandatory incubation holds, and sterility tests take on addi-
tional significance. Thus, seal integrity and maintenance of hermeticity in
aseptics is a key determinant of sterility assurance.
Precise control of flow and temperature are essential for proper design
and delivery of an approved thermal process, followed by prompt cooling.
Inability to control temperatures within 5°F in the UHT regime can lead
to irreversible damage, because this may correspond to a doubling or tri-
pling of process lethality (Fo). The food industry should strive for defining
the safety and quality and biofunctionality limits in a scheduled process
to prevent departure from process optimum.

1.3 Current and future opportunities

for optimization
The future of aseptic processing will depend upon reducing the depar-
tures from process optima, and capturing findings from ongoing research
in both basic and applied research leading to the use of both novel ther-
mal sterilization methods coupled with innovative nonthermal processes,
sensors, and nanotechnologies. It is important to underscore that no one
single technology can replace the shelf-stable capabilities of either classi-
cal retorting or aseptic processing. However, many of the innovative ther-
mal and nonthermal processes, sensor, and nanotechnologies can be used
either additively or synergistically to build “hurdles” in tandem with an
objective to produce superior products with minimal heat-induced dam-
age and at an affordable price (see Figure 1.2 and Chapter 15).
Developments on the filling and packaging side of the aseptic technol-
ogy will continue to be the major driving force in the further expansion of
this technology. Emerging package and packaging material sterilization
processes like plasma generation and glass lining will expand the number
and variety of polymers in use for aseptic packaging as well as available
package shapes and sizes (Sandeep et al. 2004).
 Chapter 1:  Aseptic processing and packaging: Past, present, and future
Canning

Optimization and
Business
Opportunities Optimized Aseptic
Pasteurization ESL Pasteurization Aseptic Processing Processing
Continuum

Other Thermal and

Nonthermal
Processes, Sensor, and
Nanotechnologies

Figure 1.2  A schematic diagram of an ultra-high temperature (UHT) processing and aseptic filling and packaging system—
optimization continuum. (ESL: extended shelf life.)

5
6 Handbook of aseptic processing and packaging

Larger (institutional and industrial ingredient) sizes of aseptically

packaged products currently have the most favorable (low) ratio of pack-
aging material used per unit of product weight and volume, and this
advantage will continue to grow, especially for products yet to make a sig-
nificant impact in the aseptic processing area, such as low-acid particulate
products. There is the need to avoid re- or double-processing of previously
bulk processed aseptic high value-added commodity products (orange
juice, purees of banana, prunes, and other exotic berries) via development
of reliable proper transfer fitment and techniques for ambient repackag-
ing into retail-sized containers.
Uniform quality, reduced need for frozen and refrigerated distribution
and storage as well as progressively more favorable ratios of packaging
material used per unit product will positively impact the environmental
and economic advantage of this technology over currently dominant con-
ventional technologies.
Developments in conventional tube-in-tube heat exchanger design
will also continue. Helical, dimpled, corrugated, and agitated heat
exchangers will be introduced in commercial production with increas-
ing frequency. Emerging thermal processing technologies, specifically
volumetric heating methods like continuous flow microwave heat-
ing (microwave-assisted thermal sterilization [MATS], North Carolina
State University and Washington State University), radio frequency, and
ohmic/electric resistance heating will have a major impact on quality and
variety of available aseptic food products in the near future. Applications
of emerging nonthermal and thermally assisted technologies like ultra-
high pressure processing (pressure-assisted thermal sterilization [PATS],
Institute of Food Safety & Health [IFSH]), pulsed electric field treatments,
irradiation, sonication, thermosonication, and manothermosonication
will expand and integrate with other aseptic processing operations in
single and multiple concurrent and sequential bactericidal treatment to
achieve extended refrigerated shelf life and shelf stability.
Incremental adjustments will be made to all processing stages and
equipment to accommodate multiphase products, especially low-acid
products containing large particulate components. Particle-compatible
pumps, heat exchangers, tanks, back pressure valves, filler heads, and
package transfer fitments will continue to be improved and integrated
into aseptic production lines.
Improper removal of heat from bulk sterilized foods can lead to con-
tinual degradation of quality, and nutritional and functional loss. Prompt
cooling and an adequate cooling rate is integral to aseptic processing.
Emerging cooling methods will be introduced and integrated into aseptic
processes over an extended period of time. Evaporative, cryogenic, reverse
thermocouple/peltier cooling, and newer volumetric cooling technologies
Chapter 1:  Aseptic processing and packaging: Past, present, and future 7

such as magnetic field cooling and ultrasonic cooling will have an impact
on quality and economy of aseptic product processing.
Spore-sensitive ingredients of concern are cocoa, tapioca granules,
nonfat dry milk (NFDM), carboxymethylcellulose (CMC), starches, sugar,
corn, mushrooms, and spices. It is a good practice to monitor, measure,
track, and control the mesophilic and thermophilic spore loads of each
batch of raw product based on ingredients in a formulation. In addition,
these ingredients must be completely hydrated prior to batching to ensure
that any spores (if and when present) are fully exposed to a designed and
delivered thermal process via a direct or indirect method of heating for
prevention of economic spoilage.
The concept of cold, in-line sterile formulation, wherein one or more
HTST/UHT sterile streams are operated in tandem with one or more filter
sterilized streams into aseptic surge tank, filler bowl, or sterile container
is sometimes utilized for very heat-sensitive ingredients or components.
Some very heat-labile products are exclusively filter sterilized and asepti-
cally filled and sealed with no heat trauma at all. The availability of a wide
array of membrane, ceramic, and sintered metal filters are making this
process option more commonplace, as do a few process, validation, and
production safety concerns.
New techniques of real time and postprocess measurement and mon-
itoring will be implemented to accurately and reliably monitor and quan-
tify all lethality delivered to all segments of an aseptic processing system.
These emerging techniques and tools will take advantage of miniaturiza-
tion of sensing elements and nanotechnology level development currently
taking place in other areas of research and development. Unavailability or
inconsistent application of process establishment, monitoring, and valida-
tion tools have been one of the most significant hurdles in expanding the
range of aseptic processing of more difficult, particularly multiphase food
products (K.R. Swartzel, North Carolina State University, personal com-
munication, 2011; see Chapter 14).
As the locus of research and development and commercialization
of aseptics moves toward large particulates, sterile formulation, higher
throughputs, and extended production runs (120 hours) for better overall
equipment effectiveness (OEE), the demands for control and monitoring
will no doubt increase. Maintenance of sterility and prevention of recon-
tamination are the aseptic equivalents of postprocess contamination (his-
torically the canning industry’s Achilles’ heel), except that in aseptics they
are so intertwined with the system’s design and operation that they will
require constant, significant, and specialized attention including preven-
tive maintenance, breakdown maintenance, and intermittent cleanup and
clean-in-place (CIP) to keep aseptic systems acceptable from public safety
concerns (K. Purohit, Process Tek, personal communication, 2008).
8 Handbook of aseptic processing and packaging

There is the need to develop sensitive, reliable, and cost-effective non-

destructive at-line package integrity tests compatible with current and
future line speeds.
Troubleshooting of microbial spoilage problems often can be resolved
using known problem solving tools including Six Sigma. Further iden-
tification and speciation via modern molecular methods is needed for
proper root cause analysis (RCA) and definitive corrective action and pre-
ventive action (CAPA). Tracking sources of microbial contaminants has
been a concern, given the uncertainties associated with the integrity and
maintenance decontamination of the “sterile working zone” or the aseptic
tunnel during normative and extended production runs up to 120 hours.
However, recent advances in the development of molecular subtyping
methods have provided tools that allow more rapid and highly accurate
determinations of these sources (J. Kornacki, Kornacki Microbiology
Solutions, Inc., personal communication, 2011). Sometimes spoilage prob-
lems due to compromises in the aseptic sterile zone cannot be resolved
by traditional RCA leading to meaningful CAPA. In such cases, advanced
problem solving tools such as TRIZ (theory of inventive problem solving,
developed by Genrich Altshuller) should be deployed (Cameron 2010).
Aseptic processing and packaging is an attractive and a challeng-
ing alternative compared to conventional methods of canning of foods.
New aseptic facilities are continuing to be constructed around the world.
Continuous sterilization of heat-sensitive foods at ultra-high tempera-
tures, followed by prompt cooling results in a superior finished product,
which can be filled into containers of varying compositions, of different
shapes, and with many consumer-attractive features. Compared to classi-
cal canning, the definitive market advantage of aseptically processed and
packaged foods originates from the ability to incorporate several value-
added features, such as substantially increased sensory and nutritional
qualities, microwaveability, several user-friendly conveniences, and cost
saving from use of plastics.

References
Ball, Charles Olin. 1936. Apparatus for and a method of canning. U.S. Patent
2,029,303, issued February 4, 1936.
Cameron, G. 2010. TRIZICS—Teach Yourself TRIZ. Lexington, KY: Createspace
Printers.
Martin, William McKinley. 1951. Apparatus and method for preserving products
in sealed containers. U.S. Patent 2,549,216, issued April 17, 1951.
Sandeep, K.P., Simunovic, J., and Swartzel, K.R. 2004. Developments in aseptic
processing. In Improving the Thermal Processing of Foods, edited by Philip
Richardson. Boca Raton, FL: CRC Press.
chapter 2

United States history

and evolution
Ralph H. Graves

2.1  Early pioneers

C. Olin Ball (Figure 2.1) is credited with being the earliest pioneer in the
development of aseptic processing and packaging in the United States.
His research in conjunction with the American Can Research Department
in 1927 led to the development of the Heat/hold–Fill/hold–Cool (HCF)
process. The processes received its name from the first letters of the words
heat, cool, and fill. Numerous pilot tests were run on many different prod-
ucts. In 1938, two HCF units were installed for commercial production
of a chocolate milk beverage. The HCF process did not expand beyond
these two commercial lines, and these lines are no longer in operation.
Although the HCF process was not a commercial success, it was a great
success in that it was the initiator of all the work that followed.
In 1942, at the Avoset plant in Gustine, California, George Grindrod
developed the Avoset process. Whipping cream was sterilized by steam
injection and packaged in cans, and later in glass bottles. Containers were
sterilized in retorts using saturated steam. The retort method of steril-
ization was eventually abandoned and replaced by a continuous hot-air
system and utilized ultraviolet lamps to protect the filling and closing
area. Like the HCF process, the Avoset process is no longer in operation,
but it served as a stepping stone in the evolution of aseptic processing and
packaging technology.
In 1948, William McKinley Martin (Figure 2.2) entered the arena with
the Dole aseptic process. The Dole aseptic process involved four separate
operations: (1) sterilization of the product in a tubular heat exchanger sys-
tem; (2) sterilization of the containers and covers with superheated steam;
(3) aseptic filling of the cooled sterile product into the sterile containers;
and (4) sealing the lids in an atmosphere of superheated steam. Martin’s
aseptic canner overcame many of the obstacles that prevented wider
application of the HCF unit. The use of superheated steam at atmospheric

9
10 Handbook of aseptic processing and packaging

Figure 2.1  C. Olin Ball.

pressure eliminated the need for rotary valves for passing empty cans
into the system and finished cans out of the system. Also, the use of
atmospheric pressure negated the need for construction of high-pressure
equipment. This early unit was the forerunner of the Dole aseptic canner.
Dole aseptic canners are still in use today. The first commercial units
were installed in 1951 for Andersen Pea Soup and sterilized milk at the
Med-O-Milk plant in East Stanwood, Washington.

Figure 2.2  William McKinley Martin.

Chapter 2:  United States history and evolution 11

2.2  The Graves era

Roy Graves (Figure  2.3) had a restless mind. He was a creative genius
that could have used a full-time staff to follow him around and pick up
on his pearls of wisdom. A brief look at his accomplishments over a span
of 70 years in the dairy industry is impressive. After completing gradu-
ate work at the University of Missouri in 1912, he became the head of the
fledgling Dairy Department at Oregon State College at Corvalis, Oregon.
After World War II, he became part of the U.S. Department of Agriculture’s
(USDA) Food for Peace Program, which encouraged new food sources.
Graves joined the Bureau of Dairy Services, USDA, rising to become chief
of the Division of Cattle Breeding, Feeding, and Management. His duties
included overseeing the extensive research programs at its Beltsville,
Maryland, facility. He was the author of over 100 scientific papers and
bulletins, and acted in an advisory capacity to several university and

Figure 2.3  “Pea Soup” Andersen in front of a Martin aseptic filler, which made
perfect soup possible.
12 Handbook of aseptic processing and packaging

college dairy departments. In 1931, he served as the U.S. delegate to the

World’s Dairy Congress in Copenhagen. From 1935 to 1939, he was secre-
tary-treasurer of the American Dairy Science Association and served as
its president in 1937.
He patented the combine-pipeline milking machine along with the
merry-go-round milking platform called the Rotolactor. The first unit was
installed at the Walker Gordon Dairy in New Jersey and later became a
live display at the 1939 World’s Fair in New York. Subsequently, these pat-
ents were acquired by De Laval Ltd., which continues to manufacture and
market adaptations of the original combine milking machine.
In the 1940s Graves began work with other scientists on sterilizing
milk. They reasoned that fresh milk could be drawn from the cow without
it being exposed to the air, sterilized and packaged aseptically, and retain
its natural quality and nutrition. His patent-owning company, Graves–
Stambaugh, Inc., obtained the patents that were put to commercial test by
Real Fresh, Inc., and several other licensees.
The original patents described a method whereby milk was trans-
ferred from the cow via a pipeline to a vacuum tank mounted on wheels.
The vacuum tank was then transported to the dairy plant; the milk was
removed by pump, heat treated to 285°F, cooled immediately to room tem-
perature, and packaged aseptically into metal cans. The product found
immediate acceptance by the U.S. military, diplomatic, and commercial
personnel living around the world with no access to fresh milk.
Graves actively continued improving his original ideas up to his
death in 1976 at the age of 90. The patents have expired, and the vacuum
tanks retired, but the understanding of the need for high-quality raw
milk remains a top priority for all ultra-high temperature (UHT) process-
ing and aseptic packaging plants.

2.3  Jack Stambaugh

Jack Stambaugh, Graves’ patent coholder, was the owner of Wood Jon
Farms and the dairy in Valparaiso, Indiana, where the original research
work was performed from 1946 to 1950. The friendship between Stambaugh
and Graves began in Washington, DC, during World War II. Stambaugh, an
army officer, was assigned to the USDA to oversee a program to increase
dairy foods production. Motivated by an interest in purebred Holstein dairy
cattle, he looked to Graves for advice. Graves in turn found a willing and
eager ear for his ideas on the genetics of dairy cattle, methods for preserving
green roughage, loose housing, milking parlors, and on to UHT processing.
This dialogue included discussions on a new type of heat exchanger Graves
had designed for UHT processing and a method for aseptically packaging
milk so it did not need refrigeration to extend its shelf life.
Chapter 2:  United States history and evolution 13

When Graves retired from the USDA in 1945, he moved his own
herd of purebred Holsteins to Indiana and joined in a partnership with
Stambaugh. They enlisted help from the Continental Can Company, which
provided financial and technical expertise from its Chicago research cen-
ter. Together they shared a vision for the future of the dairy industry.

2.4  The first commercial aseptic plant

The first commercial plant to use the Graves–Stambaugh process was
built in 1951 at East Stanwood, Washington. Their brand name was Med-
O-Milk. One of the first Martin (later became Dole) aseptic canning
machines was purchased and installed there to carry out the aseptic pack-
aging part of the process. The initial market was Alaska, because most of
its milk supplies had to be imported from the lower 48 states.
Two other licensees quickly followed: one in Visalia, California,
using the brand name Real Fresh, and the other, the International Milk
Processors, Inc., plant in Ridgeland, Wisconsin.

2.5  The real fresh company

In 1952, utilizing the Graves–Stambaugh patents, Robert Graves, Roy
Graves’ son, opened the new Real Fresh Milk, Inc., in Visalia, California.
Though largely unnoticed by the rest of the dairy industry, it was a truly
unique facility as it was the second American dairy plant, in one year,
dedicated solely to sterilizing milk at ultra-high temperatures and pack-
aging aseptically.

2.6  The first aseptic form–fill–seal packages

In 1959, work was underway at Real Fresh to move beyond metal cans into
paper–foil–plastic laminated packages. It began with the conversion of the
Tetra Pak tetrahedron filler of pasteurized dairy products into an aseptic
unit. In 1962 Roy Graves’ patent-owning company received patent num-
bers 3,063,845 and 3,063,211 on this chemically sterilized aseptic packag-
ing system using chlorine as the web sterilant. The tetrahedron package,
however, was never widely accepted by the American consumer, but large
quantities were produced for the U.S. Navy during the Korean conflict. In
1981, Tetra Pak returned to the United States and introduced the Brik Pak
carton. The system used hydrogen peroxide as a sterilant on the form-fill
container and was approved by the U.S. Food and Drug Administration
(FDA) in January 1981. Real Fresh commissioned and operated the first
commercial Brik Pak filler in the United States, in partnership with the
National Food Processors Association (NFPA) and Tetra Pak Company.
14 Handbook of aseptic processing and packaging

The Graves–Stambaugh heat exchangers were used at Real Fresh for

over 20 years, when they were replaced by steam injection-direct heating
systems and a new state-of-the-art tubular/indirect heating processor.
Graves believed that enzyme reactivation and oxidative deterioration due
to exposure to air, along with the reaction from certain strains of bacteria,
were the prime culprits in preventing preservation of unrefrigerated milk
for extended periods of time. His patents and subsequent research were
devoted to correcting those problems and were instrumental in bringing
many new aseptically packaged products to market. To name a few: infant
formula, flavored milks, sour cream, cheese spreads and sauces, hollan-
daise sauce, a dairy spread (butter substitute), eggnog, ice cream and ice
milk mixes, meal replacement drinks, soups, and puddings.

2.7  Early aseptic packers

Although Graves is credited with being the pioneer in producing commer-
cially viable sterilized milk in the United States, concurrently Nestle with its
Bear Brand was an early aseptic canner of milk in Switzerland. Other early
entries in the United States were Tom Conley at Amboy Sterile Packaging
in Amboy, Illinois; Dr. Robert Stewart’s plant in Corning, Iowa; the Land
Ο’Lakes plant in Clear Lake, Wisconsin; Sol Zausner in New Holland,
Pennsylvania; the Maryland–Virginia Milk Producers Association’s man-
ufacturing plant in Laurel, Maryland; the Avoset Company in Gustine,
California; the Borden company at its Galloway West plant in Fond Du
Lac, Wisconsin; and Foremost Dairies in Newman, California.
Many of these companies produced a single product. A good exam-
ple is Andersen Pea Soup. Andersen’s Restaurant in Buelton, California,
was famous for its split pea soup. Tom Andersen wanted to expand his
sales and market his soup through grocery stores. He tried retort can-
ning and was disappointed with the results, so he turned to aseptic can-
ning in 1952 (Figure 2.4). This provided the flavor profile he wanted. After
a succession of copackers came and went, Real Fresh bought the name
and rights to can and market Andersen Soups, which now covers a span
of over 40  years. Others of note were Avoset with its aseptically canned
creams, and Foremost Dairies, which produced Fresh Tasting Evap, an
aseptically canned evaporated milk, in Newman, California. Foremost also
purchased and operated the original Med-O-Milk plant in East Stanwood,
Washington, and the Ridgeland, Wisconsin, plant originally owned and
operated by International Milk Processors in Chicago, Illinois. Real Fresh,
Foremost, General Mills, Hunt Wesson, and the Del Monte were pioneers
in aseptically packaged puddings. Borden was also an early entry with its
aseptically canned eggnog from its plant in Fond Du Lac, Wisconsin. In
1982, Dairymen, Inc., a Georgia-based cooperative, began the production
and marketing of sterilized milk in Tetra Brik containers. This continues to
Chapter 2:  United States history and evolution 15

Figure 2.4  Roy R. Graves.

the present under the Farm Fresh brand name. Early producers of cheese
sauce and puddings for the institutional market in #10 cans were the AMPI
plant in Dawson, Minnesota; Michigan Fruit in Benton Harbor, Michigan;
John Gehl in Germantown, Wisconsin; the Land O’Lakes plant in Clear
Lake, Wisconsin; Dean’s plant in Dixon, Illinois; Carnation with its Flash
18 process; and Real Fresh, Inc., in Visalia, California. Many of these plants
have shifted from cans to aseptically filled pouches and bags for economic
reasons.
Real Fresh, Inc., was the only firm completely committed to aseptic
food packaging. This required the flexibility of several different process-
ing and packaging lines to pack the diverse number of products it mar-
keted and contract packed for other store labels.
There are now over 30 plants in the United States producing one or
more low-acid, shelf-stable, aseptically packaged products. They range
from milks (including soymilk), flavored milks and drinks, to cheese
sauces and dips, puddings, soups, sauces (Aunt Penny’s Hollandaise Sauce,
Atwater Canning Company, Atwater, California), diet drinks, infant for-
mulas, creams, and milkshake mixes.

2.8  Restrictions for growth

There are many factors that have restricted growth of UHT processing
and aseptic packaging. The following list is not necessarily in order of
dominance. First, due to lack of controls and technical specifications,
16 Handbook of aseptic processing and packaging

much has been left up to the expertise and skill of the individual opera-
tors. Second, regulatory control of low-acid food products marketed unre-
frigerated in the United States is onerous. The major players are the Food
Safety Branch of the FDA and the Milk Safety Branch in the FDA, which
oversee states’ inspection of milk under the Pasteurized Milk Ordinance.
The USDA also plays two roles in that it is responsible for the inspection
of dairy products sold to the government and for the inspection of meat
products under the Meat Inspection Branch (FSIS) for all of the U.S. mar-
ket. So, we not only have federal and state involvement, but also county
and municipal health departments having to be dealt with and educated.
Third, the cost of aseptic packaging is generally higher. Milk, for example,
has a higher energy cost due to the higher processing temperatures, and
the packaging costs are more because of the more robust barrier proper-
ties needed to maintain asepsis and oxygen barrier. The speeds of aseptic
fillers are generally slower than pasteurized milk fillers, which also add
to higher costs. The offsetting costs will be unrefrigerated storage and
distribution along with reduced outdated returns, which plague pasteur-
ized and ultra-pasteurized milk distributors. Thus a product-by-product
evaluation must be carried out to determine if the advantages of superior
value outweigh the additional cost of production and packaging.

2.9  Trends for the future

The trends for the future continue to look bright. Improved processing
equipment and controls will upgrade flavor profiles, which will provide
greater consumer acceptance. These new methods will include the pro-
cessing of particulates, such as meat and rice, beans, and other vegetables.
Barrier properties of container materials will continue to improve, reduc-
ing cost and extending shelf life. Line speeds of processing and packaging,
along with more automated controls, will be another important factor in
cost reduction.
UHT processing is energy intensive and can impart objectionable
cooked flavors. The amount of cooked flavor is often dependent on the
type of process used and the product itself. Direct steam injection or infu-
sion is considered to give an improved flavor profile in some products,
such as milk. Indirect systems, however, have improved immeasurably
with the advent of hot water sets or the use of hot water under 33 psig in
lieu of steam to reduce heat shock to the product. The cooked flavor and
odor tends to dissipate with age.
Look for more emphasis in the future on “cold sterilization” methods.
Radiation, electron beams, pulsed light energy, and radio frequency (RF)
are some methods that will receive considerable attention, and, hopefully,
improved consumer acceptance. Other systems may include microfiltra-
tion and even a genetically modified bacteria that secretes a bacteriostatic
Chapter 2:  United States history and evolution 17

substance such as bacteriocins. This is already in use in cheese making

here and abroad.
In order to be competitive with high-speed retort canning speeds,
aseptic canners and form–fill–seal units must operate at higher speeds in
the future. To accomplish this, engineers need to come up with alterna-
tives to heat and hydrogen peroxide as the method of sterilizing contain-
ers prior to filling. The exposure time required for heat and chemicals to
achieve sterilization adds additional constraints, increasing line speeds.
The “Flash 18” process used by Carnation is a unique hybrid alterna-
tive in that the product is filled in the can at 255°F in a room less than
18  psi pressure. This prevents flashing, and the product and container
are sterilized simultaneously.
Cans as a preferred container will continue to get a boost because
of their strength and barrier properties. Lighter weight plate will reduce
cost, and strength can be retained by injecting nitrogen or carbon dioxide
in the headspace prior to sealing.
Fillers have been developed for pouches that can fill particulates up to
¾ inch, in pouch sizes ranging from 8 fluid ounces to 4 liters. This technol-
ogy will undoubtedly be made available to other types of fillers.

References
Ball, C.O., and Olson, F.C.W. 1957. Sterilization in Food Technology: Theory, Practice,
and Calculations, 2nd ed. New York: McGraw-Hill.
David, J.R.D., Graves, R.H., and Carlson, V.R. 1996. Aseptic Processing and Packaging
of Food: A Food Industry Perspective, Chapter 2. Boca Raton, FL: CRC Press.
Goldblith, S.A., Joslyn, M.A., and Nickerson, J.T.R. 1961. Introduction to Thermal
Processing of Foods, Volume 1. Westport, CT: AVI Publishing.
chapter 3

The U.S. markets for

aseptic packaging
Thomas Szemplenski

3.1  Development
Even though aseptic processing and packaging was invented decades
before, there was no significant activity in the commercialization of asep-
tic processing and packaging until the late 1960s and early 1970s when
the Dole Canning System was used by food processors with foresight.
These processors started to aseptically process and package shelf-stable
milk, puddings, and soup. At about the same time, Tetra Pak, a Swedish
company, introduced its laminated paper-aluminum foil-plastic container
to the United States. The system was, at that time, a continuous form–
fill–seal system for fluid pasteurized milk and beverages. The container
was a tetrahedron. This package was extremely efficient in material use
but complicated to pack or stack, and a real challenge to open. The U.S.
licensee of this system was the Milliken Company in South Carolina,
and in conjunction with Real Fresh of California, the Tetra system was
modified to include a chlorine sterilizing bath of the packaging web. This
allowed sterilized milk to be filled and sealed aseptically in a hermeti-
cally sealed container. These packages were followed by fruit products
being aseptically filled using the aseptic bag-in-box system developed by
William Scholle in the early 1970s.
In 1981, Tetra Pak returned to the United States with a new and
improved container. The basic system remained the same with a web
of laminated material being formed, filled, and sealed in a continuous
motion. What was different was that after the container was sealed and
cut from the web, it was formed and folded into a rectangle or brick. This
presented the consumer with a container that looked familiar and suit-
able, and could be displayed on store shelves.
The real growth in aseptic processing and packaging was experienced
starting in the early 1980s. Following Tetra Pak’s introduction of the Brik-
type package and the Scholle aseptic bag-in-box filler, other packaging

19
20 Handbook of aseptic processing and packaging

alternatives started to be introduced, as well as other manufacturers of

paperboard packaging and bag-in-box aseptic filling equipment. There
are now quite a number of aseptic containing alternatives, including
plastic cups, coffee creamers, steel drums, form–fill–seal pouches, plastic
bottles of various polymers, and even aseptic bulk storage tanks (some of
these tanks holding nearly 2 million gallons of aseptically processed acid
products). The market growth or driving force of each aseptic packaging
alternative is different and will be reviewed in this chapter.

3.2  Aseptic metal can market

The Dole canning system was very reliable. It was based on heat for pre-
sterilization and maintenance of sterilization of the filler and the metal
cans and lids. Filling speeds varied from 30 cans per minute for #10 cans
(see Figure 3.1) up to 450 cans per minute for 4-ounce cans.
There was considerable interest and acceptance of aseptic packag-
ing of food into metal cans as Dole eventually supplied more than 60
canning systems, many of which are still in operation. As the learning
curve for aseptic packaging using the Dole Canner increased, so did
the number of different products that were aseptically filled. Products
such as cheese sauces, ketchup, cream-style corn, baby food, eggnog, ice
cream mix, banana puree, tomato paste, dietetic drinks, and sandwich
spreads all were aseptically filled into metal cans using the Dole can-
ning system.
The driving force for interest and the growth factor in aseptically
packaging into metal cans was the improved organoleptic and nutritional

Figure 3.1  Asceptically canned pudding. (Photograph courtesy of Real Fresh.)

Chapter 3:  The U.S. markets for aseptic packaging 21

properties of the food being canned. The products no longer had to be

overcooked for long periods of time in retorts. Instead of the food prod-
ucts being subjected to a temperature of 250°F from 45 minutes to some-
times 2 hours resulting in overcooking, it now could be homogeneously
heated in a matter of seconds from an ambient temperature to around
275°F, held for a short period of time and then cooled very fast to a filling
temperature of between 70°F and 90°F. Aseptic processing and canning
resulted in dramatic quality and taste improvement in the food being pro-
cessed and food processors embraced the technology.
The Dole canning system was the only aseptic packaging system that
was ever developed for metal cans, other than the aseptic filling system
into 55-gallon metal drums invented in the 1970s by Fran Rica for tomato
products. Unfortunately for the Dole system, alternative, less expensive
aseptic packaging was developed that became the choice of food proces-
sors. Aseptic plastic cups, bag-in-box, and pouches are far less expensive
than the metal can, so very few other Dole canning systems have been
installed in the last 20 years.

3.3  Aseptic bag-in-box

In the early 1970s, William Scholle of the Scholle Corporation, a leading
manufacturer of flexible packaging of various polymers, visualized the
potential for flexible packaging to replace the expensive, rigid packag-
ing that was being used to transport food products such as tomatoes and
other fruit products. Instead of using existing retorting technologies to
commercially sterilize the product to be packaged in flexible packaging,
he leaned toward applying a relatively new technology that was rapidly
developing at the time, aseptic processing and packaging. Scholle engi-
neered and manufactured a prototype of an aseptic filler to fill preformed,
flexible bags. He tested and improved upon the initial design at Purdue
University’s food processing facility in West Lafayette, Indiana.
The first Scholle aseptic filler was developed to fill bags from 1 to
5 gallons. Improvements to the original Scholle were made to the point they
now can aseptically fill bags up to 330 gallons. Scholle’s prototype aseptic
filler was presterilized with steam, superheated water, and chlorine. The
flexible bags were and still are sealed and presterilized by gamma radia-
tion. Aseptic bag-in-box packaging was an immediate success (Figure 3.2).
Prior to the development of aseptic bag-in-box packaging, most acid food
products such as tomato paste and fruits for pies, yogurt, and so forth
were either hot filled into #10 cans, aseptically filled into metal drums,
or frozen in 30-pound plastic pails. Number 10 cans were and still are
quite expensive, troublesome to open and dispose of, and yielded loss of
product due to residuals, not to mention liabilities due to workers getting
cut handling these containers. Fifty-five-gallon metal drums were very
22 Handbook of aseptic processing and packaging

Figure 3.2  The Scholle aseptic bag-in-box filler.

expensive and additionally sacrificed yield at the use point. Thirty-pound

plastic pails were the most common way to transport fruit that was frozen
at the growing area and shipped all over the United States for remanu-
facturing into pies, fruit for yogurt, and so forth. Not only were the pails
expensive, but the cost of freezing was additionally pricey.
Economics is the main driving force for the aseptic bag-in-box market.
As an example, a brief comparative analysis of aseptic bag-in-box compared
to product packaged into number #10 cans will be presented. Many food
products destined for food service are packaged into #10 cans and delivered
6 cans per case. Food service is one of the largest markets for bag-in-box.

Case of #10 cans

• A #10 size can will normally contain approximately 96 ounces,
therefore a case of #10 cans will usually be about 4.5 gallons.
• Although the price of a #10 can will vary depending upon the
cost of the raw material at the time and the size of the customer
based on the number of cans purchased, the average price for a
#10 can at the time of this writing is $0.75 each.
• 6 × $0.75 = $4.50 per case (usually about 4.5 gallons)
5-gallon aseptic bag-in-box
• A 5-gallon, presterilized bag will vary in price depending upon
packaging materials, barriers, metallization, and so forth, but
usually will cost between $0.80 and $1.20. If an average price of
Chapter 3:  The U.S. markets for aseptic packaging 23

$1.00 is used in the calculation, the savings would be $4.50 – $1.00

= $3.50 per case savings.
• Adding the price for the corrugated container would increase the
price of the flexible bag packaging by as much as $0.20 more. If this
is entered into the comparison the savings would be $3.20 for the
aseptic bag-in-box compared to a case of #10 cans, but it should be
noted that the bag holds approximately a half a gallon more product.
An extended economic comparison was generated for an actual
food processor. This food processing facility utilizes 9 million #10 cans
per year. During the fresh-fruit season it packages all the product into
#10 cans. During the off-season it opens the #10 cans and reprocesses the
product into alternative packaging. To elaborate on the initial comparison:

• 9,000,000 #10 cans divided by 6 cans per case = 1,500,000 cases × 4.5
gallons per case = 6,750,000 gallons of product being processed
• Cost of cans: 9,000,000 × $0.75 = $6,750,000; yearly cost of #10 cans
• Cost of bag-in-box: 6,750,000 gallons divided by 5-gallon bags =
1,350,000 bags @ $1.00 per bag = $1,350,000 yearly cost of bags
• Yearly savings to package product into bag-in-box: $6,750.000 –
$1,350,000 = $5,400,000

Additionally, the processor advised the cost of reopening and disposing

of the #10 cans was approximately $1,500,000 annually.
Further economic savings to be realized by aseptic bag-in-box com-
pared to rigid metal cans are:

• Reduced space required for bags compared to empty and full

metal cans
• Reduced shipping cost
• Reduced liability
• Reduced disposal cost

Based on advantages similar to those described in our comparison,

economics is the main driving force for the aseptic bag-in-box market.
Other manufacturers of food packaging equipment realized this and
quite a few competitors to Scholle have introduced their versions of asep-
tic fillers for bag-in-box. There are now at least 10 different aseptic bag-in-
box fillers installed in the United States alone with more than 200 aseptic
bag-in-box fillers operating. There are also approximately six major sup-
pliers of presterilized aseptic bags of various polymers and oxygen barrier
materials. Improvements have been made in aseptic bag-in-box fillers to
the extent that several have received U.S. Food and Drug Administration
(FDA) validation for aseptically filling low-acid foods, and bag sizes have
increased to the point some of the fillers can fill bags up to 300 gallons.
24 Handbook of aseptic processing and packaging

The market for aseptic bag-in-box is actually two distinct markets: the
market for product packaged in smaller bags from 1 to 5 gallons and the
market for larger bags packaged in bags from 55 to 300 gallons. The mar-
ket for smaller bags is generally for product destined for the food service
industry. Initially the market for the smaller bags was for acidified products,
such as stabilized fruit for pies and yogurt, but this market has given way
to saturation and the larger bags. The market segment for smaller bags that
is experiencing growth now is for low-acid food products such as prepared
sauces for restaurants, soups, chili, milk, and condiments, like ketchup,
salsa, mustard, and single-strength juices. There is hardly a convenience
in the United States that does not have a dispenser from Gehl’s installed
to dispense warm cheddar cheese sauce and chili over nacho chips. These
products are aseptically processed and packaged. It is estimated that there
are more than 100 aseptic bag-in-box fillers installed filling smaller bags in
the United States. This market is not mature. Most assuredly more prod-
ucts will be aseptically packaged into flexible bag-in-box packaging.
There are approximately 140 aseptic fillers installed to fill larger (55 to
300 gallons) bags. This market is additionally divided into two predomi-
nate markets: one for tomato paste and the other for citrus products. The
total market for bulk bags in the United States is estimated at 4,500,000
units in 2008. Based on the average price for a bulk bag in 2008, this would
amount to an approximate $50 million market for bags.
With approximately 90 aseptic bag-in-box fillers for bulk packaging
operating, the larger of the two markets for bulk bags is for tomato prod-
ucts. California grows and supplies most of the tomatoes in the United
States and aseptically packages paste and diced tomatoes for shipment to
other parts of the country. The product is harvested, condensed, and asep-
tically processed and packaged in California. It is then shipped to various
points around the United States to be reprocessed into ketchup, sauces,
soups, and so on. JBT FoodTech is the leading manufacturer of aseptic fill-
ers for bulk bags, although JBT FoodTech does not manufacture the pack-
aging. The demand for aseptic bag-in-box packaging for tomato product
continues to grow but at a slower pace than when the aseptic bag-in-box
fillers were rapidly replacing nearly all the aseptic drum fillers. Nearly all
tomatoes in California that are harvested and packaged to be reprocessed
are aseptically filled into the bag-in-box.
The other major market for bulk aseptic bags is in the citrus
industry. The citrus industry does not have as many aseptic bag fill-
ers installed as the tomato industry, however, the citrus industry is
afforded two crops creating an approximate season of 250 days com-
pared to the 100-day tomato season. In the 1990s, the citrus industry
embraced aseptic filling of juice into bulk bags. Almost all the oper-
ating aseptic fillers are for the larger 300 gallon bags, and although
Scholle and JBT FoodTech have a few aseptic fillers installed for citrus
Chapter 3:  The U.S. markets for aseptic packaging 25

products, the DuPont/Liqui-Box StarAsept filler is the predominate

filler being used in the citrus industry.
The market for citrus products beings aseptically stored in the bag-in-
box has been in steady decline for the past decade. Aseptic bags are rapidly
being replaced with aseptic bulk storage tanks capable of aseptically con-
taining millions of gallons of citrus juices. Even at that, industry sources
have reported that in 2008, approximately 1.5-million bulk aseptic bags were
utilized in the citrus industry (P. Brocher, personal communication, 2008).

3.4  Aseptic paperboard market

In the early 1980s, Tetra Pak returned to the United States with a new and
improved package. The basic system remained the same with a web of
laminated material being form, filled, and sealed in a continuous motion.
What was different was that after the package was sealed and cut from
the web, it was formed and folded into a rectangle or brick. This presented
the consumer with a container that looked familiar and suitable to be
displayed on the store shelves. The real functional feature was the straw
for the smaller containers that was designed to puncture an opening at
the specially scored spot. This made the container popular with many
consumers who like the portability and ease of consuming whatever the
package contained.
Aseptic milk and flavored milks experienced their first real introduc-
tion to the mass market in Tetra Pak’s Brik-Pak packaging. At that time
the demand for Tetra Pak aseptic filling equipment for acid products such
as fruit juices and flavored liquid beverages far exceeded the demand for
fillers for milk. It was not until the processing of milk was significantly
improved upon with the introduction of steam injection when the real
growth occurred in the dairy segment.
The acceptance of juices in Tetra Pak Brik packaging was phenome-
nal. The consuming public embraced the new package and products with
a passion as evidenced by the grocery store shelves that were lined with
the many different products packaged and offered by the many beverage
processors who installed Tetra Pak fillers or had the product copacked at
various locations (Figure 3.3).
The market for new Tetra Pak fillers for acid products is somewhat
static at the time of this writing due to the many fillers that are already
installed and operating. However, as the learning curve in aseptic pro-
cessing and packaging improved, so has the scope of new products that
are being aseptically packaged into paperboard-laminated containers.
It appears that new products are being aseptically packaged every day.
Products such as soups, broths, nutritional drinks, and many sauces like
the ones pictured in Figure  3.4 are all being aseptically packaged into
paperboard-type containers.
26 Handbook of aseptic processing and packaging

Figure 3.3  Aseptic product in Tetra packaging. (Photograph courtesy of Tetra Pak.)

Figure 3.4  Low-acid aseptic product in Tetra packaging. (Photographs from sales
literature.)
Chapter 3:  The U.S. markets for aseptic packaging 27

It appears that the real growth in the paperboard laminate packages

is in specialty food and beverages other than juices and fruit flavored bev-
erages. Tetra Pak now has approximately 200 aseptic fillers installed and
operating in the United States. Almost half of these fillers are now for low-
acid beverages and other foods. This trend will continue.
The other supplier of aseptic filling equipment for products into
paperboard-laminated packages is SIG Combibloc. Unlike the Tetra Pak
form–fill–seal principle of producing sterile packages, the Combibloc
filler uses preformed packages that are supplied to the filler, folded flat.
The filler then automatically opens, forms, sterilizes, fills, and seals the
packages. The packages with the Combibloc filler are sterilized with
hydrogen peroxide and hot air. Both the Tetra Pak and Combibloc fillers
are FDA validated for aseptically filling low-acid foods, but the Combibloc
filler was the first filler used in a commercial aseptic processing system
containing a low-acid food with particulates. The installation is located at
a Campbell Soup facility in Canada aseptically filling soups with small
particulates like the one pictured in Figure 3.5.
Tetra Pak is by far the leading supplier in the world for the supply of
aseptic fillers and packaging material. Aseptic packaging at Tetra Pak is
dynamic. They now have many different types of fillers designed to asep-
tically fill into many different packaging configurations, the most recently
being a form–fill–seal gable top design. One thing can be counted on with
Tetra Pak and that is innovation.

Figure 3.5  Low-acid aseptic product containing particulates.

28 Handbook of aseptic processing and packaging

3.5  Aseptic plastic cup market

The market for food products aseptically filled into plastic cups enjoyed
tremendous growth starting in the early 1980s. Robert Bosch Company
installed the first aseptic filler in the United States for filling food prod-
ucts into plastic cups. This installation was followed by a number of
other manufacturers such as Hassia, Metal Box, ERCA, Benco, Gasti, and
Hamba. The Gasti and Hamba fillers never received FDA validation for
aseptically filling low-acid foods but were used as extended shelf-life
(ESL) fillers for refrigerated products.
The introduction of these aseptic fillers for filling into plastic cups
all but took away the market for the Dole canning system due to high
speeds and economics of packaging materials. In all, 26 aseptic fillers
and 12 more extended shelf-life fillers were installed starting in the 1980s.
Due to excellent engineering, high production speeds, lack of chemical
sterilants, and aggressive marketing, Hassia, now OYSTAR Hassia, has
become the dominant supplier of aseptic cup fillers in the United States
(Figure 3.6). The latest OYSTAR Hassia aseptic cup filler can fill almost
1700 cups per minute (C. Ravalli, personal communication, 2010).

Figure 3.6  Some products aseptically filled using an OYSTAR Hassia filler.
Chapter 3:  The U.S. markets for aseptic packaging 29

The first products to be aseptically filled into plastic cups were pud-
dings. The interest in aseptic filling into plastic cups was driven not only
by the economics of higher production and less expensive packaging,
but also by the much improved organoleptic quality of the aseptically
processed pudding. Over the years the scope of products expanded to
include cheese and other sauces, condiments, soup, baby food, and fla-
vored gels. Of late, however, the market for aseptic fillers for cups has
softened considerably and not many new aseptic cup fillers have been
installed. Manufacturing sources have advised that this is most likely
due to the capital-intensive cost of aseptic processing and packaging
and saturation.

3.6  Aseptic pouch market

The aseptic pouch market is believed to be in its infancy. This is an under-
developed market that is expected to explode with activity mainly due to
the economic savings in packaging, but also due to
−− Improved nutritional and organoleptic quality of the food
product compared to retorting or hot filling
−− Convenience compared to #10 cans
−− Less disposal cost
−− Less space required
−− Less manpower requirement at the end use point
The economic savings are exceptional and are the main driving force.
The predominate market for product to be supplied in pouches is the insti-
tutional or food service market for replacing product in #10 cans. Cans are
not only costly but take up considerable space, can be difficult to open
and dispose of, and incur liability cases from users cutting themselves
handling them. Aseptic filling equipment and packaging material sup-
pliers in addition to food processors have advised that #10 cans generally
cost about $0.75 per can. They additionally have advised that a compara-
ble pouch costs approximately $0.27. That is an overwhelming difference
in cost. For each million cans a food processor uses it would save approxi-
mately $480,000 in packaging cost alone.
Another major savings is in floor space. The photograph in Figure 3.7
taken (with permission) at a trade show demonstrates the space required
for 832 #10 metal cans compared to the space requirement for 832 pouches
in the roll on the bottom left or in one corrugated box on the bottom right
of the photograph (B. Pritchard, personal communication, 2010).
Robert Bosch was the first company to develop an aseptic filler for
flexible pouches. Bosch supplied a number of aseptic pouch fillers to
replace fillers that were using the Dole canning system filling puddings
and cheese sauces in #10 cans. The market for cheese sauce exploded with
30 Handbook of aseptic processing and packaging

Figure 3.7  Space requirements for pouches compared to cans—each showing

832 packages.

activity, and today there is hardly a convenience store that does not have
a dispenser for aseptic cheese sauces for chips.
Inpaco, DuPont/Liqui-Box, Fres-co, OYSTAR Hassia, and Cryovac all
have developed aseptic fillers for pouches that operate at varying filling
capacities, size of pouches, handling of different particulate size and tech-
nology, such as fitment attachment offered by Fres-co.
As the technology to aseptically process and receive FDA valida-
tion for food products containing particulate matter develops, so will
the market for aseptic pouch fillers and packaging material. The food
service industry will embrace these food products as a wonderful alter-
native to not only metal cans but also consistent and organoleptically
more palatable foods compared to over- or undercooking foods due to
human judgment by restaurant cooking staffs.
Chapter 3:  The U.S. markets for aseptic packaging 31

3.7  Aseptic plastic bottle market

Besides Tetra Pak’s paperboard laminate fillers, the market with the
most activity in recent years has been the introduction and installation
of aseptic fillers for plastic bottles of polypropylene (PP), high-density
polyethylene (HDPE), and polyethylene terepthalate (PET). The beverage
industry has embraced the plastic bottle. The first aseptic plastic bottle
filler installed in the United States and validated for the filling of low-acid
foods was manufactured and installed by Bosch for nutritional beverages.
Since then many aseptic bottle fillers have been installed to fill high-acid
beverages, whereas others are using their aseptic fillers to fill extended
shelf-life, refrigerated dairy products. Many fillers being used in an ESL
mode are not FDA validated and therefore cannot be used to fill shelf-
stable low-acid beverages.
In all there are nine manufacturers of aseptic filling equipment with
installations in the United States; six manufacturers have received FDA
validation. In all, there are approximately 75 installations, aseptically fill-
ing high- and low-acid beverages including extended shelf-life products.
These suppliers include:

Bottle Filler Manufacturer FDA Validation

Robert Bosch Yes
OYSTAR Hamba No
KHS Yes
Krones No
Procomac Yes
Serac No
Shibuya Yes
Sidel–Rotary No
Sidel–Linear (Tetra Pak) Yes
Stork Yes

Consumer acceptance of the plastic bottle is outstanding and is chipping

away at the market for beverages that were previously supplied in paper-
board or Brik-type packages. The primary reasons for this acceptance are,
but not limited to:

• With plastic bottles, the consumer can see the product

• The bottles fit easier into the cup holders in automobiles
• Bottles are easier to open and easier to reclose
• Bottles can come in many sizes and shapes
• They are easier to recycle
32 Handbook of aseptic processing and packaging

The market for beverages is interesting and very dynamic. It is also

quite segmented between high- and low-acid beverages. Initially, beverage
processors could justify the capital-intensive aseptic processing and filling
system based on the reduced cost of resin compared to a heat-set bottle for
hot filling. Initially, this cost difference could be as much as 20% more than
a lighter weight bottle used on the aseptic fillers. Over the years the blow
molders have improved upon the technology and have reduced the cost of
the heat-set bottles to the point that it is now economically more attractive
to hot fill high-acid beverages. In a detailed economic comparative analy-
sis of hot fill versus aseptic including, but not limited to, capital cost for
processing and filling equipment, bottle cost, utility costs, and operating
costs it was calculated that the overall difference between the cost to hot
fill versus aseptically filling was less than 1 cent. It is no wonder beverage
processors are now returning to hot filling high-acid beverages.
The market for low-acid beverages is quite different. It is almost impos-
sible to hot fill low-acid beverages for shelf stability, therefore aseptic pro-
cessing of mostly dairy products and some other high-acid beverages is
divided between aseptic shelf-stable beverages and extended shelf-life
beverages. Although there are a number of aseptic fillers producing shelf-
stable dairy products, this is not a growing market. U.S. and Canadian
consumers are accustomed to drinking their dairy products refrigerated
and prefer them that way. The market growth for low-acid beverages
in plastic bottles is in extended shelf-life products. Extended shelf-life
products in most cases are processed the same way as aseptic products
with the general exception of two differences: first, with extended shelf-
life products, the end product must be distributed refrigerated, therefore
the filling temperature is approximately 40°F or less; second, the products
are normally not filled using an FDA-validated filler. This does not mean
the filler is not clean and sterile. It only means the filler more than likely
did not go through the validation process. In both cases, the processing
system and filler are both presterilized prior to production. With extended
shelf-life dairy products processors can generally expect a 90- to 110-day
refrigerated shelf life.
chapter 4

Aseptic processing
equipment and systems
Thomas Szemplenski

4.1  Introduction
Aseptic processing of food and beverages is a continuous commercial
sterilization of these products preceded by the sterilization of the pro-
cessing system. Many different types of equipment can be employed in
the development of an aseptic processing system, however, each must be
capable of being sterilized and maintained in a sterile state during pro-
cessing. Compared to all other methods of sterilizing food in pursuit of
a shelf-stable product, aseptic processing subjects the product to substan-
tially reduced heating and cooling time resulting in an end product that is
most often more nutritious and organoleptically more palatable.
Many people believe that aseptic processing and packaging was
invented in the early 1980s when Tetra Pak introduced the first brick-
type paperboard packaging into the United States. In reality, the first
patent (no. 2,029,303) for aseptic packaging was granted to C. Olin Ball
on February 4, 1936, for aseptic filling into metal cans. There was no
significant activity in the commercialization of aseptic processing and
packaging since the patent was issued until the late 1960s and early
1970s, when the Dole aseptic canner was invented and a number of pro-
cessors started aseptically packaging shelf-stable puddings. This was
followed by Tetra Pak form–fill–seal paperboard and aseptic bag-in-box
systems.
Even after all these years, aseptic processing and packaging remains a
dynamic means of preserving food and beverage products. Many changes
have been and continue to be made to aseptic processing and packaging
systems. The more paramount changes or improvements in processing
will be identified in this chapter.

33
34 Handbook of aseptic processing and packaging

All aseptic processing systems use continuous processing techniques.

In this regard, the primary components in aseptic processing systems will
be reviewed and include:

• Blending tank/formulation of product

• Metering pump for accurately controlling the flow of product
through the system
• Continuous heat exchangers for rapidly elevating the product to the
required sterilization temperature
• A continuous holding tube to hold the product at the sterilization
temperature long enough to effect commercial sterilization
• Continuous heat exchangers for rapidly cooling the product to the
filling temperature
• Steam-sealed, air-operated valves to direct the product to the
desired locations
• Accurate controls for the system to ensure presterilization of the sys-
tem and sterilization of the product
• Optional aseptic surge tank

The equipment used in any aseptic processing system must fulfill

the same sanitary and regulatory requirement as those used in con-
ventional food processing in addition to those necessary for steril-
ization and maintenance of a sterile state during processing. Formal
regulations for the design of aseptic processing equipment do not exist,
however, principles that must be followed in the design of aseptic pro-
cessing equipment have been determined over the course of the evo-
lution of aseptic technology. These principles have been developed
through experimental work in food and dairy processing operations
and testing laboratories.

4.2  Aseptic processing equipment

4.2.1  Basic requirements of aseptic processing equipment
1. Like all other food processing equipment, it must be of sanitary
design and capable of being thoroughly cleaned.
2. The equipment must be capable of being sterilized. The presteril-
ization is usually accomplished with steam, chemicals, or high-
temperature water at elevated pressures.
3. The equipment should be free of any cracks, crevices, or dead spots so
the sterilizing media can adequately contact all the equipment surfaces.
4. The equipment must be capable of being maintained in a sterile
state. This includes maintaining a closed system at greater pressure
than the surrounding area or heat-exchange media.
Chapter 4:  Aseptic processing equipment and systems 35

5. The equipment must be capable of being maintained in a constant

operating mode.
6. The equipment must conform to design, state, and federal regulatory
codes if they exist.

4.2.2  Blending vessel, balance surge, formulation of product

Delivering a uniform product to the timing pump is important. Any
inconsistency in the product could potentially affect the overall sterility of
the product. If one portion of the batch has a different consistency and per-
centage of ingredients than another, not only will the final product vary
but the different characteristics of the batch could jeopardize the sterility.
The blending vessel and the balance tank for the supply of product to
the aseptic processing system may or may not be the same, but should be
of sanitary design. This vessel does not need to conform to aseptic require-
ments, such as steam sealing the moving parts, as they are upstream of
the sterile part of the system.
Many liquid products, such as milk and juices, must be standardized
to the desired solids and viscosity. Usually, formulating or standardizing
of fluid products is done with vertical tanks that have vertical agitation.
Occasionally, if the product is easily kept at a constant concentration, the
agitation may be horizontal, such as milk storage tanks with horizontal
propeller-type agitators.
With citrus products, the final product to be delivered to the consumer
is a combination of juices produced at varying times of the year. This will
require a very good mixing system to ensure that the final composition
of the product contains the proper amounts of all components. Mixing
should be complete and thorough to ensure the product has equal compo-
sition throughout. If pulp is to be added, the pulp should be metered into
the process stream consistently, so the proper amount exists throughout.
The incorporation of pulp can be a very difficult task. Pulp that is dry will
tend to float and must be compensated for by agitation without adding a
significant amount of air.
Formulated products, such as fruit for yogurt that contain sweeteners
(dry, liquid sugar, or corn syrup), fruit or fruit pieces, thickeners (such as
starches, pectin, and gums), and other ingredients (such as flavors, colors,
and antioxidants) are usually blended in horizontal mixers. A good hori-
zontal blender will keep all materials in suspension so the final product
will be consistent. Difficult to incorporate ingredients such as pectins are
usually mixed with water in a high-shear mixer and then added to the
final formulation of the fruit-based product in the blender prior to enter-
ing the aseptic processing system.
In other cases, starch or viscosity enhancers are added to water. The
mixture is heated and then cooled resulting in a slurry with enhanced
36 Handbook of aseptic processing and packaging

viscosity. Fruit pieces, which can tend to float or settle, are then added
to this viscous mixture to effect an even composition of the fruits
throughout.

4.2.3  Timing pump

The timing or metering pump is one of the most critical areas of an aseptic
process system. Pumping of the product through the system is extremely
critical and must be done at a measurable, constant rate. Thermal destruc-
tion of pathogenic microorganisms is a time–temperature relationship.
In a continuous processing system, the food product must be held for a
specific amount of time at a designated temperature to ensure destruction
of unwanted bacteria. The time and temperature cannot deviate below
these set parameters otherwise complete destruction of the microorgan-
isms will not result and food spoilage will occur. To ensure an accurate
time at a set temperature, the flow through the aseptic system should be
as consistent as possible.
Many aseptic processing systems utilize rotary positive displacement
or progressive cavity pumps as the metering pump (Figure 4.1).
Some aseptic systems that are processing low-viscosity products
utilize centrifugal pumps as the metering pump and control flow by
means of a backpressure valve. All rotary positive displacement and
centrifugal pumps are designed to slip. The degree of slip is directly
related to:

• Clearances, age, and wear of the moving parts of the pump

• Viscosity of the product or water being pumped
• Processing pressure drop in the system
• Processing temperature of the product being pumped

Therefore, the use of rotary positive displacement or centrifugal

pumps as metering pumps in aseptic processing systems can introduce

Figure 4.1  Typical rotary positive displacement pump.

Chapter 4:  Aseptic processing equipment and systems 37

Figure 4.2  High-pressure pump.

some degree of variability to the very critical flow of the product through
the system, making temperature control of the product that much more
difficult. Additionally, quite often heat exchangers will tend to foul and
air-operated valves may be opening or closing causing a change in the
flow pattern and resultant pressure of the system. Rotary positive dis-
placement or progressive cavity pumps tend to vary output based upon
this inconsistent pressure.
Many times high-pressure piston or reciprocating piston pumps are
used as the metering pump (Figure 4.2). Slippage in a high-pressure pis-
ton pump is almost nonexistent, therefore, the rate at which the product is
being transferred through the system is constant. This assumes the piston
pump is fed adequately and has the net positive suction head required to
pump the full amount of which it is capable. If the total pressure against
which it is pumping is not excessive, piston pumps will produce a con-
stant flow.

4.2.3.1  Pumping of foods containing particulates

Due to the continued interest in aseptically processing food products con-
taining discrete particulates, many processors are utilizing a reciprocat-
ing piston pump as the metering pump in the system. A reciprocating
piston pump like that which Marlen International manufactures is ideally
suited for aseptically processing food products containing distinct food
pieces and has zero slip. The Marlen reciprocating piston pump is specifi-
cally designed to deliver a consistent and accurate flow, and not slip under
any variable conditions including temperature or viscosity changes in the
product or any pressure deviations (Figure 4.3).
The Marlen pump consists of two hydraulically driven reciprocating
pistons. The pistons are housed in two cylindrical sleeves within a pumping
38 Handbook of aseptic processing and packaging

Figure 4.3  Marlen reciprocating piston pump. (Photo courtesy of Marlen

International.)

chamber. The pumping of the product alternates from one piston to the
other with a constant flow rate. Depicted in Figure 4.4 (step 1) is the left pis-
ton and sleeve retract. This retracting action makes a void, creating a strong
suction that draws the product into the pumping chamber areas ahead
of the sleeve. The left sleeve then moves forward to trap the product and
seals against the outlet. The left piston then begins its forward movement

The Heart of the Marlen System

Right side Left side

Piston

Sleeve

Product
1. Valve 2. 3.

Figure 4.4  The operating principle of the Marlen pump. (Courtesy of Marlen
International.)
Chapter 4:  Aseptic processing equipment and systems 39

to compress the product to the same pressure that is in the right piston (step
2). As the right piston nears the end of its pumping stroke, the product valve
shifts to open flow from the left side and blocks the flow to the right side
(step 3). The right side can now retract and reload the same as the left side
did in step 1. During front-valve shifting there is no change in product flow
as the front valve opens on one side and simultaneously closes on the other.

4.2.4  Heat exchangers

In most cases, the primary reason for aseptic processing is to quickly
destroy the unwanted microorganisms without adversely affecting
product quality. Generally the product to be processed dictates the type
of heat exchangers that will be used to sterilize and aseptically cool the
product. Many times a combination of different types of heat exchangers
are used in the same aseptic processing system to optimize product qual-
ity and production efficiency. For each product, one system will be ideal.
Consideration should be given to the sterilization of the product that will
produce the highest quality finished product.

4.2.4.1  Heating: Sterilization of the products

There are multiple ways product can be continuously heated to effect ster-
ilization of the product. The more paramount methods include:

• Direct steam: steam injection or steam infusion

• Plate heat exchangers
• Tubular heat exchangers
• Scraped surface heat exchangers
• Ohmic heating
• Microwave heating

4.2.4.2  Steam injection or infusion heaters

Steam injection or infusion has been of interest since aseptic processing
was initially conceived. The theory was that if the product was heated very
quickly, adverse quality to the product (burnt flavors and odors, color, and
stability) would be minimal. With steam injection, steam is injected into a
continuous flow of product to heat it to the desired sterilization tempera-
ture. When steam infusion is used, the product flows through a chamber
filled with steam. In either case, the product is heated in the fastest pos-
sible way. With either steam injection or steam infusion, water is added to
the product and this water generally must be removed.
Steam injectors and infusers have a variety of ways of introducing
steam into the product. The objective of most of these is to provide a
design that will have the least number of mechanical problems, including
40 Handbook of aseptic processing and packaging

vibration and pounding, which is caused by the steam condensing in the

product. The steam that condenses into the product becomes part of the
product, therefore, the quality of the steam added is very important. In
the United States, culinary steam, per the definitions established by 3A
as minimum, should be used. Steam used in a steam injector or infuser
should be produced using distilled water with no added chemicals that
could react with components of the product.
A concept developed to produce a better quality product and reduce
the mechanical vibrations associated with conventional steam injection
systems was the steam infuser. In a steam infuser, the product is intro-
duced into a chamber that contains steam at the temperature needed
for sterilization. When the product enters the hot steam atmosphere, the
product is heated to the temperature of the steam. Some of the products
that utilize steam injection and infusion in aseptic processing systems
include dairy, juice-based drinks, soy products, creams, ice cream mix,
and tomato paste.
With steam injection or infusion devices, often a flash cooler is used.
The flash cooler has dual purposes. First, it reduces the sterilization tem-
perature in a very short time, and, second, it removes water from the prod-
uct. An added bonus is that undesirable volatile odors and flavors of the
product are removed.
Ideally, with milk or other dairy products, the temperature is accu-
rately controlled so that the amount of water flashed from the product
is the same as that added as steam, so there is no dilution or concentra-
tion. However, if the flash chamber is operated at pressures below atmo-
spheric (vacuum), contaminants will try to enter it. Because of this, all
potential areas of leakage, such as unions, connections for temperature/
pressure or vacuum probes, manholes, or covers must be flushed. Often
steam is used in the flush area and is maintained as a barrier so any
possible contaminants that may try to enter the sterile zone (because
of the reduced pressure) are first drawn through the sterilizing media.
With certain heat-sensitive products this can be a problem. Sometimes a
sterile chamber is used afterward that may be at reduced pressures but
still at pressures above atmospheric. In this manner, the pressure of the
product flowing through the flash chamber can be maintained above
atmospheric, so the product may be partially cooled safely. The use of
a sterile flash chamber at this point still may be required because the
temperature may not be high enough to sterilize contaminants should
they enter.
Another problem generally related to steam injection–flash cool-
ing systems is they are quite expensive. Whether the system operates at
5 gallons per minute or 100 gallons per minute, the controls, interlocks,
and other safety devices, for a practical commercial system, must be
incorporated.
Chapter 4:  Aseptic processing equipment and systems 41

Figure 4.5  A typical plate heat exchanger. (Courtesy of AGC.)

4.2.4.3  Plate heat exchangers

The first aseptic processing systems utilized plate heat exchangers for
either heating the products, cooling the products, or both (Figure 4.5).
Beverages and fairly low viscosity food products such as sauces, milk,
and juices still utilize plate heat exchangers in the aseptic processing
systems. In essence, the use of plates was an extension of commercial
pasteurizing operations accomplished at lower temperatures. Some of
the inherent problems with plate heat exchangers in aseptic process-
ing systems are their pressure limitation and their ability to be cleaned
in place (CIP). Plate heat exchangers were originally developed for
use in food applications where they could be disassembled, manually
cleaned, inspected, and reassembled into the plate pack. With higher
capacity systems, plates are now cleaned in place by washing with vari-
ous solutions.
One must use caution when utilizing plate heat exchangers at aseptic
processing temperatures because the product can tend to burn onto the
plates. CIP operations may not remove all of the burnt material adversely
affecting flow rate and temperature control. Another problem with clean-
ing of plates is with juices containing pulp. When juice-containing pulp is
processed, the pulp tends to gather in the low-velocity section of the plate
42 Handbook of aseptic processing and packaging

and removing it using CIP is difficult. In either of these two mentioned

instances, continuous fouling increased over a period of days, weeks, or
months, the initial sterilization cycle may not be adequate to sterilize the
plates. The plate heat exchangers can then contaminate the commercially
sterile cold product.
Differential pressure control with plate heat exchangers is essential.
On one side of the plate is a sterile cool product. On the other side of
the plate is potentially unsterile heat exchange media. If the plate heat
exchanger does not have greater pressure on the sterile side of the plate
heat exchanger than that on the unsterile side, then contaminants can lit-
erally be sucked into the already sterile product. Proper and precise con-
trol of differential pressure is required so that the pressure on the sterile
side of the plate heat exchanger is always greater than the product on the
unsterile side of the plates.
In addition to other potential problems with plate heat exchangers,
there can be mechanical problems. When plates are sterilized with heat
they expand. However, the frame and tie bolts that hold the sections of the
frame together (follower and fixed ends) do not expand. This puts enor-
mous stresses on the gaskets and failure on the relatively thin plates can
be at an accelerated rate. This is further accentuated due to the elastomers
used for gaskets. The gaskets generally soften and weaken at the elevated
sterilization temperatures and leakage can occur during sterilization.
When this happens efforts are usually made to put more pressure on the
gaskets by tightening the plate pack; however, this puts more stress on the
gaskets to the point they sometimes sheared and failed.
Since plates were initially used, other heat exchangers have been
designed and perfected such that plate heat exchangers are being replaced
by more reliable and efficient heat exchangers in aseptic processing systems.
Not only do the new heat exchanger designs withstand sterilization opera-
tions, but they also operate in a reliable manner so sterility is not in question.

4.2.4.4  Tubular heat exchangers

In pursuit of more efficient aseptic processing systems, equipment manu-
facturers and design engineers have continued to improve on the design
of tubular heat exchangers. Whereas in the past, most heat exchangers in
aseptic processing systems utilized either plate heat exchangers for very
low viscosity beverages and scraped surface heat exchangers for all other
products, most of the newer aseptic processing systems utilize tubular
heat exchangers or a combination of tubular heat exchangers with steam
injection or infusion.
In some of the early systems when aseptic technology was first being
developed and commercial lines were being installed, the processing flow
rates were quite low. Some simple tubular heat exchangers were used in
lieu of plate heat exchangers. A section of small-diameter tubing was
Chapter 4:  Aseptic processing equipment and systems 43

formed into a helical coil, which was then placed in a casing with flanges
on both ends.
The coil entered the casing through a packing gland and discharged
in the same manner. Inlets and outlets were provided for steam or water.
On heaters, steam was introduced and as the product was pumped
through the small-diameter coiled tubing it was heated indirectly by the
steam. Condensate was trapped off the bottom and this sufficed. The cool-
ers were made by introducing countercurrent cold water in the shell to
cool the product. For low-capacity systems (3 to 4 gpm) and on products
that were easy to heat and cool, such as milk and juices, this was perfectly
adequate. Some of these heat exchangers are still being used today, but
most of them are in research and development labs (Figure 4.6).
As filling equipment improved and container sizes increased, the
production rate of the systems increased, therefore this design was inad-
equate for the higher capacities. At the higher flow rates, the number of
tubes became excessive and mechanical problems such as vibration and
water hammer became a problem, therefore, design modifications had to
be made. One design that came from this basic idea was to place a core
inside the tube to displace volume.
The stainless steel tube was wrapped tightly around the core, and the
shell was then wrapped around the tube that would force the water or
steam to flow in a helical manner countercurrent (when a liquid coolant was
used) to the product in the tubes. This design was somewhat improved but
resulted in certain other problems, such as excessive vibration of the tube,
particularly with heaters using steam, which caused many tubes to fail.
Although effective in reduced maintenance and able to handle much
higher pressures compared to plate heat exchangers, the first tubular heat
exchangers were more expensive, tended to develop product building up
on the walls of the heat exchangers due to burn-on, and were still limited
to low-viscosity products.
Within the last 15 or 20 years, the design improvements to tubular
heat exchangers have been phenomenal. Various methods of tube config-
urations and twisted or corrugation have improved flow patterns through
tubular heat exchangers to the extent of substantially reduced fouling and
increased processing time between cleaning and resterilization. Several
designs of new tubular heat exchangers are depicted in Figures 4.7, 4.8,
and 4.9.
The new designs have also allowed the tubular heat exchangers to
process food products containing discrete particulate matter with mini-
mal or no damage to the particulates. Food products such as puddings,
cheese sauces, diced tomatoes, soups, and others that were previously
aseptically processed on very expensive and maintenance-demanding
scraped surface heat exchangers are now being replaced with new, less
expensive tubular-type heat exchangers. With no moving parts, tubular
44 Handbook of aseptic processing and packaging

Figure 4.6  A coiled heat exchanger. (Diagram courtesy of Advanced Process

Solutions.)

heat exchangers are also much less expensive to operate and maintain.
The new tubular heat exchangers use pressurized hot water for heating
and tower or refrigerated water for cooling and regeneration. The water
acts as a cushion and tube failure has all but been eliminated. In essence,
the liquid acts as an absorber of the energy.
Tubular heat exchange systems can be very compact and even
SKIDDED facilitating installation. A couple of tubular heat exchange sys-
tems are depicted in Figures 4.8 and 4.9.

4.2.4.5  Regeneration
Regeneration is generally used when plate or tubular heat exchangers are
used in the aseptic process. Regeneration normally consists of the cold
incoming product cooling the hot sterilized product, and in turn, the
hot sterilized product heating the cold incoming product. Other types
of regeneration include the use of heating or cooling media. The process
Chapter 4:  Aseptic processing equipment and systems 45

Figure 4.7  Various types of tubular exchangers. (Diagram courtesy of Advanced

Process Solutions.)

of regeneration basically results in free or reduced-cost heating and

cooling.
When product-to-product regeneration is used, extreme care must be
taken to keep the two continuous flows apart, because the raw incoming
products contain microorganisms that can contaminate the product that
has been sterilized. If direct regeneration is used where a hot product is
separated by a relatively thin piece of metal, as in plate heat exchangers or
gasket, from the cold product that contains large bacteria counts, even a
small leak can cause contamination.
46 Handbook of aseptic processing and packaging

Figure 4.8  Commercial aseptic processing systems using tubular heat exchangers.
(Courtesy of Advanced Process Solutions.)

Figure 4.9  Commercial aseptic processing systems using tubular heat exchangers.
(Courtesy of Advanced Process Solutions.)
Chapter 4:  Aseptic processing equipment and systems 47

When the heating or cooling media is used for regeneration, the

regeneration is usually indirectly accomplished. The hot sterilized prod-
uct is used to heat water, which in turn heats the raw incoming product,
and the water is cooled. Depending upon how the system is designed,
the hot water next to the cold raw product can be sterile if it is heated to a
high enough temperature. In some cases, sterile water can be generated by
filtration. Filters, if properly specified, and the system properly designed,
will remove all, or at least most, of the organisms so the cooling water will
contain no organisms.
Regeneration should be engineered so the pressure on the sterile side
of the heat exchanger is always higher than the product on the raw side. If
there is ever a leak in the heat exchanger, the leak would be from the ster-
ile product to the raw product or media. If per chance the flow is the other
way, the sterile product could get recontaminated. If the heat exchanger
has no gaskets and is made of heavy wall tubing, this should not be a
problem. Contamination can be a major problem in regenerative systems
and they should be arranged so this does not happen. Regeneration is
most logically used if only one product is being processed or many prod-
ucts that are very similar are being processed and all other conditions are
the same. If product characteristics vary, then the temperature profiles
will most probably vary.

4.2.4.6  Scraped surface heat exchangers

Most of the initial aseptic processing systems for the ever-popular shelf-
stable puddings and cheese sauces utilized scraped surface heat exchang-
ers (SSHE) for heating and cooling the food products. A photograph of
an aseptic processing system utilizing scraped surface heat exchangers
is depicted in Figure  4.10. This particular system utilizing ten scraped
surface heat exchangers is being used to aseptically process and package
cheese sauces and puddings into cans.
Today, many of these systems are replacing the scraped surface heat
exchangers with less expensive tubular heat exchangers. Over the years
improvement in the designs of tubular heat exchangers has resulted in
these heat exchangers having the ability to heat and cool the same prod-
ucts as the initial systems using scraped surface heat exchangers.
Not only are scraped surface heat exchangers more expensive to pur-
chase, but the maintenance cost due to moving parts are much higher than
alternative heat exchangers. There are certain problems that are inher-
ent with scraped surface heat exchangers; the most paramount includes
the excessive wear of plastic scraper blades and steam-flushed seals. The
heat exchange tubes are normally supplied with stainless steel or other
corrosion-resistant material, such as nickel, therefore a softer material
such as various types of plastics are used for the scraper blades. The plas-
tic blades, particularly at high temperatures, tend to deteriorate and can
48 Handbook of aseptic processing and packaging

Figure 4.10  Aseptic processing system utilizing scraped surface heat exchangers.
(Partial view of a Dole aseptic canner is in the foreground.) (Photo courtesy of
AMPI.)

break, resulting in plastic getting into the product. This also causes an
increase in overall production cost due to product loss and downtime to
resterilize the system.
In some cases, when aseptically processing low-acid food products, the
scraped surface heat exchange tubes can be chrome plated, allowing the
use of stainless steel scraper blades. Stainless steel scraper blades are more
effective than plastic scraper blades, but CIP solutions that are usually used
to clean the systems are corrosive and can attack the hard chrome plat-
ing on the tubes. When the chrome is adversely affected, the stainless steel
scraper blades then scrape against the stainless steel or nickel heat exchange
tubes allowing abnormal wear and metal getting into the product.
Another potential mechanical problem with scraped surface heat
exchangers that may lead to sterility problems is with the rotors or muta-
tors containing scraper blades. Some of these rotating shafts are made of
stainless steel tubing to which pins were welded and then the blades were
attached to the pins. When the welds fail they cause leakage. The shafts
then can fill with product that accumulates and cannot be cleaned or
sterilized. This bacteria buildup can then migrate into the product being
processed. The ability to presterilize this equipment is usually jeopar-
dized and repeated contamination of the product being processed results.

4.2.4.7  Ohmic heating

The ohmic heater was developed in the United Kingdom by C-Tech
Innovation. The ohmic is a direct electrical resistance heater for food
Chapter 4:  Aseptic processing equipment and systems 49

products by the passage of current through the product that is being con-
tinuously pumped through the heater. The ohmic heater uses electrical
current that passes directly through the food product being processed
to generate rapid, uniform heating. The liquid and food particulates are
both heated at nearly the same rate and unlike the use of conventional
heat exchangers, fouling or burn-on of the surfaces of the product piping
is eliminated.
The ohmic heater cannot be used for all food products. The use of an
ohmic heater depends on the electrical conductivity of the food product
being processed and on whether the food product is an insulator or a con-
ductor. Food products that are insulators, such as alcohols, fats, and oils,
cannot be heated with an ohmic heater. In addition, the ohmic cannot be
used to heat water unless some salts are added to the water to increase
conductivity.
The advantages of using an ohmic heater in an aseptic processing sys-
tem include:

• The liquid phase of the product and the particulate phase are simul-
taneously heated at the same rate.
• There is very rapid heating.
• There are no moving parts with the ohmic.
• There are no hot heat transfer walls of the heat exchanger.
• There are no obstructions in the ohmic, unlike in the use of scraped
surface heat exchangers.

It is unknown if there are any commercial installations utilizing

the ohmic heater in aseptic processing systems, however, consider-
able research work in ohmic heating is being generated at Ohio State
University in Columbus. Ohio State has an ohmic heater installed in
the food research facility and has demonstrated that the ohmic heater
is a viable alternative to other methods of commercially sterilizing
products.

4.2.4.8  Microwave heating

A new method of heating food products in aseptic processing systems has
recently been developed and commercially installed. The new equipment
and technology is using continuous microwave heating to sterilize the food
products prior to aseptic cooling and packaging. Industrial Microwave
Systems (IMS), based in Raleigh, North Carolina, has developed, tested,
and installed a microwave system for use in an aseptic processing sys-
tem for low-acid, sweet potato puree. The commercial processing facility,
located in North Carolina, received a letter of nonobjection from the U.S.
Food and Drug Administration (FDA) in February 2008 and began produc-
tion soon thereafter. The concept was originally proven at North Carolina
50 Handbook of aseptic processing and packaging

State University by researchers from the U.S. Department of Agriculture’s

(USDA) Agricultural Research Services Group, the Department of Food
Science, and IMS. The latest commercialized design was recently commis-
sioned at Purdue University where the equipment is installed in its food
processing laboratory for testing potential user’s products.
Unlike conventional heat exchangers that heat the food by conduction
and convection through a hot heating surface, the microwave processor
heats the food volumetrically throughout at the molecular level. The
microwave energy is provided by using 2450 and 915 MHz magnetrons.
As the product is being pumped through a noncorrosive, FDA-approved
tube material, microwaves are introduced into a chamber or applicator
that surrounds the product to accurately heat it to the desired tempera-
ture necessary to affect sterilization. The lack of a hot heating surface,
combined with fast and uniform heating of the food product, invariably
results in improved product quality with microwave heating compared to
conventional surface heat exchangers.
Microwave heating can then be combined with other technologies,
such as regeneration and tubular coolers, for improved product definition.
The use of microwave heating no doubt will facilitate the aseptic process-
ing of food product containing discrete particulate matter. Initial studies
indicate that these multiphase fluids heat the particulates at a rate similar
to their carrier fluid in a continuous microwave energy field. A diagram
showing the pilot plant size microwave heating system is depicted in
Figure 4.11.

60 KW Cylindrical Heating System

TEMP. 3 (Exit from 2nd Stage)

2nd Stage Heater

Hold
Tube
TEMP. 2 (Exit from 1st Stage)

1st Stage Heater

TEMP. 1 (Product Inlet into 1st Stage)

Figure 4.11  A pilot plant size microwave heating system.

Chapter 4:  Aseptic processing equipment and systems 51

4.2.5  Continuous holding tubes

Aseptic processing is based on sterilization of the food product in the
holding tube. The length of time the product is in the heat exchanger to
bring it up to the sterilization temperature and the time the product is
in any other piping must be ignored. It is the time the product is in the
holding tube and the temperature that it is at that time, which is used to
establish the safe aseptic process. The accuracy of this time–temperature
relationship determines the commercial sterility of the product being pro-
cessed. Therefore, the control of the product flow or pumping rate at a
known consistent rate is vitally important.
Once the food and beverages have been heated to the specified ster-
ilization temperature, generally a holding time at this temperature is
required to affect sterilization. Holding products at elevated temperature
is usually accomplished by having a series of straight, stainless steel, insu-
lated tubes and 180-degree return bends. This is an inexpensive method
and a long hold can be provided easily without consuming vast amounts
of floor space.
Besides inactivation of bacteria, many other events may take place in
the hold tube, such as inactivation of enzymes and thickeners hydrolyze
to increase viscosity. In addition, many adverse reactions can occur to
the product, such as caramelization of sugars, burned odors and flavors,
vitamin destruction, color development, and stability changes. Because
so many things are happening during holding, care should be taken to
accurately engineer and fabricate the holding tube correctly.

4.2.6  Deaerator
Deaeration is necessary for aseptically processing many products to
remove undesirable air before final sterilization and cooling operations. If
the product contains desirable volatiles, as those in orange juice, they may
be lost at elevated temperatures. The deaerator may be placed immedi-
ately after the supply vessel where the product is at a lower temperature.
In other instances, the deaerator is placed after preheating. Air expands
as it increases in temperature, and therefore, it is easier to remove the air
if the temperature of deaeration is elevated.
The removal of air is important for a variety of reasons. The first is
that adverse chemical reactions between various components of the prod-
uct and air can occur if the air is not removed or minimized. The rate of
reaction approximately increases as the temperature increases. Therefore,
removing air before high-temperature heating is usually desirable. A
compromise determines what deaeration temperature is used. The sec-
ond reason is to reduce fouling of heat exchangers. Air in the product will
cause heat exchangers to foul much more than if it is removed. The third
52 Handbook of aseptic processing and packaging

reason is to maintain constant filling conditions and prevent foaming

during filling. If air is present, fills will be erratic and overfilling may
be necessary to ensure a minimum amount of product in the container.
The fourth reason is to maintain the specific volume of the product. If
considerable amounts of air are present, the hold time will decrease. This
reduction in hold time may be enough to affect sterilization and result in
a spoiled product.
If a deaerator is used, it must be fed at a constant rate and the level in
the deaerator maintained sufficiently to provide enough head on the dis-
charge pump that will be feeding the timing pump of the system. Many
deaerators do not have an adequate length discharge and consequently
the net positive suction head (NPSH) on the discharge pump is inade-
quate and the pump tends to cavitate. This cavitation results in varying
feed pressure to the timing pump. Because of this the timing pump will
produce erratic flows and filling, sterilization, possibly aeration (as air
may be drawn in when the discharge pressure goes from high to low),
and fouling can be a problem.
With some products, the value of deaerators is questionable. Because
deaerators are another item in the processing system that needs to be bal-
anced as far as the flow into and out of it, they should be eliminated in
those situations in which their value is questionable. If the product has
considerable amounts of air before its introduction to the system, the air
should be removed through the application of heat, which will tend to
drive it off, or through a vacuum that will physically remove it, or both.

4.2.7  Controls
The basis for aseptic processing involves the continuous and rapid heat-
ing of a food product to a predetermined sterilization temperature, and
the holding of the product at this temperature for at least the minimum
period of time to destroy the unwanted microorganisms followed by the
rapid cooling of the product to the filling temperature under sterile condi-
tions. It is suffice to say that all areas of aseptic processing and packaging
are critical. There is no such thing as almost aseptic, therefore all areas of
aseptic processing must be accurately controlled. It is the control of the
aseptic processing system that guarantees a successful operation and a
commercially sterile product. Controls may be fairly basic and simple, or
sophisticated, with each operation being accomplished automatically.
As previously stated, “the basis for aseptic processing involves the
continuous and rapid heating of the product.” In order to be continuous,
the product must be pumped, therefore, pumping is one area within an
aseptic processing system that must be accurately controlled. The next
step in the definition of aseptic processing is the “rapid heating of the
food product to the predetermined sterilization temperature.” Temperature
Chapter 4:  Aseptic processing equipment and systems 53

is then another important part of an aseptic system that must be accu-

rately controlled. Most often when aseptically processing low-acid food
products, the temperature required for sterilization is considerably above
that of the atmospheric boiling point. To reach these temperatures, which
may be as high as 280°F (138°C), pressure must be induced to the asep-
tic processing system that will be above the atmospheric boiling point.
Therefore, pressure control within the aseptic processing system is vitally
important. The product to be processed will generally dictate how the
pressure is mechanically induced to the aseptic processing system.
Anything within the aseptic process that will jeopardize the com-
mercial sterility of the finished product is critical. From the aspect of
overall importance, however, pumping, temperature, and pressure are
the three most critical and potentially difficult areas of aseptic processing
to control.
It is vitally important that the final temperature at the end of the
holding tube to which the product is heated be set, indicated, and con-
tinuously recorded. The sterilization product temperature should be
sensed and validated with a high-quality sensor that is often calibrated.
The controlling instrument may be electronic; however, a transducer is
used to convert the electronic output of the instrument to the pneumatic
actuation of the valve. It is important that the sensors used with the indi-
cating and control instruments be connected to the instrument in the
proper manner. The electrical lead should be an extension wire of the
type that is compatible with the sensor and the controlling instrument.
The temperature at the end of the aseptic processing system should be
recorded, at least when the system is being initially presterilized. It is
important that this point be at the minimum temperature for a mini-
mum period of time to ensure the equipment, piping system, and valves
are sterilized.
Controlling preheat temperatures automatically is desirable so the
temperature of the product entering the final heater will be consistent.
The preheat temperature will affect the final product temperature and
govern the water or steam temperature used for final heating.
If the product is an acid product, and a system incorporates a provi-
sion for idling, the water used must be acidified to the pH of the product
or lower. If this water is not of the proper pH and the switch is made from
product to water, a chance for contamination exists. Therefore, the pH of
the water that will be used must be recorded and controlled at the proper
level. If it is not at the set pH, the system should divert sterilized product
from the filler and be interlocked so product cannot enter the system.
The production flow rate of the system must be set and locked such that
any unauthorized personnel may not alter the flow rate. Additionally, the
system should be interlocked so if the sterilization temperature and time
are not met, the system cannot go to the forward flow position and be filled.
54 Handbook of aseptic processing and packaging

4.2.8 Aseptic surge tanks, barrier seals, and

automatic air-operated valves
4.2.8.1  Aseptic surge tanks
Aseptic surge tanks are used to balance the flow from the processing
system to the demands of the packaging equipment. Most often aseptic
surge tanks are used to process products that will be adversely affected
by recirculating and reprocessing. Dairy products are a good example.
Reprocessing dairy product generally results in caramelizing of the milk
solids and development of off flavors.
Generally, aseptic surge tanks add no value to the product; they are an
additional means of potential contamination, and they are initially very
expensive to purchase and operate due to the sophisticated controls nec-
essary to sterilize and maintain sterility in these vessels. Aseptic surge
tanks should be avoided if possible.
Aseptic tanks are most generally used with low-acid products and are
therefore ASME vessels designed for higher pressures. Sometimes asep-
tic surge tanks are used with acid products and non-ASME coded tanks.
Regardless of the pressure rating, the tank must first be sterilized, which
is often done with steam. The steam pressure and temperature are held
for a minimal period of time. The steam backflows through filters, which
may be connected to an incinerating system to provide particle-free air.
After sterilization the tank is cooled. Cooling may be done with air (gas)
or water in the tank jackets. If air is used as the cooling medium it must
first be sterilized, usually by filtration. The cooling operation is critical
because steam that is in the tank condenses as the temperature is lowered
and the pressure is reduced. Positive pressure must be maintained during
cooling to prevent contaminating microorganisms being drawn into the
tank from the atmosphere. This pressure is maintained by air or gas that
has been sterilized either through a filter or filter–incinerator combina-
tion. The pressure is controlled so the maximum pressure desired in the
tank is not exceeded.
Potential points of leakage include flanges, connections, and agitator
shafts (if the tank is agitated), which are flushed with barrier seals. If the
product being held is not heat sensitive and will not burn, steam is used
as the barrier medium, and temperature and pressure can be measured.
If the product is heat sensitive, steam is usually used to initially steril-
ize potential points of leakage followed by a bactericidal solution such
as a peracetic acid, hydrogen peroxide, iodophor, or something similar.
Any contaminants that try to enter the tank must move across the barrier
unless the tank has a leak.
Usually, aseptic tanks are insulated because they can be quite large
and are excellent radiators. Insulation prevents the tank from heating
the area and requiring an extra large boiler to heat the tank to sterilizing
Chapter 4:  Aseptic processing equipment and systems 55

temperatures. If the product to be stored in the tank must be kept cold,

the tank will have a cold-wall surface for cooling with tower or refriger-
ated water.
Pressure in the tank is often used for discharging the product after the
tank is cooled. With some products, a pump may be used to unload the
tank. This generally is an added expense that is not normally required. If
the product in the tank is oxygen sensitive, nitrogen may be used in place
of air to push the product from the tank.
The tank should be sterilized with culinary steam that passes through
a separator and purifier per recommendations published by 3A. Residuals
of the steam that contact the product zones of the tank may stick to the
walls of the tank and later become part of the product.
A certain amount of air or gas used to maintain or build pressure in the
tank is absorbed at the interface of the product and the gas. Consequently,
lines feeding the air or gas, filter housings, and pressure control valves should
be stainless steel of sanitary design, and they should be regularly cleaned.

4.2.8.2  Barrier seals

Barrier seals are necessary to separate contamination from product that
has been commercially sterilized. They are necessary for any moving
parts in the sterile zone and to keep contaminating bacteria from a vac-
uum vessel or anywhere the sterilized product is at a lesser pressure than
the surrounding area.
Barrier seals should have a space sufficient to allow the flow of steril-
izing media. If the item to be sealed is the plunger of an aseptic homoge-
nizer or a valve stem of an air operated valve, the sealing distance (barrier)
should be greater than the stroke of the pump or of the valve. In this way
no portion of the plunger or valve stems that are in the sterile zone ever
move to the atmosphere and become contaminated. Pump plungers and
valve stems can move faster than contaminants can be sterilized, therefore,
the seal area needs to be of greater length than the stroke. Any portion of
the plunger or valve stem that moves must travel from the sterile product
zone into the seal area only. The plunger or valve seal cavity must initially
be sterilized with heat that can be conducted to all portions, including the
areas between gaskets and sealing flanges, and in cracks and crevices.
Heat can travel to these areas and sterilize them. After heat from steam or
water is used to sterilize the area, it can be maintained in a sterile condi-
tion by chemicals. This technique is used with heat-sensitive products, for
instance, liquid eggs and dairy products, which tend to burn or denature
when heat is applied.

4.2.8.3  Valves
Aseptic valves have been developed as aseptic processing and packag-
ing has evolved. Initially, aseptic processing systems were used with
56 Handbook of aseptic processing and packaging

Dole aseptic canning systems and the aseptic valves that were used were
furnished with the Dole aseptic canning system. These valves were a
combination, primarily, of hand-actuated piston-type valves that were
maintained sterile by enclosing them in the filling chamber, which was
maintained at 265°F with superheated steam. Hence, the main require-
ment of the valves at that point was to be able to take this temperature.
Because of this requirement, most of these valves had metal-to-metal seats
and the use of elastomers was limited.
The routing valves, which were initially used on the Dole canners in
either tee or tee-tee, were piston valves. These valves were used to direct
the product to a filler, aseptic tank, or the drain supply. The concept used
with these valves was having the piston in a barrier material, such as
steam, and the barrier was of greater length than the stroke of the valve.
Hence, no portion of the valve that was sterile ever moved to the con-
taminating atmosphere. These valves were available with barrier seals on
the connections so if the valve was applied where a vacuum existed, any
contaminant that was drawn into the sterile area would first have to move
through the barrier. The product was sealed from the barrier with a sani-
tary seal and the barrier was sealed from the atmosphere with an O-ring
seal. Hence, a double seal existed and leaks did not occur.
One of the disadvantages of using a barrier such as steam was if
the flow of the product was small, the steam would cause the product
to increase in temperature. This increase in temperature was several
degrees. In addition, because the flow was minimal, the product would
burn to the hot barrier surface; hence, with heat-sensitive products such as
liquid eggs or milk, the barrier was first sterilized with heat and then the
barrier material was changed to a cool liquid sterilant. This sterilant was
effective against any organism that entered the zone; however, it could
not sterilize between gaskets and the sealing surface or cracks and crev-
ices that may have existed. As systems became more complex and more
sterile valves were required, the number of barrier seals became exces-
sive. A system with a number of seals was complicated. Also, in order
for integrity to be guaranteed, the failure areas all had to be interlocked.
This further complicated the piping system and the control system that
was used.
Piston valves were equipped with diaphragms so as the piston moved
up or down, the diaphragm flexed when the stem moved, and no barrier
seal was required. This appeared to be satisfactory; however, the valve
would be actuated at high temperatures (up to 300°F) and low tempera-
tures (40°F), and materials that could withstand a number of cycles under
these conditions did not exist. Hence, the early design and materials were
not satisfactory. As time progressed and new materials were developed,
along with different designs, this situation improved. Today reliable
valves are available.
Chapter 4:  Aseptic processing equipment and systems 57

One of the most logical ways to provide a flexible diaphragm is to

use a diaphragm-type valve made of stainless steel to sanitary standards
where the diaphragm is made of high-grade materials. Initially, the major
manufacturers of diaphragm valves did not make stainless steel versions
with diaphragms approved for food handling as they do today. The dia-
phragms are quite reliable and will withstand a number of cycles and
varying temperatures; however, the diaphragms should be changed on a
regular basis. Certain users of these types of valves have gone to the point
of using sterilizing solutions on the top of the diaphragm to guard against
such failures such as pinholes or cracks. If a failure occurs, then leakage is
to the sterile material from the sterilizing liquid, such as Oxonia or iodine.
The use of aseptic processing techniques has escalated rapidly in the
pharmaceutical industry, and development efforts by valve manufactur-
ers have increased to satisfy this demand. In the future, improved materi-
als and designs are anticipated for larger sizes as needed by the food and
dairy industries. At the present, piston-type valves that are normally used
in the food industry are available in 1½- to 4-inch sizes. Diaphragm valves
are available in ½- to 3-inch sizes.

4.2.9  Homogenizers
Homogenization reduces particle size by subjecting the product to high
levels of shear. Shear is usually directly proportional to the pressure, or
energy, used to create it. Milk, ice cream mix, and certain other dairy prod-
ucts are homogenized to reduce the size of the fat globules, whether the
products are sterilized, then aseptically packaged, or pasteurized. If high
pressures are used, homogenizing the product in a pasteurization system
that is not part of the aseptic system is desirable. Aseptic homogenizers
are expensive to purchase and maintain, and are potentially contaminat-
ing devices (Figure 4.12).

Figure 4.12  A typical homogenizer.

58 Handbook of aseptic processing and packaging

The general design of aseptic homogenizers is to flush the pistons

with steam in a chamber that is of greater length than the stroke of the
piston. In this manner, no portion of the piston that is in the sterile zone
ever gets to the nonsterile atmosphere. Other portions of the homogenizer
that will be modified include the pressure-adjusting stems used with the
homogenizing valves. Again, the adjusting valve stem is in a chamber that
is of greater length than the stroke to ensure no portion of the valve stem
used for adjusting the pressure is exposed to the atmosphere.
With certain heat exchangers, such as HydroCoils, containing high
pressures in the several thousand-pound range is possible. Sometimes, if
the pressures to be transmitted are relatively low, a remote homogenizing
valve is used. By using a remote valve, the homogenizing operation can
be accomplished after the product is heated and cooled to a point at which
thermal development of viscosity will no longer take place. The viscosity
increase that has developed can be reduced by shearing the product at
fairly low pressures (500 to 1000 psig).
Some manufacturers make systems for sterilizing dairy or dairy-
based products that incorporate homogenization on the sterile side. This
is done to make total processing of the product the most economical
(equipment costs are minimized). In this manner, when the product is
being heated-held-cooled for sterilization, it is also homogenized, much
as it would be in a conventional pasteurizing system. As indicated, the
aseptic homogenizer is more expensive to purchase and maintain, and it
is a concern if there is ever a question regarding sterility.
If a remote homogenizing valve is used and the pressure exceeds 1000
psig (which is the published safe operating pressure for CIP clamp-type
fittings), then high-pressure hydraulic-type fittings must be used.

4.2.10  Ingredients
Usually, if a raw product is used, such as milk, juices, or creams, the qual-
ity of the final product will be no better than the raw product. In other
words, if the raw quality is good, the final product can be good. If the raw
product is poor, the final product will be poor. The raw product must be
received and stored properly before its use in the aseptic processing and
packaging system. If the product is of dairy origin, such as milk or cream,
the product may be raw or it may have received minimal heat treatment
before its receipt in the aseptic processing and packaging plant. With
dairy products the raw product should be examined for quality using
conventional tests identifying the number and types of bacteria present,
acidity, and pH, and physically examined for color, smell, and sedimenta-
tion. If the raw product is not of the desired quality, it should be rejected.
If the product quality is satisfactory, it should be stored in clean tanks,
Chapter 4:  Aseptic processing equipment and systems 59

which should be refrigerated. By doing so, microorganism growth and

enzymatic activity will be minimized.
Often, enzymatic changes cannot be detected using conventional
testing methods used in production plants. Further, microorganisms can
produce various enzymes that will increase in number as time of storage
increases. The result of a product that has excessive enzymatic develop-
ment will vary from fouling of the heat exchangers, meaning the aseptic
process may be shortened, to stability problems, when the product may
separate, coagulate, or become “sandy” during storage. In addition, the
finished product may prematurely develop off flavors or other undesir-
able characteristics.

4.2.11  Clean-in-place (CIP)

Proper cleaning of equipment in an aseptic processing system is vital.
Otherwise, there is a question whether it has been sterilized during the
initial sterilization procedure. Although the sterilizing temperature may
have been obtained, if the system is not properly cleaned, sterilizing it
may be impossible.
The CIP system does not have to be sophisticated and interlocked;
however, if cleaning efficiency is determined through manual inspec-
tion, or by observing charts, thermometers, and gauges, then an exact
procedure must be established followed with records being provided
on a daily basis to ensure cleaning is being accomplished. If cleaning
is being accomplished by a sophisticated system that delivers clean-
ing solutions at desired temperatures to the process system that is to
be cleaned, the system should be inspected regularly after CIP has
been completed. This inspection should be made of the most difficult-
to-clean components in the process system. During this inspection, the
equipment, pipelines, and valves can be examined to ensure they are
operating properly, and do not have any cracks or crevices, or gaskets
that should be replaced. Gaskets should be taken from joints regularly,
inspected, cleaned if necessary, and replaced if bad. It is important to
realize that automatic controls with sensors can indicate, control, and
record items such as pressure, temperature, and pH. However, they can-
not look at a gasket and determine whether it needs to be replaced or
cleaned, or whether it is hard and brittle. Therefore, it is important that
a program be established to inspect critical points at regular times to
verify that they are correct.

4.2.11.1  Clean-in-place solutions

CIP solutions are normally made by adding certain chemicals to well
or city water that may or may not be filtered or treated. If the water
60 Handbook of aseptic processing and packaging

used is very hard or contains numerous minerals, excessive cleaning

compounds must be used to adequately clean the equipment in the
system. If the strength of the chemicals is excessive, reaction between
these chemicals and the stainless steel of the equipment will proceed
at a much faster rate. The equipment will deteriorate and will need to
be replaced at more frequent intervals. Also, many cleaning chemical
companies use halogens, perhaps chlorine, to enhance the ability of the
chemicals to clean. A compound such as chlorine will react with soil
and do an excellent job of cleaning. Unfortunately, it also will cause
stainless steel to corrode and fail. This is accentuated at the elevated
temperatures that are often used in the CIP cycle. If difficult-to-clean
products are being processed, such as liquid eggs or dairy products,
the CIP cycle may be extended and may be at elevated temperatures.
This further suggests the need for stronger CIP solutions that attack
the stainless steel and cause it to fail that much faster. Probably the best
approach is to prepare CIP solutions from high-quality water that is low
in mineral content. This may mean using distilled or reverse osmosis
(RO) treated water. Often, the cost of supplying water of this type will
be returned many times over.
If the equipment is not properly cleaned, the questions of how dirty it
is and whether the initial sterilization cycle is adequate for sterilizing dirty
equipment must be addressed. Therefore, equipment should be examined
after cleaning to verify the CIP cycle has been adequate. The design of the
equipment should be assessed to verify it can be cleaned by CIP, and the
CIP cycle should be done at regular intervals, and the CIP solution should
be as weak as possible to do the job. Heating of the CIP solution should
be by the CIP system, not the heat exchangers in the aseptic process sys-
tem. Heating with the equipment in the aseptic processing system may
cause films or precipitated minerals to adhere more tenaciously to the heat
exchange surface and cause cleaning to be less effective. The results are
the CIP cycle must be longer, which will have a greater negative effect on
the equipment, or the CIP solution must be stronger or hotter, which can
also cause problems.
This whole subject of CIP solutions, the type of solution that should
be used, the duration it should be used for, and the temperatures that it
can be used for, is very involved. However, suffice to say this is a subject
in itself, and competent individuals should be involved in this portion of
the operation to make sure the CIP system is properly designed, proper
chemicals are used, proper cycles are established, and inspections are
done regularly to verify that the results that are being obtained are those
wanted. It cannot be emphasized enough that the quality of the water, and
steam if added directly to the CIP vats, has a significant effect on the CIP
solutions and cycles required.
Chapter 4:  Aseptic processing equipment and systems 61

4.3  Plant layout considerations

4.3.1  Preparation and processing equipment and systems
As with any food processing plant, the heart of the plant is the processing
and packaging equipment. The objective of the processing/packaging sys-
tem is to render the product to its final shelf-stable state. Processing is usu-
ally in a closed system so contaminants cannot enter after the product has
been sterilized. Possible contaminating devices, such as deaerators, timing
pumps, and preheaters, are often located away from the sterile segment of
the packaging system to help maintain desirable bacteriological conditions.
In most processing facilities, the preparation equipment, such as mix-
ing and blending equipment, raw supply tanks and CIP equipment are
in one room that is physically separated from the sterile processing area
by a wall or air curtain. The sterile processing equipment, including the
heaters, holding tubes, and coolers, are in another room where the desired
bacteriological quality is maintained. This is done through filtered air that
is at a positive pressure, and the air is changed often (at least 20 times per
hour) to ensure clean conditions exist.

4.3.2  Packaging system area (bacteriological conditions)

Certain aseptic packaging equipment is designed to withstand highly
contaminated areas where moisture, food products, contaminated air,
and filth may be present. An example is the Dole aseptic canning system
that uses superheated steam. The superheated steam is at such a tempera-
ture that contamination can be eliminated by killing the causative micro-
organisms. The Dole system assumes the metal cans (which are heated
with superheated steam) will be “clean and dry.” Usually, the cans are
inspected either visually or with an electronic device to verify their
sanitary condition. The cans must be dry and must not be transferred
through an area where moisture-laden air exists. If moisture is present,
the cans may not be sterilized. Superheated steam (which does not
contain much heat) will be used to convert the moisture to steam, and the
temperature of the can will not be as high as what has been assumed (it
is not measured) and is required for sterilization. If the condition exists
where moisture is present, the product packed may not be sterile. One
way of ensuring the containers do not have undesirable contaminants
is to have them travel through an area where the humidity is controlled.
Air systems that control the temperature, humidity, and bacterial loads
by filtering the air are available as commercial items from many compa-
nies and should be used.
The use of flexible aseptic packaging depends upon the packaging
material being in very good condition from a microbiological standpoint
62 Handbook of aseptic processing and packaging

before it is sterilized and filled, which may include forming if a form–

fill–seal system is used. Most systems use chemicals such as hydrogen
peroxide, peracetic acid, or chlorine spray alone or possibly with heat to
cause the chemical to change form and dry. Usually, the heat is not suf-
ficient to sterilize the packages or to flow into cracks or crevices that may
exist in the packaging machinery or the packages themselves. In the case
where hydrogen peroxide is used as the sterilizing chemical, most of the
sterilizing action occurs when the hot air causes the hydrogen peroxide to
change to water vapor and oxygen. Considering that most chemicals are
not strong sterilants, it is recommended that this type of aseptic packag-
ing equipment be installed in a very clean area, which could be classified
as a Class 1000 Clean Room or better. A clean area or clean room must be
maintained in a clean condition by designing the facility so it can be read-
ily cleaned and possibly treated with a bactericidal solution.
Utility pipes, such as those that may be required for tower or cold
water, should be insulated, otherwise, condensate may form on them,
which will tend to collect airborne microorganisms. If such condensate
should get in the packaging machinery or on the packaging material, the
sterilization process may not be adequate.
Traffic from personnel or lift trucks and conveyors should be mini-
mal, and ideally the facility should be designed so such traffic does not
exist. Maintenance should not be accomplished during aseptic packaging
operations to reduce the number of microbiological contaminants in the
area. The temperature, humidity, and microorganism level in the facility
should be checked regularly, and standards should be adopted that have
been proven satisfactory for a successful operation.
Raw materials for packaging should be brought into the room or facil-
ity through sealed conveyors and equipment should be arranged so that
packaged product is discharged or moved from the area without adding
excessive numbers to the microbiological load. After the product is pack-
aged, it should be warehoused and the production or packaging lot cleared
by quality control to verify it is satisfactory from a bacteriological stand-
point. This area should be maintained at room temperature or below. If
the product is a “long-life” product, the area should be refrigerated at 45°F
or below. The warehouse area should be as far from the packaging area as
possible and in the vicinity where the delivery trucks or vehicles can be
loaded and unloaded without increasing the microbiological numbers in
the packaging area.
Providing samples that can be evaluated by the end user before accept-
ing a container of commercially sterile product may be desirable, particu-
larly with large packages. Large packages, such as 200- to 300-gallon tote
bins or bags, may represent the product in the first, middle, and final por-
tion of the package. The warehouse used to store this product must be
Chapter 4:  Aseptic processing equipment and systems 63

arranged in such a manner that the product can be readily removed and
shipped to the consumer once the lot is accepted.
Particularly with large packages of several hundred gallons, the
stresses placed on seals, and valves that may be sealing the product, are
much greater than what would exist with an individual portion. Therefore,
the physical arrangement should be such that seals, packaging materials,
valves, and flanges are not disturbed when the product is being moved
from the warehouse to the vehicle transporting the product to the user.
For many products, such as liquid eggs, citrus products, and certain
dairy products, it is mandatory that the warehouse be refrigerated. This
is a precaution to maintain the maximum quality of the product from a
chemical standpoint so that undesirable flavors, odors, and colors do not
develop, and vitamin retention is at a maximum.
The viscosity of the materials is also critical and is affected by storage
at cooler or cold temperatures. Some products, such as flavors or fruits
added to ice cream or yogurt, should be at 45°F or below, so they will not
warm the product when added to it. However, viscosity at these tempera-
tures must be considered, and it must be determined whether the product
can be removed from the container.
If product is not cooled to the final room temperature, cooled “stack
burn” can result if the product is not placed in the warehouse so cold air
can circulate and cooling in the package can take place rapidly. Products
have been placed in warehouses that reach extremely high temperatures
and the product literally continues to cook. This is particularly true if the
product is stored at elevated points in the warehouse, and the warehouse
is not refrigerated.

4.4  Utilities
4.4.1  System sterilization water
Water used initially to sterilize the system must be of high quality from
microbiological and chemical standpoints. It should be low in microor-
ganisms and not contain spores that will be difficult or impossible to
sterilize. It must be considered that some of this water will stick to the
surfaces of the equipment used to sterilize the product. After the water
has been transferred through the heating units, it will move to the other
downstream equipment and be used to sterilize it. The process of initially
sterilizing the equipment consists of continually circulating the water and
increasing the temperature as it moves through the system. The equip-
ment at the end of the system will be lower in temperature than the water
discharging from the heater. If the water or equipment has numerous
microorganisms in it or if the microorganisms are very heat resistant, they
64 Handbook of aseptic processing and packaging

may not be sterilized. This is of particular concern when acid products

are sterilized. The temperatures used during initial sterilization are lower
and surviving organisms may grow if the pH is high enough so the condi-
tion is nonacid, or organisms in cracks or crevices may survive if they are
not contacted with the sterilizing water.
To improve the quality of the water from a microbiological standpoint,
it can be filtered before use. If the system has equipment downstream of the
final heater that have a large number of cracks or crevices in them, such as an
aseptic homogenizer, certain types of heat exchangers, or valves, heat-resis-
tant organisms may be trapped and lodge in difficult-to-reach areas. These
phenomena have happened on occasion when the heat present during the
sterilization cycle was not adequate to penetrate all the difficult-to-sterilize
areas. If the initial sterilization process is minimal, survivors may contami-
nate the product during processing. Another concern is that the water may
contain various minerals that adhere to the surfaces of equipment. After
sterilization these minerals can slough into the product and cause the prod-
uct to be of a different chemical makeup than that desired. Varying adverse
qualities can result, including flavors, viscosities, and color changes.
Also, if the water contains particular chemicals, it can form a film
on the heating surfaces that causes fouling prematurely and a shortened
operation result. Fouling can be caused by many factors, but it often starts
with buildup on the surface of the equipment. One technique used to
reduce fouling is to flush the surface after sterilization with water that
contains a food-grade acid. The acid tends to remove the precipitated min-
erals and make the heat exchange surface clean. By doing this it will allow
for a longer operation before fouling occurs.

4.4.2  Preparation water

Water used in the preparation of product is of concern because it may con-
tain undesirable minerals or have excessive bacteriological loads. These
factors can cause the product to be off quality and possibly have bacte-
riological numbers that are excessive and can survive the sterilization
process. Filtration can help by removing microorganisms to a tolerable
level—assuming proper filters are used. Reverse osmosis, or ultrafiltra-
tion, can remove certain chemicals that may make the water tolerable con-
sidering the chemical characteristics wanted. Other approaches are to use
pure distilled water that does not have chemicals.
Water from a municipal source is often treated with chemicals such
as chlorine or fluorine. These chemicals may or may not be tolerable
and allow production of the product with the characteristics wanted.
Sometimes, formulas are developed in the research lab using distilled
water, and yet they are produced in a plant using city water and a dif-
ferent product(s) result. Of particular concern is the use of municipal
Chapter 4:  Aseptic processing equipment and systems 65

waters if the chlorine or fluorine level varies. Although the target level of
certain compounds, for example, chlorine, may be 1 ppm, the level may
vary between 0.1 and 5 ppm. This can affect the chemical characteristics
and qualities of the product. It can also cause other undesirable results,
from fouling of heat exchangers to premature failures caused by chemical
attack of the stainless steel or other materials used in the manufacture of
the equipment. Therefore, the water used in the preparation of formulated
products should be analyzed to verify it is of the quality necessary to pro-
duce the product wanted.
Other problems can result if the water chemistry is not correct as the
heating process can cause a film to develop that is extremely difficult, if
not impossible, to remove using conventional CIP solutions. Special CIP
solutions may have to be used occasionally. For example, a CIP solution
may have to be used every week or two that will remove this film. Usually
such solutions contain acids and will dissolve salts that have precipitated
on the heat exchange surfaces. These salts may be the result of the water
used to prepare the formula.

4.4.3  Heating/cooling water

Water is used in certain types of heat exchangers for heating the prod-
uct for several reasons; the temperature can be more accurately controlled
than steam; and it does not vary in temperature because valves and traps
are opening and closing. It also contains more Btus in a sensible heat form
than steam, considering both sensible and latent heat if the pipe carry-
ing the water is a minimal size. This is true once the pipe is larger than
2 inches. If the water used is in a closed circuit, generally, undesirable
chemicals will be precipitated in the first few minutes and the water will
be fairly inactive chemically.
If the water is used for a single pass and then is used for another
function in the plant, such as CIP or rinsing and cleaning raw products,
minerals in the water can stick to heat exchanger surfaces and a film will
develop. After a period of time the film can become so great that cool-
ing is impaired. This often happens in high-temperature coolers if the
water is not maintained at the proper pressure. If the pressure is not regu-
lated above the flash point, then salts in the water precipitate on the heat
exchange surface and cooling is impaired. Additionally, the salts may
react with the metal of the heat exchanger and cause it to fail. This can be
a particular problem if well water is used as a single-pass coolant and the
pressure on the water is not adequate to prevent flashing.
If tower water is used as a coolant, two concerns exist. One is that
the chemicals used in the tower may be harmful to the equipment being
used, and, second, is the bacteriological loads that may exist. Some tower
water, particularly in high ambient temperature areas, have a very high
66 Handbook of aseptic processing and packaging

bacteriological content. If this water ever gets to the product it can cause
contamination. It could get to the product because of a pinhole or stress
crack in the heat exchanger or through a gasket.
Sometimes tower water is treated with a bactericidal agent to keep
microbiological growth within reasonable levels. However, the com-
pounds used to control the bacteriological level are often harmful to pro-
cessing equipment, in that they will cause chemical reactions between the
chemical bactericide and the stainless steel.
Tower water, if used with thin-wall heat exchangers or gasketed
joints, should be filtered before it is used to ensure the microbiological
levels are low. It should be determined that any chemicals used will not
cause the process equipment to corrode. The system used to circulate the
water should also be arranged in such a manner that adequate pressures
always exist and “flashing” does not occur. The use of tower water coolant
is perfectly logical; however, the system for using the tower water must be
designed and operated properly. Another consideration with the use of
tower water is that it should be removed from the heat exchangers when
they are initially sterilized by using an “air blow” or by pumping it back
to the tower. By using this process the chemicals added will not be lost.

4.4.4  Refrigerated water

Refrigerated water usually comes from one or two sources. It may be pro-
duced in an ice bank, which is a common technique if the process is only
operated for part of each day. The other method is to use a continuous
heat exchanger, such as a shell-and-tube, which uses a direct-expansion
refrigerant, such as ammonia, to cool the water. Often, the equipment
used to cool the water is not sanitary and cannot be adequately or prop-
erly cleaned. Bacterial buildup can be significant and contamination can
result if the aseptic processing coolers were to leak.
It must be considered that cooling water can leak into the prod-
uct although the pressure of the product may be higher than the cool-
ing water. Venturi effects can literally suck the water into the product
although the pressure (product) may be several pounds higher than the
water. This problem is increased if a pulsating pump is used to drive the
product through the heat exchanger. If the pressure varies, although it
may be higher, pulsation on the bacterial cells or spores causes them to
be drawn into the product leading to contamination. It must be remem-
bered that bacteria will move and grow against high pressures, and pres-
sures must be exceedingly high (100,000 psi or more) to inactivate them.
Even high pressures in the 100,000-psi range will not inactivate certain
types of bacteria, enzymes, or spores. To protect against bacterial con-
tamination, refrigerated water should be filtered before being used in the
cooling heat exchangers.
Chapter 4:  Aseptic processing equipment and systems 67

Aseptic processing heat exchangers should have thick walls and be

arranged so that stresses either during initial sterilization or processing can
be withstood and cracks do not develop. Thick walls of 316 or 316L stain-
less steel are probably the best impediment to the formation of pinholes.

4.4.5  Steam
Steam is used in many areas of aseptic processing and packaging plants. It
is used in the preparation of the product by heating it indirectly through
the wall of a preparation vessel or by direct addition to the product being
prepared. It is used for sterilizing equipment used in processing or pack-
aging operations, for sterilizing seals, and for maintaining a sterile atmo-
sphere in the seal area. It is also used for developing heat that causes ster-
ilants to vaporize or breakdown, such as with hydrogen peroxide.
The steam that is used indirectly to heat the product through a heat
exchanger wall that will heat water, which in turn is used to heat the prod-
uct, or used where it will not become a part of the product does not have
to be culinary or pure. If the steam is used to directly heat the product-
contacting surface, for instance, the wall of a tank, it should be culinary
per 3A definition. This definition requires that no boiler compounds can
be used that are not listed or will cause the product to deteriorate or react
negatively and generate off colors, have off flavors or odors, or be harmful
to the consumer.
If the steam becomes part of the product, such as in the preparation
or sterilization process, then it should be produced from a reboiler that is
sanitary and the steam should be made from distilled water. Not only are
there possible regulatory implications, but the product itself may develop
undesirable characteristics from the chemicals that may be in the steam.
These chemicals may not be harmful to humans, but they may cause
undesirable reactions to occur between the product and the steam.
Steam generally should be at least ideally 150 psi at the boiler. After the
steam travels through the various distribution lines and headers, it may be
at a reduced pressure at the use point. At the use point it should be regu-
lated at a constant stable pressure of 125 psig. From the constant 125 psig,
the steam can be controlled to the desired use pressure whether it is in a
preparation vat, heat exchanger, aseptic tank, or packaging machine. If the
pressure fluctuates, degrees of superheat can vary and cause the heat con-
tent of the steam to vary, and the final temperature of the product can vary.
Steam should be treated in such a manner that superheat is removed.
One condition that exists when steam is used to heat products is
that as the control valve opens and closes, the temperature of the steam
entering the heat exchanger varies. This will cause the temperature of the
heated product to vary. A better way of heating products is to use hot
water as the heating medium. This is particularly true with indirect heat
68 Handbook of aseptic processing and packaging

exchangers. Opening and closing the steam valve and trap tends to mini-
mize temperature fluctuations and hot water is more likely to maintain
a constant, or very close to constant, temperature. When hot water fills a
pipe, the number of Btus carried in the hot water in a sensible heat form
is greater than the number of Btus that can be carried in the same sized
pipe with pressurized steam, considering that pressurized steam contains
both latent and sensible heat. This is one reason that hot water is used to
initially sterilize large aseptic processing systems. Because more Btus can
be carried, the time that it takes to heat the equipment on the sterile side
of the system to the sterilizing temperature is less and the total cycle time
is reduced.
Regulations in certain areas now require that steam added to CIP
solutions be filtered. Actually, this steam should be culinary per regu-
latory requirements or 3A recommendations because there is a chance
the chemicals in the steam may be left on the heat exchanger or pipe-
line walls.

4.4.6  Air
Air is used in several applications in aseptic processing and packaging
facilities. For instance, it is used for instruments where the normal pres-
sure requirement is 20 psi. Most instruments today are electronic and
require a transducer to convert the electric signal to a pneumatic signal
to actuate steam valves, directional valves (sanitary), or solenoid valves.
Directional sanitary valves normally require between 60 and 80 psi air for
actuation. The air used with steam valves, routing valves, and solenoid
valves should be clean and dry and should be purified so particles are not
present that cause the valves to improperly operate. Air used with instru-
ments or valves should have the moisture removed and should be filtered
to remove particles. Moisture removal is normally done with a dryer or
it can be a filter that removes small amounts of moisture as air passes
through it. A coalescing filter is used for this purpose. To remove par-
ticles, various filters are used that are generally rated at some efficiency
level for a given size of a particle and the volume of gas they will pass at a
specified pressure. Because filters for air or other gases are different from
filters used with liquids, they should not be interchanged and used for
both purposes.
If the compressor is an oil type that produces significant quantities of
oil (which ends in the air), then this should be corrected or changed. The
oil used to lubricate compressors is not the same type that should be used
for lubricating instruments or directional valves. Usually, the oil from
the compressor is removed in a second type of filter, or an oil-removing
device, which usually uses carbon as the absorbing agent. If the compres-
sor is in a condition such that the amount of oil passed is significant, using
Chapter 4:  Aseptic processing equipment and systems 69

an absorber that can handle large quantities may be necessary. Air used in
direct contact with the product, such as air used to agitate tanks, should
be clean and sanitary. This means a filter that has smaller pores than fil-
ters normally considered satisfactory for filtering the air used with instru-
ments or valves should be used. The air should not contain any lubricant
(oil), water, or particles. The air should be transferred through lines, filter
housings, and control valves that are sanitary and can be cleaned. It must
be noted that the air is actually part of the product or will become part
of the product. The lines and equipment transferring and controlling the
flow of air to the product must be clean and treated just as if they were a
product line.
If a product contains sterile gases that are part of the product when
it is packed, such as a mousse or other aerated product, it must be sterile.
Sterilization of gases is done using filters, preferably in conjunction with
incineration. If only filters are used at least two sterilizing-grade filters
should be used. It is very difficult to tell whether a filter is operating cor-
rectly until after a lot is processed, which may be very expensive. The
use of filters must be incorporated in the design and particles, not only
those that carry bacteria, but other undesirable particles must be removed.
Incineration systems are used with filters to provide a record of the tem-
perature to which the gas has been heated for sterilization. This tempera-
ture must be chosen so it is adequate for sterilizing the gases, considering
the product into which it will be injected.
Sanitary air systems used for delivering air to products should not
only be made of stainless steel and sanitary, but should also be cleaned and
inspected regularly. Filter housings, pressure regulating valves, and on/
off and modulating valves are available today in stainless steel of sanitary
design. These components, along with the distribution system, should be
cleaned just as the product lines and control valves in the product distribu-
tion system. Usually, the air-handling system should be considered sanitary
from the discharge of the check valve of the air-producing system, which is
probably nonsanitary (compressor, receiver, dryers, etc.), through the sanitary
portion, which is the distribution system, pressure-regulating valves, on/off
valves, and lines. The air system from a sanitary point should be designed in
a similar manner to the product-handling system so it can be CIP.

4.5  Filters
4.5.1  Gases
Filters used in aseptic processing and packaging systems generally fall
into one of two classes: one class is filters applied to gases; and the second
class is those applied to liquids, such as vitamins, chemicals, flavors, col-
ors, and enzymes. Generally, filters used for gases are designed to remove
70 Handbook of aseptic processing and packaging

undesirable constituents from the gases. This could include oil, water,
undesirable odors and vapors, and particles. Filters that are meant to pass
gases are made of many different materials that may or may not with-
stand in-line sterilization. Those element constituents that do not neces-
sarily hold up well to in-line sterilization where steam pressure up to 100
psig or more may be experienced should not be designed into the system.
Coalescing filters, charcoal filters, and prefilters are usually made of heat-
sensitive materials, and they will not withstand steam or sterilizing tem-
peratures, and should not be in that portion of the system where steam
will be prevalent.
Sterilizing-grade gas filters normally use borosilicate-type elements
that can pass steam through the element without damage. Borosilicate is
a hygroscopic material, meaning it will not pass water; therefore, the filter
must be arranged in the system so that as steam contacts the element it is
on the outside of the cartridge rather than on the inside. If steam contacts
the inside of the element, condensate will be formed and it probably can-
not move through the element. Therefore, after a few cycles the cartridge
will fill with condensate, be exposed to sterilizing temperatures and pres-
sures, and fail prematurely. If the steam is on the outside of the filter, con-
densate will form, and can be trapped off without doing damage. The
temperature of the condensate must be adequate for sterilization. The gas
can be either on the outside or inside the cartridge as it will pass through
the element without damaging it.
The sterilizing-grade element can be formed in either a pleated or
round circular version. The pleated version has the advantage in that as
the temperature increases during sterilization, the pleats expand, much as
the pleats in an accordion. This results in minimal stress. However, if the
cartridge is not pleated, and only a round circular element is used, expan-
sion must be accommodated in the element and the metal band holding
the cartridge at the top and bottom. After a few cycles, stresses at these
points develop to such a point that the filter will fail and leakage will
occur. Filter elements can be tested with a smoke-type tester. In essence,
this unit produces black smoke that is directed to and contained in the fil-
ter element unless there is a leak. If there is a leak, the black smoke escapes
through the crack or hole.
Steam filters are normally in stainless steel housings and are made
of elements formed from sintered stainless steel or woven stainless steel
mesh. These elements usually have a size rating of 25 to 1 μm. When the
element becomes clogged, it can be removed, hosed off, or cleaned manu-
ally, and replaced in the housing. It can be reused often in this manner.
Sterile-grade elements, coalescing elements, and charcoal-impregnated
elements cannot be reused. Therefore, because elements of sintered stain-
less steel are available to 1 μm, they are often used as prefilters for sterile
gas systems as well as steam filters.
Chapter 4:  Aseptic processing equipment and systems 71

Prefilters are normally 25 μm or larger. They remove most of the large

particles from the gas, so the fine-grade filters do not have as large a job
to do. They not only remove particles, but they can also remove a cer-
tain amount of moisture, oil, and even odors. Therefore, systems may be
designed with a steam-grade filter as a prefilter followed by finer-grade
filters to remove smaller particles that exist in the gas system. If the gas is
air and the air is produced by an oil-type compressor, the air filtration sys-
tem should include a coalescing filter to remove moisture, a charcoal-type
filter or absorber to remove oil and oil odors, and two sterilizing-grade
filters capable of removing particles down to 0.015 μm (a standard size).
As indicated, all the filters except the sterilizing-grade filter that contains
a borosilicate-type element, should be in the low-pressure/temperature
side of the system.

4.5.2  Liquids
Liquids are filtered, primarily, with depth-type filters (although they
may be in a cartridge form) that retain the particles that are in the liquid.
Usually, they are rated to 0.2, 0.45, and 1.0 μm. This is the maximum size of
most organisms that will be in a liquid that must be kept out of the sterile
product. Liquid filters will not filter out flavors, colors, viruses, or similar
materials that are smaller than 0.2 μm.
Many liquid filters are made of fairly heat-sensitive materials, for
example, polypropylene or cellulose acetate and will not take above 250°F
or 15-psig steam. They are often sterilized in a laboratory autoclave where
they are not subjected on one side or the other to high pressures. They
are generally used for sterilizing using nonthermal means. They are used
extensively for purifying water, or other liquids, which may be used in the
preparation of a material. The use of liquid filters in an aseptic processing
plant is a judgment decision that is based upon the quality of the liquid to
be used. If the liquid is of questionable quality or is to be used in a critical
operation, then it should be filtered.

4.5.3  HEPA filters

High-efficiency purified air (HEPA) filters were developed for use with
gases where the gas was continually treated with the filter through recir-
culation. Filters of this classification are very high-volume filters and have
been developed to the point that they can be subjected to quite high tem-
peratures (300°F or more) to be initially sterilized. However, the theory
behind the use of a HEPA filter is to keep moving the same gas through the
filter several times, so after a period of time it is pure. If the gas contains
contaminants, they will be trapped by the filter. After a period of time, the
filter basically is producing sterile gas. Because the flow of gas is laminar
72 Handbook of aseptic processing and packaging

and at a greater pressure than the atmosphere (1 to 2 inches of water), con-

taminants are not drawn into the field, but rather are excluded because of
the pressure barrier. Air or gas that is not recalculated must be fairly pure.
Purifying air may be accomplished by prefilters or “roughing” filters.
HEPA filters are commonly used with aseptic packaging systems
where the area to be protected is quite large. Using a cartridge-type air
filter to protect a large area from contamination would be impractical.
HEPA filters are usually employed with air where the air will be trans-
ferred through the filters for a minimum period of time before the air
being emitted from the filters is considered sterile. The filter then is
continuously operated with air flowing through it until the operation is
stopped, the filter removed for cleaning or replacement, or for another
reason. After the filter has been replaced or cleaned, operating this system
for a period of time until it can be assured that sterile air is being emitted
from the filter will be necessary.

4.5.4  General information on filtration

Generally, with gas filtration, removal of particles is by initial impaction,
diffusion, and interception. In liquids, diffusion and initial impaction are
unimportant and only interception is involved. There are other factors
involved in gas filtration, including the filtered particles acting as filtering
media themselves.
Because the technology of filtration is not reviewed in detail, the reader
should understand that gas filtration and the filters used are considerably
different from liquid filtration that may employ depth filters and that state-
ments made concerning liquid filters are not necessarily applicable to gas
filters or vice versa. The statements made by certain manufacturers con-
cerning the ability of their filters to withstand various conditions may not
apply. The number of manufacturers having experience in large-volume
operations such as those existing in the food or related industries is mini-
mal. Most of the experience of filter manufacturers has been in areas other
than food or dairy and may not be applicable to needs in these areas.

4.6 Chemicals used as sterilizing

agents (equipment)
Chemicals are used in aseptic processing and packaging systems to con-
trol the numbers and types of bacteria that are present on equipment.
They may be used to kill bacterial forms (vegetative cells, spores, yeasts,
and molds) to render equipment commercially sterile or to maintain the
sterility desired for processing and packaging systems/machines, aseptic
tanks, or other critical components.
Chapter 4:  Aseptic processing equipment and systems 73

The review of chemicals that are added does not include those that are
part of the formula in prepared foods or the chemicals added to certain
products to guarantee they have a pH less than 4.6 and can be processed,
packaged, and sold to the consumer as an acidified product.

4.6.1  Chlorine and iodine

Chlorine is added to most municipal water supplies in the United States to
inactivate bacteria that are harmful to humans and to keep the numbers
that are present at a very low level. Chlorine added to water in municipal
systems is usually at a concentration where the maximum residual chlo-
rine content is 1 ppm. This presumes that the water that contains the chlo-
rine will travel throughout the distribution system of the municipality,
which may be many miles and include dead ends. Therefore, the starting
concentration may be twice, or more, than the use concentration, or in the
2- to 3-ppm range.
Chlorine is very effective and probably kills bacteria through oxida-
tion of critical elements. It is most effective against vegetative cells, which
are easily inactivated by this method. Resistant organisms (some vegeta-
tive cells and many spores), although the water is chlorinated, may sur-
vive and be present. Most yeasts and molds are more sensitive to chlorine
than vegetative cells or spores.
In aseptic processing systems, chlorinated water is often used after
cleaning as a sanitizing agent. It may be left in the equipment overnight
so organisms that are not contacted, such as those behind gaskets but later
move into the mainstream of the processing system, are inactivated.
If chlorine is used, even at low concentrations, and the equipment is
heated for sterilization, it can cause stainless steel to corrode. This is much
more prevalent if 304 stainless steel is used as opposed to 316 or 316L
stainless steel. Because the price differential between 304, 316, and 316L
stainless steel is quite small, 316 should be used for all aseptic processing
and packaging equipment.
The difference between chlorine and iodine, from a practical stand-
point, relates to the effectiveness and the strengths that must be used to
get equal kill levels. Usually, iodine is much more effective than chlorine
and when used as a sanitizer the concentration can be 10% to 25% as great.
The kill levels at somewhere between 12 and 25 ppm of iodine may be
equivalent to what is possible with chlorine at 100 to 200 ppm. The actual
difference will depend upon many factors, including pH and solids that
are present.
Iodine is not desirable because it leaves a color (yellow to orange,
depending upon concentration). However, it is desirable because it is less
corrosive than chlorine at concentrations that will yield equal kills. Part
of this is due to the fact that iodine may be used at roughly 10% to 25%
74 Handbook of aseptic processing and packaging

the strength of chlorine. Both chlorine and iodine are very dependent
upon pH. Because chlorine is more stable at high pH, it is often sold and
made available as sodium hypochlorite. This is a common form available
industrially and sold to the consumer primarily for bleaching purposes.
Conversely, iodine is much more stable than chlorine in the acidic form.
Therefore, it is often sold as a sanitizer in an acid base. Partly because of
its acidity, it is much more effective as a bactericide.

4.6.2  Oxonia
Oxonia is available from many chemical companies and is a combina-
tion of peroxyacetic acid and hydrogen peroxide. It is because it is not
corrosive to metal and does not discolor it. This is at the most effective
use pH, which is on the acidic side. Normal pH values will be some-
where between 3 and 4. As with chlorine, iodine, and other halogens, it
is very reactive with organic material and should be handled and used
accordingly. Oxonia is a very effective bactericidal agent and is used
primarily for sterilizing difficult-to-contact pieces of aseptic processing
or packaging equipment by fogging or spraying. Because of its noncor-
rosiveness to stainless steels and its excellent bactericidal action, it has
been used as a sterilant for food-containing packages and aseptic pack-
aging equipment. It is approved by the FDA for sanitizing equipment
and reasonable residuals are not harmful to humans when it comes in
contact with food products.

4.6.3  Food acids

Food acids have been used for several purposes in aseptic processing
and packaging systems. Packages have been sterilized and subsequently
filled with acid-type fruit juices or other similar products (acidic) where
hot citric acid has been used as the sterilizing agent. The hot food acid
inactivates vegetative cells, spores, yeasts, and molds that would grow in
the acid product at room temperatures. By using a hot food acid, a natural
food component is used during the package sterilization process so there
is no regulatory restriction. This concept was used by at least one aseptic
packaging system.
Another use of food acids has been to maintain the sterility of pro-
cessing systems used for commercially sterilizing acid products when the
system is idling. By maintaining sterility in this manner, the system will
not lose sterility if it is operated on idle while packaging operations are
delayed. Sterilization varies with time, temperature, and pH of an acidi-
fied product-processing system. Acids must be used if the temperatures of
sterilization are to be the same, otherwise loss of sterility of the processing
equipment or system may occur.
Chapter 4:  Aseptic processing equipment and systems 75

Usually, the pH of the water used during idling is the same as the
pH of the product that is being processed. For example, if a juice being
processed has a pH of 4.0, the pH of the water used during idling should
be no more than 4.0.

4.6.4  Ozone
Ozone is a strong oxidizing agent that is normally in a gas form and has
been used primarily in the past for preventing the increase of microbio-
logical deterioration of raw products. Ozone is a very effective sterilant
working in much the same manner as halogen compounds that inactivate
bacteria; however, it is very unstable in water or liquid solutions. Usually,
it must be prepared continuously and applied or put in the media regu-
larly. One way of producing ozone is to pass gaseous oxygen through a
high-voltage electrical field that converts the oxygen to ozone. Because
ozone cannot be purchased or supplied in liquid form, such as chlorine
or other halogens, it is not as convenient and consequently has not been
used to the same extent.

4.6.5  Hydrogen peroxide

Hydrogen peroxide is used for sterilizing packaging equipment and the
packaging material, usually at a 35% concentration. The efficiency of
hydrogen peroxide as a sterilizing agent increases with temperature and
concentration. It is much more effective if the hydrogen peroxide is con-
verted to oxygen and water vapor through the application of heat to drive
the reaction. Frequently, when a solution of hydrogen peroxide is used as
a sterilizing agent, heat is applied after application to cause the hydrogen
peroxide to break down into water vapor and nascent oxygen, which is the
main sterilizing agent.

4.6.6  Ultraviolet
Ultraviolet (UV) is not in the truest sense a chemical; rather, it is a wave
band that consists of three general regions. The three regions are the vac-
uum region of 1000 to 1900 Å, which are wave bands absorbed by water
and air; the far region of 1900 to 3000 Å, absorbed by biological molecules;
and the near region of 3000 to 3800 Å, where the waves are absorbed only
by a few molecules. Most germicidal lamps (2537 Å) are used to inacti-
vate bacteria on flat packaging materials, or to a lesser degree, they are
used to inactivate bacteria or other biological forms that are in water. As
with any form of radiation, the strength decreases as the distance away
from the object to which it is being directed increases. The sterilization
action is achieved by breaking certain key chemical bonds that are in
76 Handbook of aseptic processing and packaging

DNA molecules of bacteria. Once these critical molecules are disrupted

by cleaving certain chemical chains, the microorganism dies.
UV has been used to inactivate certain microorganisms on packaging
material. One problem is that if the UV is strong enough to inactive all
of the critical microorganisms, the packaging material may be affected.
This effect may be in terms of the ability to heat seal; the packaging mate-
rial may discolor or become brittle, it may react with the food product
being packed, or it may lose the ability to restrict the movement of critical
chemicals that may cause the food product to deteriorate, such as oxy-
gen and air. It should also be considered that a lamp that produces UV
light of a certain wavelength will be at maximum power when it is new.
This power will decrease gradually as the lamp is used. After somewhere
around 2000 to 2500 hours of operation, the lamp strength will be one half
of what it originally was. When the lamp reaches this strength level it is
often at, or below, the strength level required to inactivate organisms that
may be on the packaging material, with a reasonable safety factor.
One reason UV light is not used extensively for inactivating microor-
ganisms on equipment or packages is it can be shadowed and rendered
ineffective in the shadowed area. For example, if a material contains dirt
or is creased, the area protected will not be exposed to the UV light and
microorganisms in this area will not be inactivated. This is one reason it
has been used primarily with flat sheets, because normal configurations do
not provide shadowing protection. However, the flat sheet must be abso-
lutely clean, which suggests it must first be washed. UV light with very
dilute hydrogen peroxide has been reported to be effective as a sterilant.

References
3A Accepted Practices for a Method of Producing Steam of Culinary Quality, no.
609–00. 1996. Formulated by International Association of Milk, Food, and
Environmental Sanitarians, United States Public Health Service, and the
Dairy Industry Committee.
Homer, C., More Changes. Dairy Field Magazine, September 1992, p. 90.
Janoschek, R., and Du Moulin, G. 1994. Ultraviolet Disinfection in Biotechnology:
Myth vs. Practice. Biopharm Magazine, January–February 1994, pp. 24–31.
LeBlanc, D.A., Danforth, D.D., and Smith, J.M. 1993, October. Cleaning Technology
for Pharmaceutical Manufacturing. Pharmaceutical Technology Magazine.
Tichener-Hooker, N.J., Sinclair, P.A., Hoare, M., Vranch, S.P., Cottam, A., and
Turner, M.K. The Specifications of Static Seals for Contained Operations: An
Engineering Appraisal. Pharmaceutical Technology Magazine, October 1993,
pp. 60–66.
Zander Filter Brochures. 1: Ecodry, The Range of Dryers with Performance; 2:
Sterile Filters, Aeration Filters and Steam Infusers.
chapter 5

Aseptic filling and

packaging equipment
Thomas Szemplenski

5.1  Development of aseptic packaging

Many people believe that aseptic processing and packaging was invented
in the early 1980s when Tetra Pak introduced the first Brik-type paper-
board packaging into the United States. In reality, the first patent (no.
2,029,303) for aseptic packaging was granted to C. Olin Ball on February 4,
1936, for aseptic filling into metal cans.
The development of aseptic technology grew out of a desire to pre-
serve the beverage quality of milk. The ability to preserve milk before had
required the complete alteration of product that came from the cow, goat,
or sheep either by drying, condensing, or coagulating. All these altera-
tions maintained the nutritional qualities of milk as a food, but it no lon-
ger was the refreshing beverage it was originally.
In the early 1960s, the Swedish company Tetra Pak brought its lami-
nated paper-aluminum foil-plastic container to the United States. The
system was at that time a continuous form–fill–seal system for fluid
pasteurized milk and beverages. The container was a tetrahedron. This
package was extremely efficient in material use, but complicated to
pack or stack, and a real challenge to open. The U.S. licensee of this sys-
tem was the Milliken Company in South Carolina, and in conjunction
with Real Fresh of California, the Tetra system was modified to include
a chlorine sterilizing bath of the packaging web. This allowed steril-
ized milk to be filled and sealed aseptically, in a hermetically sealed
container (R. Graves, personal communication, 2010).
Sterilized milk in the tetrahedron achieved a remarkable degree of
use within the U.S. armed forces, even though in more than one prod-
uct demonstration to senior military personnel, milk squirted out of the
container onto their dress uniforms. On board submarines the container
reduced weight and the ease of disposal made it a hit. On surface ships the
tetrahedron was almost impossible to tip over, which was a big advantage

77
78 Handbook of aseptic processing and packaging

in stormy weather. The container made little inroad into the civilian mar-
ket, however, mainly due to the difficulty of opening it.
As has been previously discussed, the development of aseptic fluid
milk was the confluence of the technology of a system to treat the milk
and bring it together with a previously sterilized container. The result was
milk treated by the Graves–Stambaugh system filled into a metal can pro-
cessed by the Dole canning system.
There was no significant activity in the commercialization of aseptic
processing and packaging since the patent was issued until the late 1960s
and early 1970s when several food processors with foresight started asep-
tically processing and packaging shelf-stable puddings using the Dole
canning system. In the early 1970s William Scholle invented aseptic bag-
in-box packaging. The first products to be aseptically packaged into bag-
in-box were tomato products such as ketchup and tomato paste.
In 1981, Tetra Pak returned to the United States with a new and
improved packaging using hydrogen peroxide as a sterilant. The basic
principle of the system remained the same with a web of laminated
material being formed, filled, and sealed in a continuous motion. The
new package, unlike the triangle-shaped tetrahedron, was formed and
folded into a rectangle or brick. This presented the consumer with a
container that looked familiar and suitable and could be displayed on
store shelves. The real functional feature was the straw for the smaller
containers that was designed to puncture an opening at a specially
scored spot. This made the container popular with legions of consumers
who liked the portability and ease of consuming whatever the container
contained.
Aseptic milk and flavored milks experienced their first real introduc-
tion to the mass market in the Tetra Brik rectangular-type container. The
manufacturers of aseptic milk were hampered by the confusion of find-
ing a suitable and usable term with which the product would be known.
Over time, the acceptance of the container for juice products temporarily
shelved the need for a new name for true aseptic products.
Although aseptic packaging was invented in the 1930s, the real
growth was not experienced until the late 1970s and early 1980s. What
started out with Dole canning system has exploded into a myriad of
aseptic packaging systems that include not only cans, bag-in-box, and
Tetra Pak form–fill–seal systems, but also glass, plastic cups and bottles,
pouches, coffee creamers, bulk stainless steel containers, aseptic stor-
age tank farms capable of holding nearly 2 million gallons of product
each, and even large aseptic ships capable of aseptically transport-
ing 3.2  million gallons of citrus products. There are now more than
30 manufacturers of aseptic filling systems installed in the United States
alone with over 600 aseptic installations operating. There are far more
aseptic processing and packaging installations internationally where
Chapter 5:  Aseptic filling and packaging equipment 79

refrigeration is at a premium or does not exist. The food and beverage

industry has embraced aseptic packaging. It is surely one of the most
dynamic areas of the food processing industry, and more aseptic pack-
aging alternatives are sure to be developed in the coming years.

5.2  Dole aseptic canning system

As previously mentioned, aseptic packaging was invented using the Dole
canner. The Dole aseptic canning system has been utilized in commercial
applications since the 1960s. Since its introduction, over 60 systems have
been placed into production throughout the world aseptically packaging
mainly low-acid foods, such as dairy products, puddings, sauces, soups,
eggnog, banana puree, sandwich spreads, tomato paste, applesauce, nutri-
tional beverages, and cheese sauces. Approximately 40 Dole canners are
still operating. The Dole system is currently owned and operated by the
Graham Corporation.
The Dole system fills aseptically processed food products into metal
cans at speeds up to 450 cans per minute. Dole is the only system avail-
able to fill aseptically processed products into metal cans. Metal cans
with seam-on ends are used in all Dole systems. Can sizes range from
4.5 ounces (202 × 214) up to the #10 can (603 × 700). The smaller cans are
gen­erally aluminum. The larger cans are two- or three-piece steel. The
cans are manufactured with heat-resistance coatings common to the can
industry. The lids are made with a high-temperature plastisol sealant,
which is standard in the industry.
The Dole system consists of four basic components: the can sterilizer,
the filling section, the lid sterilizer, and the sealing machine. The com-
ponents are linked together with an integrated network of instruments,
controls, and alarms (Figure 5.1).

5.2.1  Can sterilizing unit

The can sterilizing unit is a stainless steel, double insulated tunnel.
Superheated steam at a temperature of approximately 500°F (260°C) is
introduced into the tunnel sections to provide the heat required for ster-
ilization. The steam is superheated by electric heaters supplied with the
system. The cans are moved through the tunnels and the speed of the
conveyors is varied to establish the overall capacity of the system.
The cans are conveyed in the sterilized unit for approximately 45 sec-
onds until the surface of the container reaches 435°F (224°C), which is the
temperature required for the destruction of heat-resistant bacteria. The
superheated steam is more lethal than dry hot air and requires less time
to destroy the bacteria.
80 Handbook of aseptic processing and packaging

Can Sterilizer

Empty Can In

Can Diverter Filled Can Exit

Filler
Can and Cover
Cover Feed Make-Up Station
Cover Sterilizer
Seamer

Figure 5.1  A Dole aseptic canner.

5.2.2  The filling section

As the hot, sterile containers move into the filling sections, jets of cold,
sterile water are directed against the lower portions of the can exterior
substantially reducing the container temperature. At this point, the asep-
tic product is introduced into the container by one of several specially
designed filling mechanisms.
The Dole system is equipped with specially designed fillers. The basic
model is the slit filler. With the slit filler, the cans pass underneath a slit
opening in a tube-type filler. The slit is approximately ¼ inch wide by
6 inches long, although the size is variable depending upon the type of
product and speed of filling.
The slit filler consists of a thick walled, stainless steel pipe that is slit
along the lower side. This pipe has a second inner pipe that has multi-
ple parts and provides consistent flow to the filling system. The annulus
between the pipes is approximately ½ inch. The sterile product is fed into
the inner pipe and flows lows out to the slit in the outside pipe.

5.2.3  Lid sterilizer

The third basic component of the Dole aseptic canning system is the
cover sterilizing unit. It is arranged as part of the closing machine.
Covers or lids are fed in stacks into the unit through one of several
Chapter 5:  Aseptic filling and packaging equipment 81

mechanical devices and are completely enveloped in superheated

steam for approximately 80 seconds. At the discharge, the lids are ster-
ile and are conveyed into the closing machine. Either aluminum or
steel lids can be used with the Dole canner. Aluminum lids require
about 20% less time to be sterilized. Easy-open lids can also be used
in the unit.

5.2.4  The sealer

The fourth component of the Dole system is the sealing machine. This
equipment is often standard machinery that is modified to operate in
an aseptic canning system. To accommodate the sterile container filled
with cold sterile product and the seaming of the presterilized containers,
the closing machine is enclosed and heated with superheated steam. The
enclosure permits initial sterilization of the equipment and maintains a
completely sterile atmosphere in the area where the sterile container, lid,
and product come together. The continuous flow of superheated steam
creates a positive pressure inside the can seamer, preventing external,
bacteria-laden air from entering.

5.3  Aseptic bag-in-box

In the late 1950s William Scholle invented, developed, and patented a more
efficient means of containing battery electrolyte using flexible packaging
constructed of polyethylene (PE). In time, Scholle visualized potential
uses for flexible packaging in the commercial food processing industry.
In the late 1960s and early 1970s two things caught Bill Scholle’s attention;
first, aseptic processing, a relatively new food processing technology was
gaining acceptance by processors; and second, bulk packaging of com-
mercial products such as tomato paste and fruits was costly. At that time,
most tomato paste was either hot filled into #10 cans or aseptically filled
into expensive 55-gallon steel drums in California and shipped great dis-
tances to be reprocessed into other products such as, ketchup, soups, and
sauces. Additionally, most fruit products were being filled into 30-pound
plastic pails and frozen to be shipped to other parts of the country for
reprocessing into flavored yogurts, ice cream, and fruit pies. The plastic
pails and cost of freezing was also a very expensive means of packaging
and transporting food products to be reprocessed.
Scholle Corporation, already one of the largest manufacturers of flex-
ible packaging material, visualized expanding demand for his packaging
business by developing a means of aseptically filling acid products such
as tomatoes and fruit into less expensive flexible packaging. To this end,
Scholle engineered and manufactured a prototype of an aseptic filler for
preformed bags into which these products could be filled. The prototype
82 Handbook of aseptic processing and packaging

filler was installed and improved upon at Purdue University in West

Lafayette, Indiana, with the assistance of Dr. Phil Nelson and graduate
students. At the time, Purdue University already was improving upon
aseptic processing techniques in the food processing facility on campus.
With an aseptic processing system already in place, Purdue was a logical
place to prove Scholle’s aseptic filler for flexible packaging.
Even today, the filling equipment is presterilized with steam, hot water,
and chlorine, and the preformed packaging is presterilized with gamma
radiation. The sterile zone and product contact parts of the aseptic fillers
are subjected to high temperatures (approximately 250°F) for 30 minutes
to presterilize the filler prior to production. The bags are manufactured of
various polymers with a fitment and cap. After manufacturing, the bags
of varying sizes from 1 gallon up to 330 gallons are subjected to the steril-
izing gamma radiation before being sent to the end use for filling.
With the original Scholle aseptic filler, and even with several models
today, the presterilized bags are manually inserted into the filling cham-
bers. Once the fitment and cap are inserted into the sterile filling chamber
it is automatically resterilized with steam. The cap is then automatically
removed, the filling valve is inserted into the bag, and a vacuum pulled.
The sterile product is volumetrically filled into the bags by a flowmeter.
After filling, there is a nitrogen flush, then the cap is replaced, and the bag
is ejected from the sterile filling zone (Figure 5.2).
Over the years there have been many improvements to the original
Scholle design, including but not limited to the ability to fill larger bags,
the introduction of an automatic continuous web fed bag filler, and vali-
dation by the U.S. Food and Drug Administration (FDA) to aseptically fill
and package low acid (>pH 4.6) food products. It should be noted that the
Scholle filler is capable of filling food products with particulates, such as
diced and sliced fruit as depicted in Figure 5.3.
While conducting many tests in aseptic processing facilities several
processors wanted to push the limit with regard to aseptically processing
and packaging low-acid foods with larger and larger particulates. One
such international processor wanted to try aseptic processing and pack-
aging ravioli and spaghetti. The products were aseptically processed at
approximately 280°F, held for a period of time, and then cooled to a filling
temperature of approximately 90°F prior to filling through the fitment on
the Scholle bags. Photographs of these products are shown in Figure 5.4.
Note the remarkable particulate identity.
The international processor who requested this test shipped the prod-
uct back to his plant in Europe under refrigeration, but later incubated
the product because of an indication of bacteria growth. He reported that
after one year the product was still commercially sterile.
It should be noted, that although the FDA has validated the Scholle
and other aseptic bag-in-box fillers for filling low-acid foods, they have
Chapter 5:  Aseptic filling and packaging equipment 83

AUTO-FILL
10-2E
SERIES
Aseptic Filling System
for High Acid Foods

Figure 5.2  One of many Scholle aseptic bag-in-box fillers. (Photograph from a
Scholle brochure.)

approved only a few aseptic processing systems containing low acid par-
ticulates. Those systems that are FDA approved to fill particulates are fill-
ing particulates that are relatively small. As the technology to aseptically
process low-acid foods containing larger particulates evolves and the abil-
ity to prove sterility improves, it is nice to know that the filling technology
has already been proven.
William Scholle’s vision regarding market potential was right on, as
Scholle Corporation and others manufacturers have installed hundreds
of aseptic bag-in-box fillers all over the world. For many years Scholle
had almost a monopolistic advantage to the aseptic bag-in-box market,
but over the years a number of manufacturers have introduced alterna-
tive aseptic bag-in-box fillers. Scholle is still the market leader in the sup-
ply of aseptic fillers and most assuredly the supply of aseptic bags and
84 Handbook of aseptic processing and packaging

Figure 5.3  Aseptic product in aseptic bags. The outer packaging layer has been
removed to show the particulate identity.

packaging materials. Some of the other suppliers of aseptic bag-in-box fill-

ers include but are not limited to:

Company Where Manufactured

Astepo Italy
Elpo Italy
Liqui-Box United States
Fenco Italy
HRS Argentina and Spain
JBT FoodTech United States
Rapak United States and United Kingdom
Rossi Catelli Italy
Chapter 5:  Aseptic filling and packaging equipment 85

Figure 5.4  Aseptic product in aseptic bags.

All the aforementioned fillers utilize basically the same technology for
presterilization of the fillers with steam. Some use a combination of
steam and chlorine. All preformed bags are sealed and presterilized with
gamma radiation.

5.4  Aseptic paperboard fillers

5.4.1  Tetra Pak
By no narrow margin the most aseptic packaging equipment for food
and beverages is for filling into paperboard carton laminates. In the early
1960s, Tetra Pak, headquartered in Lund, Sweden, reengineered its form–
fill–seal tetrahedral packaging filler to be able to fill milk aseptically.
86 Handbook of aseptic processing and packaging

Figure 5.5  The principle of Tetra Pak asceptic packaging. (Photograph courtesy
of Tetra Pak.)

Within several years, Tetra Pak introduced the first Tetra Brik carton, a
rectangular-type package of varying sizes and shapes. In the ensuing
years Tetra Pak has introduced a myriad of aseptic packaging alternatives
each formed by forming packages from roll-fed material, as depicted in
Figure 5.5.
Prior to filling and forming, the packaging material goes through a
bath of 35% hydrogen peroxide at approximately 130°F. This is followed
by hot air drying in the sterile zone of the filler, thereby ensuring a sterile
package for the independently sterilized product.
The paperboard laminate consists of a number of different layers of
material based mainly on the product to be packaged. The different layers
generally consist of paper, aluminum foil, and several polyethylene layers,
as shown in Figure 5.6 obtained from Tetra Pak general literature.
Chapter 5:  Aseptic filling and packaging equipment 87

The layers of the Tetra Brik aseptic package,

from the outer layer inward

Polyethylene
Printed design

Paper

Polyethylene
Aluminum foil
Polyethylene
Polyethylene

Figure 5.6  One diagram sample of Tetra Pak packaging construction.

As previously mentioned, Tetra Pak has developed many different

types of aseptic packaging for food and beverages, including but not lim-
ited to the Tetra Brik-type package, Tetra Prisma, Tetra Gemina, and Tetra
Fino. On a worldwide basis, no other supplier of aseptic filling equipment
or aseptic packaging material even comes close to Tetra Pak’s dominance
in aseptic filling and packaging. According to published reports from Tetra
Pak in 2008, more than 140 billion aseptic packages were filled throughout
150 different countries. Additionally, Tetra Pak installed almost 600 new
aseptic fillers in 2007, bringing their world installations to nearly 10,000.
Tetra Pak can fill package sizes from 80 mL up to 2000 mL in many
different sizes and shapes at varying fill rates. The list of products being
aseptically filled on Tetra Pak fillers is endless. The fillers that were origi-
nally developed for aseptically filling milk are now filling fruit and veg-
etable juices, teas, soups, syrups, sauces, broths, and nutritional beverages,
to name a few.
With the acquisition of Alfa Laval, a major worldwide supplier of
aseptic processing equipment and systems, Tetra Pak can now supply
not only the aseptic filling/packaging equipment but also the mutually
dependent aseptic processing system. This is a major competitive advan-
tage in the marketplace. Another powerful marketing tool that Tetra Pak
has is an FDA-approved aseptic processing testing facility located in
Texas where processors interested in aseptic processing and packaging
techniques can go to test and generate finished products prior to making
a decision to purchase.
88 Handbook of aseptic processing and packaging

5.4.2  SIG Combibloc

SIG Combibloc (hereafter Combibloc) is the second largest manufacturer
of aseptic filling equipment and supplier of packaging for beverages
into composite cardboard, polyethylene, and aluminum packaging.
Combibloc’s home office is in Germany with sales and services in the
United States and other countries. Combibloc has many variations of
aseptic filling equipment that can fill package sizes from 125 mL up to
2000 mL at varying flow rates up to 24000 pph.
Unlike Tetra Pak’s form–fill–seal technique for forming packages,
Combibloc’s packaging is preformed into individual packages that are
then shipped to the end user as a flat carton that is opened, shaped, and
sterilized inside the filling machine. The interior of the carton is sterilized
by hydrogen peroxide in the sterile zone, which has a slight overpressure.
After sterilization the carton is heated with hot air to dry the hydrogen
peroxide. Filling takes place after package sterilization and drying of the
hydrogen peroxide. After filling, the carton is ultrasonically sealed above
the fill level, not through the product like most Tetra Pak fillers. Filling
above the fill level and not through the product facilitates the aseptic fill-
ing of food products containing particulates.

5.5  Aseptic plastic cups

5.5.1  Bosch and Erca
In the 1970s two new aseptic fillers were introduced to the United States
market: the German manufactured Bosch and the French manufactured
Erca/Conoffast (now OYSTAR Erca). Both fillers are aseptic linear fill-
ers for form–fill–seal cups. These fillers gained market acceptance as a
less expensive alternative to the metal can. The products currently being
aseptically canned with the Dole system could now be filled into plas-
tic cups. Puddings, cheese sauces, tomato sauces, and flavored gels are
all being aseptically filled using Bosch (Figure 5.7) and Conoffast fillers.
Although the Bosch could fill cups at much higher production rates than
the Conoffast filler, it was considerably more expensive to purchase. Both
aseptic fillers enjoyed market acceptance and success, and both are still
being used to aseptically fill food products.
Both linear fillers used form­–fill–seal to produce the cups. The Bosch
filler used various polymers including polypropylene (PP) to form the
cups and the Conoffast used a combination of polystyrene, polypropyl-
ene, and polyethylene terepthalate (PET) with a barrier of ethylene vinyl
alcohol (EVOH). However, the technology to sterilize the cups was vastly
different. The Bosch filler sterilizes the roll-fed packaging material with
hydrogen peroxide, whereas the OYSTAR Erca uses either hydrogen
Chapter 5:  Aseptic filling and packaging equipment 89

Figure 5.7  Some product aseptically filled on the Bosch cup filler. (Photograph
from Bosch literature.)

peroxide or the neutral aseptic system (NAS). The NAS system sterilizes
the material during the coextrusion process. In operation the material is
separated and the inner sterile layers form the cups and lid.

5.5.2  OYSTAR Hassia, Erca, Gasti, and Hamba

In the 1980s, Hassia, a German manufacturer of form–fill–seal fillers for
plastic cups, engineered and introduced to the United States market a
high-speed aseptic filler for cups at a very attractive price. Hassia contin-
ued to improve upon the production speed of their cup fillers and now
can aseptically fill nearly 1700 cups per minute. Unlike most other aseptic
fillers that use hydrogen peroxide to sterilize the packaging, Hassia steril-
izes the packaging with steam. With its high-speed fillers and aggressive
marketing, Hassia has become the leading supplier of aseptic plastic cup
fillers in the United States. Puddings, sauces, baby food, and gels are all
being aseptically filled using Hassia fillers.
Hassia has recently become a member of the OYSTAR organization.
The OYSTAR organization also owns other aseptic filler manufacturers
including but not limited to Erca, Gasti, and Hamba. All the aseptic fill-
ers are supported by a substantial sales and service organization and
spare parts inventory that is based in New Jersey. It should be noted that
the only two OYSTAR fillers that are FDA-validated for aseptically fill-
ing low-acid foods in the United States are the Hassia (Figure 5.8) and
Erca models. The Gasti and Hamba models are being used to asepti-
cally fill acid food products or for filling refrigerated, extended shelf-life
products (C. Ravalli, personal communication, 2010).

5.5.3  Ampack Ammann, Benco, and Metal Box

Ampack Ammann is a German manufacturer of aseptic filling equip-
ment for preformed plastic cups and bottles of various polymers.
90 Handbook of aseptic processing and packaging

Figure 5.8  OYSTAR Hassia form–fill–seal aseptic cup filler. (Photograph courtesy
of OYSTAR Hassia.)

Ampack is the only company that offers both linear (Figure  5.9) and
rotary cup fillers that can fill up to 65,000 cph. Both fillers presterilize
the filler with steam and utilize hydrogen peroxide as the sterilizing
media for their packaging.
Ampack Ammann has been manufacturing aseptic filling equipment
since 1978 and has more than 130 aseptic filler installations; however,

Figure 5.9  Ampack Ammann linear aseptic cup filler. (Photograph courtesy of
Ampack Ammann and Evergreen Packaging.)
Chapter 5:  Aseptic filling and packaging equipment 91

Ampack does not have any installations in the United States. In the United
States Ampack Ammann is represented by Evergreen Packaging located
in Cedar Rapids, Iowa. Internationally, Ampack aseptic cup fillers are fill-
ing puddings and other desserts, dairy products, fruit conserve with fruit
pieces, and layered yogurt. Ampack is the only aseptic cup filler that can
aseptically fill two compartment cups.
Benco is an Italian manufacturer of aseptic filling equipment for
form–fill–seal plastic cups. The Benco filler utilizes steam and hydrogen
peroxide to presterilize the filler and hydrogen peroxide to sterilize the
packaging. Compared to other aseptic cup fillers the production rate of
the Benco filler is slower. At the only installation in the United States,
the Benco was being used to aseptically fill puddings, cheese sauces, and
fruit-based gels at 220 cpm. At that installation, the Benco was FDA vali-
dated to aseptically fill low-acid foods. The plant using the Benco went out
of business in the late 1990s.
In the 1980s, Metal Box, a manufacturer located in the United
Kingdom, introduced an aseptic cup filler utilizing preformed cups.
Although relatively slow at 160 cups per minute, Metal Box was able to
install several at commercial installations, aseptically packaging pud-
dings, desserts, oatmeal, and cheese sauces. Most of those installations
have opted for higher production-rate fillers. At the present, there is only
one Metal Box aseptic cup filler at a commercial installation in the United
States. It is currently at a copacking facility in Minnesota where it is
mainly packaging cheese sauces.
The Metal Box aseptic filler was purchased by FMC FoodTech, which
has recently changed the name to JBT FoodTech. However, JBT FoodTech
does not appear to be aggressively promoting the Metal Box filler any longer.

5.6  Coffee creamers

In the United States there are 3 suppliers of aseptic filling equipment for
coffee creamers with more than 20 installed and operating. The three sup-
pliers of aseptic filling equipment for coffee creamers are Purity, OYSTAR
Hassia, and Bosch. Bosch is the dominant supplier with 13 aseptic coffee
creamer fillers installed. Some of these coffee creamer fillers can asepti-
cally fill up to 1400 creamers per minute using Bosch’s Model TFA 4940
filler (Figure 5.10).

5.7  Aseptic pouches

All aseptic pouch fillers use form–fill–seal for forming the pouches.
Additionally, all aseptic pouch material of various polymers are sterilized
by warm, 35% hydrogen peroxide, and followed by hot air drying.
92 Handbook of aseptic processing and packaging

Aseptically operating thermoform

fill and seal machine TFA 4940 for safe packaging
of coffee cream

Figure 5.10  An aseptic coffee creamer filler. (Photograph from a Bosch brochure.)

5.7.1  Bosch
In the 1970s, Robert Bosch GmbH, a German manufacturer of food pack-
aging equipment, engineered, manufactured, and installed the first asep-
tic filler for filling food products into form–­fill–seal pouches. The first
products to be filled were puddings and cheese sauces that were previ-
ously filled into #10 cans.
Other manufacturers of aseptic filling equipment saw the potential
for food products to be aseptically packaged into flexible packaging and
several introduced alternative aseptic fillers for flexible pouches. At the
present, there are five suppliers of aseptic filling equipment for pouches
at about 20 aseptic pouch installations in the United States alone filling
products such as puddings, cheese sauces, chili, dairy products, juices, ice
cream mix, and tomato products such as ketchup and paste.
Customers and end users found that not only were flexible pouches
much less expensive, but they were easier to open, easier to dispose of, and
less expensive to ship. The flexible pouches are constructed of low-, medium-,
or high-barrier materials from multiple layers of polyethylene, linear low-
density polyethylene, and EVOH. Some of the pouches are metallized as an
extra barrier. Pouches generally range in size from 200 mL up to 10 L.

5.7.2  DuPont/Liqui-Box and Inpaco

Inpaco, a manufacturer of pouch fillers located in Nazareth, Pennsylvania,
followed Bosch with the introduction of an aseptic pouch filler and was
Chapter 5:  Aseptic filling and packaging equipment 93

quick to grab a share of the market and installed six aseptic pouch fillers in
the United States. In the ensuing years, Inpaco sold this business to Liqui-
Box in Worthington, Ohio. Liqui-Box was a likely buyer as it had already
established itself as one of the leading suppliers of flexible packaging and
additionally had aseptic filling equipment for bag-in-box. DuPont Canada
had previously purchased Liqui-Box Corporation. With the Liqui-Box pur-
chase, DuPont already had an established aseptic pouch filler and there-
fore discontinued the Inpaco model, although it still services the Inpaco
fillers that are operating and would take an order for an Inpaco filler.

5.7.3  Fres-co
One of the most recent aseptic pouch filler introductions in the food indus-
try is manufactured by Fres-co System, a Telford, Pennsylvania, corporation.
The Fres-co pouch filler is well engineered and is a fully automatic pouch
filler that can aseptically fill high- and low-acid food into pouches. Filling
speeds vary with pouch size, product characteristics, and film selection,
but generally the Fres-co filler can fill 1-gallon single lane pouches up to
30 pouches per minute and ½-ounce multilane pouches up to 500 pouches
per minute. The Fres-co filler can fill into either flat or stand-up pouch con-
figuration. Additionally, the Fres-co filler is the only pouch filler that can fill
pouches with fitments (B. Pritchard, personal communication, 2010).
Fres-co has placed several aseptic pouch fillers in commercial instal-
lations and has received FDA validation for aseptically filling low-acid
food and beverages. The Fres-co pouch filler is also capable of filling food
products containing particulates. A photograph depicting the Fres-co
filler and accompanying aseptic module and aseptic surge tank is shown
in Figure  5.11. Note the system is skidded and requires relatively little
floor space.

5.7.4  OYSTAR Hassia

A relatively new aseptic pouch filler has been introduced by OYSTAR
Hassia. The Hassia pouch filler can fill food products into pouches up to
6 inches wide and 10 inches long at a filling rate of 10 pouches per min-
ute. Hassia’s aseptic pouch filler has FDA validation for aseptically filling
low-acid food products. Several Hassia pouch fillers are operating in the
United States filling puddings and sour cream.

5.7.5  Cryovac
Cryovac Food Packaging is a division of Sealed Air Corporation. Cryovac
is the leading manufacturer of filling equipment and packaging material
for food products into flexible pouches. Cryovac pouch fillers are capable
94 Handbook of aseptic processing and packaging

FSU-1000
Automatic Form, Fill, and Seal Aseptic Packaging System

Figure 5.11  An aseptic pouch filler. (Photograph courtesy of Fres-co System

USA, Inc.)

of filling food products containing particulates exceeding 1 inch with lit-

tle or no damage to the particulates.
Within the last several years Cryovac developed and manufactured
a pouch filler capable of aseptically filling high- and low-acid foods. The
first aseptic pouch filler is installed in Europe, but with Cryovac’s aggres-
sive marketing it is expected that this filler will be introduced to the
United States market in the near future.

5.8  Aseptic plastic bottle fillers

There are 11 manufacturers of filling equipment for filling aseptically pro-
cessed beverages into plastic bottles being marketed in the United States.
Some of the aseptic fillers are FDA validated for filling low-acid beverages;
others can only fill high-acid beverages and products that are destined for
refrigerated, extended shelf life. Beverages that are filled using extended
shelf-life fillers usually process the product using aseptic processing tech-
niques and fill the product at a much lower temperature for refrigerated
warehousing and distribution. This product must be kept under refrigera-
tion. Extended shelf-life products normally have a refrigerated shelf life of
3 to 4 months depending upon the product being packaged.
Most plastic bottles destined for aseptic filling are produced from
polypropylene, high-density polyethylene (HDPE), or PET. Prior to filling,
Chapter 5:  Aseptic filling and packaging equipment 95

the bottles are presterilized using either 35% warm, hydrogen peroxide or
various concentrations of peracetic acid.

5.8.1  Ampack Ammann

The German manufacturer of aseptic bottle filling equipment, Ampack
Amman is only one of two manufacturers that offers both linear and
rotary bottler fillers. The linear filler is an aseptic filler. Ampack rotary
filler for plastic bottles is marketed as a filler for extended shelf-life prod-
ucts. Ampack has many aseptic bottle fillers installed internationally,
however, they have yet to place one in the United States in spite of strong
representation through Evergreen Packaging. Needless to say, with no
installations in the United States, Ampack has not received FDA valida-
tion for aseptically filling low-acid beverages.

5.8.2  Bosch
The first manufacturer to introduce an aseptic filler for beverages in the
United States was the Robert Bosch Company. In the late 1970s or early 1980s
Bosch installed two bottle fillers for aseptically filling nutritional beverages
(Figure 5.12). Bosch received FDA validation at this installation for aseptically
filling low-acid beverages into plastic bottles. The fillers filled products at a
relatively slow production rate compared to the fillers being supplied by the
latest aseptic bottle fillers being offered today. Since the initial installation,
Bosch has not supplied any other aseptic bottle fillers in the United States.

5.8.3  Krones
Krones is a German manufacturer of both aseptic equipment for process-
ing and packaging beverages into plastic bottles. Only a few equipment
manufacturers offer both the aseptic filling and mutually dependent pro-
cessing equipment, affording their customers a single source of supply
and responsibility. Krones has a major sales and service organization
located in Wisconsin.
Krones can fill bottles sizes up to 2 liters and have production rates
up to 700 bottles per minute. Krones has aseptic filler installations for acid
foods and extended shelf-life fillers for low-acid beverages in the United
States. At present Krones has not received FDA validation for aseptically
filling low-acid beverages.

5.8.4  OYSTAR Hamba

Hamba, now a member of the OYSTAR organization, has been manufac-
turing aseptic filling equipment for many years. Hamba’s initial aseptic
 96
Bosch Aseptic Filler for Bottles
Aseptically operating filling and closing lines
for bottles and wide-mouth containers
of glass and plastics
2. Bottle sterilizing

3. Filler 4. Lidding

Handbook of aseptic processing and packaging

4

1. Presterilizing unit
5

5. Discharge

Figure 5.12  An aseptic bottle filler. (Diagram from Bosch published literature.)
Chapter 5:  Aseptic filling and packaging equipment 97

equipment was developed for filling food products into preformed cups
using a linear filler. Most recently Hamba introduced a linear aseptic
bottle filler for plastic bottles. At the time of this publication Hamba was
installing this filler in the United States but had not yet applied to the FDA
for validation to fill low-acid beverages.
The Hamba manufacturing facility has recently been relocated to the
OYSTAR Hassia facility in Ranstadt, Germany, and is being marketed in
the United States through the OYSTAR facility in New Jersey where man-
agement, sales, service, and spare parts are located.

5.8.5  Procomac
GEA Procomac S.p.A. is an Italian manufacturer of rotary aseptic fill-
ing equipment for beverages into HDPE and PET bottles. Sales, service,
and spare parts for Procomac in the United States is located in Hudson,
Wisconsin. Procomac also has a testing facility located in Parma, Italy,
for potential users to test their product using the equipment prior to
purchasing.
Procomac first developed an aseptic bottle filler in 1994, and is now
one of the world’s leading suppliers of aseptic bottle filling equipment
(Figure  5.13). In the United States, Procomac has been very success-
ful and has installed many aseptic bottle fillers for high- and low-acid
beverages. Procomac has received FDA validation for filling low-acid

Figure 5.13  Procomac aseptic filler for plastic bottles. (Photograph courtesy of
Procomac.)
98 Handbook of aseptic processing and packaging

beverages. Additionally, Procomac fillers can fill beverages with small

particulates.
Procomac aseptic bottle fillers can fill bottles sizes from 250 mL up
to 2 L. Depending upon bottle size and configuration, Procomac fillers
can fill at a production rate of up to 800 bottles per minute.

5.8.6  Serac
Serac is one of the world’s leading suppliers of aseptic filling equipment
for plastic bottles and the leading supplier of aseptic and extended
shelf-life (ESL) fillers in the United States. Most Serac aseptic fillers are
manufactured at the home office in France, however, several aseptic
and extended shelf-life fillers are manufactured at the Serac sales and
service facility located in Carol Stream, Illinois, where Serac also main-
tains a large spare parts inventory.
Depending upon bottle sizes and configuration, Serac bottle fillers
can fill up to 800 bottles per minute. Both the high- and low-acid fillers can
fill bottle sizes from 75 mL up to 3 L. Bottle material can be constructed of
PET, HDPE, PE, or Barex (Figure 5.14).

Figure 5.14  Some beverages being filled on Serac fillers. (Photograph courtesy of
Serac USA.)
Chapter 5:  Aseptic filling and packaging equipment 99

Serac has not received FDA validation for aseptically filling low-acid
beverages but expects to do so in the near future.

5.8.7  Shibuya Kogyo

Shibuya Kogyo is one of the leading suppliers of aseptic fillers for plastic
bottles. Shibuya installed its first aseptic bottle filler in 1994 and has since
installed over 100 others, filling products such as milk, teas, coffee, and
juices. The Shibuya bottle filler has received FDA validation for asepti-
cally filling low-acid beverages. With filling speed up to 1200, the Shibuya
bottle filler has the highest production rate of all aseptic bottle fillers.
Shibuya has recently developed the first electron beam sterilization
method for PET bottles achieving a log 6 reduction. The use of electron
beam for sterilization of the bottles eliminates any possibility of chemical
residuals and substantially reduces the cost of not only chemical steril-
ants, but also steam, water, and other utilities. It also substantially reduces
required floor space.

5.8.8  Sidel/Tetra Laval

Sidel is a division of Tetra Laval and offers two styles of aseptic fillers for
plastic bottles: two models of rotary fillers and a linear filler. Sidel has
over 100 installed and operating aseptic bottle fillers, filling products such
as teas, milk and other dairy products, juices, and flavored water. The fill-
ers will fill into polypropylene, PET, or HDPE bottles. Sidel’s rotary fillers
are for aseptic acid products and for refrigerated extended shelf-life prod-
ucts. The Tetra Pak linear fillers (LFA-20) are FDA validated for aseptic
filling of low-acid beverages (Figures 5.15 and 5.16). The linear fillers have
a much lower production rate than the rotary fillers, which can fill up to
60,000 bph.
Sidel offers three methods of sterilization of the plastic bottles: wet
decontamination with peracetic acid, wet decontamination with hydrogen
peroxide, and a patented (PredisTM) dry decontamination using hydrogen
peroxide vapor. Sidel’s rotary fillers use either the wet decontamination
with hydrogen peroxide or the Predis method. Sidel’s (Tetra Pak) linear
filler utilizes hydrogen peroxide to sterilize the bottles.
Sidel’s patented Predis method of sterilizing the bottles is quite unique
and reduces the cost and chance of chemical residuals. The method uses
preforms. Hydrogen peroxide is deposited onto the internal wall of each
preform as condensation (120°C to 140°C). The preforms are then heated
in the oven until they reach a temperature of up to 100°C, which activates
the H2O2 in a controlled atmosphere. The bottles are then blown using 0.01
micron filtered air after which they are transferred by the neck into the
sterile filler to be filled and capped (Figure 5.17).
100 Handbook of aseptic processing and packaging

Figure 5.15  Sidel/Tetra Pak LFA-20 linear aseptic bottle filler. (Photograph cour-
tesy of Tetra Pak.)

Figure 5.16  Samples of some aseptic product filled on the LFA-20. (Photograph
courtesy of Tetra Pak.)
Chapter 5:  Aseptic filling and packaging equipment 101

Figure 5.17  Sidel’s SensofillTM FMa aseptic bottle filler. (1) The multiwheel bottle
sterilization system. (2) High-pressure bottle sterilization. (3) Aseptic filling. (4)
Cap sterilization. (Photograph from a Sidel brochure.)

5.9  Stork
Stork is a leading and long-time manufacturer of aseptic processing and
filling equipment for beverages into plastic bottles, and one of the few
manufacturers that offers a linear bottle filler. Products such as fruit
juices, milk and other dairy products, soy milk, teas, and coffee drinks are
all being aseptically filled with Stork bottle fillers. Additionally, the Stork

Figure 5.18  Stork linear aseptic filler for plastic bottles. (Photograph from a Stork
brochure.)
102 Handbook of aseptic processing and packaging

bottle filler can fill beverages with particulates up to 12 mm in diameter.

In the United States, Stork has received FDA validation for aseptically fill-
ing low-acid beverages into plastic bottles.
The Stork filler can fill bottle sizes from 20 mL up to 2 L at a filling rate
of 400 bpm (Figure 5.18). Plastic bottles of PET, HDPE, and PP are being
sterilized with hydrogen peroxide and aseptically filled using Stork fillers.
Bottles can be monolayer, three layer with light barrier, or up to six layers
with both light and oxygen barriers (P. Schweitzer, personal communica-
tion, 2010).
chapter 6

Aseptic packaging
materials and sterilants
Robert Fox

6.1  Product requirements

All products have specific package requirements necessary to keep the
product in a safe and acceptable condition for its expected shelf life. In
order to maintain the integrity of the package, these requirements may
include functional barriers to light, oxygen, and moisture as well as
mechanical properties such as the container’s distortion temperature,
stiffness, and impact properties.
Figure 6.1 provides a broad view of the oxygen tolerance of various
products found in shelf-stable and refrigerated packages. Low-acid par-
ticulate products that are aseptically packed present a U.S. Food and Drug
Administration (FDA) challenge in the United States but can be found in
the European Union and other countries outside the United States. For
that reason they are included in this chart.
Some products have a need for a high degree of protection from the
effects of ultraviolet (UV) light. A UV inhibitor can be added to mini-
mize product degradation or the container can have an opaque layer. Most
products have a need for a high degree of protection from moisture gain
or loss. The next section discusses materials that have been identified as
capable of providing suitable protection from either the ingress or egress
of oxygen or water vapor.

6.2  Materials
Thermoplastic materials used in sheet production for both aseptically
packed nonbarrier and barrier thermoformed packages have been chosen
for properties that they provide.

103
 104
Oxygen Sensitivity and Fill/Process Temperatures for Foods and Beverages
250°F Baby Food, Seafood,
Soups, Meats, Pudding,
RETORT/LOW-ACID ASEPTIC Pet Food, Canned Milk,
219°F Vegetables

212°F

205°F

Applesauce, Spaghetti Sauce, Baby Food, Ketchup, Fruits,

190°F Salsa/Taco Sauce, Fruit Juice and Drinks
Hot Pack Pickles
Jams/Jellies

185°F
Isotonics, Juices RTD Tea

Handbook of aseptic processing and packaging

HOT FILL/PASTEURIZATION/HIGH-ACID ASEPTIC Pasteurized
176°F Beer
BBQ Sauce,
Salad Dressing,
Syrup, Mustard

WARM FILL Warm-Filled Ketchup

100°F
Condiments, Liquers,
Dried Foods, Nuts,
Edible Oil Shortening, Cultured Dairy Snacks, Coffee
Peanut Butter Products
Refrig. RTD Tea Nonpasteurized
Isotonics Beer/Wine
COLD FILL Refrigerated Cold-Filled Ketchup

200 100 50 40 35 30 25 20 15 10 5 1
Oxygen Sensitivity in Parts per Million (ppm)

Figure 6.1  Oxygen tolerance of food groups.

Chapter 6:  Aseptic packaging materials and sterilants 105

6.2.1  Nonbarrier sheeting

Nonbarrier sheeting can be made of a single material but usually has two
or more layers of different materials to reduce cost. Materials are chosen
so that the outer layer(s) provide notch sensitivity resistance, cold tem-
perature impact strength, and improved heat seal capability. The inner
core material provides stiffness.

6.2.2  Barrier sheeting

No single material can supply all of the properties required to pro-
duce a barrier container at an acceptable cost. Different materials are
brought together in a layered structure (typically five to seven layers)
to provide an adequate level of protection to the product at an accept-
able cost.
Oxygen barriers of all materials can be significantly improved by the
use of nanoclays, active scavengers, and vacuum deposition of metal or
glass. Heat distortion can also be improved by the addition of inorganic
fillers. In actuality, within a given material, changing any one property by
the introduction of an additive influences all the other properties.
The following chart lists some of the common materials used in pack-
aging and their respective barrier and physical properties.

Oxygen Heat Flex

Material Density Barriera MVTRb Distortionc (°F) Modulusd
LLDPE 0.91–0.94420 1.0–1.5 <100 40–105
HDPE 0.95–0.96 160 0.4 149–176 145–225
PP 0.90–0.91 150–240 0.7 125–250 170–250
HIPS 1.06 226 10.0 165–200 160–390
EVOH 1.1–1.2 .02 3.8–6.5 >250 —
PET 1.29–1.40 90.0 1.0–1.3 167 350–450
NYLON 6 1.12–1.14 2.6 16.0–22.0 311–365 405
PLA 1.23–1.25 >150 >10.0 104–150 350–450
a cc/mil/100 sq in2/24 hr at 65% RH/20°C
b grams/mil/100 in2/24 hr at 90% RH/100°F; MVTR: moisture vapor transmission rate
c ASTM D-648 at 66 psi
d ASTM D-790 at 103/73°F

6.3  Sterilizing Agents

Heat, chemicals, radiation, and ultraviolet light have been used inde-
pendently or in combination to sterilize materials for aseptic packaging.
Regulatory requirements and cost considerations have put a practical
limit on the number of sterilants in commercial use.
106 Handbook of aseptic processing and packaging

6.3.1  Heat
Steam is an effective sterilant demonstrated by the fact that it has been
in commercial use longer than any other sterilant. Although steam is not
suitable for some thermoplastic materials whose heat distortion temper-
atures are below the high-pressure steam temperatures required, it has
had a recent revival in the OYSTAR Hassia aseptic form–fill–seal pack-
aging system (Figure  6.2). Incoming rolls of plastic sheeting are heated
on the top (food contact) surface with culinary steam (320°F) sufficient
to sterilize the contact surface. The sheet is then indexed to the forming
area where it is heated to its forming temperature and then indexed to
the forming station where it is formed into the desired container shape.
The next index moves it into the filling area followed by the sealing sta-
tion and indexed out of the sterile zone. Container sterilization starts with
the steam sterilization of the sheet’s surface and continues through the
forming, filling, and sealing stations after which containers exit the sterile
zone. Lidding material is similarly sterilized prior to entering the sterile
zone and sealed to the container.

6.3.2  Hot water

Hot water (sometimes acidified) has been used commercially for high-
acid products. The CrossCheck system, developed and patented by Mead
Packaging (U.S. patent 4,152,464), was commercialized by a joint venture of
Mead Packaging and Rampart Packaging. CrossCheck was used success-
fully by Seneca Foods for single-serve applesauce for more than 10 years.
Preformed containers were carried through a hot water (180°F) bath, exit-
ing the bath in an inverted position (Figure 6.3). The heat seal flanges and
inside of the containers were dried by the flow of warm sterile nitrogen
as they rotated to an upright position prior to filling. Sterile nitrogen also
maintained a slight positive pressure on the inside of the sterile zone. The
sterile zone was presterilized by the use of culinary steam. Cups were
filled volumetrically, sealed, and exited through a sterile water lock. Mead
and Rampart stopped supporting the technology in 1990.

6.3.3  Neutral aseptic system (NAS)

Manufactured by OYSTAR Erca-Formseal, the system uses the heat of
the forming and lidding web coextrusion to sterilize the two webs. The
bottom web is typically made up of polystyrene–adhesive–EVOH–
adhesive–LDPE–PP. The top web is typically made of PP–LDPE–
adhesive–aluminum foil. In both structures, the edges of the webs are
trimmed as they enter the sterile zone. The polypropylene layer of the
bottom web is stripped away and exits the sterile zone. The remaining
 Chapter 6:  Aseptic packaging materials and sterilants
DAMPF
Forming oven Sealing station
Steam header Aseptically packed
Forming Filling area
station cups

Roll of plastic sheet

Figure 6.2  OYSTAR Hassia aseptic form–fill–seal system schematic.

107
 108
Sealing station with
sterilant bath
Aseptic volumetric
Preformed cup filler
loading station
Sterilant bath & 40 Sterile zone
water lock exit 20
feature 21 41
16

Handbook of aseptic processing and packaging

7 19 18
27 24 25 37
22 17
1 23 36
15a
2
Sterilant bath 3 26
89 6

5 34
4 8a 12 50
13

14 11

Figure 6.3  Cross Check aseptic deposit, fill, and seal system.
Chapter 6:  Aseptic packaging materials and sterilants 109

web has the newly exposed sterile surface and is indexed into the heating,
forming, and filling stations. The top web, similarily having had its poly-
propylene layer trimmed and removed as it entered the positive pressure
sterile zone, is indexed to the sealing and trimming stations.

6.3.4  Chemical sterilants

Hydrogen peroxide (H2O2) is a clear, slightly viscous oxidizing agent that
has been the chemical sterilant of choice for most packaging equipment
manufacturers. It is an effective sterilant when used in concentrations of
30% to 35% followed by hot air at 60°C to 125°C. The hot air substantially
increases sporicidal activity in addition to dissipating the residual hydro-
gen peroxide.
Hydrogen peroxide identified in the Code of Federal Regulations
under 21 CFR 178.1005 may be safely used to sterilize polymeric food-
contact surfaces identified in paragraph (e)(1) of the regulation. Hydrogen
peroxide also meets the specifications of the Food Chemicals Codex (3rd ed.,
1981, pp. 146–147).
Peracetic acid (CH3CO3H) is a colorless, liquid organic compound that
is highly corrosive. It is always sold in solution with acetic acid and hydro-
gen peroxide to maintain its stability. The concentration of the acid as the
active ingredient can vary depending on its application. It has an advan-
tage over hydrogen peroxide in that it can be used at lower temperatures
(40°C). This is a benefit for aseptic packaging applications using materials
like polyethylene terepthalate (PET) and LDPE, which have low heat dis-
tortion temperatures. It can also be used as an aseptic bottle rinse, spray,
or mist without the need for a secondary sterile water rinse.
Peracetic acid is accepted by the FDA for sanitizing and disinfecting
(21 CFR 178.1005-1010).

6.3.5  Radiation
Irradiation has been evaluated for several forms of packaging and found
to be an effective solution for large capacity bags such as Scholle’s bag-
in-box aseptic packaging system. The dominant method of sterilizing
hermetically sealed bags, pouches, and drum liners is by electron beam
irradiation. Gamma irradiation has been evaluated and is not used for
these types of applications due to its initial installation costs and regula-
tory considerations and potential damage to polymeric packaging mate-
rials. Scholle, the leader in bag-in-box aseptic packaging systems, has
developed closure features and filling equipment that maintain asepsis
during the filling operation. Guidelines for radiation sterilization can be
found in 21 CFR Part 178.1005.
110 Handbook of aseptic processing and packaging

6.4  Packaging systems

6.4.1  Dole aseptic canning
The Dole aseptic canning method differs from other aseptic packaging
methods in that the packaging materials are subjected to culinary steam
as the primary method of container sterilization. Containers are subjected
to surface temperatures of 215.6°C to 218.3°C (420°F to 425°F) and cover
temperatures of approximately 210°C to 212.8°C (410°F to 415°F). Today,
the high temperatures required in their container sterilization restrict the
choice of materials to metal two- or three-piece cans. Work is ongoing to
develop a CPET container that would withstand the temperature require-
ments of the process and provide a cost effective replacement with the
benefit of microwavability.

6.4.2  Preformed thermoformed containers

Aseptic preformed plastic container usage appears to be on the rise in
Europe with recent installations of OYSTAR Gasti’s Dogaseptic aseptic
packaging system. The system utilizes hydrogen peroxide as the steril-
izing agent in the aseptic system.
OYSTAR Gasti also has a Dogatherm preform aseptic cup filling sys-
tem that uses steam to sterilize the inside of the cups and a long-life ver-
sion that utilizes high intensity UV-C light for sterilizing the container
flange and interior surfaces.

6.4.3  Form–fill–seal (FFS)

Form–fill–seal includes four main methods of container manufacture:

1. Paper-based packages such as fiberboard cartons and “brick packs.”

2. Thermoformed plastic packages, commonly referred to as cups
and trays.
3. Injection and extrusion blow-molded bottles.
4. Bag-in-box and large volume pouches.

The best known of the aseptic FFS packages is the paper-brick-style

package that utilizes a multilayered web (Figure 6.4) consisting of an

• Outside layer—polyethylene (for protection of fiberboard)

• Structural layer—paper (typically one side preprinted)
• Adhesive layer (bonds foil and paper, minimizes fiber penetration)
• Barrier layer— aluminum foil
• Adhesive layer
• Food contact layer— polyethylene
Chapter 6:  Aseptic packaging materials and sterilants 111

Polyethylene
Paperboard
Tie Layer
Aluminum Barrier
Tie Layer
Polyethylene

Figure 6.4  A typical material structure in preformed, paper-based barrier cartons.

Paper-brick and carton-style packages are produced by two differ-

ent methods. These packages are usually used for dairy-based beverages,
juices, stock, and sauces.

1. Roll-fed, paper-based systems (Figure 6.5)—The leading producers

of roll-fed, paper-based packaging systems and materials are Tetra
Pak, Division of Tetra-Laval, Elopak, subsidiary of the Ferd Group
of Norway, and GA Pack, a new Chinese supplier of paper-based
packaging j for roll-fed aseptic packaging systems.
Efforts to minimize the effects of energy-related cost increases dur-
ing the 30-plus years that the brick pack has been in commercial use pro-
duced a 30% reduction in aluminum foil thickness and a 20% increase
in board stiffness while reducing package weight by 15%. Although
costs have been positively affected by these changes, other aspects of
the carton have been adversely affected. These would include:
• Thinner aluminum foil increases the potential for pinholes to
develop.
• Stiffer board increases the potential for pinholes to develop as a
result of stiffer fiber content.
• Increased thickness of the adhesive material between the foil,
the board, and the PE layer, and the foil and PE layers on the
inside of the carton, to minimize/eliminate fiber-induced pin-
holes through the foil and PE layers increasing the risk of organ-
oleptic impact as a result of chemical migration.
2. Preformed cartons—Preformed brick pack and gable top, fiberboard
cartons are used in either high- or low-acid aseptic filling systems.
The cartons are manufactured so that the bodies are preassembled
and distributed in the flat. They are opened just prior to the filling
process with the container body being fin sealed at the bottom. The
112 Handbook of aseptic processing and packaging

Tetra Brick cartons are

filled and sealed
below the surface of
the liquid.

Figure 6.5  A typical roll-fed process schematic.

tabs that result from the fin seal are folded over the bottom seam
or up along the sides of the container body. Materials used to pro-
duce the containers are similar in construction to those used to pro-
duce the roll-fed, brick-style cartons. Differences are usually found
in the thickness of the fiberboard to compensate for increased carton
stiffness required for larger container capacities. Pinhole issues and
solutions to them are similar to those of the roll-fed laminate.

Recently, SIG Combibloc, a unit of the Rand Group, commercialized

a nonfoil-based barrier carton. The EcoPlus carton replaced the foil bar-
rier layer with a nylon-6-based barrier polymer. It was introduced in the
European Union and is expected to replace its foil-based barrier board
materials over the next few years with positive environmental advantages.
Chapter 6:  Aseptic packaging materials and sterilants 113

The Net Results of “cb3 EcoPlus” Are More Loss

Favorable than those of “cb3” (=100%)
Acidification by 22%
Climate change by 20%
Aquatic eutrophication by 12%
Terrestrial eutrophication by 7%
Summer smog (POCP) by 19%
Human Toxicity—PM10 by 20%
Fossil resource consumption by 22%
Use of nature—forestry by 8%
Total primary energy demand by 15%
Nonrenewable primary energy demand by 20%
Transport intensity—lorry by 3%
Left column:
“cb3 EcoPlus w/cCap” has lower indicator values (i.e., a more favorable performance) than “cb3 w/cSwift”
Right column:
“cb3 EcoPlus w/cCap” has higher indicator values (i.e., a less favorable performance) than “cb3 w/cSwift”
Note: Percentages shaded in gray are smaller than 10% and thus considered insignificant.

Figure 6.6  An environmental comparison of paper/polymeric versus paper/foil

barrier materials used in food packaging.

Combibloc contracted the Institute for Energy and Environmental

Research, Heidelberg, Germany, to investigate some of the environmental
impacts of the new EcoPlus carton and compare its findings to those of tra-
ditional foil-based cartons of similar sizes. Figure 6.6 summarizes the insti-
tute’s findings. The comparison of EcoPlus carton and cCap closure was made
against Combibloc’s similar standard “cb3” carton with a cSwift closure.
The net result of the institute’s study confirmed the polymeric barrier
carton has significant energy savings and carbon footprint advantages
over the foil-based traditional carton. It appears that foil’s advantage of
low tensile strength, useful in opening features that require puncturing
the foil and inner polymer contact layer of the carton by straw inser-
tion or leveraged spout opening, may have been met with the polymeric
structure.
Both the roll fed and preformed aseptic fiberboard packages are typi-
cally sterilized by hydrogen peroxide when packages are to be used with
low-acid foods. Packages to be used with high-acid foods can include ster-
ilants such as peracetic acid-based sterilants in addition to hydrogen per-
oxide. Other methods that have been used, to a far lesser degree, include
UV-C, gamma, and electron beam radiation.
The environmental impact of the paper-based packages has not lived
up to its expectation as there is no good reuse of this scrap material (sustain-
ability) other than as a source of energy through incineration or as a com-
ponent in the production of extruded lumber replacement. In purposeful
114 Handbook of aseptic processing and packaging

incineration, toxic byproducts are reduced compared to traditional fossil

fuel resources found in other packaging materials. Additionally, the bulk
of the package is comprised of a renewable resource wood pulp that helps
to keep its carbon footprint small.
Thermoformed plastic packages are commonly referred to as cups
and trays. These packages are typically used for an individual serving
of products such as puddings, baby foods, dairy creamers, yogurts, and
long-life entrées.

1. Sheet/roll-fed systems—Widely used today for all-plastic contain-

ers are being commercially sterilized using the acceptable methods
of hydrogen peroxide, peracetic acid, and steam (product/package
dependent).
2. Preformed container aseptic systems—Not widely used in the
United States, preformed aseptic container systems are commercial
in other parts of the world. Sterilization methods include chemical,
steam, and ultraviolet light.
• Injection and extrusion blow-molded bottles—These packages
are typically used for dairy-based beverages and juices.
• Preformed injection blow-molded bottles typically utilize pre-
forms in the manufacturing process. While many systems are in
commercial operation today, the two primary methods of steril-
izing the container prior to filling are:
−− Dry preform decontamination method—Sterilants are dep­
osited onto the internal wall of each preform. Preforms are
then heated in the forming oven until they reach their form-
ing temperature (greater than 100°C), which activates the
H2O2, sterilizing the interior of the container. Containers are
then blown into their final shape and transported to the filling
and sealing stations in a sterile overpressure environment.
−− Wet-sterilization process—This process uses hydrogen per-
oxide or peracetic acid-based sterilants. Bottles are formed
and the sterilant is dispensed into the formed container. An
activation temperature of 100°C is required for hydrogen
peroxide and 40°C for peracetic acid. The low activation tem-
perature of peracetic acid-based sterilants is well suited to
PET as it is well below the thermal distortion temperature of
the polymer.
• Extrusion blow-molded bottles are typically provided to the
aseptic filling system in bottle form. If the bottle is in a closed-
top format, its interior is sterile. This is not the case if the bottle
is open topped.
• Closed-top aseptic filling process—The closed-top process blow
molds bottles using sterile air and maintains sterility prior to
Chapter 6:  Aseptic packaging materials and sterilants 115

filling by pinching closed the bottle above the container finish at

the time the bottle is produced. The combination of the polymers’
temperature during the extrusion and blow-molding process, in
combination with the sterile air used to blow the bottle into its
desired shape, guarantees a sterile container. The top above the
finish is removed in a sterile, controlled environment prior to
being aseptically filled.
• Open-top aseptic process—Open top blow molded bottles have
the top section above the finish removed during the blow molding
process. Sterilization of these types of containers is identical to
the wet sterilization process identified for injection blow molded
containers.

Bag-in-box and pouch containers are typically used for bulk packages
of foods to reduce storage or shipping costs. Products shipped or stored in
this manner are usually transferred aseptically to smaller packaging for-
mats for retail distribution. Large volume (typically ½ to 1 gallon) pouches
are also used for retail and institutional sizes and are commonly used to
package wine, cheese sauce, and ketchup and tomato sauces, as well as
dairy based products.
Large volume bag-in-box and pouches are fabricated of coated, metal-
ized, laminated, or co-extruded films. Due to their size and lack of being
able to maintain shape independently, they are sterilized using radiation.
Radiation sterilization allows bags and large volume pouches to be ster-
ilized in a closed, hermetically sealed condition. Access fitments such as
molded openings or valves are attached with their upper and lower open-
ings sealed with a plastic or foil membrane. These fitments are welded to
the interior or exterior of the bag or pouch prior to final sterilization.
Presterilized bags are stored and shipped to filling sites in a lay-flat
condition. At the filling site, the bags are placed in a box or container and
the filling fitment is suspended at the top of the box or container to mini-
mize any air entrapment during filling. The container-opening feature is
connected to a sterile filling head/valve and the exterior of the opening
feature is sterilized prior to the aseptic filling head puncturing the mem-
brane seal across the top of the fitment. Once filled, the opening feature is
resealed and a protective overcap applied.
Smaller bags and pouches are fabricated and aseptically filled in the
same manner as rolled-fed, paper-brick-pack-type packages.

6.5  Environmental considerations

Sustainability is a main consideration when looking at packaging options
today. Energy conservation is also a main concern as it relates to sus-
tainability and the environment. Figure  6.7 shows the recoverable and
116 Handbook of aseptic processing and packaging

LDPE
Energy Content
Flex, microcellular foam of Various
Rigid urethane foam Packaging
HDPE Materials
Polystyrene
PVC
ABS
Polypropylene
Acrylic
Recoverable
Polycarbonate Feedstrock
Polyester Fuel
Nylon 66
Nylon 6
Mod PPO
Acetal
Glass
Steel
Zinc, die cast
Aluminum, die cast
Magnesium

1000 2000 3000 4000 5000 6000 7000 8000 9000 10,000
BTU/Cubic Inch of Packaging Material

Figure 6.7  Recoverable energy components of various packaging materials.

nonrecoverable energy component of various materials used in packag-

ing. It becomes easy to see which materials will have the largest carbon
footprint and which materials will be the most environmentally friendly.
Assuming that all packaging materials will end up in the municipal
waste stream at some point in time, it is important to look at the long-term
effects of that reality.
Aseptic packaging deals primarily with only a few of the materials
shown: LDPE, high-density polyethylene (HDPE), polystyrene, polypro-
pylene, polyester, steel, and aluminum.
Figure 6.8 shows the benefit of thermoplastic containers in terms of
recoverable Btus available to aid in the incineration process with the addi-
tional benefit of providing heat to power steam driven electrical genera-
tion systems.
Those materials that do not a have a recoverable energy component
require energy from other sources to move, distribute, or recondition or
 Chapter 6:  Aseptic packaging materials and sterilants
Typical Heat Content of Materials in Municipal Solid Waste (MSW)
(Million Btu per Ton)
Materials Million Btu per Ton
Plastics
Polyethylene terephthalatec,e (PET) 20.5
High-density polyethylenee (HDPE) 19
Polyvinyl chloridec (PVC) 16.5
Low-density polyethylene/ Linear low-density polyethylenee
24.1
(LDPE/LLDPE)
Polypropylenec (PP) 38
Polystyrenec (PS) 35.6
Othere 20.5
Newspaperc 16
Corrugated cardboardc,d 16.5
Mixed papere 6.7
Glass 0
Steel 0
Aluminum 0
b: Energy Information Administration, Renewable Energy Annual 2004, “Average Heat Content of Selected
Biomass Fuels” (Washington, DC, 2005).
c: Penn State Agricultural College Agricultural and Biological Engineering and Council for Solid Waste
Solutions, Garth, J. and Kowal, P. Resource Recovery, Turning Waste into Energy, University Park, PA,
1993.
d: Bahillo, A. et al. Journal of Energy Resources Technology, “NOx and N2O Emissions during Fluidized Bed
Combustion of Leather Wastes,” Volume 128, Issue 2, June 2006, pp. 99–103.
e: Utah State University Recycling Center Frequently Asked Questions.

117
Figure 6.8  Recoverable energy content of packaging materials found in municipal waste streams.
118 Handbook of aseptic processing and packaging

Glass PE PET Alu Steel

Container
Type

Mass
[g] 325 38 25 20 15

Mass/Volume
433 38 62 45 102
[g/liter]
Energy/Mass
14 80 84 200 23
[MJ/kg]

Energy/Volume
8.2 3.2 5.4 9.0 2.4
[MJ/liter]
“Embodied Energy of Drink Containers” from the ImpEE resource on
“Recycling of Plastics.” A study from the Cambridge–MIT Institute.

Figure 6.9  Energy content per volume (1 liter) of common rigid packages.

reshape them for future use. Figure 6.9 compares the energy cost per vol-
ume (liter). With energy costs continually rising, the energy cost advan-
tages have slipped away from all of the traditional packaging materials
except steel and that is expected to change to the benefit of plastics in the
near future.
chapter 7

Aseptic bulk packaging

Thomas Szemplenski

7.1  Aseptic bag-in-box

In the early 1970s, William Scholle, an entrepreneur with tremendous
foresight, visualized the potential for flexible packaging to replace the
expensive, rigid packaging that was being used to transport food products
such as tomatoes and other fruit products. Many years prior to this vision,
Scholle developed flexible pouches of various propylene derivatives for
packaging battery acid. Even today, virtually all battery acid is packaged,
transported, and sold in flexible packaging invented by Scholle. Scholle
felt that he could use the same packaging technology that was being used
to package battery acid to package shelf-stable food products. Instead of
using existing retorting technologies to commercially sterilize the product
to be packaged in flexible packaging, he leaned toward applying a rela-
tively new technology that was rapidly developing at the time: aseptic pro-
cessing and packaging.
By the early 1970s, the process for aseptically processing food prod-
ucts was proven and commercially operating at approximately a dozen
food processing facilities, sterilizing such food products as tomato and
fruit pastes, puddings, and dairy-based products. At each of these exist-
ing facilities, the aseptically processed product was being aseptically filled
into rigid containers using either the Dole aseptic canner or the FranRica
aseptic metal drum filler. The can sizes being filled on Dole equipment
ranged in sizes from 4 ounces up to the #10 cans that held approximately
96 ounces. The aseptic drum filler aseptically filled product into 55-gallon
steel drums.
Scholle’s vision was to utilize aseptic processing methods to fill larger
quantities for industrial and commercial uses into less expensive flexible
packages. At the time, tomato paste and fruit purees and concentrates
were hot filled into #10 cans, aseptically packaged into 55-gallon metal
drums, or, in the case of fruit products, alternatively filled into plastic
pails and frozen for shipment to the end user for reprocessing. All of these

119
120 Handbook of aseptic processing and packaging

methods of packaging were expensive, as was the cost of refrigeration

when plastic pails were used.
Scholle engineered and manufactured a prototype of an aseptic filler to
fill preformed bags. The prototype was then installed at the food process-
ing laboratory at Purdue University in West Lafayette, Indiana, and a mutu-
ally dependent aseptic processing system was simultaneously installed
so a sterile product could be delivered to the filler. Scholle, together with
Dr. Phil Nelson, who was then a professor at Purdue, were able to make
the necessary modifications to the prototype filler to successfully package
high-acid (<pH 4.6) food products into presterilized, preformed bags. The
bags were then, and continue to be, presterilized by gamma radiation.
The vision Scholle had about the flexible market was extremely accu-
rate, for soon after the Purdue modifications and numerous customer
trials, the market exploded with interest in this new technology and sub-
sequent commercial installations. The first installations were for tomato
paste that was being processed in California and shipped to the East Coast
to be remanufactured into sauces and ketchup. Prior to the Scholle aseptic
filler, almost all this product was being aseptically filled into very expen-
sive 55-gallon metal drums. Today, almost every installation of aseptic
drum fillers has been replaced by aseptic flexible packaging. Most tomato
paste today is being aseptically filled into bags that range in size from 55
gallons up to 330 gallons (Figure 7.1).

Scholle Aseptic Packaging System

Bag-in-box
Bag-in-drum
Bag-in-bin

Figure 7.1  Various types of asceptic preformed bag packaging. (Photograph from
a Scholle brochure.)
Chapter 7:  Aseptic bulk packaging 121

Many improvements to the original Scholle filler have been made since
the early days at Purdue. The Scholle filler can now fill preformed bags up
to 330 gallons and it is no longer limited to high-acid foods. The U.S. Food
and Drug Administration (FDA) has validated the Scholle filler to now fill
low-acid foods (>pH 4.6), and in fact, the most recent low acid filler is a con-
tinuous web filler that is capable of filling up to 15 bags per minute. Over
the years other companies have manufactured aseptic bag-in-box fillers,
however, the Scholle filler remains the dominant market leader for aseptic
fillers and supply of preformed flexible bag packaging. Since the formative
days for the Scholle aseptic filler in the 1970s, hundreds of aseptic fillers for
preformed bags have been installed all over the world and the list of prod-
ucts being aseptically filled into the bags continues to increase.
The tomato paste market for aseptic bag fillers was followed by the
market for fruit for yogurt and other fruit-based products and citrus prod-
ucts. Some of these products were filled into 3- and 5-gallon bags and
others into 55-gallon bags.

7.2  Aseptic bulk container

Following aseptic bag-in-box packaging was the development of reus-
able aseptic stainless steel containers for high-acid products. These con-
tainers are usually manufactured in sizes of 200 to 300 gallons and are
constructed of either 304 or 316 stainless steel (Figure  7.2). Some of the
advantages of this type of aseptic storage include:

Figure 7.2  Stainless steel aseptic tote (800 to 100 liters). (Photograph courtesy of
CCR Containers.)
122 Handbook of aseptic processing and packaging

Figure 7.3  Aseptic totes stacked. (Photograph courtesy of CCR Containers.)

• One-time charge for packaging

• Stainless totes are easily sterilized with steam
• Ability to remove partial product with remaining product stay-
ing sterile
• No oxygen or light penetration through flexible packaging
• Ability to nitrogen flush the head space
• Ability to be stacked high (Figure 7.3)
• Able to be cleaned in place
• Easily transported by forklift and pallet jacks

Products such as diced tomatoes, citrus juices and concentrates, fruit

purees, and stabilized fruit for yogurt are some of the products being
aseptic packaged and delivered in stainless steel totes. There are a num-
ber of suppliers of stainless steel totes. These manufacturers have advised
that they will either sell or lease the totes to processors.

7.3  Aseptic bulk storage

While working with Scholle to commercialize aseptic bag-in-box technol-
ogy, Nelson partnered with several other synergistic companies to design
and develop equipment to store massive quantities of fruit and vegetable
products for long periods at room temperature in bulk holding tanks.
Chapter 7:  Aseptic bulk packaging 123

The more paramount companies that Nelson partnered with included

Bishopric Products (now called Enerfab) and FranRica (now called JBT
FoodTech). The aseptic processing system is generally the same that is
used to process the products for bag-in-box, however, Nelson and his new
partners developed a means of epoxy lining carbon steel tanks and steril-
izing them so they could be filled and stored with aseptically processed
acid products (<pH 4.5) for long periods of time.
This innovative group proved the concept with two 100-gallon stain-
less steel and three carbon steel epoxy-lined tanks at Purdue University’s
food processing laboratory. The first products that they were able to store
aseptically were tomato products followed closely by fruit juices, such as
apple and grape. Eventually, they found that food-grade, epoxy-lined car-
bon steel tanks were easier to sterilize and considerably more economical
than stainless steel tanks.
Commercialization followed with the installation of a 40,000 bulk
aseptic storage tank for tomatoes and several 250,000- to 600,000-gallon
storage tanks for apple and grape juices. Later, the technology was intro-
duced for citrus products. Further research dictated that although the cit-
rus products were commercially sterile, refrigeration after filling into the
tanks enhanced the shelf life. Today, the citrus industry has embraced the
aseptic bulk storing of refrigerated (35°F) citrus juices as there are now
more than 300 million gallons of citrus juice stored in approximately 330
bulk tanks utilizing this technology in the state of Florida alone (Figure 7.4
and Figure  7.5). The largest aseptic storage tank holds 1.8 million gal-
lons; however, tanks of 2.1 million gallons of volume are currently under
construction. This technology developed by Nelson and his associates,
in addition to the facilities installed within the United States, now have
international installations in Brazil, Belgium, and Spain. Others are sure
to follow (R. Brocker, personal communication, 2010).
There are many benefits of aseptic bulk storage, including, but not
limited to:
• Reduced storage cost
• Flexibility, the ability to aseptically blend different juices
• Improved product quality
• Inactivation of microbes and enzymes for a stable product
• Improved vitamin C retention and other light-sensitive products
Unlike other smaller (500 to 20,000 gallons) aseptic storage tanks
that are presterilized by steam, the larger tanks cannot be sterilized by
steam due to their massive size. Presterilization of the larger tanks is
done by initially filling the tanks with the chemical sterilant iodophor,
supplied by Klenzade and other chemical companies servicing the food
industry. Once the tanks are sterilized, they can be maintained in a
sterile state for long periods of time. In fact, at an installation in Florida
124 Handbook of aseptic processing and packaging

Figure 7.4  Aseptic bulk storage tanks in construction, 1-million gallons each.
(Photograph courtesy of Enerfab.)

Figure 7.5  Refrigerated room being built around field fabricated tanks.
Chapter 7:  Aseptic bulk packaging 125

Aseptic Tank Sterilization

Sterilant Filling Operation

Iodophor
Aseptic
Tank
Phosphoric
Solution
Acid
Iodophor Sterilization
Solution

Swing 900 Liters / M

Valve Panel

Figure 7.6  Presterilization of aseptic bulk storage tanks. (Diagram courtesy of

JBT FoodTech.)

one tank has been continuously used for 6 years without it having to
be resterilized.
During sterilization, the large tanks are completely filled with the
sterilizing iodophor solution as depicted in Figure  7.6, supplied by JBT
FoodTech. Once the tank is deemed sterile, the iodophor is removed and
replaced by filtered sterile nitrogen and held under pressure during the
filling, storage, and removal of product, as shown in Figure 7.7.
There are now more than 565 aseptic bulk storage tanks installed
throughout the world storing more than 473 million gallons of product.
Most of these tanks are 1-million-gallon storage tanks aseptically hold-
ing citrus juices and concentrates, grape juices, and tomato products.
What started out as an idea that Dr. Nelson and his associates had more
than 25 years ago has turned into a technology that the food industry has
embraced and will continue to embrace as more and different food prod-
ucts will be aseptically stored in larger tanks.

7.4 Aseptic ocean liner transportation and storage

A number of years after aseptic bulk storage was commercialized, Nelson
was contracted to develop a means of aseptically transporting large quan-
tities of citrus by means of an ocean liner. This successful technology
would facilitate the transportation of citrus products from Florida and
South America to Europe. Nelson visualized using the already developed
126 Handbook of aseptic processing and packaging

Aseptic Tank Sterilization Sterilant Emptying Operation

Neutralizer

Static Mixer
Sterile Water
Nitrogen
Sterilant
Positive Solution
Sterilant
Pressure Solution
Phosphoric
Tank
pH Acid
pH

Valve
900 Liters / M
Pump Swing
Panel Waste Treatment

Figure 7.7  Presterilization of aseptic bulk storage tanks. (Diagram courtesy of

JBT FoodTech.)

and proven aseptic bulk storage tanks installed inside the hull of a large
ocean liner.
In 1993, the first ship dedicated to transporting aseptic processed
and stored citrus was manufactured and put into use. The Ouro do
Brazil was put into service to ship citrus juices for Citrosuco Paulista of
Brazil to Europe, Japan, and the United States. Built in Norway, the first
ship was 564 feet long and enclosed 16 vertical tanks that each held
200,000 gallons of product. In all, 3,200,000 gallons of product can be
shipped (P. Nelson, personal communication, 2009).

Figure 7.8  An aseptic bulk transfer ship. (Photograph courtesy of Citrus Coolstores,
Inc.)
Chapter 7:  Aseptic bulk packaging 127

Since the Ouro do Brazil, several other larger ships have been built
using this technology, carrying up to 8 million gallons of product in each
vessel. No doubt more ships will be manufactured for the purpose of
shipping aseptically stored product from the source to points all over the
world (Figure 7.8).
chapter 8

Regulations for aseptic processing

and packaging of food
Ralph H. Graves

8.1 U.S. Food and Drug Administration

requirements and approval
We should start with the regulatory requirements since they dictate many
of the controls and tests that need to be performed.

8.1.1  European versus U.S. approach

Differences between regulations in the United States and Europe have
profoundly influenced the development of aseptic equipment. For exam-
ple, in the United States before 1981 the James Dole aseptic canning system
was the only aseptic filling and packaging system of commercial impor-
tance for ultra-high temperature (UHT) milk and milk-based (low-acid)
products. In 1981, the U.S. Food and Drug Administration (FDA) approval
of the food additive petition for the use of hydrogen peroxide as a sterilant
for food contact surfaces provided the impetus for introduction of various
aseptic filling and packaging systems into the U.S. market.
Most European regulations rely on spoilage data as a measure of how
well an aseptic system works. The FDA, however, requires microbiologi-
cal (challenge) and chemical tests to document whether an aseptic system
provides an adequate margin of safety. Lack of understanding of this dif-
ference has hampered adoption of “European” aseptic packing systems in
the United States.

8.1.2 U.S. Food and Drug Administration

and U.S. Department of Agriculture
Regulations for UHT milk and milk-based products that contain little
or no meat or poultry are contained in Title 21 of the Code of Federal
Regulations (CFR), Parts 108, 113, and 114. Section 113 40(g) lists specific

129
130 Handbook of aseptic processing and packaging

requirements for aseptic processing and packaging systems. The UHT

products that contain at least 3% raw meat or 2% cooked poultry are
regulated by the U.S. Department of Agriculture (USDA). The USDA has
developed guidelines for aseptic processing and packaging systems in
meat and poultry plants, which describe the requirements for obtaining
approval for aseptic processing and packaging systems.

8.1.3  Pasteurized milk ordinance

Processors of UHT milk or milk-based products must adhere to the
appropriate FDA and USDA regulations and guidelines cited and also
the requirements imposed by the Pasteurized Milk Ordinance (PMO). The
PMO was revised in 1983 and 1985 to include UHT milk. Unfortunately,
there are some conflicts between requirements in the PMO and Title 21
CFR 113. There is a distinct need for revisions in the PMO and Title 21 CFR
113 to make these regulations compatible and up to date.

8.1.4  State regulations

Many states actively regulate the processing of food products, but, in
general, their regulations have had little effect on aseptic processing.
Two major exceptions include PMO-regulated products in states where
the PMO is adopted and enforced; and products produced in California,
where the state’s Department of Health Services issues all processes
for acidified and low-acid foods produced in California, and the state’s
Department of Food and Agriculture has regulations similar to those in
the PMO.

8.1.5  Hazard analysis critical control point approach

The hazard analysis critical control point (HACCP) system has been
successfully applied by the FDA to the regulation of acidified and low-
acid canned foods. A recent report by the Food and Nutrition Board
Subcommittee on Microbiological Criteria recommended the HACCP sys-
tem be applied by industry and regulatory agencies to all U.S. food pro-
tection programs. The introduction of UHT products, aseptically packed
in containers other than glass jars or metal cans in the United States, was
delayed by several years because of the FDA’s different and more compre-
hensive requirements.
It took more than 2 years for the FDA to approve the use of hydrogen
peroxide for the sterilization of packaging materials. When the FDA finally
granted the petition for the use of hydrogen peroxide, it set maximum res-
idue levels at 0.5 ppm (originally it was 0.1 ppm). As a consequence, U.S.
processors must concern themselves with maximum hydrogen peroxide
Chapter 8:  Regulations for aseptic processing and packaging of food 131

levels, as well as minimum levels, to ensure proper sterilization. The

resulting effect of these regulations is a much lower peroxide level in the
United States as compared to the rest of the world and a greater potential
for the production of defective containers due to an insufficient amount
of peroxide for proper sterilization. Initially, the approval was granted for
H2O2 use on polyethylene food contact surfaces. This was expanded in
1984 to include other polymers as well. It is interesting to note that the
FDA permits the use of hydrogen peroxide in milk for cheese making at
the 500-ppm level. It is supposed to be destroyed by catalase, leaving no
residual H2O2.

8.2  Code of Federal Regulations (CFR)

UHT-sterilized products to be aseptically packaged are regulated by the
Code of Federal Regulations and approved process authorities. Regulatory
aspects governing aseptic processing are similar to canning. However, it
is important to realize that unlike retorting, aseptic process filling must
be separately done for sterilization of product, package, and aseptic filler.
Packaging is considered to be an indirect food additive and is governed
separately under Title 21, as shown in Table 8.1.

8.3  Low-acid food regulations and definitions

Let us look at the FDA low-acid food regulations as they pertain to asepti-
cally packaged foods, starting with a few key FDA definitions as stated in
these regulations:

1. Aseptic processing
2. Commercial processor
3. Commercial sterility of foods
4. Commercial sterility of equipment
5. Hermetically sealed containers

Operators of low-acid food processing systems must have attended

a special short course developed by the FDA in conjunction with the
National Food Processors Association (NFPA), or they must be under the
supervision of an individual who has attended such a course. Most of
these go into great detail on retort operations and seam inspections, but
touch lightly on UHT processing and aseptic packaging systems. This
is due to the wide differences in critical control factors among the dif-
ferent aseptic processing and packaging systems. In order to process
low-acid foods at a given location, the plant must be registered with
the FDA. Next, each product and process must be filed with the FDA.
The scheduled process when filed must include a full description of the
132 Handbook of aseptic processing and packaging

Table 8.1  Federal Regulations for Aseptic Processing and

Packaging of Foods

I. Authority

Title 21 CFR
Part 108 Emergency Permit
Part 113 Low-acid in hermetically sealed package
Part 114 Acidified low-acid product
PMO Dairy products (PMO/IMS)
USDA Poultry & meat FSIS & USDA guidelines

II. Regulatory Aspects

High-acid food
• Not regulated/GMP only

Low-acid food
Separate filing
for:
• Product sterilization
• Package sterilization*
• Aseptic filler sterilization
• Maintenance of aseptic filler
*Aseptic Packaging Materials as Indirect Food Additives

Title 21 CFR
Part 171 Petition
Part 174–179 Materials:  Resins, coatings, paper, etc.
Part 178 Sterilants

equipment, the critical control points, and list the “authority” that has
reviewed the entire system and has verified the fact that the system will
yield a safe product.
The FDA has not clearly defined what constitutes a processing author-
ity. Just being the originator does not cut it. In California, the state’s
Department of Health is the processing authority. Some process control
devices are spelled out in the regulations, others are not. Basically, this
is because most UHT processing systems differ and aseptic packaging
systems differ sufficiently in design that process safety controls must be
tailored to a specific installation.
Although it does not formally approve equipment or processes, the
FDA does exert its authority over the types of aseptic processing and
packaging systems that can be utilized to produce foods for distribution
in U.S. commerce by reviewing and either accepting or rejecting process
Chapter 8:  Regulations for aseptic processing and packaging of food 133

filing forms from individual processing firms. When a company files pro-
cessing schedules for a new aseptic processing or packaging system, the
FDA technical staff may request sufficient technical information from the
processor to evaluate the adequacy of the equipment and the procedures
used to produce a commercially sterile product.
Legally, a processor could submit a process to the FDA within the
required 10-day period from the start of production, and continue produc-
ing and marketing the product without official approval. Only an inexpe-
rienced operator would follow such a course, because when the FDA gets
around to reviewing the process, it may find a questionable practice that
could trigger the recall of all the product that is out in the marketplace.
It is definitely best to discuss the proposed system with the FDA or the
recognized authority before starting production. The FDA may require a
change in the heating process, which in turn may alter the organoleptic
and physical characteristics of the product. It is not easy to get FDA per-
sonnel to sit down with you to review a new system or process. Budgetary
constraints within the government have curtailed the manpower avail-
able for such tasks, and the FDA finds it difficult to justify assigning a high
priority to such requests. With all the publicity aseptically packaged foods
have received recently, the FDA is flooded with requests from equipment
manufacturers from all over the world for advisory opinions on their sys-
tems. As a result, long delays and frustration are not uncommon. It helps
to have a processing authority with credibility such as the NFPA, which
is both known to the FDA and experienced in dealing with such matters.
Two arguments that will not carry any weight with the FDA are

1. The fact that the system has been operating satisfactorily under
identical conditions for years somewhere outside the United States
2. The fact that there are several hundred similar systems currently in
operation in the rest of the world

In fairness to the FDA, that agency carries the heavy responsibility of

protecting public health. The potential for health hazards due to improp-
erly processed aseptically packaged low-acid foods is much greater than
that with refrigerated foods. The FDA is well aware of this and will insist
on wide margins of safety, often considered overkill.

8.4 U.S. Food and Drug Administration:

Specific concerns
Starting with equipment, let us illustrate some of the FDA’s specific con-
cerns. In all indirect heating systems, and particularly plate-type heat
exchangers, the sterile product must at all times be under greater pressure
134 Handbook of aseptic processing and packaging

than the unsterile or raw product. In case of a pinhole leak or crack in

a seal, the sterile product will not become contaminated with nonsterile
product. Without such a pressure differential, and if there was a pinhole
leak in a plate, milk could reach the marketplace with a potential pub-
lic health hazard. A well-designed quality control plan should, however,
identify any such crossover in the incubated samples well before the
product is released for distribution. In order to comply with this pres-
sure differential requirement, an ordinary homogenizer or positive pump
may be used to push the product through the heating system. A recorder
controller is used to maintain the 1-pound pressure differential. Sensors
are installed at the raw product entrance and the sterile product exit of the
heat exchanger. The potential for product contamination from a pinhole
or crack in a metal part is very real, as many experienced operators can
attest. Another potential source of contamination is the aseptic homog-
enizer. All it takes is one of the many steam seals getting clogged. This
is not an uncommon occurrence and requires close observation on the
operator’s part.
In a direct heating system, the product is heated with the injection
of steam into the product or infusion of product into an atmosphere of
steam. In order to remove from the product the amount of water added by
the condensed steam, the product is flash cooled in a vacuum chamber.
The pressure on the outside of the vacuum vessel is greater than that on
the inside; hence, any crack or leak will allow the entry of contaminating
organisms from the environment. Steam seals are required at all connec-
tions on the sterile side of the processing line. If such contamination were
to take place, it would be detected before the product is released when the
incubated samples are examined.
The FDA will only accept Fo values for thermal processes based solely
upon the time and temperature of the product in the holding tube. We
know that a direct heating system will heat the product much faster than
an indirect system. We also know that the total amount of heat given a
product will affect kill as well as organoleptic and physical characteris-
tics. The FDA takes the position that due to possible channeling in the heat
exchanger or variances in flow rates due to product bake-on, the come up
time cannot be included in the calculation of the Fo value for a scheduled
process. It is a standard practice in Europe to include the total heating
process in the Fo calculation. For example, in Europe, milk is processed at
a 3 to 4 Fo, thus requiring a minimal holding time.
The FDA is also concerned about the type of flow in the holding
tube. It is necessary to demonstrate the flow is turbulent to ensure a uni-
form temperature and holding time; otherwise the FDA will require a
higher Fo value to compensate for the potential of laminar flow. Note that
Clostridium botulinum is considered to be inactivated by a Fo of 3.0 in low-
acid canned foods.
Chapter 8:  Regulations for aseptic processing and packaging of food 135

In order to obtain an advisory opinion on a proposed processing

system, the FDA relies heavily on inoculated pack data. Three separate
experiments are expected to be performed. First, the raw product is inocu-
lated with a specific number and type of organism, and its absence must
be demonstrated in the finished product. The processing temperature
is gradually lowered until some organisms are found to survive. This
enables one to calculate the safety factor of the process. Next, the pack-
aging material, paper stock or plastic film, needs to be inoculated with
an organism to demonstrate that the peroxide treatment, or whatever
sterilization method is used, destroys all organisms present. The third
test consists of inoculating the air space in the sterile zone of the filler to
demonstrate the effectiveness of the presterilization procedures. Different
organisms are used for these tests.

8.5  Other requirements

Aseptic processing systems for low-acid products should be provided
with a flow diversion valve actuated automatically when the product
temperature at the end of the holding tube falls below that listed in the
scheduled process. Location of the diversion valve is very important and
should be engineered by a competent supplier. The timing pump should
be a positive pump and must be sealed so that its throughput cannot
exceed the flow rate in the filed process. A homogenizer is often used as
the timing pump. Recording and temperature-indicating devices must be
located at specific prescribed locations. A mercury-in-glass thermometer
or approved alternate is required as a cross-check on the accuracy of the
recording and indicating thermometers.
In the event of a process deviation, specific procedures must be fol-
lowed—assuming that the deviation is accidental. Usually the product
will be placed on hold by the processing authority. California law requires
the state’s Department of Health to fully evaluate any process deviation,
and the product cannot be released until that evaluation has been com-
pleted and officially released by that agency. The FDA has very specific
requirements for record keeping. Critical process control points must be
monitored at given frequencies. The results must be recorded and made
available to the FDA upon request. A large number of direct and indirect
heating systems have met FDA requirements for low-acid foods.
With regard to packaging systems, the one that has been around
the longest is the Dole aseptic canner for metal cans, first used in 1951
at the Med-O-Milk plant in East Stanwood, Washington. Regarding
the form–fill–seal fillers, using polyethylene, aluminum foil, and kraft
paper materials, we note the Tetra Brik has been around the longest.
Others that have FDA approval are International Paper, Autoprod, and
Combibloc. In the bag-in-box systems we have Scholle and Liqui-Box; in
136 Handbook of aseptic processing and packaging

pouch fillers there are two, Inpaco and Bosch. The approved form–fill–
seal systems using laminated plastic materials are Bosch, Conoffast,
and Benco. Others seeking approval are Hamba, Gasti, and Mead
Crosscheck.
Good advice for anyone planning to get into aseptic low-acid foods is
to read CFR Title 21, Parts 110, 113 and 114, and become associated with
someone who has experience in this field. Such an approach can save
time, money, and possible embarrassment.
As previously mentioned, the FDA now permits only a hydrogen per-
oxide residue of 0.5 ppm in a container. This leaves the operator with a
narrow path between having enough peroxide to sterilize the container
and not too much to meet the residual tolerances. It can be done, but
requires extra controls and monitors not found on some models of Brik
Pak or Combibloc fillers overseas.
If milk or milk products are processed, an additional FDA group, the
Milk Safety Branch, has to review the sanitary design of the equipment
and verify its compliance with the PMO. This group maintains jurisdic-
tion over milk, even if it is sterilized. Some microorganisms associated
with raw milk can produce toxins, which are not destroyed by the heat
treatments that destroy Clostridium botulinum. Milk must be handled with
proper sanitary practices from the cow to the UHT sterilizer to prevent
excessive bacterial growth during that period. This agency is also con-
cerned with the potential dilution of milk during processing. Ratio con-
trollers are required by all direct heating systems to make sure that the
flash cooling in the vacuum chamber removes an amount of water equiva-
lent to the amount of steam added in the heating process. If the tempera-
ture of the product going into the steam infuser or injector is equal to the
temperature of the product going out of the vacuum chamber, there is
neither dilution nor concentration of the product.
The Milk Safety Branch of the FDA and the Interstate Milk Shippers
(IMS) Association also concern themselves with the nomenclature of milk
products. Currently, sterilized milk must be labeled UHT and must con-
tain the statement “Refrigerate after opening.”
The 3A Sanitary Standards Committee is an association of indus-
try, public health, and the International Association of Milk, Food, and
Environmental Sanitarians (IAMFES). This group sets standards that
equipment for milk and egg processing must meet. This organization
believes that filth, even though sterilized, is still filth and should not be
found in milk or egg product. No one can argue against that position.
The Meat and Poultry Branch of the USDA (FSIS) has published its
own low-acid food guidelines. This branch of the USDA has jurisdiction
over foods containing over 3% meat or 2% poultry. These regulations dif-
fer slightly from those issued by the FDA. Various groups are attempting
to bring these regulations into conformity with the FDA’s. It is important
Chapter 8:  Regulations for aseptic processing and packaging of food 137

to remember that if a food contains more than 3% meat or 2% poultry, it

comes under USDA Meat Inspection and not FDA regulations.

References
9 CFR, Pt. 308, 318, 320, 327, and 381, 1986.
21 CFR, Pt. 110–113 and 114, 1987.
Dunkley, W.L., and Stevenson, K.E. 1987. Ultra-high temperature processing and
aseptic packaging of dairy products. Journal of Dairy Science 10: 2192–2202.
U.S. Department of Health and Human Services, Public Health Service, Food and
Drug Administration, 1985. “PMO Grade A Pasteurized Milk Ordinance.”
chapter 9

Validation and establishment

of aseptic processing and
packaging operations
Jairus R.D. David and V.R. (Bob) Carlson*

The objective of any validation process is to prove that a process works

and can work routinely, thereafter. The concept and process of validation
pertaining to aseptic processing and packaging of food is complex. The
roots of validation are in the pharmaceutical and aerospace industries.
It is important to understand the scope, information content, and limita-
tions of any validation process and its relationship to day-to-day process
capability and deliverables. This chapter is intended to be an overview.

9.1  Some considerations

As described earlier, aseptic processing and packaging equipment setup
and operation is complex. Before one commercially produces aseptic
products via a newly designed and installed aseptic system, it is neces-
sary to perform a pre- and postinstallation review, and to test and validate
the equipment to facilitate process filing. The objective of any validation
process is to prove that a process does what it says it does, or claims it
does, and not anything else. It is interesting to note that most European
regulations rely exclusively on “spoilage” data as a measure of how well
an aseptic system works. The U.S. Food and Drug Administration (FDA),
however, requires microbiological challenge and chemical tests to docu-
ment whether an aseptic system provides an adequate margin of safety.
Based on the authors’ extensive experience, it is desirable to have both
challenge data and a comprehensive spoilage database for a complete
understanding of process capability and deliverables.

* This chapter is also dedicated to V.R. (Bob) Carlson, the coauthor of this chapter, who
passed away during the writing of the book.

139
140 Handbook of aseptic processing and packaging

9.2  Decision process

Aseptic processing and packaging is attractive business wise, and a chal-
lenging technology operations wise, compared to the canning of foods.
However, high initial capital investment, operational complexity, and the
“commitment and corporate culture” required to successfully run and
manage the system have served as business constraints. The type and the
nature of aseptic processing and packaging equipment setup depends
upon the market demand for product or product mix, marketing research,
caliber of research and development, innovativeness, entrepreneurship,
regulatory constraints, and capital available for deployment.

9.3  Equipment selection

As mentioned earlier, aseptic processing and packaging of food is a con-
tinuous process. Thus, the performance of various system components is
interdependent (Bernard et al. 1987). Therefore, equipment selection must
be viewed not as a selection of a number of individual components, but as
a selection of a complete and compatible system.
The first step in the selection of aseptic processing and packaging sys-
tems is to review the pertinent regulations as described in Chapter 8. If
the food product contains at least 3% red meat (raw basis) or 2% cooked
poultry, the U.S. Department of Agriculture (USDA) Food Safety and
Inspection Service (FSIS) has regulatory oversight. These regulations are
contained in “Guidelines for Aseptic Processing and Packaging Systems
in Meat and Poultry Plants,” published by the FSIS (Anon. 1984). All equip-
ment needs approval or could be on the approved list already, prior to
installation. Prior to producing product, FSIS requires that the processor
submit an “acceptable” proposal for container and equipment testing, and
an acceptable partial quality control (PQC) program covering the opera-
tion and maintenance of the aseptic system.
For products that do not contain meat or poultry as specified earlier,
the FDA has regulatory oversight (with an exception of pet foods with
meat). In addition, FDA has regulatory authority over all commercially
sterile shelf-stable pet foods. FDA regulations can be found in Title 21,
Parts 108, 110, 113 (foods with pH greater than 4.6 and water activity
greater than 0.85), and Part 114 (foods with a pH less than 4.6 as a result of
acidification and water activity greater than 0.85) of the Code of Federal
Regulations. These regulations require that a process filing be submitted
to the FDA prior to processing and packaging the product.
Finally, if the product to be produced is either a milk or milk-based
product, the facility may additionally be required to comply with indi-
vidual state-adopted Pasteurized Milk Ordinance (PMO) promulgated by
FDA’s Milk Safety Branch.
Chapter 9:  Validation and establishment of aseptic processing 141

Due to the nature of the regulations involved, it is strongly recom-

mended that a competent process authority having expert knowledge of
regulations and thermal processing be consulted. Such consultation will
help avoid costly mistakes and unnecessary delays in production startup.
In addition to the pertinent regulations, a processor must take into con-
sideration the type of product to be processed, the type of container to be
used, the sterilant to be used, the production rate (i.e., product flow rate or
container production rate), and a variety of other production parameters.
As an example, if the product contains large particles, the type of filler to
be used will be different than for products that are homogeneous and do
not contain particles. The various factors involved in the selection process
are largely interrelated and oftentimes dictate the choice of equipment
available, especially for packaging.

9.4 Process schematic and process and

instrument diagrams (P&IDs)
9.4.1  Process schematic
The first thing that should be done for any product—whether it be meat,
poultry, or milk, or an acidified or acid product—is to prepare a process
schematic. This should be in enough detail to determine that the product
can be processed, the system can be sterilized, the system can be idled
(i.e., stop, start, restart), the system can be cleaned, and the system can be
switched from water to product or from product to water. The method(s)
of heating and cooling are often determined by a process authority, and
a cross-functional team consisting of process engineering, product devel-
opment, sensory, packaging, microbiology and other disciplines.
The process schematic should be accompanied with a general written
description, which will indicate how the various operations stated will
be accomplished and agreed to by all personnel including management,
quality assurance and control, product development, and even sales. Then
a more detailed process and instrument diagram (P&ID) should be pre-
pared. In conjunction with the P&ID, a detailed description of all unit
operations is required.

9.4.2  P&ID schematic

The P&ID should be in much greater detail than the process schematic and
must show every detail of valves, heat exchangers, holding tubes, product
line sizes, product line changes, and length of line. On an accompanying
sheet(s), because most commercial processes will be extensive, a listing of
the various components should provide enough detail that the engineers
can know important aspects required to design the system properly. For
142 Handbook of aseptic processing and packaging

example, details given for a valve should include its size, the pressure of
air that is required if it is air actuated, sanitary design, cleanability (clean-
in-place [CIP] or sterilization-in-place [SIP]), hermeticity, and compliance
to 3A standard.
The P&ID should be provided in numerous versions, that is, in stages
and sequence indicating the flow of critical materials during various opera-
tions. Critical materials would be water during sterilization or product
during operation, heating water or steam, cooling water (tower, well, or
refrigerated), air, electrical, CIP solutions, chlorination, and so on. It should
be determined by the engineer whether the pressures in the heat exchanger
shells or jackets are within the safe limit of the design of the heat exchangers.
The size of interconnecting tubing and the flow through the heat
exchangers during sterilization, operation, and CIP should be determined
and verified for their adequacy. For example, if the flow through the hold-
ing tube is not of the proper velocity, laminar flow may exist. If products
such as eggs or chocolate toppings are processed, the holding tube may
effectively decrease in size as the production run progresses through the
day, due to product buildup or fouling, if not corrected.

9.5  Preinstallation review

Once the equipment—processing, packaging, pumping, and controls—are
selected, the processor should work with a process authority in reviewing
the overall design of the aseptic system. This review should include the
processing and packaging systems and the interface, including the aseptic
surge tank, if any. The process authority will review in detail the equip-
ment presterilization procedures (processing systems, packaging systems,
filler, aseptic zone, surge tanks, interfaces, and sterile gas lines), produc-
tion procedures, procedures for maintaining sterility within the system
at all times, postprocess cleanup procedures, record keeping, and quality
control procedures.
During this review a hazard analysis and critical control points
(HACCP) system should be established. It is during this review that a haz-
ard analysis (HA) is conducted and critical control points (CCPs) are identi-
fied along with monitoring requirements and corrective actions necessary
when they are out of specification. It is important to note that the low-acid
canned food (LACF) regulations do all this.
The process authority should review the system in terms of critical fac-
tors that would have to be controlled, monitored, and recorded during all
phases of the operations. Critical factors are those parameters that could, if
out of specification, affect the eventual sterility and quality of the products.
A preliminary list of critical factors is prepared at this time. A list of critical
control parameters is generally a part of the process filing that will eventu-
ally be submitted to the appropriate regulatory agency for acceptance.
Chapter 9:  Validation and establishment of aseptic processing 143

During this review, the process authority also reviews the instrumen-
tation and controls on the aseptic processing and packaging systems to
ensure that they meet the requirements of the regulations. As a part of
this, the process control software and operation is reviewed to ensure that
appropriate alarms and monitoring functions will be conducted during
all phases of the operation. Any incompatibilities between the processing
and packaging systems should be resolved at this point.
The last phase of the preinstallation review involves the preliminary
design of the system and challenge testing that would be considered neces-
sary by the process authority to assure proper functioning of the equipment.
A process authority should be cognizant of the type of data the regulatory
agency will require during its review of the process filing. The tests should
be designed to ultimately convince the regulatory agencies that the finished
container of product would be commercially sterile and shelf stable.
Any major modifications necessary should be implemented prior to the
installation of the equipment. Modifications to equipment after installation
are almost always more difficult and often expensive. A system needs to
be revalidated after any modification. All modifications should be handled
through a dedicated change control management policy and procedure,
and reviewed, endorsed, and documented by a cross-functional team.

9.5.1  Sterilization, operation, clean-in-place, and maintenance

It must be defined, in writing, how the system will be sterilized and cleaned.
Sterilization can be readily checked through inoculated packs or inocula-
tion of vulnerable areas, and if satisfactory, the filing can be made to the
FDA. However, if the system operates only for 1 to 2 hours before fouling
occurs, it must be stopped, cleaned, resterilized, and then switched to prod-
uct for operation. This obviously is not a satisfactory procedure. The reason
for fouling must be determined and corrections must be made.
The process system and packaging machine must be designed in such
a manner that people normally available in food plants can operate the
system with the appropriate aids provided. These aids include colored
schematics and written instructions, along with periodic training and
education and certification as appropriate.
Usually, process systems are fairly simple to operate compared to the
packaging system machine. Even so, it is advisable to have the suppli-
ers provide individuals to start the system, make adjustments if required,
process product after initial sterilization, and CIP the system the first
week or two of operation, and train the operators so they can do the same
thing with confidence.
If the system is one that requires a significant amount of maintenance,
the maintenance department needs to know what makes up the system so
spare parts and critical items can be installed when required and checked
144 Handbook of aseptic processing and packaging

at certain intervals. The maintenance crew should be trained additionally

in preventive maintenance and aseptic techniques.
The same is true, and probably more so, with certain packaging sys-
tems that are used. Some packaging systems are fairly simple while oth-
ers are very complex. The strength of the peroxide solution is generally
checked in the quality control (QC) laboratory; hence, the lead operator
must verify the information regarding the strength of the hydrogen per-
oxide on a regular basis by report. Anytime the source of hydrogen perox-
ide is changed (i.e., carboy or drum) or whenever the shipment is changed,
the strength of the sterilizing solution must be recorded. Also, the opera-
tor must determine at the end of the day, and possibly throughout the day,
the strength of the hydrogen peroxide and the consumption rate required
to adequately perform the job required.
The cleaning crew, which may include individuals from the opera-
tion crew, should verify that cleaning has been performed properly and
that the system is clean. This can be done with tubes by examining them
with a flexible borescope on a routine basis. For other items of process or
packaging equipment, visual examination can indicate grossly soiled sur-
faces. Any surface that is suspect should be examined by a member of the
QC laboratory, using swabbing or some other appropriate microbiological
technique.

9.5.2  Interlocks
The design engineer must also arrange the process system so certain
interlocks are provided. A bare minimum would be the time–tempera-
ture used for initial sterilization of the system. This would be expanded
to the temperature used during processing. If an acid product is being
processed, this should be further expanded to ensure that any water
used to flush the system or to allow the system to operate (idle) intermit-
tently is of the proper pH. This is because sterilization of certain acid
products is a function of time–temperature–pH. Also, certain organisms
that may not be inactivated if the pH is too high may be deposited on a
surface and later grow and multiply and thereby cause spoilage of the
final product.

9.5.3  Hold tube

It must be determined by the engineer whether the holding tube has been
properly designed. The holding tube should provide, as a minimum, tur-
bulent flow and ideally turbulent and secondary flow. Secondary flows
tend to clean the metallic surfaces and biofilms as these surfaces are
reduced. Secondary flow provides the best opportunity for the residence
Chapter 9:  Validation and establishment of aseptic processing 145

time of particles and liquids to be the same. Without using secondary

flows, depending upon the product, the hold time may vary consider-
ably. To provide the best opportunity for secondary flows to exist, the
tube should be coiled and a proper radius to diameter (r/D) should exist.
The holding tube must be pitched so it is free draining and it should be
insulated. Considering temperatures of hold at 185°F to 300°F, insulation
is important. It is important to prevent temperature loss of the product
being held and to prevent the holding tube acting as a radiator and heat-
ing the processing area.

9.5.4  Timing pump

Certain pumps do not hold up well if they are operated on water, on
CIP solutions, or without product. When the pump wears, the process
is still legally safe; however, product quality may suffer because it may
be held for a longer period of time. Hence, any pump that has the char-
acteristics of wearing should be equipped with a flowmeter on the dis-
charge side. The flowmeter should either directly control or indicate the
rate through the system. If the timing pump needs to be adjusted, then
the operator can do this, or the operator may have maintenance do it if
interlocks are involved, which would cause problems with the control
system.

9.5.5  Controls
The control system used, in addition to providing interlocks for tem-
perature–time during sterilization and temperature during operation,
can provide interlocks on everything including the amount of product
that is available for processing, steam and cooling water temperatures/
pressures, opening and closing of steam/water valves, starting off and
stopping of pumps when the operation is complete, and so on. However,
a sophisticated control system may be difficult to operate. It is probably
more difficult to maintain because any alteration can cause the system to
stop. Usually, such control systems are used by companies that have large
engineering and maintenance staffs, so if there ever is a problem, it can be
investigated and quickly corrected.
On the other hand, certain companies do not have extensive mainte-
nance and engineering staffs. In fact, they must contract for such services.
To provide a sophisticated control system with interlocks may not be in
the best interest of the user.
The best approach may be to simplify the controls and provide the
minimum number of interlocks to ensure the proper operation and pro-
duction of a commercially sterile product. It must also be recognized that
146 Handbook of aseptic processing and packaging

all systems, no matter how sophisticated, require an operator to be on the

floor to interact with the machine and resolve alarms and other feedback
requiring follow-up or corrective action.

9.6  Postinstallation review

Reviewing aseptic processing and packaging equipment after it is
installed is an essential part of ensuring that the ultimate routine opera-
tion will not result in compromising product safety. Oftentimes, there are
subtle differences between the way the equipment is installed and the
way it appeared in an engineering drawing. These differences may be in
the way sanitary valves are installed, or the way process piping is laid
out, or the installation may have resulted in parts of the piping being dif-
ficult to clean or sterilize. Examples of these types of apparently minor
problems include improper mounting of sanitary diaphragm valves or
steam-traced sanitary valves mounted such that it may be difficult to
detect blocked steam tubing. An experienced process authority should
be able to detect the types of problems that may compromise product
sterility even on rare occasions. On occasion it may be necessary to add
additional barriers to counter potential microbial reentry points.
During this postinstallation review, a complete review of the instru-
mentation and control system as installed is conducted. It is important to
ensure that the aseptic system not only meets the letter of the law but also
satisfies the intent of the regulations, which is to ensure that only com-
mercially sterile food reaches the consumer.
A revised list of CCPs is made during this review along with corrective
actions to be taken if a deviation from a critical limit occurs. Additionally,
critical limits of all critical control points are established in consultation
with a process authority and the equipment suppliers. The critical limits,
possibly CCPs, and methods to monitor CCPs may be revised based on
the results of equipment validation tests.

9.7  Equipment testing and validation

Aseptic systems are extremely complex by their very nature (refer to
Chapters 11, 12, 13, and 15). There are, on occasion, incompatibilities
between various parts of the system. However, these incompatibilities are
generally resolved during the review phases of the project. In spite of this,
testing the aseptic processing and packaging systems is critical to ensure
that they perform as designed and required.
The major parts of the aseptic system, namely, processing system,
surge tank, packaging system, interface, cleaning, sealing, splicing, start/
stop, aborts, extended runs, and sterile CIP are tested separately using dif-
ferent procedures, as described next.
Chapter 9:  Validation and establishment of aseptic processing 147

9.7.1  Aseptic processing system

The ability of an aseptic processing system to deliver a calculated thermal
process and produce commercially sterile product is generally tested by
an inoculated pack test. An inoculated pack test consists of batch inoculat-
ing a product with an appropriate test organism and then processing and
packaging the product at different levels of preselected lethalities (process
temperatures at one residence time). The product to be used should be such
that it will support the growth of any surviving test organisms. It may be
necessary to use the specific product that the processor will eventually pro-
duce at the facility, to correlate flow characteristics, residence time distri-
bution (RTD), microbial resistance, and so on. The test organism to be used
should be such that it has a higher resistance in the product, that is, moist
heat in this case, than spores of Clostridium botulinum. The highest lethal-
ity during the test is generally the time–temperature combination result-
ing in commercial sterility to be used in the eventual filed process. This
process is generally more severe than the process that would result in a 12
log reduction of C. botulinum as described in Chapters 11 and 15. The test
organism most often used is Clostridium sporogenes (PA 3679) spores; how-
ever, other test organisms may be used. Denny et al. (1979) listed a number
of test organisms suitable for various types of microbiological challenge
tests. However, C. sporogenes is selected because surviving spores produce
gas and a characteristic putrid odor, which is easy to detect, that confirm
the presence of surviving test organism. Sometimes detection, microbio-
logical identification, and enumeration of surviving microorganisms may
require more tedious and expensive procedures.
The product processed during validation is packaged aseptically via
the packaging machine that has yet to be validated with the assumption
that all packages are sterile and hermetic. The containers are labeled to
identify the process temperature used and incubated at a temperature
suitable for growth of the test organism. If C. sporogenes is used, the incu-
bation temperature is generally 35°C because the test organism is a meso-
philic spore former. The product is incubated for a period long enough
(3 to 4 weeks) to ensure that any surviving injured spores had an oppor-
tunity to grow and produce spoilage, that is, gas and odor.
The challenge level or titer of the test organism used should be such
that there are no survivors at the highest process temperature, and the
product is commercially sterile. As an example, suppose that the test
organism has a heat resistance of D250°F = 1.0 minute in product, and
that at least a 5 log reduction of the test organism is necessary for com-
mercial sterility. If 100 containers of the product are to be incubated, the
inoculum must be such that the product would contain at least 10,000
spores or surrogate per container. A successful test would result in no
spoilage in product processed at the highest temperature, indicating that
148 Handbook of aseptic processing and packaging

the time–temperature combination is adequate for commercial sterility

and complete spoilage at the lowest temperature. Spoilage at the low-
est temperature confirms that nonspoilage at the higher temperatures
represents a kill rather than inability of the injured spores to grow in
the product. Ideally, a test is designed to result in no spoilage at the two
higher temperatures and spoilage at the two lower temperatures. This
would provide an additional safety margin built into the calculated ther-
mal process.
An essential part of this test is aseptic filling. Thus, this test should
only be conducted after the aseptic packaging system is operational and
is assured of production of sterile containers. Improper operation of the
aseptic packaging machine would invalidate this upstream test.

9.7.2  Aseptic surge tank

If the aseptic system has an aseptic surge tank to hold cold sterile prod-
uct, this tank must be sterilized prior to production. Generally, sterile
product held in the surge tank is maintained under positive pressure
using sterile air or nitrogen. Thus, the sterile gas lines and filters, if
any, used for sterilizing the gas must be presterilized. The tank is con-
nected to the processing and packaging systems with a series of auto-
matic valves. Thus, all the valves in all positions and ancillary piping
must be presterilized.
As a rule, the surge tank, sterile air filters, valves, and piping are pre-
sterilized by saturated steam. The minimum presterilization requirement
for a surge tank should be obtained from a competent process author-
ity. Generally, 30 minutes at 121°C (250°F) or equivalent is sufficient. If a
higher temperature is used, sterilization time may be reduced. However,
sterilization time less than 15 minutes is not recommended because por-
tions of the system will heat by conduction and a certain amount of time
is needed to heat these sections.
Depending on the complexity of the design of the aseptic surge tank
and the interconnecting valves and piping, testing may be restricted to
temperature monitoring at several locations (temperature distribution
test) or a microbiological challenge test may be needed. If, in the judgment
of the process authority, only temperature monitoring is necessary, the
procedure is relatively simple. Various locations in the surge tank and the
valves and piping are instrumented with temperature-monitoring devices
(thermocouples or RTDs) and the surge tank sterilized per the procedure
recommended by the manufacturer. Temperatures at the instrumented
locations are monitored to ensure that the sterilization cycle minimum
time and temperature is attained and completed as designed. If any cold
spots are identified in the system, a modified sterilization procedure is
Chapter 9:  Validation and establishment of aseptic processing 149

recommended by the process authority. Also, steam quality should be

compliant with PMO and LACF requirements.
If the surge tank, valves, and piping are so complex that, in the judg-
ment of the process authority, a microbial challenge test is recommended,
the following procedure may be used. As mentioned earlier, a microbio-
logical test requires using a test organism that has a higher resistance to
the sterilant (saturated steam in this case) than the most resistant patho-
gen, namely, C. botulinum spores. Appropriate quantities of the test organ-
ism are placed at preselected locations in the surge tank, valves, and piping
prior to running the surge tank sterilization cycle. There are a number of
ways of placing test organisms at selected locations. The most common
method is to place a measured quantity of spore suspension on prester-
ilized aluminum or stainless steel strips with a foil tape for attachment.
These strips are then attached at the test site just prior to the test. After
the test, the strips are aseptically recovered and placed in an appropriate
growth medium and incubated at an appropriate temperature for recov-
ery of the test organism. Based on the number of organisms on the strips
(103, 104, 105, or 106) and the heat resistance of the microorganism, the total
lethality delivered can be estimated. Alternative methods, such as drying
spores directly on equipment surfaces and recovery of survivors by swab-
bing after sterilization, may also be useful. The microbial lethality deliv-
ered should be at least sufficient for commercial sterility.
The choice of the test organism is left to the process authority. As a
general rule, heat-resistant spores of Bacillus stearothermophilus are used.
Because the strips recovered after the test are directly transferred into
transparent tubes of an appropriate growth medium, detecting surviv-
ing organisms is relatively easy and quick (3 to 5 days at 45°C to 55°C).
However, other suitable organisms may be used with equal effectiveness.
The surge tank sterilization cycle recommended may be modified if
the microbiological test results are not satisfactory. On occasion, instru-
mentation requirements and monitoring procedures may be changed.
If microbial filters are used for sterilizing air or nitrogen, the filters
should be tested for integrity by the ASTM method prior to installa-
tion and to ensure that they are functioning properly. Depending on the
design, a postinstallation test may be necessary to ensure proper seating
of the filter.
If an incinerator is used with the filter for producing sterile gas, it is
important to ensure proper functioning of the temperature-monitoring
and recording instrumentation. In addition, proper functioning of the
sterile air cooler must be ensured. Both filters and incinerators are recom-
mended for producing sterile air or gas used with a surge tank used with
LACFs. Need to develop specific procedures to properly handle presteril-
ization of hydrophobic filters.
150 Handbook of aseptic processing and packaging

9.7.3  Aseptic packaging system

Testing an aseptic packaging machine is by far the most complex and
resource intensive of all the tests that are necessary to assure commercial
sterility. U.S. regulators are the only ones that require the kind of exten-
sive testing described in the following sections.
A typical aseptic packaging machine consists of a product filler
and ancillary piping and filler bowl, sterile gas lines and filters, sec-
tions where containers and lid materials are sterilized, an aseptic zone
where containers are filled and sealed, and perhaps a container conveyor
that may enter and exit the sterile zone. These sections are presterilized
before containers can be filled and sealed. The same sterilant may or may
not be used in all of the aforementioned sections. Once these sections are
presterilized, they are maintained sterile during all phases of produc-
tion. Thus, testing of this type of aseptic packaging machine involves
several tests:

1. Filler and filler bowl sterilization tests, and sterile gas lines and filter
sterilization tests
2. Aseptic zone sterilization tests
3. Container and lid sterilization tests
4. Conveyor (if any) sterilization tests

9.7.3.1 Filler and filler bowl sterilization tests and

sterile gas lines and fiber sterilization tests
The product filler and filler bowl (if any) are generally presterilized by
saturated steam along with sterile gas lines and sterile filters. There are
some exceptions where the sterile gas lines and filters are sterilized with
hydrogen peroxide (H2O2) or the filler is sterilized with superheated
steam. Testing of the sections presterilized by saturated steam involves
monitoring the temperature of steam leaving the system during presteril-
ization to ensure that the temperature is at least 121°C (250°F) for at least
30 minutes or its equivalent (as long as the time is no less than 15 min-
utes). If the design of the machine is complex or if the temperature can-
not be monitored where required, the process authority may recommend
conducting a microbiological challenge test to assess the adequacy of the
presterilization cycle. The procedure would be similar to that described
in Section 9.7.2.
If hydrogen peroxide is used as a sterilant, microbiological challenge
tests will be necessary to ensure that commercial sterility is achieved.
Thus, it is necessary to identify and use a test organism that is more resis-
tant to H2O2 than C. botulinum. Test methods and recovery procedures to
be used are similar to those described in Section 9.7.2. Generally, hot, 35%
Chapter 9:  Validation and establishment of aseptic processing 151

H2O2 is used as a sterilant. Liquid or vapor phase H2O2 may also be used.
However, during microbiological challenge testing, 32% to 34%  H2O2 is
generally used. The temperature of H2O2 used must be the lowest tem-
perature recommended by the equipment manufacturer. During subse-
quent production, if the temperature drops below the test temperature or
the H2O2 concentration drops below the test concentration, commercial
sterility of the product may be jeopardized and the product may have to
be prevented from reaching the consumer. Careful records of the H2O2
concentration, temperature, consumption rate, and contact time must be
kept to correlate with the lethality achieved.
For fillers presterilized by superheated steam, temperatures as high
as 232°C (450°F) for 30 to 60 minutes may be necessary. Testing procedures
would be similar to those that use saturated steam.

9.7.3.2  Aseptic zone sterilization tests

9.7.3.2.1   Presterilization  The aseptic zone of the machine may
be sterilized by H2O2, superheated, saturated steam, or hot air. Tests to
assure adequacy of the presterilization cycle almost always have to be
done using microbiological methods. Test strips inoculated with a mea-
sured quantity of the appropriate test organism are placed in a number
of locations and the test conducted in the manner described for surge
tanks. The actual presterilization test must be run using the lowest tem-
perature, the lowest concentration of the sterilant, and the shortest time
recommended by the equipment manufacturer (minimum operating
conditions of all critical factors). If the results indicate commercial ste-
rility, one is assured of commercial sterility during normal production
conditions. If tests fail, adjustments in the presterilization procedure are
often necessary.

9.7.3.2.2   Maintenance decontamination  During production, the ste-

rility of the aseptic zone is sustained by maintaining a positive pressure
inside the aseptic zone, generally by sterile air. If this sterile air is pro-
duced by a flow of air through HEPA filters, the surface of the HEPA filter
must be presterilized. The presterilization cycle for the HEPA filters must
also be tested for adequacy in a manner similar to the procedure for the
sterile zone.
As in the pharmaceutical industry, maintenance decontamination is
routinely validated using 3 × 3000 media fill runs. The low-acid medium
of choice in the food industry is skim milk with iron salt. The three con-
secutive runs are separated by deliberate stops. The subsequent runs
are restarted without any intermittent presterilization step. The finished
product (9000 containers) is incubated for 10 to 14 days at 35°C, followed
by microbiological and package integrity tests.
152 Handbook of aseptic processing and packaging

The limitations of these 3 × 3000 runs are

1. Short duration of 5 to 30 minutes at the most

2. Not reflective of longer production runs of 8 to 16 hours
3. Validation of preceding “severe” presterilization test rather than the
intended “gentle” decontamination process

Alternative methods for validating the maintenance decontamination

of the aseptic zone are discussed in Chapter 15.

9.7.3.3  Container and lid sterilization tests

The containers and lids are generally sterilized separately prior to entry
into the sterile zone. The test of adequacy of container and lid material
sterilization requires inoculating the container or container material and
lids or lid material with a test organism suitable for the sterilant used. A
set of inoculated containers and a set of inoculated lids are then sterilized
alternatively using the minimum conditions recommended by the equip-
ment manufacturer (minimum sterilant quantity, minimum temperature,
minimum concentration, time, etc.). The container is then filled with ster-
ile food material or media, preferably sterilized through the aseptic pro-
cessing system, sealed, and incubated under appropriate conditions for
the test organism used.
Inoculating the container material for machines that form the con-
tainers themselves is tricky because it is necessary to ensure that the
section of the material inoculated eventually ends up being inside the
container. Inoculated containers and lids should be incubated in a man-
ner to ensure that any surviving test organisms will be in contact with the
growth media filled in the container and can be detected during incuba-
tion. The tests conducted are specific for the package materials tested. A
process authority should be consulted if any changes are made, because
additional testing may be required.

9.7.3.4  Conveyor chain sterilization tests

If a conveyor or conveyor chain is used to transfer the containers or con-
tainer material through the aseptic zone, then it is necessary to presteril-
ize the conveyor or conveyor chain prior to product filling and sealing. In
addition, because the conveyor or chain leaves the aseptic zone and reen-
ters, it can possibly recontaminate the aseptic zone. Thus, the conveyor or
chain must be washed to remove any spilled product and continuously
resterilized prior to entry into the aseptic zone. This is an extremely dif-
ficult task and the procedure must be tested using microbiological tests
described in earlier sections. As always, a test organism appropriate to the
sterilant used must be used.
Chapter 9:  Validation and establishment of aseptic processing 153

9.8 Thermal process design for products

containing particles (principles
applicable to homogenous fluid foods)
The regulations governing the production of aseptically processed and
packaged low-acid foods containing particles are the same as those
described in Section 9.3. These regulations are very general in nature;
publications such as those by Dignan et al. (1989) and Pflug et al. (1990)
provide an interpretation of FDA regulations and may be helpful to pro-
cessors considering LACF production of aseptically processed and pack-
aged foods containing particles.

9.8.1  Scraped surface heat exchangers with straight hold tubes

Thermal process design for aseptically processed low-acid heterogeneous
foods containing discrete particulates in scraped surface heat exchangers
(SSHE) with straight hold tubes represents a special case and is complex.
A basic thermal process consists of an elevated temperature applied to
product for a predetermined time, resulting in a specific lethality or bacte-
rial destruction. A commonly used index of lethality is referred to as an Fo
value, as described in Chapter 11. In any food processing system, instant
elevation of temperature to the processing temperature is almost impossi-
ble. Thus, knowledge of the rate of temperature increase becomes critical,
especially for foods that heat slowly. In a retort process, the temperature of
the contents of a container can be monitored during heating to determine
this relationship. However, for discrete particles, suspended in a fluid and
moving continuously, particle temperature cannot be reliably monitored.
Thus, one must resort to predicting the rate of temperature change using
sound engineering principles based on the mathematics of transient heat
transfer. Fortunately, this problem has been studied extensively over the
past 20 years (de Ruyter and Brunet 1973; Manson and Cullen 1974; Dail
1985; Sastry 1986; Chandarana and Gavin 1989; Chandarana et al. 1989;
Chang and Toledo 1989; Larkin 1989). Each of these researchers used
sound principles but used different techniques and assumptions, some
of which may not be realistic, in their model development. The accuracy
of the prediction of the rate of temperature change then depends in part
on the target Fo value selected, thermophysical properties of the prod-
uct, particle dimension, shape, and distribution, particle–fluid interface
convective heat transfer coefficient, residence time distribution, and the
fluid temperature variation with time. The fluid temperature essentially
provides the driving force for the transfer of heat into the particle. The
process of biological validation is extremely complex and the details are
outlined by Chandarana (1994) and Bhamidipati and Singh (1995).
154 Handbook of aseptic processing and packaging

To aid processors in developing a validated process schedule for

low-acid particulate foods, a series of industry–university–government
workshops on aseptic processing of multiphase foods were conducted
by the National Center for Food Safety and Technology in Chicago, the
University of California at Davis, and the Center for Aseptic Processing
and Packaging Studies at North Carolina State University at Raleigh. This
resulted in the publication of the Case Study for Condensed Cream of Potato
Soup from the Aseptic Processing of Multiphase Foods Workshop (Anon. 1996).
Other results of the workshop were summarized in a series of articles that
appeared in Food Technology magazine (Damiano et al. 1997). Based on the
recommendations of the workshops, Tetra Pak, Inc. (with the assistance of
the National Food Processors Association [NFPA]) developed the neces-
sary data required for filing a scheduled process for aseptic processing of a
low-acid product (cream of potato soup). The filing resulted in a “no-objec-
tion” letter from the FDA in May of 1997. It was thus demonstrated that it
was indeed possible for processors to adopt the recommendations of the
workshop to gain the “approval” of the FDA for aseptically processing low-
acid foods containing large particulates. A detailed description of process
filing using the FDA form 2541c (for aseptic processing of low-acid foods)
has been described by Sastry and Cornelius (2002). Chapter 14 of this book
focuses on aseptic processing of particulate foods and validation tools.

9.8.2  Microbiological validation

9.8.2.1  Microbiological aspects
Microbiological validation of a calculated process for aseptically pro-
cessed and packaged foods containing particles is necessary according
to the regulatory agencies. For traditionally canned foods, microbiologi-
cal validation is not required if the filed process is based on properly
designed heat penetration tests. This unusual requirement for aseptically
processed foods containing particles is because the calculated process
is not based, in a strict sense, on heat penetration testing under actual
processing conditions and there is no operating history for these types
of products.
A microbiological validation test consists of inoculating particles
of food with heat-resistant spores of an indicator organism, processing
the food through the aseptic system under a number of conditions, and
recovering the product aseptically. There are two distinct methods used:
inoculated pack and count reduction. Both these methods essentially con-
firm the calculated process by biological means. Pflug et al. (1990) have
described, in some detail, the microbiological validation tests along with
some of the difficulties encountered.
Bacterial spores have been inoculated into the food by the method
described by Segner et al. (1989), who threaded bacterial spores on a string
Chapter 9:  Validation and establishment of aseptic processing 155

into food particles, or by the method described by Dallyn et al. (1977),

in which bacterial spores were mixed and immobilized in alginate gel.
This method was also applied to food/alginate particles by Brown et al.
(1984). A third method was described by Sastry (1986), who actually drew
spores into mushrooms by using a vacuum. The method of Brown et al.
has an advantage over the other methods in that inoculated cubes with
spores suspended uniformly can be manufactured in large quantities.
The FDA has taken the position that the microbiological validation tests
do not necessarily validate commercial sterility of the product at the hold-
ing tube exit, but include lethality contributed by the entire processing
system (i.e., heaters, hold tube, and coolers). The NFPA, in conjunction
with several member companies, has studied the effect of cooling lethality
on inoculated pack tests (Unverferth and Chandarana 1994). Inoculated
packs with and without particle disruption in the coolers were conducted.
Results indicated that microbiological validation tests confirmed the con-
servative nature of the process calculation method used in describing the
thermal process.

9.8.2.2  Quality and optimization considerations

It has been the experience of several food processors that making con-
servative assumptions at every step of the process development results
in a product with less than optimum quality. However, with appropriate
experimental research on the critical parameters, quality improvement
and optimization is possible. Even minor formulation changes may have
an impact on the final thermal process recommended by a process author-
ity. It is recommended that a competent process authority be involved
early in the development phase.

9.8.3  Process filing

The preparation of a process filing actually begins from the time the new
product–process–package combination is conceived. Process develop-
ment, product development, engineering, packaging, and quality control/
assurance staff should simultaneously consult with a competent thermal
process authority experienced with low-acid process filing. Based on gen-
eral product description and formulation information, it is possible for a
process authority to provide an experimental process that could be used
as a starting point for product development purposes only.
Depending on the product, it is recommended that the processor or
process authority experimentally determine the target Fo value and the
thermophysical properties of the food while the product development
group is finalizing the product formulation. Initially, it is likely that the
time–temperature combination found to be acceptable for product qual-
ity may be wholly inadequate for submission as a thermal process filing.
156 Handbook of aseptic processing and packaging

This usually occurs because only the lethal effect in the holding tube can
be used to support a process filing. This is a conservative approach and
it results in some overprocessing. If experimental determination of target
Fo and thermophysical properties is not possible, a literature search for
appropriate information should be initiated.
It is very important to emphasize that due to the nature of the prod-
uct, process, or package, the processors should meet with the regulatory
agency in question early in the development phase. Keeping the regula-
tory agency informed could save a processor a lot of time and expense
of repeated tests. If the regulatory agency has questions or concerns,
they should be addressed as soon as possible. This type of information
exchange is common for USDA-regulated products.
After an appropriate incubation period and comprehensive review, if
the data support the calculated process, the process filing along with the
necessary supporting information (data, list of critical factors, operational
procedures, quality control procedures, and equipment sterilization pro-
cedure) should be submitted to the regulatory agency.
It is difficult to estimate the time it would take to have regulatory
acceptance (FDA) or approval (USDA) of the designed schedule process.
The time frame depends in part on the initial research phase and in part
on the review process at the regulatory agency.

9.9 Factors other than temperature

contributing to nonsterility
Sterilization of the product assumes the heat transfer surfaces and all the
surfaces that can contaminate the product are clean. If they are not clean
then the questions are: How dirty are they? Is the soil 1/10 inch, or 1/100
inch, or something in between? Hence, the system should be checked reg-
ularly to verify that the cleaning cycle is adequate. As indicated, this can
be done by visually observing surfaces that can be seen, use of a flexible
borescope to examine the inside of pipelines and gaskets or joints, and
so on. If there is any question whether the equipment in the system has
been cleaned, the process of cleaning should be evaluated and possibly
changed. As a minimum, another cleaning cycle should be performed.
This examination should occur at least weekly or more often when the
system is initially started. The cleaning procedure must be documented
and stated explicitly in written terms. It should be checked more often when
the system is first started to verify that cleaning has been properly done.
The equipment should be checked for leaks by either pressure testing
or vacuum testing to ensure contaminants are not being drawn into the
sterile portions of the system. This check should be performed to verify
that the system will contain pressure or hold a vacuum, and swab tests
Chapter 9:  Validation and establishment of aseptic processing 157

may be desirable. Certain devices, such as agitator shafts, pump seals, and
heat exchanger seals, can contribute contaminants on an infrequent basis.
They should be taken apart and hand cleaned regularly to ensure con-
tamination does not occur.
Samples of the product in the final container should be examined.
Microbiological sampling, tests, and data interpretation are discussed in
Chapter 12.
If the product is filled into large industrial-sized containers (e.g.,
55- or 300-gallon bags, or 200-gallon stainless steel totes), then the prod-
uct should be sampled and tested. These packages should be evaluated
with samples taken at the beginning and end or the top and bottom of a
55-gallon bag, and at the middle of a larger bag or stainless steel tote. The
bacteriologist must determine what type of test should be performed for
the types of organisms that traditionally grow and cause problems with
these products. Usually, a duplicate set of samples is taken. One set of
samples is tested and examined by the processor and a report indicat-
ing the results and comments filed for each container. A duplicate set of
samples is usually supplied to the customer with a copy of the report cov-
ering the analysis of the samples by the processor. The customer will then
often test the samples provided, and a separate analysis will be made. If
both analyses are satisfactory, then the container will be used. If there are
any problems and the customer’s analysis indicates contamination, the
container with product should be returned to the processor.

9.10  Summary
Aseptic processing and packaging of foods is an attractive technology,
though complex compared to canning operations. This chapter briefly
outlined some considerations pertaining to the management decision
process, equipment selection, process schematic and P&ID, pre- and post-
installation reviews, equipment testing, and thermal process design for
products containing particles using SSHE.
It is very important to obtain both microbiological challenge and
spoilage track data for evaluation of process, product, and package capa-
bilities and deliverables. Challenge testing, though severe, are performed
over a short period of time and do not include system perturbance and
compromises typical of long and extended production runs of 12 to 120
hours. Also, it is difficult to partition the protective effect of sanitation,
CIP, and presterilization from that of short validation and commissioning
runs intended to test maintenance decontamination of the aseptic zone.
In other words, it is necessary to evolve validation and online measure-
ment tools to evaluate long-term “dynamic sterility” of the aseptic zone,
as discussed in Chapter 15. As stated earlier, it is desirable to have both
158 Handbook of aseptic processing and packaging

challenge data and historical process spoilage analysis for an understand-

ing of process capability and deliverables.

Acknowledgments
The authors express appreciation to Dr. Dilip I. Chandarana, Center for
Food & Pharmaceutical Process (IEH Laboratories & Consulting Group),
Dublin, California; and Dr. Kai Purohit, Process Tek, Prospect Heights,
Illinois, for their useful discussion and critical review of this chapter,
and for permission to use several of their published and unpublished
materials in the evolution of this chapter.

References
Anon. 1984. Guidelines for Aseptic Processing and Packaging Systems in Meat
and Poultry Plants. Washington, DC: U.S. Department of Agriculture.
Anon. 1996. Case Study for Condensed Cream of Potato Soup from the Aseptic Processing
of Multiphase Foods Workshop. Published by the National Center for Food
Safety and Technology in Chicago, IL, and the Center for Aseptic Processing
and Packaging Studies at North Carolina State University at Raleigh, NC.
Bernard, D.T., Gavin, A., Scott, V.N., Polvino, D.A., and Chandarana, D. 1987.
Establishing the aseptic processing and packaging operation. In Principles
of Aseptic Processing and Packaging, edited by P.E. Nelson, J.V. Chambers, J.H.
Rodriguez. Washington, DC: The Food Processors Institute.
Bhamidipati, S., and Singh, R.K. 1995. Design considerations in aseptic process-
ing of foods. In Food Process Design and Evaluation, edited by R.K. Singh.
Lancaster, PA: Technomic Publication.
Brown, K.L., Ayres, C.A., Gaze, J.E., and Newman, M.E. 1984. Thermal destruction
of bacterial spores immobilized in food/alginate particles. Food Microbiology
1:187–198.
Chandarana, D.I. 1994. Aseptic Processing and Packaging of Foods: A U.S.
Perspective. Symposium on Appertization—Art and Manner. Paris, France,
December 14.
Chandarana, D.I., and Gavin, A. 1989. Establishing thermal processes for heteroge-
neous foods to be processed aseptically: A theoretical comparison of process
development methods. Journal of Food Science 54(1):198–204.
Chandarana, D.I., Gavin, A., and Wheaton, F.W. 1989. Simulation of parameters
for modeling aseptic processing of foods containing particulates. Food
Technology 43(3):137–143.
Chang, S.Y., and Toledo, R.T. 1989. Heat transfer and simulated sterilization of
particulate solids in a continuously flowing system. Journal of Food Science
54(4):1017–1023, 1030.
Dail, R. 1985. Calculation of required hold time of aseptically processed low acid
foods containing particulates utilizing the Ball method. Journal of Food Science
50:1703–1706.
Dallyn, H., Falloon, W.C., and Bean, P.G. 1977. Method for immobilization of bac-
terial spores in alginate gel. Laboratory Practice 26:773–775.
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Damiano, D., Digeronimo, M., Garthwright, W., Marcy, J., and Sastry, S.K. 1997.
Workshop targets continuous multiphase aseptic processing of foods. Food
Technology 51(10):43–62.
Denny, C.B., Shafer, B., and Ito, K. 1979. Inactivation of bacterial spores in products
and on container surfaces. In: Proceedings of the International Conference
UHT Processing and Aseptic Packaging of Milk and Milk Products. North
Carolina State University, Department of Food Science, Raleigh, N.C. and
Dairy Research, Inc., U.D.I.A., p. 82.
de Ruyter, P.W., and Brunet, I.R. 1973. Estimation of process conditions for continu-
ous sterilization of food containing particulates. Food Technology 27(7):44–51.
Dignan, D.M., Berry, M.R., Pflug, I.J., and Gardine, T.D. 1989. Safety considerations
in establishing aseptic processes for low-acid foods containing particulates.
Food Technology 43(3):118–121, 131.
Larkin, J.N. 1989. Use of a modified Ball’s formula method to evaluate aseptic
processing of foods containing particulates. Food Technology 43(3):124–131.
Manson, J., and Cullen, J.F. 1974. Thermal process simulation for aseptic process-
ing of foods containing discrete particulate matter. Journal of Food Science
39:1084–1089.
Pflug, I.J., Berry, M.R., and Dignan, D.M. 1990. Establishing the heat preservation
process for aseptically packaged low-acid food containing large participates,
sterilized in a continuous heat-hold-cool system. Journal of Food Protection
53(4):312–321.
Sastry, S.K. 1986. Mathematical evaluation of process schedules for aseptic pro-
cessing of low-acid foods containing discrete particulates. Journal of Food
Science 51(5):1323–1328.
Sastry, S.K., and Cornelius, B.D. 2002. Aseptic Processing of Foods Containing Solid
Particulates. New York: Wiley-Interscience.
Segner, W.P., Ragusa, T.P., Marcus, C.L., and Soutter, E.A. 1989. Biological eval-
uation of heat transfer simulation for sterilizing low-acid large particu-
late foods for aseptic packaging. Journal of Food Processing and Preservation
13(4):257–274.
Unverferth, J.A., and Chandarana, D.I. 1994. Aseptic processing of foods contain-
ing particles: Microbiological validation of thermal process design. Presented
at the IFT Annual Meeting, Atlanta, June 25–29.
chapter 10

Aseptic processing operations

Thomas Szemplenski

10.1  Introduction
Aseptic processing of food and beverages is a continuous commercial
sterilization of these products preceded by the sterilization of the process-
ing system. Aseptic processing of food is a continuous process requiring
strict control. Unlike the past, today most aseptic processing systems are
accurately controlled by programmable logic controllers (PLCs).
Aseptic processing is an area of food processing wherein the process-
ing and packaging are mutually dependent. A failure in any one area will
result in food spoilage. Unlike most other food processing operations,
the processing equipment in the system are interdependent and must
be presterilized prior to processing the product. The equipment used in
aseptic processing systems must fulfill the same sanitary and regulatory
requirements as those used in conventional food processing, in addition
to those necessary for sterilization and maintenance of a sterile state dur-
ing processing.
To reiterate, the aseptic processing system and aseptic filler are mutu-
ally dependent and both most be presterilized prior to processing the
product. Presterilization of the system and filler is usually accomplished
by hydrogen peroxide; peracetic acid; superheated, saturated steam; or
high-temperature, continuous water flow. The aseptic processing sys-
tem is almost always presterilized by steam or high-temperature water
flow for a designated period of time. Once presterilized, the system is
sustained in a sterile state by maintaining a positive pressure inside the
sterile zone. The temperature for initial sterilization of the system and
ultimate sterilization of the product vary based on the product to be pro-
cessed, but heat is always used to render the system and product sterile.
Heat is used for a number of reasons:

• Heat is easily measured and controlled.

• The thermal death time and temperatures required for rendering food
products commercially sterile are established and universally accepted.

161
162 Handbook of aseptic processing and packaging

• The sterilization of equipment surfaces is dependent upon the uni-

form distribution of the sterilant. Steam and high-temperature water
are able to penetrate any cracks and crevices and render them sterile.

The sterilization temperature of the equipment in the system is

mostly influenced by the pH of the product to be processed. With acid
products (<pH 4.6) concern is most generally with the growth of yeast
and mold. Yeast and mold will not survive temperatures above 200°F,
therefore the sterilization of the system is generally accomplished slightly
above this temperature for a designated period of time. Most processors
of acid products presterilize the aseptic system with water at somewhere
between 235°F and 250°F for 30 minutes. With low acid products (>pH 4.6)
preservation is based on killing the more heat resistant spoilage microor-
ganisms such as Clostridium botulinum, and the sterilization of the aseptic
processing system is usually accomplished at temperatures above 275°F
for a designated time.

10.2  Presterilization of the processing system

Aseptic processing of food and beverages is always based on a controlled,
continuous flow of product; therefore, the easiest method of presterilizing
the system is to use water at or near the same flow rate as the production.
This is especially true if the flow control pump, such as a high-pressure
piston pump, does not slip due to differences in viscosity between the
sterilization water and the product to be processed.
Whether the system is being presterilized for high- or low-acid prod-
ucts, the sterilization water required is always above the atmospheric boil-
ing point, therefore a back pressure valve is required to pressurize the
system to obtain the elevated temperature. All equipment and piping in
the system from the end of the final heater to and including the asep-
tic divert valve at the filler must reach the sterilization temperature for
a designated period of time. The back pressure valve, therefore, must be
located after the aseptic divert valve at the filler.
Sterilization of the aseptic processing system is generally accomplished
in one of two ways. With the first way, water is recirculated using the flow
control pump for the system or an alternative pump such as a centrifu-
gal pump from the water supply tank that normally is part of the system,
through the heat exchangers and holding tube past the aseptic divert valve
and back pressure valve back to the water supply tank. Any cooling media
in the cooling section of the heat exchangers is either drained from the heat
exchangers or not activated, as in the case of ammonia or Freon. The water
is heated to the sterilization temperature by means of heating the heat
exchangers in the processing system. Once the sterilization temperature is
reached at the farthermost part of the aseptic system, which in most cases
Chapter 10:  Aseptic processing operations 163

is the aseptic divert valve at the filler, a timer in the control panel starts
the necessary time requirement to deem the system sterile. After the super-
heated sterilization water passes the aseptic divert valve at the filler it needs
to be cooled back down below the boiling point. With this method of ster-
ilization, an auxiliary heat exchanger, such as a plate and frame or tubular
heat exchanger, is used to cool the sterilization water returning to the water
supply tank for the system. This water recirculation continues until the
timer in the control panel indicates the necessary time to deem the system
sterile is reached. If, at any time in the sterilization cycle the temperature
drops below the temperature set point necessary for sterilization, the timer
resets and the cycle must start all over again. Once the timer declares the
time and temperature necessary to deem the system sterile, cooling of the
system can begin. The cooling media such as tower or chilled water, glycol,
or ammonia is pumped or activated to the cooling heat exchangers in the
system. When the system has cooled the recirculating water to the fill tem-
perature of the product, processing of the product can begin.
Another method of presterilization is to use an auxiliary pump, such
as a centrifugal to recirculate the sterilization water. Once the system is
filled with water it is put into a closed loop to pressurize the system. Like
the first method, all the cooling media is removed from the cooling heat
exchangers and the heating media, which is generally steam, is turned on
to the systems heaters to elevate the water in the system to the sterilization
point. The sterilization water is recirculated in a closed loop exposing all
the equipment to the sterilization temperature. Again, when the tempera-
ture after the aseptic divert valve reaches the sterilization temperature the
timer in the control panel sets and the timing begins. After the designated
period of time to deem the system sterile is reached, cooldown can begin.

10.3  Loss of sterility

Once the system has completed the sterilization and has been declared ster-
ile, it will remain so unless the temperature falls below the hold tube steril-
ity set point or the flow rate is above the flow rate sterility set point. If that
happens, the system will change to unsterile and the ability to separate from
sterilization water to product will be locked out. Additionally, if sterility is
lost while separating from water to product or while processing product,
the valves to direct the product to the filler will be locked out and a product-
to-water separation will be activated so the system can be resterilized.

10.4  Water-to-product separation

With most aseptic processing systems there are normally two tanks sup-
plied: one for water and the other is the product balance tank for the sys-
tem. Prior to beginning water to product separation, the operator should
164 Handbook of aseptic processing and packaging

assure that product is in the balance tank and the aseptic filler has been
sterilized and is ready to receive product.
To initiate the water-to-product separation sequence, the operator uses
the PLC to confirm the “Start Water to Product” from the process menu
screen. The PLC will automatically switch the valve to return to drain,
switch the valve that controls the flow from the water to product, and acti-
vate the flow control pump. Normally the PLC starts timing the flow rate
while the product purges the water in the system to the drain. When the
PLC indicates that good product is at the fillers, the aseptic divert valve
switches to deliver product to the filler.
Due to differences in specific heat, water/product characteristics, such
as viscosity and temperatures, the PLC will make the necessary adjust-
ments so as not to have the product fall below the sterilization tempera-
ture and designated flow rate. The PLC will then automatically maintain
all temperatures, flow rate, and back pressure. This will continue until
one of the following occurs:

• The product tank is empty.

• The process loses sterility.
• The operator manually selects product to water separation or shut-
down from the menu screen.

If one of these conditions becomes true, the PLC will automatically initiate
a product to water separation.

10.5  Product-to-water separation

When a product-to-water separation is activated, the PLC will automati-
cally activate the water/clean-in-place (CIP) pump and then switch the sup-
ply to the flow control pump from the product tank to the water tank. Once
the switch in the flow control pump is made, the PLC starts metering the
flow while water from the supply tank purges the product from the system.
During the initial phase of product-to-water separation, filling of product
being purged from the system can continue. When the PLC indicates the
dilute product is at the fillers the “Product Available” signal to the fillers is
deactivated and filling will stop.
The discharge of the system now switches to drain as the remainder
of the dilute product is purged from the system. When the PLC indicates
that all traces of product have been purged, the return switches back to
the water tank and the product-to-water separation is complete. During the
product-to-water separation sequence, the PLC will make the necessary
adjustments to keep the product temperatures and pressure within the sys-
tem specifications. When production is finished and the system is full of
water, it is normally shut down and prepared for cleaning in place.
Chapter 10:  Aseptic processing operations 165

10.6  Cleaning
Cleaning of an aseptic system is generally with a clean-in-place system
that is supplied with the system. The CIP system does not have to be
sophisticated and interlocked; however, if cleaning efficiency is deter-
mined through manual inspection, or by observing charts, thermometers,
and gauges, then an exact procedure must be established followed with
records being provided on a daily basis to ensure cleaning is being accom-
plished. If cleaning is being accomplished by a sophisticated system that
delivers cleaning solutions at desired temperatures to the process system
that is to be cleaned, the system should be inspected regularly after CIP
has been completed. This inspection should be made of the most diffi-
cult to clean components in the process system. During this inspection,
the equipment, pipelines, and valves can be examined to ensure they are
operating properly, and do not have any cracks or crevices, or gaskets
that should be replaced. Gaskets should be taken from joints regularly,
inspected, cleaned if necessary, and replaced if bad. It is important to real-
ize that automatic controls with sensors can indicate, control, and record
items such as pressure, temperature, and pH; however, they cannot look
at a gasket and determine whether it needs to be replaced or cleaned or
whether it is hard and brittle. Therefore, it is important that a program be
established to inspect critical points at regular times to verify that they
are correct.
CIP solutions are normally made by adding certain chemicals to well
or city water that may or may not be filtered or treated. If the water used is
very hard or contains numerous minerals, excessive cleaning compounds
must be used to adequately clean the equipment in the system. If the
strength of the chemicals is excessive, reaction between these chemicals
and the stainless steel of the equipment will proceed at a much faster rate.
The equipment will deteriorate and will need to be replaced at more fre-
quent intervals. A compound such as chlorine will react with soil and do
an excellent job of cleaning. Unfortunately, it also will cause stainless steel
to corrode and fail. This is accentuated at the elevated temperatures that
are often used in the CIP cycle.

10.7  Control
Almost every new aseptic processing system is controlled by sophis-
ticated PLC controls and there is considerably more to control in an
aseptic processing system than just temperature. The assurance of a com-
mercially sterile product depends upon many factors in an aseptic pro-
cessing system, therefore, extreme consideration should be given to the
166 Handbook of aseptic processing and packaging

programming of the PLC. The two most paramount set points in the PLC
in the aseptic system include:

• Loss of sterility temperature set point—The minimum hold tube

outlet temperature. If the temperature of the product goes below this
set point the system will lose sterility.
• Flow control device—The PLC must control the product flow. If the
system exceeds the maximum flow rate, the system will lose sterility.
Additionally, a means of preventing unauthorized flow adjustments
needs to be provided.

In addition, most PLCs in an aseptic system will also control:

• The timing of the presterilization cycle and cooling of the steriliza-

tion water
• The control of the sterilization water-to-product separation
• The filling temperature of the product
• The temperature and flow of the heating and cooling medias
• The control of the product-to-water separation
• The differential pressure recorder-control in the heat exchangers
when product-to-product regeneration is being used ensuring the
product on the sterile side of the heat exchanger is greater than the
pressure on the unsterile product side of the heat exchanger
• The level in the water tank
• The level in the product tank
• The back pressure in the system (back pressure valves)
• CIP solution formulation
• CIP system and final rinse

The engineering programmer for the PLC should include interlocks

to ensure that should anything that will jeopardize commercial steril-
ity happen the system will not allow the product to be packaged. In this
regard, scheduled processes for low-acid foods should be established
by qualified persons who have expert knowledge of thermal processing
requirements for low-acid foods.
Observation and measurements of operating conditions shall be made
and recorded at intervals of sufficient frequency to ensure that commer-
cial sterility of the food product is being achieved; such measurements
shall include the sterilization media flow rates and temperatures through
the sterilization system.
chapter 11

Thermal processing
and optimization
Jairus R.D. David

This chapter covers the principles of thermal processing and optimiza-

tion, comparison of different processing methods, some advantages of
aseptic processing, and definitions of important terms at the end of the
chapter. Because the roots of aseptic processing and packaging are in the
dairy industry, this chapter is written with milk and milk products as
examples but can be applied easily to other food products.

11.1  Thermal processing and optimization

11.1.1  Introduction
Thermal processing is a significant and common method by which fresh
foods are preserved and made available out of season or to areas remote
from growing areas. With this process, food is given a sufficient heat treat-
ment to destroy pathogenic or spoilage-causing microorganisms, antinu-
trients such as antitrypsin and lectins, and enzyme systems that cause
degradation in the food. A review of the theories and methods to deter-
mine a sufficient heat treatment was given by Stumbo (1973). Routinely,
low-acid foods are canned or retorted to ensure destruction of Clostridium
botulinum spores by heating so that the center of the containerized product
receives a heat treatment of 3 to 6 minutes at a temperature of 250°F or
an equivalent sterilizing process at another time and temperature com-
bination. The resultant product in hermetically sealed containers is shelf
stable under normal conditions of storage and handling for up to 2 years
(“Canned Food” 2007).

11.1.2  Principles of thermal process calculations

When a homogeneous population of viable spores is subjected to a con-
stant lethal temperature, T, the rate of death of spores generally follows

167
168 Handbook of aseptic processing and packaging

a first-order reaction in which the reactant, N (viable spores), decreases

exponentially or logarithmically with time, t, and is expressed as

dN
= − kT N (11.1)
dt

This is equivalent in terms of common logarithms (to base 10) to

d(log 10 ) 1 (11.2)
=−
dt DT

where DT = 2.303/kT. Thus, a plot of the logarithm of the concentration N

of surviving spores versus time is a straight line called a time–survivor
curve.
The heat resistance parameter (DT) is a characteristic of the type of
spore, pH, and water activity (aW) of the suspending menstruum, bacterio-
logical recovery medium, and laboratory protocol and procedures under
consideration, and is found experimentally to vary with temperature
according to

(Tref −T )/z
DT = DTref ⋅ 10 (11.3)

where DT is the D value at temperature T, Tref is an arbitrary reference

temperature, DTref is the D value at Tref, and z is a temperature dependence
characteristic of the microorganism, assumed to be constant over normal
processing conditions.
Consider a homogeneous or purified population of viable spores sus-
pended in a hermetically sealed can of food, which is heated and cooled
in a retort. The temperature at a given spatial position in the can is a
function of time, T(t). The change in spore concentration at that position
is found by substituting Equation 11.3 into Equation 11.2. Integrating
between terms ti and tf , when spore concentrations are Ni and Nf , respec-
tively, yields

tf tf
1 dt
∫
− d(log 10 N) =  
D Tref ∫ 10 (Tref − T(t))
(11.4)
ti ti

Evaluating the integrals results in two expressions for the F value

tf
dt

FTzref = DTref (log N i − log N f ) =
∫ti 10
(Tref −T ( t )) z (11.5)
Chapter 11:  Thermal processing and optimization 169

The expression on the left gives the relationship between F and the
change in concentration of spores in food, as a result of heating and cool-
ing. Ni is the initial microbial load of pathogenic mesophilic spores of
public health significance or other mesophilic and thermophilic spore
bioburden in the food, established experimentally. Nf is a “safe” probabi-
listic final concentration of spores established from public health or eco-
nomic spoilage rate considerations. This forms the basis for the definition
of a required F value.

(F )
z
Tref
required
= Frequired = DTref (log N i − log N f ) (11.6)

The right-hand side of Equation 11.5 relates F to the time–tempera-

ture of the heating and cooling process T(t) experienced by the spores
between times ti and tf. This forms the basis for the definition of a process
F value.

(F )
tf
1

z
Tref
process
= Fprocess =
∫ti 10
(Tref −T ( t )) z ⋅ dt (11.7)

The subscript Tref on F in Equation 11.6 and Equation 11.7 indicates that
the entire integrated time–temperature effect on the spores is equivalent
to the time F minutes at the single temperature Tref. Common reference
temperatures are 250°F for low-acid foods and 212°F or 200°F for high-acid
and intermediate or acidified products. The superscript z emphasizes that
only one type of spore is considered.
The lethality of a process is the ratio of the F value of the actual pro-
cess to the F value required for commercial sterility:

(F ) z
Tref
process
Lethality = L =
(F ) z
Tref
required
(11.8)
tf
1 dt
=
( )
FTzref
required
∫
ti 10
(Tref −T ( t )) z

(T −T ( t )) z
In the literature, the product Frequired × 10 ref is called the thermal
death time, time required “to destroy all the mesophilic spore forming
microorganisms capable of spoiling the food.” Thus, the right-hand side
of Equation 11.8 is often written
tf
dt

L=
∫
ti TDT
(11.9)
170 Handbook of aseptic processing and packaging

Obviously, the lethality must be at least unity for commercial sterility

(Merson and Leonard 1979). Prevention of postprocess microbial recon-
tamination and maintenance of container hermetic seal are integral to
assurance of commercial sterility and shelf life of thermally processed
foods.

11.1.3  Thermal process design and commercial sterility

If Fprocess is greater than Frequired, then the thermal process design will be
adequate. If Fprocess is less than Frequired, then economic spoilage of food or
foodborne disease is likely to result. The determination of Frequired is the
most difficult step in thermal process evaluation. In essence, this determi-
nation means defining commercial sterility in quantitative terms. One set
of procedures to establish Frequired makes use of Equation 11.6. One deter-
mines the DT for the most heat-resistant microorganism or their spores of
economic spoilage or public health significance. One then estimates the
highest concentration of this microorganism expected to be encountered
(Ni), and finally determines a safe final level or probability of a nonsterile
unit (Nf) in a large production lot. The latter step basically defines com-
mercial sterility. Commercial sterility of thermally processed food refers
to absence of disease-causing microorganisms, absence of toxic sub-
stances, and absence of spoilage-causing microorganisms capable of mul-
tiplication under a variety of nonrefrigerated conditions of storage and
distribution (Downes and Ito 2001). Shown in the following equation is
the concept of 12D requirement for C. botulinum or the “12D Bot cook”:

Frequired =  DTref  (log 1012 −  log100 ) = 12D (11.10)

An alternative procedure to establish a safe value of Frequired is to
use Equation 11.7 to evaluate a process that is known to be safe. Time–
temperature data from a process that has been used for many years may
be used to numerically evaluate the integral in Equation 11.7 for the z
value of the most heat-resistant organism in the product. This provides
a safe Frequired.

11.1.4  Economic spoilage

Sometimes foods thermally processed to inactivate spore-forming patho-
gens exhibit high spoilage rates as a result of growth of nonpathogenic
mesophilic spore-forming bacteria. In the food industry, this is com-
monly known as economic spoilage. In this case, it is necessary to use
these microorganisms as a basis for the process. These microorganisms
are characterized by a D250 of about 1 minute and a 12D process would
result in a Fo of 12 minutes. A thermal process of Fo of 12 minutes would
Chapter 11:  Thermal processing and optimization 171

result in a product of poor quality due to the many heat-induced physical

and chemical changes. Many products require a 5D value with a resultant
Fo of 5 to 6 minutes (Lund 2003).
When canned foods are stored at high temperatures (100°F to 125°F)
in tropical or desert areas, where nonpathogenic thermophilic aerobes
and anaerobes can cause economic spoilage, the designed thermal pro-
cess must be extremely severe. The D250°F value for B. stearothermophilus
and C. thermosaccharolyticum is about 4 minutes, and thus a 5D process
would result in a Fo of 20 minutes.
When the 5D process is used, it is important to verify that the Fo is at
least equivalent to a 12D process based on the most heat-resistant spore-
forming pathogen presumed present in the food. Also, it is important to
have a vendor-specific hazard analysis critical control points (HACCP)
program for incoming ingredients vulnerable or known to contain high
numbers of nonpathogenic mesophilic spores and thermophilic aerobic
and anaerobic spores (Chapter 12). The sole intention here is to “mini-
mize” the initial spore load (Ni). It is acceptable to selectively pretreat sen-
sitive or contaminated ingredients by appropriate physical or chemical
methods, prior to the delivery of an optimal thermal process, and this will
be discussed in greater detail in Chapter 15.

11.1.5 Thermal destruction of enzymes,

nutrients, and quality factors
The objective of thermal processing with respect to enzymes is generally
their inactivation, whereas with nutrients and other quality attributes,
such as flavor, color, or texture, the objective is maximum retention.
It is the responsibility of the food processor to not only produce a com-
mercially sterile product, but also to provide a product that is wholesome
and one that retains its nutritional and quality attributes to a maximum
degree. From the literature and from fundamental science theory, it is evi-
dent that D and z values for nutrients and quality-factor destruction are
larger than for microorganisms or heat-labile enzymes (D250 of up to 150
minutes versus 0.1 to 5 minutes; z value of 45 to 100°F versus 10 to 20°F).
This situation forms the basis for high-temperature short-time (HTST)
and ultra-high temperature (UHT) processing (270°F to 300°F for a few
seconds). For example, at 270°F the rate of destruction of microorganisms
would be at least tenfold greater, and the rate of destruction of nutrients
and quality factors would be only two- to threefold greater than at 250°F.
For many enzymes the D and z values are of the same order of mag-
nitude as those for microorganisms. Therefore, a process based on inacti-
vation of heat-resistant microorganisms should inactivate a good portion
of the enzymes. However, many foods contain enzymes that are more
172 Handbook of aseptic processing and packaging

resistant and lower than typical z values, and the “process” must consider
inactivation of these enzymes.
During the past decade, extensive research has reported the presence
and characteristics of heat-resistant enzymes such as proteases and lipases
secreted by psychrotrophs in milk and their effects on UHT products dur-
ing storage. These enzymes are not completely destroyed by many UHT
treatments, and play a role in deterioration of UHT products during stor-
age, especially with respect to changes in flavor and physical stability if
the storage time is long, or the temperature is high. The beneficial role of
protease inhibitors in prevention of gelation and off-flavor, and the role of
thermization in control of psychrotrophs is discussed in Chapter 15.

11.1.6 Optimization of thermal processes for

nutrients and quality retention
During thermal processing, while thermal destruction of detrimental
microorganisms and enzymes are occurring, nutrients and other desirable
quality attributes are simultaneously being destroyed at varying rates. In
general, the vulnerability of microorganisms and enzymes to thermal
destruction is much greater than that of nutrients or quality attributes.
This difference in vulnerability, combined with the heating characteris-
tics of foods, has led to the development of a variety of thermal process-
ing methods, with an aim of optimizing reaction rates. Optimization of
safety, quality, nutrition, and sensory attributes have been achieved by the
development of agitating sterilizers or retorts, the “Flash 18” process, and
aseptic processing and packaging technology.

11.1.6.1  Agitated retort

For foods sterilized in still retorts the heat transfer is the rate-limiting
step and is affected by the heating medium, resistance encountered at the
container wall, size of the container, and thermophysical properties of the
food. Heat transfer in liquid, semiviscous, or particulated foods can be
significantly increased by mechanical agitation of containers during pro-
cessing. This is the underlying principle of agitating sterilizers or retorts.

11.1.6.2  The “Flash 18” process

The “Flash 18” process represents an interim milestone in optimization,
between agitated retorts and UHT processing and aseptic packaging of
foods. The “Flash 18” process is similar to the hot–fill–hold–cool process
routinely used for processing of high-acid or acidified foods but is done
for low-acid foods at very high temperatures.
In this procedure, low-acid foods such as soups containing particulates
are brought to high temperature of 265°F in bulk, for example, through
steam injection heating, and then pumped while at sterilizing temperature
Chapter 11:  Thermal processing and optimization 173

to a hot-fill operation, carried out under pressure to accomplish sterilization

of the metal container and lid. Conventional filling equipment and steam-
flow can sealers are housed in a pressurized room or vessel maintained at
18 psig of air pressure. Hot product enters the vessel at a temperature up to
265°F, followed by flash cooling to 255°F—boiling point at 18 psig of pres-
sure. The filled and sealed cans are then processed through a continuous
horizontal retort for a controlled hold time at 255°F to sterilize the inside
surfaces of can and lid, and deliver the scheduled process time before final
cooling and release to the outside through pressure-sealed valves. This
system is used primarily for large institutional-size cans that would other-
wise require long retort processes, yielding unacceptable product quality.
It is interesting to note that benefits of UHT sterilization have been
achieved by partitioning bulk sterilization of low-acid food, followed by
heat–hold–fill–hold–cool for sterilization of container and lid. This repre-
sents a definite departure from heat–hold–cool–aseptic fill Dole aseptic
canner, in which UHT-sterilized low-acid food is promptly cooled prior to
filling and double seaming. Superheated steam is used to presterilize the
container, lid, and aseptic zone at ambient pressure. Also, in the “Flash
18” process, food safety constraints related to residence time distribution
in hold tube for aseptic processing of low-acid foods containing particu-
lates is overcome by “scheduled” hold time in individual hot-filled and
hermetically sealed containers, in a continuous horizontal retort.

11.1.6.3 Ultra-high temperature (UHT)

processing and aseptic packaging
Aseptic processing and packaging encompasses the filling of sterilized
and cooled food into presterilized containers, followed by hermetic sealing
with a presterilized closure in a presterilized tunnel or aseptic zone. The
principles and manufacturing mechanics for aseptic processing of foods is
based upon theory, practice, and regulations originating from pharmaceu-
tical, continuous dairy pasteurization, and classical canning industries.
Raw product sterilization is accomplished by continuous methods of
heating at HTST (up to 265°F) or UHT (270°F to 300°F) regimes. During
UHT sterilization, a pumpable fluid food product is exposed to brief but
intense heating, normally temperatures in the range of 130°C to 145°C
(265°F to 295°F). Common holding times for fluid foods range from 2 to 45
seconds. The principles of thermal processing are similar to conventional
canning; in this case an equivalent process or Fprocess is delivered at much
higher temperatures allowing for shorter exposure times (David 1985).
UHT processing has been concentrated in the dairy industry. However,
other products such as low-acid viscous liquids and high-acid particu-
late foods are also similarly processed. The benefits of aseptic processing
stem from UHT sterilization of foods. These benefits depend on a high
174 Handbook of aseptic processing and packaging

temperature being maintained for only a few seconds, as time–temperature

response for microbial inactivation and for chemical reactions are differ-
ent. In other words, heat treatment of products at much higher tempera-
tures for only a few seconds can achieve sterilization with greatly reduced
product sensory and nutritional damage. The benefits of UHT sterilization
cannot be realized in conventional canning or terminal sterilization due to
long process times needed to achieve high temperatures. Come-up times
(CUT) associated with transient or unsteady-state heat transfer can account
for significant thermal degradation yielding overcooked or mushy product.
The other overriding mechanical constraint is the inability of containers
to withstand high internal pressure in retorts corresponding to tempera-
tures in the UHT regimes. In aseptic processing, this is overcome by par-
titioning UHT sterilization of raw food product from that of container and
lid. Compared to raw product, container and lid may experience different
and milder methods of sterilization. The containers and lids are sterilized
using steam, hydrogen peroxide, heat of coextrusion, or irradiation, where
approved. Also, other sterilants have been approved and are used (National
Food Processors Association 2004). The resistance to heat transfer in UHT
applications is not determined by container shape or dimension as it is in
canning. This results in more uniform product quality over hours of pro-
duction run, independent of container shape and dimension.
Finally, the cooled sterile product is filled into sterile containers and
hermetically sealed in a presterilized and continuously decontaminated
tunnel or aseptic zone. Similar to canning, the products are shelf stable
with a shelf life of about 1 to 2 years at ambient temperatures. The shelf
life is a function of the barrier characteristics of the container in terms
of loss of moisture and oxygen transmission, which may possibly cause
physicochemical changes, and not necessarily due to contaminating
microorganisms. Storage at high temperatures may dramatically reduce
the shelf life of heat-sensitive products or promote economic spoilage due
to the presence of thermophilic anaerobes.
Thermal process calculations for continuously processed foods is not
in the scope of this chapter. Interested readers are referred to reviews by
Morgan et al. (2010), and Singh and Morgan (2010).

11.2 Comparison of conventional canning and

aseptic processing and packaging of foods
11.2.1  Comparison of conventional canning and
aseptic processing and packaging of foods
During the past two decades, there has been a significant market growth
and associated technical development in the area of aseptic processing and
packaging of foods. Compared to classical canning, aseptic processing is
Chapter 11:  Thermal processing and optimization 175

best suited for heat-sensitive and nutritional foods and beverages in order
to obtain a finished product with better sensory qualities and higher nutri-
ent retention. In addition, it is possible to fill finished products into differ-
ent container types and sizes, with features attractive to consumers and
manufacturers. It is possible to aseptically fill and package portion packs,
and bulk transport containers and industrial drums, totes, and so on des-
tined for remanufacturing into retail and institutional and industrial con-
tainers. Salient features distinguishing conventional canning and aseptic
processing and packaging technology are summarized in Table 11.1.

11.2.2 Some advantages of aseptic processing

and packaging of foods
Compared to canning, aseptically processed product easily lends itself to
value-added features, such as increased quality, microwaveability, user-
friendly convenience, and cost saving from use of plastics.

11.2.2.1  Nutritional quality

The literature is replete with kinetic data that point to better nutritional
quality. Examples are shown in Tables 11.2 and 11.3 (Wilhelmi 1988).
Also, research done at the University of California at Davis (Luh 1970)
compared basic differences in chemical and quality changes of four veg-
etable purees—strained carrots, peas, corn, and green beans—processed
by aseptic and retort methods. Overall, the aseptic canning process
appeared to be superior to the retort method. The aseptic products were
of better organoleptic quality and higher in vitamin retention.

11.2.2.2  Sensory quality

Typical retorted tomato soup in metal cans sells for about 1.6¢/oz, com-
pared to 4.6¢/oz for typical aseptically processed tomato soup in Dole
aseptic metal cans. Aseptically processed foods command a higher price
due to substantially increased discernible qualities, that is, color, flavor,
and taste (T.E. Szemplenski, of Aseptic Resources, personal communica-
tion, 2010).

11.2.2.3  Microwaveability
Microwaveability is another value-added feature that can be easily incor-
porated into flexible and semirigid nonfoil containers commonly used in
aseptic filling operations. This is a consumer-friendly feature that can com-
mand two to three times the price of that for similar products in metal cans.
As of 1988–1989, the market niche for shelf-stable microwaveable products
was estimated to be $2 billion. The projection for 1994 was $4.4 billion (T.E.
Szemplenski, Aseptic Resources, personal communication, 2010).
 Table 11.1  Comparison of Conventional Canning and Aseptic Processing and Packaging of Foods

176
Criteria Retorting Aseptic Processing and Packaging of Foods
I. Sterilization
  A. Product
   1. Temperature regime 220°F–250°F HTST (180°F–220°F) and UHT (260–290°F)
   2. Delivery Unsteady state Precise—square wave
   3. Heat/cool lethality credit Possible Isothermal temperature in hold tube only
   4. Process calculation
     Fluid Routine–convection Routine
     Particulate Routine–conduction or broken heating Complex
  B. Other sterilization (process None Complex; many

Handbook of aseptic processing and packaging

equipment, container, lid,
and aseptic tunnel)
  C. Energy efficiency Lower 30% saving or more
II. Quality
  A. Psychophysical or sensory Mushy; not suitable for heat-sensitive Superior; suitable for homogeneous heat-
and nutritional products sensitive and nutritional products
  B. Nutrient loss High Minimum
  C. Value added Lower Higher
    Convenience Shelf stable Shelf stable and other features
   Microwaveability Semirigid containers (bowls and trays) All nonfoil flexible and rigid containers
  D. Product quality Dependent on container size and shape Independent of container size and shape
III. Production Aspects
  A. Container speed High; 600–1000+ containers per minute Medium; 500–700 containers per minute is
common; higher speeds via multiple lanes
 Chapter 11:  Thermal processing and optimization
  B. Handling/labor High Low
  C. Downtime Minimal, typically at seamer and Resterilization due to sterility loss in sterilizer
labeler or filler
  D. Versatility/flexibility for Different size containers need different Need one or two aseptic fillers to fill different
manufacture of a product process delivery and/or retorts size containers
in different container sizes
IV. Process Deviation
  A. Under processing Reprocess intact container-in-product Reprocess product after destructive opening
after removal of labels if possible of containers
  B. Survival of heat-resistant Rare Common in certain foods, especially in fluid
enzymes milk; problem could be overcome, if system
is designed properly (refer to Chapter 15)
V. Spoilage Analysis
  A. Troubleshooting Simple; preprocess, inadequate process Complex; need to deal with compromises in
and postprocess recontamination CIP and sanitation, and aseptic zone and its
elements (refer to Chapters 12 and 13)
  B. Traceability: container code Usually not identical; may differ by Usually identical
versus case code 1/2 to 6 hours
VI. L
 ow Acid Particulate In practice Work in progress by industry consortium and
Processing regulatory agencies; data from numerous
high-acid particulate systems may be used
for design basis of low-acid systems with
additional validation and modeling
VII. P
 ostprocess prepackage Not possible Possible and in practice to add filter sterilized
sterile additives enzymes (lactase), bioactive compounds,
therapeutic agents, and probiotics

177
178 Handbook of aseptic processing and packaging

Table 11.2  Difference in Vitamin C Retention between Retorted and

Aseptically Processed Tomato Soup
Vitamin C Retained
Sample Vitamin C (mg/100 g) Compared to Raw Product
Raw product 27.8 —
Aseptically processed 25.3 91%
Retort processed 16.3 59%
Source: W
 ilhelmi, F., 1988, Soups and Sauces: The Aseptically Packed Feast Ready for
the Table, Dragoco Report, 3, pp. 63–77.

11.3  Comparison of processing methods

With the advent of ultra pasteurization for refrigerated dairy products,
there has been confusion in usage of the term UHT sterilization as applied
to dairy products among producers and consumers, as evidenced by pub-
lications and advertisements in a number of trade and scientific journals.
The name UHT should not be used for ultra-pasteurized products. In the
following sections, the different methods of heat treatments—pasteuri-
zation, ultra-pasteurization, and canning—are compared with respect to
process time–temperature, target microorganisms, shelf life, packaging
and refrigeration requirements, and regulatory ordinances.

11.3.1  Pasteurization
Pasteurization is a mild heat treatment process for milk and fluid foods to
specifically inactivate certain pathogenic vegetative microorganisms with
low heat resistance. The usual minimum time–temperature combina-
tions are low-temperature, long-time (LTLT) 145°F for 30 minutes or high-
temperature, short-time (HTST) 162°F for 15 seconds. The process can be
delivered either by batch or continuous heating. It is important to note that
the heat treatment is not intended or sufficient to inactivate all spoilage-
causing vegetative cells or any heat-resistant spores, if present. This fact

Table 11.3  Difference in Thiamin Retention between Retorted and

Aseptically Processed Chicken Soup
Thiamin Retained
Sample Thiamin (mg/100 g) Compared to Raw Product
Raw product 0.11 —
Aseptically processed 0.09 82%
Retort processed 0.03 27%
Source: W
 ilhelmi, F., 1988. Soups and Sauces: The Aseptically Packed Feast Ready
for the Table, Dragoco Report, 3, pp. 63–77.
Chapter 11:  Thermal processing and optimization 179

determines a short keeping-quality period up to about 2 to 3 weeks under

refrigerated conditions (less than 45°F). In other words, the finished prod-
uct (low acid) is not commercially sterile. However, pasteurized high-acid
fluid packaged via the hot–fill–hold method in a hermetically sealed con-
tainer may yield a commercially sterile shelf-stable product.
Pasteurization is warranted for high-acid foods such as juices and bev-
erages, and low-acid refrigerated foods such as milk and dairy products that
have a rapid turnover in commerce. Pasteurized milk and dairy products
are regulated primarily by Grade “A” Pasteurized Milk Ordinance (2009).

11.3.2  Ultra-pasteurization
Ultra-pasteurization refers to pasteurization at very high temperatures of
280°F or above for 2 seconds or longer. The objective is similar to a pasteur-
ization process and further extends the shelf life of the product. However,
this high-temperature process is sufficient to destroy a greater proportion
of spoilage microorganisms leading to extended shelf life (ESL) of about
6 to 8 weeks under refrigeration, compared to 2 to 3 weeks for tradition-
ally pasteurized products. This process is also known as ESL technology.
Ultra-pasteurization is not UHT sterilization as the processed product is
not commercially sterile and shelf stable (refer to Table 15.1 in Chapter
15). This process has been effectively used for half-and-half, chocolate and
flavored milks, other dairy products, and nondairy creamers in portion
pack cups and tabletop containers. Ultra-pasteurized dairy products are
defined and regulated by the Grade A PMO. Ultra-pasteurization gives
producers great latitude to regulate the stock rotation, product velocity, or
turnover rate, and reduction of spoilage returns due to postdated conven-
tionally pasteurized products.

11.3.3  Conventional canning

Compared to pasteurization, canning is a severe form of heat treatment
to specifically target and inactivate mesophilic spores of C. botulinum and
prevent economic loss in low-acid foods. The heat resistance of C. botuli-
num is characterized by a D250°F of 0.21 minutes and a z of 18F°. The food
must experience at least a 12D cycle reduction at the “cold point” to be
made commercially sterile. This is also referred to as Fo of 3 minutes. In
practice, a thermal process of equal to or greater than Fo of 3 minutes is
delivered in closed pressure cookers or retorts above atmospheric pres-
sure. Canning is sufficient to inactivate heat-resistant enzymes, microor-
ganisms, and mesophilic spores that cause spoilage under normal room
temperature storage conditions.
The food to be canned is filled in metal cans, glass jars, retortable
semirigid plastic containers, or pouches, followed by double seaming or
180 Handbook of aseptic processing and packaging

heat sealing with a cap or lid. Such containers are heated and cooled in a
pressurized batch or continuous retort.
This type of conventional canning is also referred to as in-container
terminal sterilization because the thermal process is delivered after filling
and sealing operations. Both container and product experience an identi-
cal method of sterilization. Heterogenous high- and low-acid particulated
foods such as chunky fruits and soups with meats and vegetables can
be processed by this method (9 CFR 1986). The technology of containers
and seaming and capping are very well established. Canned products are
regulated by the Code of Federal Regulations (21 CFR 1987).

11.3.4  Refrigerated aseptic products

Several food companies retail their aseptically processed products such
as puddings, refrigerated or chilled for diversification, volume satura-
tion, market velocity, and repositioning. Placing shelf-stable products in
the dairy case or in chilled cabinets in supermarkets may be one way of
meeting the current consumer demand for “fresh-like” premium foods.
Interestingly, refrigeration circumvents the regulatory requirements that
govern thermally processed low-acid, shelf-stable foods. Low-acid veg-
etable and acidified products filled using aseptic fillers and processes that
are not approved by the U.S. Food and Drug Administration (FDA) or U.S.
Department of Agriculture (USDA) must be refrigerated throughout the
supply chain.

11.3.5 Comparison of continuous processing methods

based on optimization hierarchy
It is axiomatic to consider aseptic processing and packaging as the bench-
mark in optimization, for manufacture of sterile, shelf-stable canned food.
Contrasted with retorting or in-container sterilization, aseptic product
and package are independently sterilized by optimal processes; micro-
bial inactivation and quality factor degradation are also co-optimized
given first-order kinetics. Aseptic systems permit sterilizing the prod-
uct and container separately and appropriately, without the rate-limiting
heat transfer modes, or the attendant thermal and pressure stress to the
container, and permitting HTST or UHT processing of very heat-labile
products, without excessive quality factor degradation, while achieving
requisite commercial sterility (K.S. Purohit, Process Tek, personal com-
munication, 2008).
The technology has been diversified in recent years, and concepts
of aseptic processing and packaging that are somewhat removed from
the core of the original technologies are slowly being adapted to liq-
uid and solid foods, shelf stable or refrigerated. Table  11.4 shows a
 Chapter 11:  Thermal processing and optimization
Table 11.4  Comparison of Different Continuous Processing Methods Based on Optimization Hierarchy
Heat and Cool
Continuous Filling and Process Technology Finished Product and Optimization
Raw Product Processes Packaging Designation Shelf Life Hierarchy Index
High-acid food Continuous Hot fill to sterilize Core hot–fill–hold– Shelf-stable juices and Interim hierarchy
pasteurization–fill– lid and container at cool technology acidified foods;
hold–cool ambient conditions commercially sterile
Low-acid food Continuous UHT Hot fill to sterilize “Flash 18” process Shelf-stable, low-acid Higher hierarchy
sterilization and lid and containers food in institutional-
flash to 255°F in pressurized size containers;
room commercially sterile
Low-acid food Continuous HTST Cold fill in clean Conventional Refrigerated milk, dairy, Lower hierarchy
pasteurization and room; sanitized pasteurization and juice products; 2–3
cool container weeks
Low-acid food Continuous Cold fill in clean Ultra-pasteurization; Refrigerated milk, Interim hierarchy
ultra-pasteurization room; sanitized extended shelf life creamers, and juices;
and cool container (ESL) product 6–8 weeks
Low-acid food Continuous UHT Aseptic filling and Core aseptic Shelf-stable milk, Benchmark in
sterilization and packaging at technology; sauces, puddings, and optimization for
cool ambient UHT-sterilized and other homogeneous shelf-stable, low-
aseptically food; commercially acid, commercially
packaged foods sterile sterile canned foods
(Continued)

181
 Table 11.4  Comparison of Different Continuous Processing Methods Based on Optimization Hierarchy (Continued)

182
Heat and Cool
Continuous Filling and Process Technology Finished Product and Optimization
Raw Product Processes Packaging Designation Shelf Life Hierarchy Index
High-acid food Continuous HTST Aseptic filling and HTST pasteurized Shelf-stable juice box Benchmark in
pasteurization and packaging at and aseptically and juices in clear PET optimization for
cool ambient packaged foods bottles; commercially shelf-stable, high-
sterile acid and acidified
canned foods
Low-acid food UHT or HTST heat (a) Aseptic filling UHT or HTST Commercially sterile Interim hierarchy
and cool and packaging at processed and refrigerated puddings
ambient aseptically for market

Handbook of aseptic processing and packaging

packaged diversification and
refrigerated food repositioning; 6–8
weeks stock rotation
cycle
(b) Nonaseptic; UHT or HTST Refrigerated/ESL Lower hierarchy
unapproved filler processed and puddings; 6–8 weeks
or processes nonaseptically
packaged or
processed
refrigerated food
Chapter 11:  Thermal processing and optimization 183

comparison of different processing methods reflecting some key differ-

ences between the core of UHT processing and aseptic packaging tech-
nology with that of other adaptations and commercial concepts. In the
United States before 1981, the Dole aseptic canning system was the only
aseptic filling and packaging system of commercial importance for milk
and milk-based low-acid products in metal cans. This core technology
was correctly designated as an UHT-sterilized and aseptically packaged
process. The pre-1981 market drivers were better quality, low-acid, heat-
sensitive products, compared to retorted versions. It was a formidable
marketing and research and development challenge to educate consum-
ers to appreciate aseptic technology, and differentiate products in Dole
aseptic metal containers from that of classical canning or retorting.
In 1981, the FDA approval of the food additive petition for use of
hydrogen peroxide as a sterilant for food contact surfaces provided the
impetus for introduction of various aseptic filling and packaging systems
into the U.S. market. The market was primarily driven by “juice box”
technology, which involved high-acid food pasteurization at HTST fol-
lowed by aseptic filling and packaging. This process was designated as
an aseptically processed and aseptically packaged process or an asepti-
cally processed and packaged product. The post-1981 and current market
drivers are use of alternate packages, consumer convenience, light weight-
ing, cost reduction, superior quality, and package sterilization by optimal
methods. Today, any food product heated continuously either in UHT,
HTST sterilization, or pasteurization temperature regimes, followed by
aseptic filling and packaging are generally designated as an aseptically
processed and packaged product.
In the last column of Table  11.4 is an optimization hierarchy index
based on co-optimization of competing priorities, optimal method of ster-
ilization of product package and aseptic zone, aseptic zone integrity, fin-
ished product shelf stability and/or commercial sterility, and requirement
of additional hurdles, such as refrigeration required for pasteurized and
ultra-pasteurized foods (K.S. Purohit, Process Tek, personal communica-
tion, 2008).

11.4  Definitions
The following are definitions of terms used in this chapter.

Acid food is food with a natural equilibrium pH less than or equal to 4.6
and a water activity (aw) equal to or greater than 0.85.
Acidified foods refer to low-acid foods to which acid(s) or acid food(s) are
added to lower the finished equilibrium pH to 4.6 or below. Usually,
acidified foods have a water activity (aw) greater than 0.85.
184 Handbook of aseptic processing and packaging

Aseptic processing and packaging of foods is the filling of a commercially

sterilized-cooled product into presterilized containers, followed by
hermetic sealing with a presterilized closure in an atmosphere free
of microorganisms (Canned Food 2007).
Aseptic processing, when used to describe a milk product, means that
the product has been subjected to sufficient heat processing, and
packaged in a hermetically sealed container, to conform to the appli-
cable requirements of 21 CFR 113 and the provisions of Section 7,
Item 16p of Pasteurized Milk Ordinance (PMO), and to maintain the
commercial sterility of the product under normal nonrefrigerated
conditions (PMO 2009).
Commercial sterility of equipment and containers used for aseptic process-
ing and packaging of food means the condition achieved by applica-
tion of heat, chemical sterilant(s), or other appropriate treatment that
renders the equipment and containers free of viable microorgan-
isms having public health significance, as well as microorganisms
of nonhealth significance, capable of reproducing in the food under
normal nonrefrigerated conditions of storage and distribution (21
CFR 113.3 2001).
Commercial sterility of thermally processed food refers to absence of dis-
ease-causing microorganisms, absence of toxic substances, and
absence of spoilage-causing microorganisms capable of multiplica-
tion under normal nonrefrigerated conditions of storage and distri-
bution (APHA 2001).
F or F value is time required to destroy a given percentage of microor-
ganisms at a reference temperature and z value.
FTzref is a more specific notation for F or F value and is defined as the
time in minutes at reference temperature of Tref required to destroy
a given percentage of microorganisms whose thermal resistance is
characterized by z.
18
Fo is F value when Tref is 250°F and z is 18F°. (Fo = F250 ).
Frequired is time in minutes required in a thermal process to achieve a
desired degree of commercial sterility or “end point” or probability
of a nonsterile unit (PNSU); it is defined by the equation

(F )
z
Trerf
required
= Frequired = DT (log N i − log N f )

Fprocess is the time–temperature effect of a thermal process expressed

as time in minutes at reference temperature Tref for microorganisms
with a given z value; it is defined by the equation

(F )
tf
dt

z
Tref
process
= Fprocess =
∫
ti
(Tref −T ( t )) z
10
Chapter 11:  Thermal processing and optimization 185

Hermetically sealed container means a container that is designed and

intended to be secure against the entry of microorganisms and
thereby maintain the commercial sterility of its contents after pro-
cessing (21 CFR 113.3 1994).
Low-acid food is food with an equilibrium pH greater than 4.6 and a
water activity (aw) equal to or greater than 0.85; excludes alcoholic
beverages. pH 4.5 serves as a benchmark in the state of California.
Tomatoes and tomato products having a finished equilibrium pH
less than 4.7 are not classified as low-acid foods.
Pasteurization, pasteurized, and similar terms mean the process of heat-
ing every particle of milk or milk product in properly designed and
operated equipment, to one of the seven temperatures given, and
held continuously at or above the specified temperature and for
specified hold time. The process can range from 145°F for 30 minutes
to 212°F for 0.01 second (PMO 2009).
Shelf-stable food refers to food capable of being stored without refrigera-
tion at ambient environmental conditions for 1 to 2 years.
Ultra-pasteurized, when used to describe dairy products, means that
such products shall have been thermally processed at or above 280°F
for at least 2 seconds, either before or after packaging, so as to pro-
duce a product that has an extended shelf life under refrigerated
conditions (PMO 2009).

11.5  Nomenclature
aw  Water activity; a measure of available water in foods to support the
growth of microorganisms. It is the ratio of vapor pressures of a
food product to that of pure water at a specified temperature.
dN
dt   Mathematical notation in differential calculus to represent incremental
changes in the variables N and t, for example, reduction in micro-
bial concentration due to heating time.
DT  Decimal reduction time; heating time required at a given temperature,
T, for 90% reduction of microorganisms. Number of minutes for
the survivor curve to traverse one log cycle.
i  Initial condition.
f  Final condition.
kT  Rate constant for first-order thermal death model, dimension of
inverse time.
Ni  Initial concentration of microorganisms at time ti.
Nf  Final concentration of microorganisms at time tf.
pH  A measure of the intensity of acidity or alkalinity. The negative loga-
rithm of the hydrogen ion concentration.
t i  Time at beginning of thermal process (minutes).
186 Handbook of aseptic processing and packaging

t f  Time at end of thermal process, that is, at end of cooling (minutes).

Tref  Reference temperature (°F); common reference temperatures are
250°F for low-acid foods, 212°F and 200°F for high-acid and acidi-
fied foods, and 145°F and 161°F for pasteurization of milk.
T(t)  Product temperature at slowest heating point as a function of process
time, in Fahrenheit (°F).
z  Temperature difference that causes a tenfold change in the rate of micro-
bial destruction, in Fahrenheit (F°).

References
21 CFR, Parts 110-113 and 114. 1994. Washington, DC: U.S. Government Printing Office.
9 CFR, Parts 308,318,320,327 and 381. 1986. Canning of Meat and Poultry Products,
U.S. Department of Agriculture.
Canned Food: Principles of Thermal Process Control, Acidification and Container
Closure Evaluation, 7th ed. 2007. Washington, DC: GMA Science & Education
Foundation.
David, J.R.D. 1985. Kinetics of inactivation of bacterial spores at high temperature
in a computer-controlled reactor. Ph.D. dissertation, University of California
at Davis.
Downes, F.P., and Ito, K., eds. 2001. Compendium of Methods for the Microbiological
Examination of Foods, 4th ed. Washington, DC: American Public Health
Association.
Grade “A” Pasteurized Milk Ordinance. 2009 Revision. U.S. Department of Health and
Human Services, Public Health Service, Food and Drug Administration (FDA).
Luh, B.S. 1970, May. Physicochemical differences of pureed vegetables packed by
the aseptic and retort processes. A research study conducted by University of
California at Davis, for United States Steel.
Lund, D.B. 2003. Heat processing. In Physical Principles of Food Preservation, 2nd
ed., edited by M. Karel, O.R. Fennema, and D.B. Lund, Chapter 3. New York:
Marcel Dekker.
Merson, R.L., and Leonard, S.J. 1979. Principles of Thermal Processing—FST 150
Class notes. Department of Food Science and Technology, University of
California at Davis.
Morgan, M.T., Lund, D.B., and Singh, R.K. 2010. Design of the aseptic processing
system. In Principles of Aseptic Processing and Packaging, 3rd ed., edited by P.E.
Nelson, Chapter 2. Purdue University Press.
National Food Processors Association (NFPA). 2004. Technical Overview of
Alternate Sterilants for Use in Aseptic Processing. National Food Processors
Association Workshop, June, Arlington, Virginia.
Singh, R.K., and Morgan, M.T. 2010. Residence time distribution in aseptic pro-
cessing. In Principles of Aseptic Processing and Packaging, 3rd ed., edited by P.E.
Nelson, Chapter 3. Purdue University Press.
Stumbo, C.R. 1973. Thermobacteriology in Food Processing, 2nd ed., Chapters 10 and
11. New York: Academic Press.
Wilhelmi, F. 1988. Soups and sauces: The aseptically packed feast ready for the
table. Dragoco Report, 3, pp. 63–77.
chapter 12

Quality assurance and food

protection for aseptically
processed and packaged food
Jairus R.D. David

This chapter covers the quality assurance (QA) programs for aseptically
processed and packaged food products. The quality assurance program
presented here is based upon fluid and homogeneous-viscous pump-
able products, sterilized, packaged, and hermetically sealed. The finished
product is targeted to be shelf stable. The Dole Canner, Tetra Brik, and
Conoffast aseptic fillers represent the range, in terms of diversity and
complexity, of aseptic fillers for retail-size containers, and are therefore
used in this chapter to illustrate the principles of quality assurance and
food safety.

12.1  Introduction and concepts

Any food manufacturing operation consists of several value-added steps
for transforming incoming raw materials—both food and packaging
material—into finished product with acceptable safety, quality, and conve-
nience. The quality of incoming raw materials and personnel/procedure/
process/package capabilities of value-added steps will determine food
safety, quality, and conformance of finished product. A quality assurance
program will determine the success of any aseptic operation and is a true
reflection of a company’s commitment, mandate, and understanding of
technologies, processes, and consumer needs.
Food safety and quality must be a top priority to the management, as
important as return on investment (ROI), profitability, or market share.
Without safety or quality, one cannot or does not have market share, prof-
itability, or ROI.
The food industry must be proactive rather than reactive. Today’s
food processor must manage both real and perceived safety issues. The
real safety and risks need to be evaluated by scientific methods based on
objective evidence, with emphasis on statistical probability. On the other

187
188 Handbook of aseptic processing and packaging

hand, perceived risk by the public is subjective and is a political process

involving the consumer, family, the community, academia, and govern-
ment, and is often influenced more by mass media. The food industry
must continuously monitor consumer, government, academia, and media
for early warning of emerging safety, quality, and regulatory trends, con-
cerns, or issues.

12.1.1  Quality control

Quality control (QC) is defined as the process through which one measures
actual quality performance, compares it with a standard, and acts on the
difference (Juran and Godfrey 1999). In other words, quality control is a
form of “gap analysis” followed by appropriate corrective action to close
the gap.

12.1.2  Quality assurance

Quality assurance (QA) is a form of insurance purchased at a relatively
small expenditure for the purpose of securing protection against disas-
ters. Quality assurance protection consists of information that the product
is defect-free, the process is behaving normally, and the procedures are
being followed (Juran and Godfrey 1999). In a broad sense, in the food
industry QA represents a department with broad responsibility for con-
trol of incoming food ingredients and packaging materials, batching, in-
process checks, postprocess incubation, reports, inspections, regulatory
compliance, and audits. There are general guidelines found in most text-
books, but they are usually far too broad to be of much use to anyone who
plans to practice aseptic processing and packaging of foods.
One cannot instill quality and safety by inspection. Also, quality
assurance is a competitive tool and should be implemented in a cost-effec-
tive manner. There is no upper limit to sampling and testing, and atten-
dant cost. All testing and data gathering should have a clear purpose and utility.

12.2 Quality assurance for aseptically

processed and packaged food
Compared to retort or hot-fill packaging in metal and glass containers,
aseptic packaging of foods in flexible containers has shifted to the food
processor increased responsibility for evolution of quality systems, iden-
tification of defects, quality control of products, and encouraging prom-
ulgation of appropriate regulations. This has given the food industry a
strong incentive to develop a QA program in concert with suppliers of
Chapter 12:  Quality assurance and food protection 189

aseptic fillers, cans, lids, roll stocks, cups and lid stocks, and equipment
for rapid testing of seal integrity and sterility (David 1988, 1989).
A QA program must nurture a good interactive relationship with
operators of sterilizers and aseptic fillers and QC line inspectors to assure
manufacture of product in acceptable containers. Quality is not the respon-
sibility of a department, but is the joint responsibility of everyone involved
in management, design, research, procurement, supply, testing, warehous-
ing, and distribution. Some companies are currently integrating manufac-
turing and quality assurance through mandate, training, and at-line and
on-line testing by line operators. Ultra-high temperature (UHT) process-
ing and aseptic packaging systems are sophisticated operations requiring
skilled and trained individuals in production and quality assurance. This
system leaves no room for errors.
For convenience, a quality assurance program for aseptically processed
and packaged food is described as work outputs under (1) preprocess assur-
ance, (2) in-process assurance, and (3) postprocess assurance functions.

12.2.1  Preprocess assurance

Preprocess assurance consists of vendor compliance of incoming raw
material to company specifications through vendor certification pro-
grams, audits, and tests for verification.

12.2.1.1  Raw materials

12.2.1.1.1    Food ingredients  The quality of any finished product
depends to a great extent on the quality of incoming raw ingredients.
All food ingredients for manufacture of shelf-stable products must meet
physical, chemical, and microbiological specifications necessary for prod-
uct safety, physicochemical stability, and quality. One relies either on
supplier certification and conformance with company specifications and
incoming material testing. However, it is prudent to cross-check supplier
certification using a skip lot sampling plan. Any shipment that does not
meet specifications must be rejected. Accurate receiving records must be
maintained showing vendor batch codes or lot numbers. Both dry and wet
ingredients need to be stored at recommended temperature and humid-
ity. Also, pest control, particularly rodent control, is very important.
All it takes is one leaker on a pallet and various pests will be attracted
to the milkshake, fruit juice, or whatever has spilled. The presence of fruit
flies is a good indicator of a leaker. Even if one does not initially have a
leaker, it takes very little effort for a mouse or rat to chew its way through
a flexible or semirigid container. Therefore, proper pest control and sani-
tary conditions are essential in warehouses, as well as on trucks or on
rail cars.
190 Handbook of aseptic processing and packaging

12.2.1.1.2    Incoming packaging materials and sterilants  Incoming

packaging (i.e., body and lid materials) like food ingredients must meet
certain physical and functional specifications. These parameters are ulti-
mately verified by the performance of packaging material during the
forming, filling, and sealing steps via the aseptic packaging machine. It is
common not to test packaging materials for microbiological load, because
of the assumption that microorganisms cannot reproduce on the inert
container and lid materials as it does in the foods. Research indicates very
low levels of contamination with vegetative microbes rather than spores
(Bockelmann 1982). Packaging materials, though inert, must be stored
properly wrapped to protect from dirt, dust, oil, debris, and moisture, and
stacked not more than two pallets high to avoid stress. The procedures
and programs applied to ingredients should also be applied to packaging
materials to control and prevent contamination with dust, dirt, oil, and
other debris.
For chemical sterilants such as H2O2, specific gravity measurement
is common to assure strength and purity. As with all chemicals, caution
should be exercised while handling chemical sterilants as outlined in the
material safety data sheet (MSDS).

12.2.2  In-process assurance

In-process assurance is a complex program involving control of batching,
thermal processing, and aseptic packaging operations.

12.2.2.1  Batch preparation

A scheduled thermal process is designed on the basis of an anticipated
“average” initial load of microorganisms. Therefore, it is the responsibil-
ity of the manufacturer of shelf-stable food to keep the initial load to a
minimum by following good manufacturing practices (GMP) during mix-
ing, batching, and raw product storage. In addition to the initial load, the
processor needs knowledge of the physiological types of bacteria such
as spores of mesophiles, especially Clostridium botulinum, nonpathogenic
mesophilic and thermophilic spore formers responsible for economic
spoilage, and psychrotrophic bacteria present in raw product. A high ini-
tial number of bacteria, poor sanitary conditions, and storage at ambient
conditions can lead to preprocess spoilage of raw product. Also, toxin pro-
duction by heat-sensitive vegetative cells of Staphylococcus aureus in raw
product must not be permitted, because this toxin is highly heat resistant,
with a calculated D280°F of 4.6 minutes. Most UHT processes will not inac-
tivate this toxin.
Refrigeration is capable of controlling the growth of most bac-
teria in food, except psychrotrophs, which can multiply and secrete
extremely heat-resistant enzymes such as lipases and proteases. With
Chapter 12:  Quality assurance and food protection 191

UHT processing there is little inactivation of such enzymes. Also, these

enzymes may experience temporary inactivation and under certain condi-
tions may regenerate to cause product bitterness and rancidity. According
to the latest Pasteurized Milk Ordinance (PMO) (1993), raw milk must be
chilled to 45°F, instead of 50°F. It is a good practice to process milk within
2 to 4 hours after delivery; the total age of raw comingled milk should not
exceed more than 6 to 8 hours.
The art of bringing together several ingredients in proper proportions via
mixing, emulsifying, and homogenizing is complex. These steps do affect the
quality and physicochemical properties of the finished product and, there-
fore, should be specified and fully documented as standard mix procedures.

12.2.2.2  Thermal processing operations

Usually the thermal processing operation is monitored, controlled, and
documented by operators, that is, personnel in production. However, QA
monitors interact with operators to provide information on product qual-
ity parameters such as color, viscosity, total soluble solids (TSS), pH, and
product burn-on due to fouling, and to provide information for putting
products “on hold” should there be a process deviation due to tempera-
ture or pressure drop, power outage, or any other reason.
Thermal processing records reside in the QA department. These
records are checked within 24 hours for process delivery and integ-
rity by a QA supervisor or process authority and by a state inspector
periodically. Process charts and records are mandated to be retained
for 3 years; however, the food industry normally retains its records for
about 5 years.
Based on experience, it is correct to assume that thermal processing
operations are usually conservative, robust, and, therefore, less prone
to deviations compared to downstream operation of aseptic filling and
packaging.

12.2.2.2.1    Components for heating and cooling  Components required

for UHT processing can consist of a product tank, timing pump, heater,
holding tube, cooler, homogenizer, pump and filter for sterile additives,
back-pressure valve, temperature-measuring device, and interface to asep-
tic filler. Aseptic fillers are discussed in the next section. Some operations
do include aseptic surge tanks, because filler speeds do not correlate with
processing flow rates. Many food processors are cautious in employing
surge tanks as an interface between upstream processing and downstream
packaging. Surge tanks on the cold side may be vulnerable to recontamina-
tion and therefore represent a weak link in the “aseptic chain.”
A commercial UHT process consists of sterilizing the product in a
hold tube, in which every particle of food is held for at least a certain
minimum residence time. No portion of the holding tube can be heated
192 Handbook of aseptic processing and packaging

from an external source, and it must be sloped upward at least 0.25 in./
ft. A temperature-recording device must be installed in the product at the
holding tube outlet. The thermal process delivered is based on the flow
rate and length of the holding time, taking into account the residence time
of the fastest moving particle and the lowest temperature indicated at the
hold tube outlet. Both direct and indirect methods of heating and cooling
are employed for sterilizing food. Compliance with GMP and PMO are
essential for a successful operation.

12.2.2.2.2    Direct heating and cooling  The direct steam injection and
infusion method of heating consists of direct contact between steam and
product. After the hold tube, cooling may be accomplished by vacuum
flashing or regeneration. Indirect plate heat exchangers may be employed
for preheating by regeneration of heat. Monitoring of the pressure differ-
ential during regeneration between raw cold product and sterile hot prod-
uct is required by the PMO, U.S. Food and Drug Administration (FDA) (21
CFR 1987), and U.S. Department of Agriculture (USDA) (9 CFR 1986).
Some characteristics of direct heating include:

1. Rapid “square wave” heating and cooling

2. No burn-on or fouling of heat exchanger surfaces, with most products
3. Better for low viscosity products
4. Fewer moving parts compared to a scraped surface indirect heat
exchanger
5. Vacuum on cooling side is susceptible to “gasping” and recontamination
6. Need specialized clean-in-place (CIP) and sanitation program
7. Careful moisture stripping is needed during flashing for proper
control of solids and fat in the finished product

12.2.2.2.3   Indirect heating and cooling  Plate, tubular, and scraped

surface heat exchangers are used for indirect heating and cooling. This
method of heating and cooling is used for products that may require
gradual heating and cooling, compared to direct methods. Systems may
need intermittent flushing to reduce fouling or burn-on. By the use of
regeneration, indirect heating and cooling is more energy efficient than
direct heating and cooling. Because of slower heating and cooling com-
pared to direct steam heating, the total heat treatment is greater for the
indirect systems, which can result in greater intensity of desirable or
undesirable flavors.
Most equipment suppliers will provide a detailed operations manual
showing all critical control points (established during validation and
establishment of aseptic processing and packaging operations, as was out-
lined in Chapter 9) and ways to monitor these as well as how to make the
necessary adjustments, if needed. Many suppliers of equipment will train
Chapter 12:  Quality assurance and food protection 193

employees either on location or at their factory, and will provide them

with the necessary operational programs, including QC.

12.2.2.3  Aseptic filling and packaging operations

Aseptic filling and packaging functions represent the crux of the entire
aseptic operation. The aseptic filler is where several operations are cho-
reographed and synchronized: maintenance sterility, forming, steriliza-
tion of container and lid, filling, hermetic sealing, and labeling.
Successful operation of the aseptic filler depends upon a well thought-
out QA program, preventive maintenance, proper CIP and sanitation,
incoming quality of packaging materials, dedicated personnel, and con-
tinuous training and education. The output from the aseptic filler serves
as a focal point for the QA and food safety program and a primary index
of machine performance.

12.2.2.3.1    Description of fillers  Aseptic fillers provide a commer-

cially sterile or aseptic environment wherein either preformed containers
or made-in-place containers are sterilized, filled, and sealed. Dole asep-
tic canning, Tetra Brik aseptic, and Conoffast aseptic cups constitute the
aseptic filling lines illustrated in this chapter. Some important features of
these fillers are presented in Table 12.1.

Dole aseptic canner—This was the first aseptic filler to be installed

in the United States, in the 1950s, for aseptic canning of milk and
soups. This convey–fill–double seam machine utilizes preformed
cans and lids. Cans and lids are sterilized using superheated steam.
Also, the same heating medium (superheated steam) is used for
active dynamic decontamination of the filler during production.
Tetra Brik aseptic (TBA)—The first low-acid TBA was commissioned in
the United States in 1981, immediately after FDA approval of H2O2 as
a package sterilant. TBA is a vertical form–fill–seal machine utiliz-
ing roll stock. Hot hydrogen peroxide is used as a chemical sterilant
for sterilizing the roll stock. The filler is presterilized using hot air.
During production, filler asepticity is maintained using passive cold
sterile overpressure air.
Conoffast—The first low-acid Conoffast aseptic cup filler was com-
missioned in the United States in 1983. Conoffast is a thermoform–
fill–seal machine using cup and lid stocks. For sterilization of the
packaging material, this system relies on the temperatures reached
by thermoplastic resins during the laminated film coextrusion pro-
cess. Sterility is maintained until thermoformation in the aseptic
filler machine by a protective peelable layer. The filler is presterilized
using hot air. During production, filler asepticity or dynamic decon-
tamination is maintained using passive cold sterile overpressure air.
 Table 12.1  Comparison of Some Representative Aseptic Filling and Packaging Machines

194
Criteria Dole Aseptic Canner Tetra Brik Conoffast
Filler group Preformed convey–fill–seam Vertical form–fill–seal Thermoform–fill–seal
Container Preformed metal cans and lids Roll stock Coextruded cup and lid roll stock
Sterilization Superheated steam (SHS) Hot air Hot air
Presterilization of filler
Filler during production “Active” decontamination “Passive” decontamination using “Passive” decontamination using
run maintenance using SHS sterile overpressure air sterile overpressure air
Sterility (dynamic HEPA filtered HEPA filtered
decontamination)
Package SHS Hot hydrogen peroxide liquid Sterile peelable layers and heat of
coextrusion

Handbook of aseptic processing and packaging

Containers 1 to 4 cans per revolution 2 briks; 1 per jaw 12 cups per stroke
Filler type Straight-line ribbon or Cluster valve; gravity product “Mini surge tank” bell filler
valveless filler flow coupled to machine with pistons
indexing
Seal integrity Mechanical seal resistant to Induction bar seal resistant to Heat seal; susceptible to spills
spills and drips nonparticulate spills and drips and particulates
Number of seals 3: side and double seams 3: longitudinal and transversal Only one seal
seals; other folds, pre-scores,
straw-hole, pull tab
Relative barrier properties High Low-medium Medium
of the package
Chapter 12:  Quality assurance and food protection 195

The concepts of active and passive decontamination are defined and

explained in Chapter 15.

12.2.2.3.2    Quality control criteria  Packaging defects may pertain to

either cosmetic appearance or hermetic integrity (David 1988). The cos-
metic defects for an unopened container include shape and deformity,
out-of-design label, and lacking or illegible UPC and production codes.
The cosmetic defect for an opened can and double seam deviations are
outlined in standard manuals on double seams. Defect classification and
criteria for flexible and semirigid packages and composite cans are found
in the Flexible Package Integrity Bulletin, published by the National Food
Processors Association (1989).

12.2.2.3.3    Quality control checks  There are several levels of QC

checks employed. The levels are line check, package tear down, and incu-
bated product analysis. All checks are performed using representative
samples from all sealing heads or jaws: 4 samples for Dole canner and
Tetra Brik aseptic, and 12 Conoffast cups from the same stroke.
Sample size and frequency is dependent upon whether the test results
are for a regulatory agency or for management control. Specific guide-
lines are provided by the USDA for meat, and by the USDA and PMO for
milk commodities. It is customary to pull identical samples for copackers.
USDA inspectors may also collect MRE (meals ready to eat) samples for
the military. Often library samples are gathered on a daily basis for shelf
life and stability observation.
Filler speed and container identification are presented in Table 12.2.
This information is essential for troubleshooting and defect correction.
Production codes stamped on each container are useful for warehouse
inventory and product retrieval or recall.

Table 12.2  Comparison of Aseptic Filler Speed and Container Identification

Filler Filler Speed Container Identification
1. Dole aseptic 330–500 5-oz cans 4–6 seamer heads; seamer #1 leaves an
canner per minute etch mark on inside of double seam
120–200 15-oz cans 4–6 seamer heads; seamer #1 leaves an
per minute etch mark on inside of double seam
22–30 cans #10 (96 oz) Single seamer head
per minute
2. Tetra Brik 100 8-oz briks 2 transversal jaws; jaw #1 identified by
per minute production code with hyphen
3. Conoffast 264 5-oz cups 12 sealing heads; cups embossed at
per minute the bottom with codes 1 through 12
196 Handbook of aseptic processing and packaging

On-line inspection. Every 15 to 30 minutes, line inspectors check for

container cosmetic defects and record weights, vacuum, pH, total solids
or Brix degree, viscosity, flavor, and fill temperatures. One of the limita-
tions in QC checks of semirigid or flexible packages as compared to metal
containers is the inability to record simple vacuum readings as a reliable
index of a hermetic seal, because these packages have ambient pressure or
have nitrogen-flushed headspace. This limitation has been overcome by
evolving package-specific QC test procedures based upon defect criteria
and level. The line inspectors serve as primary feedback to avoid mass
production of defective product or containers.
Package tear down. QA personnel routinely sample four cans or Tetra
Briks or 12 cups every 1 to 2 hours, and check and record all cosmetic
defects and seal integrity. Frequent sampling may be necessary during
machine start-up, stops, splicing, and end of run (EOR). Can integrity is
tested by standard seam tear down procedures. Tetra Brik aseptic flexible
package integrity is validated through electrolytic and dye penetration
tests, and acid tear down of transversal seal as described in the Tetra Brik
aseptic container QC manual. Hermetic integrity of Conoffast semirigid
cups are evaluated by one or more of the following tests (David 1988): (1)
minimum seal width of 1/16 inch of frosty area on the flange, (2) ability
of cups to withstand an internal pressure during underwater pressure
tester operated at 15 in Hg for 30 seconds or more, (3) seal leak assessment
through a commonly used dye migration technique, and (4) any obvious
holes in the cup body. There are electronic devices available for objective
measurement of seal integrity.
Considerable research efforts are underway to study nondestructive
testing for evaluating package integrity. The pressure difference method
is probably the most promising technique because of its simplicity. There
is a genuine need to develop sensitive, reliable, and cost-effective non-
destructive package integrity evaluation methods, compatible with line
speeds currently used or those planned for the future.

12.2.3  Postprocess assurance

Postprocess assurance represents process analysis, data review, and tests
that are performed after the production is completed. Often these tests
are performed after storage at ambient or incubation at an elevated tem-
perature for prescribed time periods. The evaluation may include sensory,
product stability, product thinning due to enzymes, and spoilage due to
microbiological contamination.
It is well known that one cannot build quality and safety through
extensive inspection of the finished product. However, these tests are per-
formed on a small sample size as one last step in the assurance process for
management, and for regulatory compliance for USDA products.
Chapter 12:  Quality assurance and food protection 197

12.2.3.1  Incubated product evaluation

About 0.25% to 1% random samples (Department of Defense 1989) are
incubated for 7 to 14 days at 95°F to 98°F (35°C) to accelerate degradative
reactions of rheologic and sensory characteristics, and any microbiologi-
cal spoilage due to mesophiles. At the end of the incubation period, prod-
uct samples are checked for all cosmetic and seal defects, microbiological
growth, and other product characteristics such as fill weight, pH, color,
flavor, taste, and viscosity.
If a lot contains between 35,000 and 150,000 containers, it is custom-
ary to sample and incubate 315 units. The lot should be accepted on zero
defect and rejected on two defects. If there is one defect, the lot should be
resampled at a more intensified rate. Whenever results are questionable,
it is best that the lot be placed on hold and the tests repeated before the
disposition of a lot.

12.2.3.2 Microbiological testing for sterility

and sample size consideration
It is important to note that chemical composition characteristics, nutri-
tional value, and sensory characteristics can be established for a batch or
lot by random testing of end products with a high level of confidence due
to uniformity throughout the production batch. The same, however, is not
true for assuring microbiological safety of foods because spoilage events
are very rare and could be sporadic, random, or systemic.
Microorganisms are inactivated (dead) if they cannot reproduce to
appear as colonies on a microbiological solid medium plate or make liquid
medium turbid or redox color change. Sterility is absence of all life forms
and it is a concept of negative state! One cannot measure microorganisms
when they are not present and therefore negative test results do not prove
anything conclusively.
During troubleshooting to identify cause-and-effect relationships,
extensive sampling is followed by approved bacteriological validation
tests. However, lack of sterility is a rare event in a large population and
can only be identified by a very large sample size and destructive test-
ing. For example, to verify an overall defect rate of 1:10,000, one needs to
sample 22,500, 30,000, and 46,000 units at 90%, 95%, and 99% confidence
limits, respectively, as shown in Table  12.3. It is important to note that
no sampling inspection plan for finished products will catch all defective
units. Therefore, routine inspection is intended to detect serious errors.
Because the sample size is large and testing is expensive, it is bet-
ter to control and check all preproduction and process variables via QA
and hazard analysis critical control point (HACCP) programs, rather than
extensive examination, destructive testing, and rework of finished prod-
ucts. Rework is expensive and dishonorable to employees (Crosby 1984).
198 Handbook of aseptic processing and packaging

Table 12.3  Number of Samples and Defective

Fraction to Be Tested
Overall Probabilitya
Maximum
90% 95% 99%
Acceptable
Defect Rate Number of Samples to Be Tested
1:100 225 300 460
1:1,000 2,250 3,000 4,600
1:10,000 22,500 30,000 46,000
1:100,000 225,000 300,000 460,000
1:1,000,00 2,250,000 3,000,000 4,600,000
a Probability of finding at least one defective package in
the sample if the total unsterility lies at the maximum
acceptable defect rate.

In reality, commercial sterility in the food industry is assured by

design, validation, and control, and by testing a small but statistically
random sample, followed by either visual testing or by subculturing
and bacteriological analysis of preincubated product (Food and Drug
Administration 1992). This protocol is adequate for regulatory compliance
and for providing assurance to management.

12.2.3.3  Distribution, handling, and storage

The role of the quality assurance does not end with the release of product
to distribution. Products can get severely abused and damaged in distri-
bution. Semirigid or flexible containers are far less resistant to abuse than
metal cans from a Dole aseptic canner and conventional canning. All it
takes is a crack or fracture in one layer of packaging material and the
container may lose its sterility. Pallets of such products must be treated
with care. They should not be stacked more than two high. Rack stacking
gives additional protection. Storage temperatures will play a key role in
keeping quality of a product.

12.2.3.4  ASTM drop test

One of the critical qualifying tests employed by any processor or copacker
is the drop test as outlined in ASTM-D-775-80 (ASTM 1987) for finished
product in secondary packaging. This test verifies the ability of the sec-
ondary package (i.e., cardboard case containing primary containers) to
withstand damage after being dropped from a predetermined height.
Gentle handling is desirable for all aseptic containers—rigid, semi-
rigid, or flexible. Metal containers via a Dole aseptic canner need careful
handling during the annealing (20 seconds) of the cap-sealing compound
in the double seam, after exit from the seamer.
Chapter 12:  Quality assurance and food protection 199

12.2.3.5  Cumulative assurance and product release

There is no “one” single “magic” test that can unequivocally prove the
microbiological safety or sterility of the production lot. In the food indus-
try, it is common to release non-USDA products into commerce using
“cumulative assurance,” which is a form of “parametric release” practiced
in the pharmaceutical industry for release of parenterals solution termi-
nally sterilized by moist heat (K.S. Purohit, Process Tek, personal com-
munication, 2008). The principle of parametric release consists of review
of all QA data—especially sterilizer control, aseptic filler control, and rou-
tine QC monitoring programs—to judge the sterility and safety assurance
level, without the need of finished product sterility testing. USDA meat-
containing products must be incubated for about 10 days at 35°C, followed
by appropriate tests, prior to release, according to USDA regulations
(9 CFR, Parts 318 and 381 1986).

12.3 Hazard analysis critical control

point (HACCP) program
Regulatory agencies and industry organizations are promoting adop-
tion by industry of the hazard analysis critical control points program
(National Research Council 1985).

12.3.1 Principles of HACCP
HACCP principles include:

1. Identify potential hazards

2. Establish critical control points (CCPs)
3. Establish specifications for CCPs
4. Establish monitoring procedures for CCPs
5. Develop procedure/policy for corrective actions for deviations
6. Keep records
7. Develop procedure for verification

HACCP is a comprehensive tracking of an entire process. HACCP

happens on the plant floor. It is a systematic and quantitative risk assess-
ment tool. HACCP is distinctly different from a QA program and
should not be misconstrued as a mere listing of all control points and
critical control points. HACCP programs emphasize prevention rather
than inspection for defectives. The evolution of an HACCP program
depends upon careful gleaning of historical QA programs encompass-
ing incoming food and packaging ingredients, sanitation and CIP,
200 Handbook of aseptic processing and packaging

maintenance, batching, operation of processing systems and packag-

ing equipment, downstream handling, warehousing, distribution,
retailing of finished products, and consumer handling. HACCP is
compatible with most existing QC and QA programs (Schothorst and
Jorgeneel 1994).

12.3.2  Categories of hazards

The sole objective of HACCP is food safety and safety only—microbio-
logical, physical, and chemical. These three hazards may naturally occur
in the food, be contributed by the environment, or be generated by a mis-
take in the manufacturing procedure, or process, or package. Physical and
chemical hazards are nonliving; they do not grow and multiply. Their
incoming concentration may remain constant or may get diluted during
batching, thus reducing the associated risk. On the other hand, micro-
biological hazards are living; they can grow and multiply under ideal
conditions of growth, leading to toxin production, pH changes, gas forma-
tion, and other chemical degradation, thereby increasing the associated
risk. Although chemical hazards are the most feared by consumers and
physical hazards are the most commonly identified by consumers, micro-
biological hazards are the most serious from a public health perspective.
For example, a piece of metal (physical hazard) in a food may result in
a chipped tooth for one consumer, but contamination of a batch of milk
with Salmonella or meat with E. coli O157:H7 may affect hundreds or even
thousands of consumers. Because every production line is different, the
HACCP program must be tailored to be product-process-package, line-,
and factory-specific. Further work in the areas of calibration of monitor-
ing methods and alternate methods for CCPs is desired.
An HACCP program is strongly recommended for aseptically pro-
cessed and packaged foods, because the technology and associated opera-
tions are highly complex.

12.4  Others
12.4.1  Consumer complaints
Close contact between the quality assurance and consumer relations
departments needs to be maintained so that any consumer complaint gets
promptly brought to the attention of QA. Consumer complaints often pro-
vide a valuable early warning of a potentially big problem.
Also, consumer complaints can be used as a proactive QA tool. Proper
databasing of consumer complaints is necessary to evaluate performance
of a product out in the field and to compute complaint or defect rates and
analyze trends.
Chapter 12:  Quality assurance and food protection 201

12.4.2  Recalls and spoilage

A recall or withdrawal plan should be prepared in advance, describing
actions to be taken and who will perform them. These procedures and
policies do not have to accompany the process filing; however, a firm
doing any type of commercial sterilization, whether it is aseptic or can-
ning, should have these. An annual mock recall is recommended to test
the reflexes and efficiency of the plan and system.
At the same time, or before the real or mock recall procedures are in
effect, the cause and corrective action for the spoilage or contamination
must be determined, as described in Chapter 13.

References
9 CFR Parts 308, 318, 320, 327 and 381. 1986. Canning of Meat and Poultry Products
Final Rule Part II. Department of Agriculture.
21 CFR Parts 110, 113, and 114. 1987. Washington, DC: U.S. Government Printing
Office.
ASTM. 1987. Annual Book of ASTM Standards Paper; Packaging; Flexible Barrier
Materials; Business Copy Products, Vol. 15.09.
Bockelmann, V.B. 1982. Aseptic Packaging and Processing: A Collection of Lectures from
Tetra Pak Seminars, Chapters 3 and 7. Lund, Sweden: Tetra Pak.
Crosby, P.B. 1984. Quality Without Tears. New York: McGraw-Hill.
David, J.R.D. 1988. Realization of a commercial low acid thermoform-fill-seal
(TF-F-S) machine in the U.S. Part B: Quality assurance and regulatory aspects.
Proceedings of the Fifth International Conference on Aseptic Packaging,
“ASEPTIPAK 1988,” Bloomingdale, Illinois, June 8–10.
David, J.R.D. 1989. Quality assurance for UHT-sterilized and aseptically pack-
aged food at Real Fresh, Inc. Aseptic processing and packaging course. Food
Engineering and Technology Series, University of Wisconsin, Madison.
Department of Defense. 1989. Military Standard Sampling Procedures and Tables for
Inspection by Attributes, MIL-STD-105E. Washington, DC: Department of Defense.
Food and Drug Administration. 1992. Bacteriological Analytical Manual, 7th ed.,
Chapters 23 and 24. Arlington, Virginia: Association of Official Analytical
Chemists.
Juran, J.M., and Godfrey, A.B. 1999. Quality Planning and Analysis, 2nd ed. New
York: McGraw-Hill.
National Food Processors Association. 1989. Flexible Package Integrity Bulletin.
Flexible Packaging Integrity Committee. Washington, DC: National Food
Processors Association.
National Research Council (U.S.) Food Protection Committee Subcommittee on
Microbiological Criteria. 1985. An Evaluation of the Role of Microbiological Criteria
for Foods and Food Ingredients. Washington, DC: National Academy Press.
Schothorst, V.M., and Jorgeneel, S. 1994. Line monitoring, HACCP and food safety.
Food Control 5(2):107–110.
chapter 13

Failure mode and effect analysis,

and spoilage troubleshooting
Jairus R.D. David

If we can really understand the problem, the answer

will come out of it, because the answer is not sepa-
rate from the problem.
J. Krishnamurti

13.1  Failure mode and effect analysis

Failure mode and effect analysis (FMEA) is an analytical technique that
combines the technology and experience of people in identifying foresee-
able failure modes of a product or process and planning for its elimination
(Besterfield et al. 2003). In other words, FMEA can be explained as a group
of activities intended to

1. Recognize and evaluate the potential failure of a product or process

and its effects
2. Identify actions that could eliminate or reduce the chance of poten-
tial failures
3. Document the process

13.2 Failure mode and effect analysis,

and troubleshooting
The types and number of failure modes are directly related to the com-
plexity of a processing system (David 1991, 1995). It is important to recog-
nize that the benefits of aseptic processing of foods can be easily offset by
the mechanical complexity of sterilizers and aseptic fillers, surge tanks,
interfaces, improper validation and shakedown, inadequate delivery
of appropriate methods of sterilization to processing equipment, raw
product, container, lid, aseptic filler, and maintenance decontamination
(“active” or “passive”) of the aseptic tunnel or work zone.

203
204 Handbook of aseptic processing and packaging

13.2.1  Systems analysis and bioburden

The design and preparation of aseptic processing and packaging systems
is a very complex process. Different methods and intensities of steriliza-
tion are required to commercially sterilize processing equipment, raw
product, package, lid, and aseptic tunnel or work zone.
As described in Chapter 11, the fundamental equation governing any
thermal process design is given as

Frequired = DTref (log N i − log N f ) (13.1)

This equation specifies the reduction in bioburden for a target

microorganism(s) or spores in a food, package, sterilizer, or filler from an
initial count Ni (at the beginning of the process ti ) to a final safe level Nf
(at the end of the process tf) established from public health or economic
spoilage rate considerations. For proper design, one needs to know the
initial load of microorganisms, the physiology and ecology of microor-
ganisms, and the final safe level.

13.2.1.1  Canning or retorting

For canning, Equation 13.1 can be rewritten to account for bioburden from
food, container, and lid. After filling and hermetic sealing, both food and
container experience a thermal process cycle to yield a commercially ster-
ile food, as shown in Figure 13.1.

13.2.1.2  Aseptic processing and packaging

Equation 13.1 can be recast to account for different components in aseptic
processing and packaging, and is presented in Figure 13.2.

Raw Food (F): Heat

NFo (NFf + NCf + NLf ) cool
Cool

(Commercially
Bioburden

sterile shelf-
stable food
in hermetically
Preformed
NCo sealed container)
Container (C)
and
Lid (L)
NLo

Figure 13.1  Status diagram of bioburden for thermal process design of canning
operation. Status designation as described in “Nomenclature” section.
 Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 205
Sterilizers (E): Coolers (E´):
Processing equipment NEo NEs NEf NEf ´ NEs´ NEo ´
(sterilizers and coolers)

Raw food (F): NFo NFf NFf

heat cool
Bioburden

Ambient or superheated steam

Aseptic fillers (A): NAo NAs NAf NAd [NAd (NFf + NCf + NLf )]cool
and zone

Container (C): Commercially sterile

Preformed NCo NCf
or shelf-stable food
formed in hermetically
on-site Lid (L): sealed containers
NLo NLf

Figure 13.2  Status diagram of bioburden for thermal process design of aseptic processing and packaging operation (not shown are
sterile interface and aseptic balance tanks). Status designation as described in the “Nomenclature” section.
206 Handbook of aseptic processing and packaging

From Figure 13.2, it is evident that the sterilization of raw food ( N Fo ),

container ( N Co ), and lid ( N Lo ) are uncoupled or decoupled. This is neces-
sary to co-optimize all the first-order kinetic reactions in food at high-
temperature short-time (HTST) or ultra-high temperature (UHT) regime,
that is, microbial destruction and conservation of nutrients, quality, and
other desirable factors. The raw food is heated and cooled by sterilizers
(E) and coolers (E′), which in turn are prepared from “zero” or soiled state
( )
( N Eo and N Eo′ ), sanitized ( N Es and N Es′ ), and presterilized N E f and N E′f . It
is interesting to note that a retort or sterilizing vessel does not need to be
presterilized before a sterilizing load cycle. The container ( N Co ) and the lid
( N Lo ) are sterilized separately in the aseptic filler or zone ( N C f and N L f ),
usually by an optimal method compared to sterilization of food. This is
because container and lid are inert and microorganisms cannot reproduce
as they do in the foods.
The aseptic zone (A) is the most critical site in aseptic processing
and packaging of foods, wherein presterilized and cooled food and pre-
sterilized package are now recoupled, that is, via aseptic filling followed
by hermetic sealing. The aseptic zone ( N Ao ) is prepared from “zero” or
soiled state, sanitized ( N As ), and presterilized ( N A f ). During production
run, the presterilized aseptic zone integrity is preserved by maintenance
sterility or dynamic decontamination ( N Ad ). There are two common
methods of dynamic decontamination: (1) active decontamination and (2)
passive decontamination, as shown in Table 13.1. Active decontamination
is achieved by use of superheated steam in Dole aseptic canner. Passive
decontamination is common in most of the other types of aseptic fillers.
This is a gentler process, where bacteriologically filtered air or inciner-
ated cold air serves as a laminar curtain to maintain a positive tunnel
pressure (K.S. Purohit, Process Tek, personal communication, 2008). This
concept is further explained in Chapter 15.
It is very important to note that each component has an intrinsic defect
rate; aseptic processing will be prone to a higher defect rate because of the

Table 13.1  Types of Potential Failure Modes in Aseptic Processing and

Packaging of Food
Type Failure Mode
Type 1 Incoming raw ingredients, handling, storage, and batching
Type 2 EPSU preventive maintenance, CIP and sanitation, and presterilization
Type 3 Thermal process design and delivery—heating cycle including regeneration
Type 4 Thermal process design and delivery—cooling cycle including surge tanks
Type 5 Incoming package material and its sterilization
Type 6 Aseptic zone integrity and environmental load
Type 7 Container seal integrity
Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 207

mechanical complexity of heaters, coolers, aseptic filler, and packaging

machine. The overall defect rate will be determined by the weakest or
most vulnerable component. Another way of looking at this risk analysis
based on mechanical complexity (i.e., the number of components) is that
retorting is easier (and probably safer) compared to aseptic packaging.

13.2.2  Failure modes, analysis of their effects, and controls

In this section, failure modes and their ultimate effects on finished prod-
uct quality and microbiological safety are presented briefly in a summary
form. Based on the author’s extensive experience with low-acid aseptic
foods involving different types of thermal processing systems and asep-
tic fillers and containers, seven different types of potential failure modes
have been identified and are shown in Table 13.1.

13.2.2.1 Type 1: Incoming raw ingredients,

handling, storage, and batching
The quality and microbial load of incoming raw or preprocessed ingre-
dients and their control during handling, storage, and batching directly
influence the quality and microbial safety of finished product. This prin-
ciple was illustrated in Figures 13.1 and 13.2.
A fundamental understanding of microbial ecology and physiology
is required to appreciate physiological types, their numbers, and their
metabolic end products such as enzymes, toxins, off flavors, or odors. The
following discussion pertains to heat-resistant Staphylococcus toxin, heat-
resistant psychrotrophic enzymes, and economic spoilage due to thermo-
philic spores.

13.2.2.1.1   Staphylococcus toxin  This microorganism can be eas-

ily controlled or eliminated via pasteurization, refrigeration, aw, and pH
controls. Uncontrolled growth of Staphylococcus aureus to high levels of 105
or 106 cells per milliliter can lead to the secretion, by coagulase-positive
heat-sensitive S. aureus vegetative cells, of highly heat-resistant toxin with
D280°F value of about 4 to 20 minutes, which can survive either conven-
tional retorted or UHT-aseptic processes. Thus, it is easier to control the
vegetative cells rather than inactivate their toxin.

13.2.2.1.2   Psychrotrophic enzymes  Psychrotrophs are heat-sensitive

vegetative microorganisms capable of growth at refrigeration tempera-
tures. These are commonly found in milk and some dairy products.
The commonly used hurdle of refrigeration is ineffective in control of
this physiological type. This cold-loving microorganism can grow and
secrete highly heat-resistant enzymes such as lipases and proteases.
These enzymes or their precursors and activators can potentially survive
208 Handbook of aseptic processing and packaging

the sterilization process and contribute to product physical defects such

as gelation and off flavors.
The psychrotrophs can be easily controlled by thermization and also
by use of enzyme blockers, as discussed in Chapter 15.

13.2.2.1.3   Thermophilic economic spoilage  As discussed in Chapter 11,

thermophilic economic spoilage is not an issue for low-acid products with
a thermal process design (Fo of 5 to 6 minutes) based on 5D reduction
of heat-resistant mesophilic spores, cooled promptly, and distributed and
stored at normal ambient conditions. However, thermal process design
should consider the heat resistance of the thermophilic anaerobes (D250°F
of 3 to 4 minutes) and their numbers, should the finished product be stored
in tropical and desert areas (100°F to 125°F) or hot vended.
Ingredients of concern are starches, cocoa, sugar, corn, mushrooms,
spices, and other preprocessed ingredients via pasteurization or blanching
leading to enrichment of heat resistant mesophilic or thermophilic spores.
To summarize, raw ingredients directly determine the finished prod-
uct quality and microbiological safety. Batching temperatures and hold
time may inactivate microbial vegetative cells, but not their heat-resistant
toxin, and enzymes or thermophilic spores. These can survive the ther-
mal process and be detected in the finished product.
Several types of controls for suspect ingredients are discussed in
Chapter 15.

13.2.2.2  Type 2: Equipment preparation and setup

Type 2 modes of failure can occur due to improper equipment preparation
and setup (EPSU). This is evident from Figure 13.2, wherein EPSU is an
integral part of preparing sterilizers (E), coolers (E′), and the aseptic filler
and zone (A). The objective of EPSU is to provide well-maintained, soil-
free, and presterilized equipment for production.
The components of EPSU are

1. Preventive and routine maintenance

2. Clean-in-place (CIP), clean-out-of-place (COP), and sanitation
3. Environmental control of aseptic filler room
4. Presterilization
5. Intermittent cleanup to control fouling or burn-on and restarts
after interruptions

Although the details are beyond the scope of this chapter, exhaustive
manuals and procedures are available from vendors of sanitation chemi-
cals, processing equipment, and aseptic fillers for proper EPSU.
Failure can possibly occur due to compromised leaks, cracks, bad gas-
ket, valve seat, and mechanical and steam seals. Also improperly cleaned
Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 209

or delayed CIP of equipment can contribute to high levels of anaerobic

spore microbial bioburden in the equipment, especially on the cooling
side (N Eo, N Es; N Eo′ , N Es′ ; and N Ao, N As) or in the finished product. This is
especially true for cheese-based sauces processed via direct steam injec-
tion systems with vacuum cooling. Cleaning and sterilization of UHT pro-
cessing plant and aseptic fillers has been extensively reviewed by Burton
(1988). It is important to monitor and control the “repeatability” of CIP and
the sanitation cycle for the control of soil, fouling, and biofilms.

13.2.2.3 Type 3: Thermal process design and delivery—Heat cycle

13.2.2.3.1   Design  The concepts and implications of Fprocess and
Frequired were described in Chapter 11. The bioburden in aseptic process-
ing operation is contributed by food, sterilizers, coolers, aseptic zone, and
package container and lid, as shown in Figure 13.2. It is important to know
the physiological types, their heat resistance, and their numbers to arrive
at a safe thermal process design, as shown in Equation 13.1.
Routinely, low-acid foods are preserved using an Fprocess of about 5 to
6 minutes based on 5D reduction, inactivating nonpathogenic mesophilic
spores. A much more severe process may be required should one encoun-
ter high numbers (Ni) of heat-resistant (D250 values) mesophilic or thermo-
philic spores, or heat-resistant enzymes.
Control methods described under Type 1 are valid in the prevention
of S. aureus toxin, psychrotrophic enzymes, and thermophilic spores in
incoming ingredients.
A typical UHT thermal process design for low-acid liquid, viscous
fluid, and particulates should take into consideration product flow rate,
viscosity, nature of particulates, residence time distribution, and potential
for fouling.

13.2.2.3.2   Delivery  The delivery of a designed thermal process is

an equally important step from both safety and quality perspectives. The
process delivery can be described by the Fprocess equation:

(F )
tf
1

z
Tref
process
= Fprocess =
∫
ti
(Tref −T ( t )) z
10
⋅ dt (13.2)

Underprocessing—The errors associated with translation between the

design and delivery steps should be carefully controlled and moni-
tored. Any drop in temperature or pressure or improper timing of
the pump can contribute to underprocessing. Production personnel
should tag the suspect products for hold, and a disposition deci-
sion should be made by quality assurance and a competent process
210 Handbook of aseptic processing and packaging

authority. This type of failure mode is characterized by the presence

of mostly one type of mesophilic or thermophilic spores in the fin-
ished product.
Overprocessing—Oftentimes scheduled processes are delivered higher
than required to avoid underprocessing and related process devia-
tion disposition. As a result, this type of deviation is a rule than an
exception. As a result, products that are overprocessed at UHT are
severely damaged in regard to color, quality factors, and nutrients,
as described in Chapter 15 (Figure 15.2).

13.2.2.4 Type 4: Thermal process design and delivery—Cool cycle

Prompt cooling of UHT-heated product is required to quench heat-
induced damage to quality and nutrition. Also, improper or slow cooling
can lead to germination of thermophilic spores responsible for economic
spoilage in certain foods.
The cooling capacity needs to be designed based on regeneration, heat
capacity, and viscosity of food and on temperature gradient.
Type 4 failure modes are

1. System leaks—gaskets
2. Channeling in plate heat exchangers, pinholes in pipes, Venturi
effects, and product-to-product regeneration
3. Downstream homogenizer leaks
4. Valve leaks— flow diversion, cluster, etc.

Several of these failure modes could be prevented by preventive mainte-

nance, proper CIP, and sanitation and EPSU procedures outlined earlier.
This type of failure mode is characterized by the presence of anaerobic or
aerobic spores and vegetative cells in the finished product, due to adventi-
tious contamination.

13.2.2.5 Type 5: Incoming packaging material and its sterilization

Incoming packaging material, container, and lid either preformed or
formed on site contribute minimal bioburden compared to food, because
microorganisms cannot reproduce on inert packaging material. The ster-
ilization of packaging container and lid materials on preformed contain-
ers and lids is accomplished in the aseptic work zone prior to filling and
hermetic sealing.
Type 5 failure modes are

1. Microbiological overload in incoming packaging material

2. Improper storage and handling
3. Grease and dirt on the packaging material
Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 211

4. Inadequate sterilization of packaging material

5. Improper seal strength
6. Improper seal integrity
7. Sealing compound in can metal lids

These types of failure modes are characterized by the presence of mostly

vegetative cells and, on rare occasions, by spores in the finished product.

13.2.2.6  Type 6: Aseptic zone integrity and environmental load

Aseptic zone integrity and environmental load failure mode is the most
important among the seven and is perhaps the least understood. The asep-
tic zone or tunnel is not an airtight chamber but an “open” steady-state
containment system. It is a heavy-work zone, and therefore will tend
toward entropy or chaos over a period of time if not controlled and moni-
tored properly.

13.2.2.6.1   Role of aseptic zone  The aseptic zone is the place where
several functions are choreographed. Work performed by the aseptic
machine includes

1. Forming package and lid or conveying preformed package and lid

2. Optimally sterilizing package and lid
3. Aseptically filling presterilized cooled product
4. Aseptically adding heat-sensitive filter sterilized additives such as
enzymes, biotechnology-derived products, or probiotics
5. Hermetic sealing
6. Providing a continual aseptic zone via maintenance sterility or dynamic
decontamination needed during the aforementioned functions

13.2.2.6.2   Preparation of aseptic zone  The aseptic zone is prepared

for production using the following EPSU schedule and is shown in a pyra-
mid drawing in Figure 13.3.

1. Preventive maintenance
2. Environmental control of the room and machine
3. CIP and sanitation
4. Presterilization

The system is rebuilt during every production run using all the EPSU
building blocks, which are additive in their protective effect. However,
the weakest link in this chain is the capstone—dynamic decontamina-
tion—which is continually being eroded as things go in and out of the
aseptic zone. Dynamic decontamination can be either passive or active
as described earlier.
212 Handbook of aseptic processing and packaging

Capstone:
Dynamic
Decontamination
or Maintenance
Sterility of Aseptic
Work Zone

Presterilization

C.I.P. and Sanitation

Environmental Contro
ls of Room and
Machines

Preventive and Routine

Maintenance

Figure 13.3  Pyramid drawing showing the importance of foundation bases in

supporting the capstone of dynamic decontamination.

13.2.2.6.3   Factors contributing to reinfection of aseptic zone

1. Environmental bioburden of room and filler

2. Loss of filter integrity necessary for laminar curtain
3. Turbulence due to pneumatic and hydraulic actions
4. Venturi effects and aspiration or gasping due to packaging material
fed into and finished packages going out of the aseptic zone
5. Conveyor chain movement and returns
6. Other indexing operations, linkages, etc.
7. Condensate buildup
8. Product drip
9. Bacteriological seeding of aseptic chamber—aerosol, food, instru-
ment, and pneumatic leaks
10. Bacteriological seeding of filler or surge tanks
11. Cracks in filler head and pistons
12. Operator intervention, adjustment, line jams, stop–start–restart

This type of failure mode is characterized by the presence of both

spores and vegetative cells in the finished product.
Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 213

It is reassuring to note that virtually all parameters that can affect

the aseptic integrity of the machine and product are required to be auto-
mated and monitored by the programmable logic controller (PLC) and
are outside of operator control. Mandated quality assurance and
record-keeping procedures seek redundancy with these systems but
do not rely on personnel as the primary guarantor of sterility. It is dou-
bly important to validate computer and software programs that drive
the machine.

13.2.2.7  Type 7: Package seal integrity

In aseptic processing, sealing of packages is accomplished in an actively
or passively decontaminated aseptic chamber at ambient conditions.
However, in retorting, each and every package is trauma tested at steril-
izing pressure and temperatures and with cascading cooling water (K.S.
Purohit, Process Tek, personal communication, 2008). Also, there is the
absence of vacuum in most semirigid or flexible containers as an indica-
tion of seal integrity. Postprocess recontamination due to seal failure can
result in reinfection of microorganisms.

13.2.3  Cause-and-effect relationships

Whenever there is the occurrence of a failure mode(s), establishing the
cause-and-effect relationship is central to troubleshooting and the recom-
mendation and implementation of appropriate corrective action.
It is not economical to mass produce microbiologically compromised
products via a processing system exhibiting one or more of the failure
modes. Troubleshooting needs to be quick and definitive. Understanding
the symptoms and thus the problem and its association with specific
mode(s) of failure is a basic necessity when dealing with an aseptic pro-
cessing and packaging system.

13.2.3.1 Microbiological and package integrity

testing for troubleshooting
Microbiological and package integrity testing are essential for effective
troubleshooting. Microbiological data interpretation should be done with
caution. A Type 7 failure mode is easily identified due to compromised
seal integrity. Type 1 through Type 6 modes of failures normally exhibit
integral seals; Types 1 and 3 can be partitioned by investigation of pH
change, product thinning, microscopic observation, and microbial spe-
ciation or identification and heat resistance of spores present. A brief
summary is provided in Table  13.2. Types 2, 4, 5, and 6 exhibit similar
microbiological profiles and careful interpretation is needed by a micro-
bial physiologist.
214 Handbook of aseptic processing and packaging

Table 13.2  Summary of Microbiological and Package Integrity Testing for

Troubleshooting
Failure Seal
Mode Unit Operation Microbial Profile Integrity
Type 1 Raw material and Incipient psychrotrophs ✓
handling thermophilic spores
Type 2 EPSU Variable: anaerobic spores and ✓
vegetative cells
Type 3 Thermal process heat One type of spore—mesophilic ✓
cycle or thermophilic
Type 4 Thermal process cool Variable: anaerobic and aerobic ✓
cycle spores; vegetative cells
Type 5 Incoming package and Variable: vegetative cells ✓
its sterilization
Type 6 Aseptic zone filler Variable: spores, vegetative ✓
cells
Type 7 Seal integrity Variable: mostly vegetative ✘
cells

13.2.4  Summary
This chapter was devoted to developing an appreciation for the complexi-
ties involved in aseptic processing and packaging of foods. The author
identified seven different types of failure modes, their effects, and means
to either prevent or control their occurrence. Types 3 and 5 modes of
failures were analyzed and found to be less complex compared to other
modes. Type 6 was the most vulnerable mode in the entire operation. For
troubleshooting, a brief summary of cause-and-effect relationships was
provided. Microbiological test data should be interpreted with caution by
a cross-functional team consisting of a microbiologist with experience in
plant ecology and physiology, environmental engineer, thermal process-
ing specialist, and EPSU and research and development staff.
There are two groups of problems: those with generally known solu-
tions and those with unknown solutions. Those with known solutions can
usually be solved by information found in books, technical journals, or
with subject-matter experts. These solutions follow the general pattern of
problem solving. In this case, the particular problem is elevated to a stan-
dard problem of a similar nature or analogous nature. A standard solu-
tion is known and from the standard solution comes a particular solution
to the problem. On the other hand, there are problems with troubleshoot-
ing of microbial spoilage of aseptic products with no known solution. In
such cases, advanced tools such as TRIZ based on the theory of inventive
problem solving should be deployed (see Chapter 1).
Chapter 13:  Failure mode and effect analysis, and spoilage troubleshooting 215

13.3  Nomenclature
(A)  Aseptic filler and zone
(C)  Container
(E)  Sterilizers
(E′)  Coolers
(F)  Raw food
(L)  Lid
DTzref   Decimal reduction time; heating time required at temperature Tref
for 90% reduction of microorganisms with given z value (minutes)
Ni  Initial concentration of microorganisms
Nf  Final safe concentration of microorganisms or probability of a
nonsterile unit in the entire production lot
N Ao   Initial soil or load of microorganisms in aseptic tunnel or zone,
prior to sanitation
N As   Intermediate number of microorganisms after clean-in-place (CIP)
and sanitation of aseptic filler, prior to presterilization
N A f   Final safe number of microorganisms after presterilization of aseptic
filler, prior to production run
N Ad   Real-time safe number of microorganisms in aseptic filler during
production run; commercial sterility during maintenance ste-
rility or dynamic decontamination
N Co   Initial load of microorganisms in empty container or package
material
N C f   Final safe number of microorganisms in container after sterilization
(commercial sterility)
N Eo   Initial soil or load of microorganisms in processing equipment (ster-
ilizers) before sanitation
N Eo′   Initial soil or load of microorganisms in processing equipment (cool-
ers) before sanitation
N Es   Intermediate number of microorganisms after sanitation of process-
ing (sterilizers) equipment and prior to presterilization
N Es′   Intermediate number of microorganisms after sanitation of process-
ing (coolers) equipment and prior to presterilization
NEf   Final safe number of microorganisms after presterilization of pro-
cessing (sterilizers) equipment and during production run (com-
mercial sterility)
N E′f   Final safe number of microorganisms after presterilization of pro-
cessing (coolers) equipment and during production run (commer-
cial sterility)
N Fo   Initial load of microorganisms in raw food
N Ff   Final safe concentration of microorganisms in food (commercial ste-
rility) or probability of a nonsterile unit in the entire production lot
216 Handbook of aseptic processing and packaging

N Ffheat   Final safe number of microorganisms in finished product after

sterilization (commercial sterility), prior to cooling
N Ffcool   Final safe number of microorganisms in finished product after
sterilization and cooling cycle
N Lo   Initial load of microorganisms on lid
N L f   Final safe number of microorganisms in lid after sterilization (com-
mercial sterility)
( N Ff + N C f + N L f )cool  Commercially sterile, shelf-stable food in hermeti-
cally sealed containers for retort process
[NAd(N Ff + NCf + N Lf )]cool   Commercially sterile, shelf-stable food in her-
metically sealed containers for aseptic process
t i  Time at beginning of thermal or any inactivation process (minutes)
t f  Time at end of thermal or any inactivation process (minutes)
Tref  Reference temperature (°F); common reference temperatures are
250°F, 212°F, 200°F, and 161°F
T(t)  Product temperature as a function of process time (°F)
z  Temperature difference that causes tenfold change in rate of microbial
destruction (F°)

Acknowledgments
Dr. Kailash Purohit single-handedly coined and articulated the terms
“maintenance sterility and passive or active decontamination” in both food
and pharmaceutical industry. The author expresses appreciation to Purohit,
Process Tek, Prospect Heights, Illinois, of his useful discussion, critical
review of this chapter, and permission to use several unpublished materials.

References
Besterfield, D.H., Besterfield-Michna, C., Besterfield, G., and Besterfield-Sacre, M.
2003. Failure mode and effect analysis. In Total Quality Management, 3rd ed.,
Chapter 14. Upper Saddle, River, NJ: Prentice Hall.
David, J.R.D. 1991. Aseptic processing of foods: market advantages and micro-
biological risks. Aseptic Processing and Packaging Session, Paper No. 7
Conference on Food Engineering (COFE-91), AIChE, Chicago, March 12.
David, J.R.D. 1995. Research needs to ensure safety of shelf stable low acid asepti-
cally packaged products. Symposium on Current Status of Aseptic Processing
and Packaging: An Industry Perspective. Paper No 4–5, Annual IFT Meeting,
Anaheim, California, June 4.
chapter 14

Aseptic processing of
particulate foods
An industrial perspective
Pablo M. Coronel, Josip Simunovic, and Kenneth R. Swartzel

14.1  Introduction
In Chapter 2, the history and evolution of aseptic processing in the United
States is addressed. However, the advent of thermal preservation began
long before C. Olin Ball. The world changed in 1809 when Nicolas François
Appert won the 12,000 franc reward offered by Napoleon Bonaparte to any-
one who could devise a method for food preservation in order to provide
his troops with daily rations. The modern canning process is sometimes
referred to as “appertization” in honor of this great achievement. With his
prize, Appert created The House of Appert, which became the first com-
mercial cannery in the world. Remarkably, this was 53 years before Louis
Pasteur proved that heat killed bacteria and nearly 100 years before batch
pasteurization of milk was recommended for public health reasons. The
first patent issued to an aseptic system was to Nielsen for a ultra-high tem-
perature (UHT) sterilizer in Denmark in 1906. The 1920s saw thermal drip
pasteurization and 10 years later commercial thermal continuous flow pas-
teurization using plate exchangers once again changed the food process-
ing world forever. Thermal evaluation techniques (the general method)
pioneered by Bigelow in the 1920s, with modifications, are still the basis
for all thermally treated shelf-stable products throughout the world.
Today, we understand the engineering, microbiology, and design fac-
tors for many and varied continuous flow traditional thermal systems.
The basic concepts associated with residence time, fastest fluid element,
and thermal inactivation kinetics of pathogens and their spores are
well understood. The first edition of this text covered these topics well.
Except for the United States, many countries have moved into process-
ing products with particulates under aseptic continuous flow for well
over 40 years. The self-regulating standards for most of the world meant

217
218 Handbook of aseptic processing and packaging

products could be processed and packaged aseptically but often yielded

a low quality product. Uniformity of the particulate distribution varied
from package to package but has improved significantly in recent years.
Overprocessing is still a major issue. As with any thermal treatment, the
challenge has always been to identify and validate the worst case. This
would be the fluid element in a homogeneous flowing system receiv-
ing the least heat treatment. With this identification the system design
accounts for this “cold spot” and provides commercial sterility to this
element with all other elements receiving a greater treatment. As indus-
try moved into products with particulates two common heat exchangers
were used and are still the units of choice throughout the world—scraped
surface heat exchangers and tube-in-tube systems. Due to the low rate of
heat exchange from the carrier fluid to the particles both systems dramati-
cally overprocessed the fluid and the smaller particles. Even the larger
particles had their outer surfaces dramatically overprocessed in order to
ensure that the center of the particle received at least a 12D process. To
validate the treatment alginate cubes were designed with a known bio-
load. Biovalidation had served the canning industry and the aseptic filler
industry, and it was looked at as being useful for this challenge as well.
Issues related to particle insertion, collection, and leaching of the organ-
isms continued to be in doubt in most processes, so more heat or increased
residence times were incorporated to overcome the lack of real validation
knowledge for the self-regulating industry.
Research (industrial and academic) took on this challenge. An excel-
lent reference for theory and early monitoring system attempts are given by
Lechowicj and Swartzel (1996). Many novel mechanical residence time sys-
tems were invented. The Stork Rota-Hold used varied calibrated chambers
each with different rotating finger gaps. The results were that the larger
particles might remain in three or more chambers (long residence time),
moderate-sized particles might be retained in two or more, whereas the
smallest particles remained only in one. The theory was simple: provide
more residence time to the largest particles and less as the particle size
decreased. In theory this was an excellent idea. However, with so many
mechanical attempts to control residence time the integrity of the particles
was often sacrificed. Scraped surface and very long tube-in-tube systems
also resulted in particle damage, from light attrition to corner rounding to
particle break-up.
It is noteworthy to point out two other early mechanical attempts
to thermal equalization. APV and Alfa-Laval have been pioneers in the
equipment manufacturing side for many years. In the 1970s, Alfa-Laval
developed its Achilles system utilizing in-package product with a sub-
merged (water) chamber where the product was treated with micro-
waves. Although this in-pack treatment is not strictly aseptic processing,
it is noteworthy not because of its success (it was not commercially
Chapter 14:  Aseptic processing of particulate foods 219

successful) but that the technology resurfaced recently with more mod-
ern electronics and wave distribution, providing a no-objection letter
from the U.S. Food and Drug Administration (FDA) and an Institute of
Food Technology Research and Development award in 2010 (Schmidli
2010; Tang 2010).
During the 1970s APV was eagerly developing two technologies: the
Jupiter System and the ohmic heating system. The Jupiter was a large
semicontinuous system that utilized batch-heating vessels where least
heat sensitive particles were added first and later more sensitive or smaller
particles were added last. The batch would then be pumped in a continu-
ous sterilized system for cooling and packaging. This system as well as
the Achilles were cost prohibitive and the technologies at that time did
not provide the quality benefits over traditional canning, at least to the
point that industry were willing to switch over.
Through the 1970s and 1980s, APV invested heavily into electric resis-
tance heating (ohmic). Considerable time and expense demonstrated that
the electrodes had to be made from titanium to keep them from being
damaged by electrolysis. Additionally, the electrodes had to be spaced in
such a way that so-called run-away heating was not the result. Products
usually had to be reformulated to provide uniform electric resistance
between the carrier fluid and the particles, since electricity takes the path
of least resistance. As biological materials heat, a series of processes such
as rupture of wall cells, breakage of hydrocolloids (pectins and gums),
and a plain increase in the mobility of ions result in an increase in the
electrical conductivity of the materials; and thus the rate of ohmic heating
increases as the temperature increases. Ohmic heating can be extremely
fast. Early attempts usually delivered overheated products due to inability
to slow the process with control systems available at that time. Recently,
newer systems have been built and are in commercial use in several coun-
tries. Product formulations must be carefully controlled, but modern con-
trol systems have made these systems much more reliable.
In 1987, the National Science Foundation partially funded the opera-
tion of the Center for Aseptic Processing and Packaging Studies at North
Carolina State University. This Industry/University Cooperative Research
Center (IUCRC) provided industry-funded basic, preproprietary research
in the areas of aseptic processing and packaging (Swartzel and Gray 1987).
Industry provided the university researchers with numerous projects
related to the operation and validation of aseptic systems with particu-
lates that would satisfy the FDA in a low-acid shelf-stable product filing.
Over the next 8 years, numerous projects at several U.S. universities were
funded. Issues of concern on the process side were particle residence time
distribution (understanding and creating monitoring systems), develop-
ing validation tools for particulate systems including biovalidation, real-
time monitoring of particle center temperatures, and statistical modeling
220 Handbook of aseptic processing and packaging

and sampling protocols. Sastry and Cornelius summarized much of this

work in their book in 2002.
During those years the food processing industry was getting frus-
trated with both the process of the research and the perceived reluctance of
FDA to issue a no-objection letter for a process producing aseptic particu-
late food in the United States. Several companies made filings and all were
returned with numerous questions concerning the validation protocol. To
address the industries’ concerns a workshop was developed between the
National Center for Food Safety and Technology (NCFST; Summit-Argo,
Illinois) and the Center for Aseptic Processing and Packaging Studies
(CAPPS; currently the Center for Advanced Processing and Packaging
Studies), which at that time had become a two-site center between North
Carolina State University and University of California, Davis. The Aseptic
Processing of Multiphase Foods Workshop occurred over several days
between 1995 and 1996. Most meetings were held at the NCFST with the
last meeting held in Raleigh, North Carolina. The invitation-only work-
shop involved 22 food companies, 11 universities, the Agriculture and
Agri-Food Canada, the FDA, the National Food Processors Association,
US Army Natick, and Sandia National Laboratories. The objective of the
workshop was to establish a dialogue and a mechanism for exchange on
issues surrounding the application and implementation of aseptic pro-
cessing of multiphase foods and to come to a consensus on these issues
utilizing commercially ready technologies. The workshop focused on
four areas: particle residence time, mathematical modeling, biological
validation, and statistical design and analysis of data. Presentations on
the major issues were presented in a symposium at the 1996 Institute of
Food Technology Annual Meeting in New Orleans. Summaries are given
in the book by Sastry and Cornelius (2002). One subcommittee focused
on developing a mock case filing: a case study for condensed cream of
potato soup (Lechowicj and Swartzel 1996). The report of this study is
provided as an appendix in the book by Sastry and Cornelius (2002). One
company, Tetra-Pak, actually performed the case study in its pilot plant
in Chicago and received the first FDA no-objection letter for a particulate
aseptic low-acid shelf-stable process (Palaniappan and Sizer 1997).
By 1997, it was known that it was possible to insert a density compen-
sated neutrally buoyant non-food particle with a magnet. The Hall effect
(wire coils) could be used to track the particles and to get an understand-
ing of food particle residence time. Inoculated pack procedures could
be used to get a read on the statistical variability relative to a selected
thermal treatment. It was also understood that at least two mathematical
modeling procedures existed to aid the FDA requirement and only 299
samples had to be recovered in testing for system validation. So, now
after nearly 15 years where is the U.S. industry relative to shelf-stable
aseptically processed particulate food products?
Chapter 14:  Aseptic processing of particulate foods 221

Aseptic processing of particulate foods is still considered the most

advanced of the aseptic techniques, and so far only a handful of low-acid
products are available for consumers.
Products with particulates present a series of challenges that sepa-
rate them from homogeneous products due to the heterogeneous nature
of such products. Heterogeneous foods increase the complexity of the
equipment associated with aseptic processing not only because of the
thermal treatment of large solid pieces in a liquid media of varying vis-
cosity, but also with the transport and packaging of such suspensions
of solids. On the thermal processing side, heat transfer, residence time
distribution, and interactions between particulates must be well under-
stood to obtain safe products with good retention of quality. Transport of
solid particulates suspended in a liquid involves special requirements for
pumping without major physical damage or attrition of the particulate.
This requires determination of the residence time distribution; estima-
tion of the effective viscosity of the suspension, which affects sizing of
tubes; and generation of sufficient back pressure to counteract the tem-
peratures required for high-temperature processing. Transport of such
suspensions also presents an interesting challenge in surge tanks where
sedimentation and separation must be avoided. Packaging of heteroge-
neous foods with large particulates requires special filling nozzles, along
with filling and sealing systems able to cope with such large particulates
that will not cause damage.
Validation of the thermal treatment that all phases in a multiphase
system of foods with particulates receive is also a considerable chal-
lenge and is where the biggest driver for research has been observed.
Several methods have been developed and will be discussed in further
detail.

14.2  Considerations for equipment design

14.2.1  Heat exchangers
Heat processing of continuous flow of heterogeneous foods has received
attention in the last decades. Equipment design for conventional heat
transfer is well understood and summarized by Kelder et al. (2009a). In
most cases, the main obstacle to producing a uniformly heated, multi-
phase product is the heating and cooling by conduction inside solid par-
ticulates. In a conventional indirect heat exchanger thermal energy is
transferred in a cascade from a hot media (steam, pressurized water, etc.)
through the walls of a heat exchanger to the fluid and from the fluid to the
outside of the solid particulates; and finally from the outside to the inside
of the particulates, as shown in Figure 14.1. This process is inverted for the
case of cooling but the main phenomena are similar.
222 Handbook of aseptic processing and packaging

Convection Heating/Cooling Media R1

Conduction Tube Wall R2

Temperature
Product with

Field
? ?

Velocity
Particulates Vave

Field
?

?
? ? ?
Rn
Vmax

Figure 14.1  Conventional heat transfer in products with particulates.

Velocity distribution within the product flow must also be taken into
account since it determines the rates of convective heat transfer as well as
the time different parts of the product spend in the system. This velocity
field is very important in the case of products with particulates since it
is considered that the fastest moving particle moves with the maximum
velocity (vmax) of the product. Temperature will decrease from the hot
media to the center of the product creating a temperature field. For simpli-
fication, this heat transfer process can be modeled as a series of electrical
resistances, as shown in Figure 14.1 and Equation 14.1. The resistances can
then be grouped depending if they are due to conduction or convection,
as shown in Equation 14.2.

1
R
= ∑ R1 i
(14.1)
i

1
R
= ∑R 1
convection
+ ∑R 1
conduction
= ∑ h1 + ∑ λt
m
s

s
(14.2)

Heat transfer from the liquids to the particulates and subsequently
inside the particulates is a combination of the effects of velocity, viscosity,
and thermal properties of the flow, particle shape, and fraction of par-
ticles. To estimate the heat transfer coefficient between liquid and solid (h)
several studies have been published and are summarized by Palazoglu
and Sandeep (2002) and Kelder et al. (2009b). These estimations are used
to calculate the convective heat transfer coefficient through the use of the
Nusselt number. This dimensionless number relates the ratio of convec-
tive to conductive resistance. However, it is very difficult to assess such a
number and in most cases a very conservative estimate of 2 is used.
Furthermore, the conduction within solids is well understood. To esti-
mate the relative effects of conduction and convection, the Biot number
(Bi) is used and can be calculated as shown in Equation 14.3. Bi is a repre-
sentation of the ratio of conductive to conduction heat transfer rates, so a
low value (Bi <0.2) means that the conductive resistance is minimal, and
Chapter 14:  Aseptic processing of particulate foods 223

thus convection is the limiting process; on the other hand, high values of
the Biot number (Bi >10) imply a conduction limited heat transfer.

h fp ⋅ dp λ f
Bi = = ⋅ Nup (14.3)
λp λp

For these reasons conventional heat transfer equipment must be

designed to provide the maximum possible convective heat transfer. The
size and shape of the particles will have to be engineered in such a way
that an optimization of the heat transfer path is achieved, while keep-
ing the mechanical shear and quality considerations of the products.
However, validation of such thermal optimization is at best difficult and
has yet to be implemented in industry.
To address these challenges, novel heating techniques such as ohmic,
microwave, or radio frequency are now being investigated and applica-
tions will start to make their way into the ingredients and ultimately into
the consumer market.

14.2.2  Novel heating technologies

Novel heating technologies offer uniform volumetric heating; all the
product heats uniformly; does not rely on temperature differences as
driver but is a direct conversion of electromagnetic energy into heat. From
these technologies ohmic and microwave heating are currently used in
producing aseptic processed and packaged foods both homogeneous and
with particulates (Coronel et al. 2009).
Ohmic heating converts electrical energy directly into heat by the use
of the Joule effect, which states that heat is generated by the flow of elec-
trical current inside a material that is a poor conductor. This electrical
current field is generated by setting a voltage differential between two
electrodes that must be in good contact with the materials to be heated,
creating a heating chamber. Several configurations of these chambers
have been explored over the years as the effect of the geometry on the
electrical field is considerable. For continuous flow foods annular elec-
trodes or electrodes parallel to the flow are the common configurations
(Fryer et al. 1992; Coronel et al. 2009).
In practice, a high-frequency alternating current is used to pro-
duce an electric field between the electrodes. Food is pumped taking
care to evacuate all gases so that good contact with such electrodes is
confirmed, and thus the potential difference in such chamber is used
to generate heat (Figure 14.2). Heat is generated by following the resis-
tance effects of a field governed by Laplace equation (Equation 14.4). The
gradient of voltage (∇V) is dependent on the geometry of the system
224 Handbook of aseptic processing and packaging

Temperature

+ Electrode
Product with
Electrode

Field
Particulates

Velocity
Vave

Field
Vmax

Figure 14.2  Heating of particulates during ohmic heating.

and the electrical conductivity (σ) of the products being processed. In

turn, the changes in temperature of the different components can be
calculated by a balance of energy with accumulation term, as shown in
Equation 14.5.

Q = σ [ ∇V • ∇V ]

∇[σ ∇V ] = 0 (14.4)

∂T
ρCp = ∇[λ∇T ] + Q (14.5)
∂t

Although this has been known for over a century, practical systems
that used this principle were patented in the 1970s by the Electricity
Council Research Center (Capenhurst, United Kingdom) and commer-
cialized by APV but failed to gain the industrial acceptance that was
expected. Further improvements have been made by companies such
as Emmepiemme (Piacenza, Italy), OPAL (La Fleche, France), Wild-
Indag (Heidelberg, Germany), Raztek (California), and C-Tech Inno­
vation (Capenhurst, United Kingdom). These improved systems have
higher efficiency in the use of electricity and improved control sys-
tems, and in general use high frequency switching units that prevent
the electrolysis of water, and thus the formation of oxygen bubbles and
the need to use exotic electrode materials has lowered the total cost
of the  systems. Ohmic heating has been embraced in the processing
of acid foods, such as fruit pieces and purees, which are aseptically
packed in bag-in-box or bag-in-drum systems and used as intermediate
materials for processors.
Although it would then seem that applying ohmic technology to the
processing of low-acid foods would be straightforward, the microbial risk
and subsequent validation demands are much higher than in acid foods.
Ohmic heating of foods requires a detailed knowledge of the electrical
conductivity of the products. The case of liquid products with particulates
presents a unique challenge in which each component can have different
Chapter 14:  Aseptic processing of particulate foods 225

conductivity and as such the heating may not be uniform. Also, product
conductivity is known to be anisotropic, highly dependent on tempera-
ture, and on the orientation of the particulates. In the case of acid foods
such as fruit pieces in syrup or juice, the solid pieces will have an equal
or higher conductivity than the liquid and will, thus, heat faster provid-
ing a perfect scenario for process authorities. This is not the case in low-
acid foods in which the carrier liquid has generally a higher salt content
than the particles and is thus a better conductor. In this case, the liquid
tends to heat faster than the particulates. However, it has been observed
that if the particle and liquid are constrained within a range of conduc-
tivities, the differences in temperature are in a manageable range (Fryer
and Li 1993). Modeling and simulation efforts such as the ones made by
Sastry, Palapannian, Salengke, and others using advanced computational
methods will help pave the way for more applications as the regulatory
agencies collect more information and accept modeling as a valid tool
for prediction of thermal processing (Sastry and Palaniappan 1992a,b;
Sastry and Salengke 1998; Salengke and Sastry 2007; Coronel et al. 2009).
Microwave heating for continuous flow both of solid and liquid foods has
also received attention lately. In 2003, it was proved that a continuous flow
system developed by Industrial Microwave Systems (Morrisville, North
Carolina) produced smaller differences in temperature over a 1.5-inch
(39-mm) cross-sectional area than a conventional heat exchanger, and
that the maximum of temperature was located at the center of the tube
(Coronel et al. 2003). Further research resulted in a sterilized vegetable
puree that could be used as an ingredient in the industry (Coronel et al.
2005; Simunovic et al. 2006; Brinley et al. 2007; Kumar, Coronel et al. 2008).
The world’s first shelf-stable low-acid installation that uses continuous
flow microwave was commissioned in 2008 in North Carolina (YAMCO,
Snow Hill, North Carolina) and produces commercially sterile sweet
potato puree (Food Technology 07-10). Due to the success of this transfer
from research to industry, North Carolina State University, USDA-ARS,
and Industrial Microwave Systems were awarded the Institute of Food
Technologists Industrial Achievement Award in 2009.
Microwave heating uses the interactions of molecules with a rapidly
changing electromagnetic field. This interaction does not need direct con-
tact with electrodes or antennas but requires that the product be trans-
ported using sections of tube that are transparent to microwaves. Several
polymers, ceramic, and glass are materials that can be used for this pur-
pose, but care must be taken to guarantee that the required pressures for
high-temperature processing can be safely achieved.
In practice, microwave heating can be achieved by several methods.
One such method is the use of a single-mode cavity in which the electro-
magnetic field is concentrated in a cylindrical shape surrounding the tube
containing the product. Conversion of microwave into heat is dependent
226 Handbook of aseptic processing and packaging

Microwave

Temperature Product with

Field

Velocity
Particulates Vave

Field
Vmax

Figure 14.3  Heating of products with particulates during microwave heating.

on the frequency of the microwaves, geometry of the application appara-

tus, and on the dielectric properties of the product to be heated, and can
be represented by Figure 14.3 and modeled using Equation 14.6 as intro-
duced by Datta (2001):

ω ε 0 ε′′ 2
Q= E (14.6)
2
εs − ε∞
ε = ε′ − j ε′′ = ε ∞ + (14.7)
1+ j ω τ

where E is the electrical field, and ε0 and ε″ are a representation of the

dielectric properties of the material to be heated. Dielectric properties
describe the way a product reacts to the interaction with the rapidly chang-
ing electromagnetic field, where some of the energy will be absorbed and
converted into heat. These properties are similar to the electrical con-
ductivity for ohmic heating, but due to the higher frequency they need
some extra terms, as correlated by Debye (Equation 14.7), where ε s and ε ∞
are the dielectric constants at zero frequency and very high frequencies,
respectively, and τ is the relaxation time of the system that controls the
amount of energy that is converted into heat (Metaxas 1988).
Dielectric properties are not only dependent on the food product, but
also on temperature and frequency (Datta 2001). These differences will be
present in the case of food with particulates and can cause inequalities of
temperature in the product. If a single particle absorbs more energy than
the others or stays in the system too long, it can lead to extreme overheat-
ing and even burning of the aforementioned particle.
In order to produce heterogeneous products using microwave there
needs to be an identification of the worst-case scenario particle and a
further validation of the thermal processing of this particle. Since food
products are inherently variable in composition and structure, methods
Chapter 14:  Aseptic processing of particulate foods 227

to modify the dielectric properties so that they fall within a defined range
should be developed.
There is, however, the challenge of validating the temperature his-
tory or at least the thermal treatment that the center of a particle receives.
Inoculated particles and spores in tubes have been successfully used by
Brinley et al. (2007) and are very useful from a safety point of view but not
from a quality optimization point of view. In general the electrical proper-
ties of the tubes containing the spores or enzymes will not be the same as
those of the particulates in the product and thus may not be representative
of the thermal treatment received. The tubes act like an electrical insulator
that could heat much slower than the particles themselves and thus lead
to a very conservative estimation of the thermal treatment received by the
particles. This conservative estimate would lead to an overprocessing of
the particles, which in turn could diminish any improvement in quality
that can be achieved by these methods.
Control of these novel technologies requires a different strategy than
control of conventional heat exchangers. On one hand the processes are
very rapid, with response times to changes in processing conditions orders
of magnitude faster than conventional heating. Also due to the possibility
of having inlet streams with varying composition it is necessary to have
a system that could predict the type of heating behavior needed so that
over- and underheating are avoided. Feed forward control of the incom-
ing stream properties and temperature together with feed backward con-
trol of the outgoing streams should provide complete information of the
process, which in turn is converted into power outputs by the control sys-
tem. The large amount of information required and the speeds of reaction
needed in these advanced heating technologies require the use of mod-
ern intelligent control systems that are able to handle such information.
Fortunately the current generation of control computers is able to handle
such requirements from suppliers such as Siemens, Allen Bradley, and
Mitsubishi.

14.2.3  Transport of liquids with particulates

Integrity of food particulates is very interesting for consumers, who now-
adays have preference for foods that are minimally processed or natural
looking. To fulfill such requirements visual appeal of the products plays
a strong role, with a marked preference toward intact particles. Transport
of particles is thus a challenge for high-speed lines, especially when the
product is at the hottest temperatures when its structure is the weakest.
Pumps specially designed to handle particulates can be found. They
either come in reciprocating (piston pump) or rotational (positive displace-
ment) designs. Many of the equipment suppliers have designs that are adver-
tised for this but need to be tested and validated for different applications.
228 Handbook of aseptic processing and packaging

Valves can also be harmful for the attrition of particulates. If the

design of the valves is not adequate, then the restriction of the flow path
can be significant, which not only poses a risk in breakage of particu-
lates but also a hygienic risk. Back pressure valves, which are required to
avoid flashing at the temperatures used during UHT processes, also need
improvement and development. For homogeneous flow, back pressure is
achieved by reducing the flow path or by using spring-loaded devices.
These will not be practical for use with particulates. Positive displacement
pumps in reverse are used but there are constraints on the load of particu-
lates and maximum pressure.
Separation of heterogeneous foods is another concern during process-
ing. When products contain pieces of different vegetables or meats, the
differences in density can make the product separate in layers. This prob-
lem is noticeable in holding tanks where agitation is needed to keep the
distribution of particles constant, which is a larger challenge when aseptic
tanks are considered. Residence time distribution (RTD) in tubes and heat
exchangers are also affected by the differences in density of particles with
heavy particles lagging to the lighter ones. If the lighter particles are also
the slowest heating, then they will set the thermal processing of the prod-
uct. In this area advances have been made in flow monitoring and RTD
measurements for particles of different densities, sizes, and so on by the
use of magnetic implants developed at North Carolina State University.
This technology will be discussed later in this section.
All aseptic processes require the use of temperatures in excess of
100°C and thus the need of back pressure to prevent the liquids from boil-
ing. In homogeneous flow this is achieved by the use of spring-loaded
valves. These valves are not an option for fluids with particulates as they
have a narrow opening and can substantially damage the particles or get
particles in the opening, which would prevent them from closing properly.
Thus, different strategies for holding pressure in the system are needed.
The simplest of these strategies is to have pressurized aseptic surge tanks.
Each tank is filled with sterile air or nitrogen at a set pressure above the
minimal required to prevent boiling. As the tank is being filled with prod-
uct, the pressure is balanced by releasing some gas until the tank is full;
then the operation is moved to the next pressurized vessel. The big disad-
vantage is the need for more than one tank, which adds cost and complex-
ity to the operation. Lobe pumps operating in reverse can also be used to
keep back pressure, and have as a drawback the need for complex control
systems and possibilities of leakage and damage to the particulates. New
devices to maintain back pressure that limit the complexity and keep the
quality of the food particles are being developed by academia and indus-
try, such as the one patented by Cartwright (2005), and more should result
from the push of the food industry to have multiphase aseptic products
on the market.
Chapter 14:  Aseptic processing of particulate foods 229

With all the aforementioned considerations, the processing of foods

with particulates is possible with the existing technology, and the main
hurdle is the validation of such thermal processes. Advances in valida-
tion techniques must be taken into account for the success of multiphase
aseptic food products and should be part of the toolbox of the industry.

14.3 Validation of aseptic processes

with particulates
Process validation for aseptically processed multiphase (particulate)
products with large particles remains one of the most challenging and
complex tasks in the industrial application of thermal processing for pres-
ervation of foods, in spite of more than three decades of intense research
and development activities by numerous academic, industrial, and gov-
ernment scientists and researchers.
The difficulty in successful validation of the thermally delivered
lethality for multiphase aseptic products lies primarily in the inability to
continuously and reliably measure and record the time–temperature his-
tory of the least treated segment of the continuously flowing complex prod-
uct, also known as the “cold spot.” This inability to directly and reliably
measure and record the time–temperature history of the product cold spot
is the key to the remaining difficulty and complexity of validation for these
types of products, and is also the cause of the inability to properly and con-
sistently control the variety of processes implemented for their proper ther-
mal treatment and achievement of commercial sterility and shelf stability
of the final packaged products under ambient temperature conditions.
In turn, this inability to measure, record, and therefore control the
critical parameters of the thermal sterilization processes required for the
achievement and establishment of process and product safety has been
the major source of difficulty when attempting to present the appropriate
data and documentation to the regulatory agencies in charge of process
approvals for commercial implementation to assure the safety of consum-
ing public, also known as process filings. These filings are typically per-
formed by professional experts trained and experienced in process design
and monitoring, thermal data acquisition and recording, and microbial
safety assurance and validation. In the United States, these experts are
recognized by the FDA as process authorities.
The fact that the appropriate capture of thermal process time–tem-
perature histories for thermally treated multiphase food products under
continuous flow conditions in preparation for subsequent aseptic pack-
aging has required a radically different approach from the validation of
similar products processed in batch (retorted) mode, as well as from the
validation of homogeneous (single-phase fluid) food products has also
230 Handbook of aseptic processing and packaging

been the source of frustration to both process authorities and industrial

food processors attempting to implement these technologies. In the case
of batch processed (i.e., retorted products), temperatures can be measured
by inserting appropriate probes in predetermined cold spot locations and
recorded by analog or digital means to obtain a record of the cold-spot
time temperature history and therefore the ability to accurately calculate
the lethality delivered to the product cold spot. Similarly, in the case of
continuously processed homogeneous products, time–temperature his-
tory of the cold spot is obtained based on the combination of measure-
ment of temperature in the center of the holding tubes at their entrance
and exit, measurement of flow rate through the holding tube process seg-
ments, and calculation of residence time based on either laminar or tur-
bulent flow regime.
Compared to these straightforward and long-established procedures
for lethality, calculations based on reliable time–temperature data histo-
ries, determination of time–temperature history for a continuously flowing
cold spot within a complex particulate product matrix is far more difficult
and therefore required development and establishment of a number of new
technologies and validation techniques and tools for their implementation.
In some parts of the world, particularly Europe, Australia, and
Canada, thermally processed and aseptically packaged multiphase (par-
ticle-containing) food products like soups, stews, fruit cocktails, and
vegetable and fruit pieces for use in preparation of side dishes and condi-
ments are widely present and available in the commercial marketplace. In
the United States, however, due to the complexity of procedures for mea-
surement and validation of appropriate thermal treatment for the least
treated product segment, which are required to be presented to the rel-
evant regulatory agencies prior to commercial production, advancement
of these types of products (especially shelf-stable, low-acid products con-
taining large particles) has been very difficult. Presently, there are very
few low-acid, particle-containing aseptically packaged products available
commercially in the United States, in spite of the decades of extensive
research and development efforts indicating their economic, nutritional,
and environmental superiority to other comparable products (e.g., canned
products) yielding potential significant benefits to industrial processors,
consumers, as well as to the national and global trade in food and other
agricultural products overall.
Thermally processed, low-acid, shelf-stable foods packaged asepti-
cally are under the regulatory authority of the FDA. For a product with
these characteristics, processors are required to submit a process filing
with the FDA, which needs to implement scientific procedures to show evi-
dence and proof that the least thermally treated segment within the food
product has been exposed to appropriately high temperature levels for
an appropriate time in order to achieve at least the minimum cumulative
Chapter 14:  Aseptic processing of particulate foods 231

lethality levels to achieve a so-called Clostridium botulinum cook treatment.

C. botulinum cook treatment is at least equivalent to a cumulative thermal
treatment required to inactivate 12D thermoresistant endospores of a pro-
teolytic strain of C. botulinum, or the time–temperature treatment equiva-
lent to exposure of 3 minutes at 250°F (121.1°C) with a reference z-value
of 18°F (10°C). This is also known as an Fo value of 3 minutes. Any ther-
mal treatment using a referent temperature of 250°F expressed in terms of
minutes is referred to as an F0 value if it refers to a microorganism with a
z-value of 18°F.
Reasons why this documentation of achieved sterility is so complex
and difficult to provide to the regulatory agencies in order to gain access
to the commercial market in the United States are numerous:

• Thermal treatment requirement is based on an extremely highly

toxic and dangerous microbial entity (botulinum toxin produced by
the growth of Clostridium botulinum in improperly processed food
products is the most toxic substance known to occur in nature).
Experimental and laboratory investigations using this microor-
ganism directly are therefore extremely dangerous and need to be
carried under very tightly controlled conditions by personnel that
need to be extensively trained and undergo expensive and danger-
ous immunization treatments. As a result of these limitations and
hazards, only a few research laboratories in the world are properly
equipped, trained, and prepared to perform research with these
microorganisms directly. In addition to the health hazard consider-
ations, further complications and expenses arise since these organ-
isms are obligate anaerobes, requiring specialized equipment for
their growth, enumeration, and identification.
• Over the years, industrial, academic, and government researchers
have investigated and implemented substitute (surrogate) spore-
forming microorganisms for evaluation of thermal processing, such
as Bacillus subtilis, Geobacillus stearothermophilus, and Clostridium spo-
rogenes. Although experimental use and implementation of these
microorganisms is far less hazardous, the time expense, tedium,
and characteristic variability associated with living organisms
remain. For new technologies and processes such as advanced and
emerging thermal technologies, the FDA remains steadfast in its
requirement to present adequate microbial spore inactivation data
and evidence for every new product and formulation presented to
the market. Difficulty in working with bacterial spores is multiplied
if multistep development, adjustment, and optimization of ther-
mal processing are required. Each cycle in this multistage process
of optimization can add significant cost to the sequence of product
approval and commercialization.
232 Handbook of aseptic processing and packaging

• Requirement to prove and document appropriate thermal exposure

for the product applies primarily to its least treated segment, also
known as the cold spot. Appropriate thermal exposure and sufficient
delivered lethality refer to the minimum combination of times and
temperatures to accumulate lethality “credit” equal to or exceeding
C. botulinum cook, that is, at least 3 minutes at 250°F or higher. When
this is performed for canned foods, thermal history of the cold spot
can be acquired, recorded, and documented relatively simply: by
inserting a temperature probe (thermocouple or RTD probe) into the
center of a representatively large particle, positioning the particle
with the probe at several places within the package, sealing, repeat-
ing the installation and placement for a number of different cans
and positions of cans within the processing vessel (autoclave), and
recording the temperatures during one or more representative pro-
cessing runs. Acquired temperatures are then analyzed and used to
calculate and design the appropriate process.
• For homogeneous materials thermally processed under continuous
flow conditions, process determination is more indirect. Lethality
delivered while the product is flowing through a cylindrical conduit
after exiting the last stage of continuous flow heating is credited by
assuming that the product has spent all of its time at a temperature
no higher than the lowest temperature is determined in the hold
tube (typically tube center at the exit of the tube). The time aspect of
lethality is based on the fastest flowing product segment, which can
be calculated based on bulk material flow rate, tube characteristics,
material characteristics under the representative conditions present
in the hold tube, and the flow regime (laminar or turbulent).
• When complex, particle containing low acid products are thermally
processed under continuous flow conditions, neither the approach
used with canned products nor the one used with homogeneous
products processed under continuous flow are applicable. Primarily,
no wired temperature probes can be used under these conditions
since they would obstruct the flow of both particles and carrier fluid
as well as heat penetration into the product particles so the eventual
process estimation would be very unreliable at best. Second, due to
the multiphase conditions present during the flow, no assumptions
can be made a priori about the residence time or velocity distribution
of the particulate component of the product. To determine which
product element is traveling fastest through the system (needed to
determine the residence time and appropriate length of the heating
and hold tube elements of the system), experimental measurements
of residence times for a statistically representative population of par-
ticles needs to be performed. A further complication becomes imme-
diately obvious: difficulty of measuring residence times of real food
Chapter 14:  Aseptic processing of particulate foods 233

particles. Since any interference with particle structure and integrity

invariably changes its flow properties and therefore residence times,
there is a need to use simulated or fabricated particles for residence
time measurements, rather than attempt to track and time real food
particles within the system.

Nevertheless, appropriate techniques and tools have gradually emerged

over time based on numerous theoretical and experimental studies, and
are currently available for use by the industrial product developers and
process authorities.

14.3.1  Available technologies and alternatives for validation

Research and development activities in the area of technologies and alter-
natives for validation have over several decades resulted in a wide variety
of technology alternatives for validation of particle-containing products
sterilized thermally under continuous flow conditions. However, there
are currently only two alternative approaches known to be in active use
by the industry for validation of conventional and advanced continuous
flow processes. Other alternatives may also be in use at the present time,
but they are presumed to be still under development or proprietary to
individual processors.
The first approach is based on a well-known pioneering collabora-
tive effort involving numerous academic, industrial, and government
scientists and researchers active in this field. The Aseptic Processing of
Multiphase Foods Workshop took place in 1995 and 1996 resulting in
a case study for condensed cream of potato soup, which led to the first
successful filing of a low-acid shelf-stable particle containing aseptically
packaged product with the FDA.
The second approach is based on a series of projects funded by the
Center for Advanced Processing and Packing Studies and studies per-
formed at the North Carolina State University (NCSU) Department of
Food Science, which resulted in a number of granted U.S. and associated
international patents. This cluster of flow monitoring and process valida-
tion tools and technologies has been recently commercialized (2009) and
is currently marketed by ThermaLytics Inc. of Raleigh, North Carolina, as
an integrated particle flow monitoring system for continuous flow asep-
tic process design, monitoring, and validation for thermally treated food
products and biomaterials containing large particles.
The first approach in this discussion will be referred to as the NCFST/
CAPPS Workshop model, whereas the second one will be referred to as
the NCSU system.
The NCFST/CAPPS Workshop model has been discussed and des­
cri­bed in extensive detail in several publications, primarily in the
234 Handbook of aseptic processing and packaging

self-published brochure “Case Study for Condensed Cream of Potato Soup

from the Aseptic Processing of Multiphase Foods Workshop 1995–1996”
available online and as an appendix in a book by Sastry and Cornelius
(2002), as well as in a series of presentations at the 1996 IFT Annual
Meeting and papers subsequently published by the Food Technology
magazine (Digeronimo et al. 1997; Larkin 1997; Marcy 1997; Palaniappan
and Sizer 1997; Sastry 1997).
These procedures and techniques have been extensively reviewed at
the Aseptic Processing of Multiphase Foods Workshop. Issues discussed
were the hurdles to commercialization of multiphase aseptic processes
and products and ways to overcome them. Conclusions and recommenda-
tions from these workshops are still considered as one of the basic set of
principles for the establishment of a safe process for multiphase aseptic
sterilization to produce shelf-stable multiphase foods.
Four main elements recommended by the NCFST/CAPPS group of
experts were:

1. Definition and implementation of a model for heat penetration and

sterilization under continuous flow thermal processing conditions.
2. Performance of residence time measurements for a sufficient num-
ber of real or simulated particles representative of each subpopula-
tion of solid particles contained in the product. The key function of
this is to determine the residence time range of the fastest moving
population of particles in the system.
3. Establishment, design, and implementation of the processing system
based on knowledge gained from the previous two steps.
4. Confirmation of established process using real or simulated food
particles inoculated or equipped with appropriately prepared solu-
tion, suspension, or gel of thermoresistant spores of one of the
surrogate microorganisms used for thermal sterilization studies
(Clostridium sporogenes, Geobacillus stearothermophilus) under several
thermal treatment variations.

It was agreed that the sequence of tests to be performed could be sig-

nificantly simplified, and the reliability and robustness of process design
and implementation improved if a method was available to measure the
temperatures of cold centers of food particles under continuous flow
conditions. At that time, no such method was available, but research was
under way at North Carolina State University investigating the potential
alternatives. These research and development activities would eventu-
ally provide the method for real-time temperature level detection for
continuous and batch processing of foods, and establish a basis to enable
several technologies to be integrated into a first system for real-time
Chapter 14:  Aseptic processing of particulate foods 235

evaluation and measurement of thermal lethality under continuous flow

processing conditions.
The key differences between the CAPPS/NCFST Workshop approach
and the NCSU approach are as follows. The CAPPS/NCFST approach
uses two populations of particles: one loaded with magnetic tags and
one loaded with bacterial spores. These two populations are designed
and used differently: one is used for the residence time measurements
and  the other for the bacterial spore/biovalidation. At least 299 par-
ticles  and independent residence time measurements are needed to
achieve a 95% confidence that at least one of the measured 299 particles
will achieve the velocity representative of the 1% fastest population seg-
ment. This residence time (characterized by the velocity of the fastest
measured particle) is then used to establish the holding tube length in
combination with a numerical simulation program to establish the theo-
retical heat penetration characteristics and time–temperature history of
the fastest moving particle. Once the process design has been established,
at least 299 particles loaded with bacterial spore populations are pro-
cessed, collected, and incubated to check for growth. Typically, the test
for growth is repeated several times to represent underprocessing, on-
target processing, and overprocessing conditions by adjusting the hold
tube temperatures to reflect these three conditions. Successful inactiva-
tion (as evidenced by no bacterial growth following incubation) indicates
the achievement of a safe process.
Multiple sets of 299 particles may need to be used both for residence
time measurements and for subsequent bioload incubation tests to prove
the safety of the process and consistent delivery of an appropriate thermal
treatment. This is particularly the case for complex particulate food prod-
ucts, consisting of several different particle populations, such as beef stew,
minestrone soup, or garden vegetable soup. These products can contain
more than 10 particulate ingredients, each of which may require separate
and independent validation of residence time distribution and appropri-
ate thermal inactivation of bacterial spore bioloads.
Representative nature of the simulated particles used for RTD mea-
surements and bioload inactivation versus the real food particles is not
well defined but is implicitly indicated. However, under continuous flow
thermal processing conditions it is almost impossible to produce a sim-
ulated particle that successfully mimics the flow and heating behavior
of real food particles. As the temperature increases, both thermal (con-
ductivity, diffusivity, heat capacity) and physical (density, buoyancy, size,
shape, roundness, sharpness of the edges) properties change through the
system, affecting the flow and heating behavior of real food particles flow-
ing through the system. It is currently not possible to design a carrier par-
ticle fabricated from a polymer or any other nonfood material that would
236 Handbook of aseptic processing and packaging

mimic these changes in behavior under the variety of flow, temperature,

and pressure conditions routinely encountered in the processing systems.
The NCSU protocol allows for the use of a single particle population
for both residence time measurements and process validation using ther-
mosensitive implants, such as bacterial spore suspensions or gel beads, or
thermomagnetic switches.
Carrier particles are designed to have conservative flow and conser-
vative heating properties.
Conservative (fast) flow properties are achieved by adjusting the
effective density of the assembled particle (including any magnetic and
thermosensitive implants) with a shape and size of the targeted food par-
ticles at the entry into the processing system (for example, ½-inch cubes)
and adjusting the weight of the load contained in the internal cavity of the
fabricated particle to achieve an effective density of the assembled par-
ticle at a level of “critical density.” This density is the one with the highest
likelihood of containing the fastest particles. For example, in a slightly
inclined horizontal tube flow (such as the horizontal hold tube segments
used in the United States for aseptic processing), this critical density will
be slightly lower (i.e., slightly more buoyant) than the density of the carrier
fluid at that (hold tube) temperature. Any density higher or lower than the
critical density under these conditions will cause a slowing of the particle
due to the drag and friction along the tube bottom (higher than critical
densities) or along the tube top (lower than critical density). It is antici-
pated that the carrier fluid temperature within a hold tube is maintained
within a relatively narrow range in order for the critical density to remain
relatively constant during the particle travel through the hold tube seg-
ment of the processing system.
Conservative (slow) heating properties of the carrier particles are
designed with the objective of having an enclosure that will provide at
least an equal thermal protection (insulation) to the contents of the cav-
ity enclosed as the related food piece or particle provides to its geometric
center. Since most commonly used polymers typically have a much lower
thermal conductivity and thermal diffusivity properties in comparison
with almost all food materials, this can be achieved by adjusting the wall
thickness of the simulated particle to deliver the protection or insulation
required for this.
The slow-heating property characteristic is achieved by using a com-
puter simulation program that simulated concurrent heat penetration
into a polymer particle and into a real food particle. A cut-off lethality
for wall thickness construction can be selected. Typically it is at least an
Fo-value of 3 minutes accumulated in the center of the real food particle.
Once this is achieved for the real particle, the cross-sectional map of accu-
mulated lethalities for the simulated particles is examined, that is, the line
where the Fo of 3 minutes “front” has penetrated into the polymer particle
Chapter 14:  Aseptic processing of particulate foods 237

provides the internal edge of the wall thickness required to fabricate a

conservative particle.
Finally, the conservative nature of the heat penetration design aspect
of the simulated food particles is tested and confirmed by concurrent
heating of the targeted real food particle versus the fabricated simulated
particle. This allows for the final check and adjustment of the wall thick-
ness required to achieve conservative thermal insulation properties of the
carrier particle.
Therefore, with an established conservative flow and conservative
heat penetration or insulation characteristics for the simulated particle
cavity, a “cold spot carrier particle” is established.
This population of such particles is therefore designed to fall within
the fastest population segment, that is, all of the fabricated particles rather
than just at least one among the 299 as in the CAPPS/NCFST approach.
Although currently it is not recommend to use less than the 299 particles
to establish the process residence time distribution, it may be possible to
reduce this number in the future, due to the conservative nature of par-
ticles designed and fabricated in this fashion.
Therefore, if the thermo-sensitive implants carried through a process
within this cavity are appropriately thermally treated or sterilized, that by
inference means that all other less conservative segments of the product
have been also sterilized properly, at least to the level determined by the
sterilization/lethality delivered to the protected cavity contained within
the cold spot carrier particles.
This dual design criteria approach and the hollow cavity contained in
the particles allow for concurrent implementation of residence time tags
(typically miniature magnets) and thermosensitive implants (bacterial
spores, time–temperature integrators, or thermomagnetic switches), and
obtaining a residence time “record” coupled with the inactivation rate
and extent as recorded and documented by the thermosensitive implant.
This combination can be available for every tested particle, that is, rather
than having a population of 299 particles processed and incubated in an
attempt to represent the properties of the previously and independently
measured fastest particle, the developer can associate the time and tem-
perature history of each particle with its own rate of inactivation of the
thermosensitive implant via plating, incubation of a chemical means of
detection.
Specifically, thermosensitive implants such as bacterial spores can
be extracted from individual particles (for example, the fastest particle
or several particles among the fastest as determined by residence time
measurements) and the extent of the inactivation of carried implant
reported and correlated with the time–temperature history of the par-
ticles followed through the system using the external magnetic field
detectors.
238 Handbook of aseptic processing and packaging

14.3.2 Practical considerations for validation of continuous

flow sterilization treatments of particulate foods based
on conservatively designed fabricated carrier particles
and residence time and thermosensitive implants
Until a method is available to monitor, record, and retrieve the time and
temperature history of the fastest moving and slowest heating element
of any heterogeneous food product thermally pasteurized or sterilized
under continuous flow conditions, or alternatively all elements of these
products at any location within the system over the entire time of expo-
sure to any thermal lethality-contributing treatment, there will be a need
to use fabricated (simulated) carrier particles and associated implants car-
ried within these carrier particles for validation of process and product
safety for these foods.
In the application of this range of methodologies for process valida-
tion, there are several practical considerations to be addressed, which can
be categorized as:

1. Fabricated carrier particles: selection, design, and relevant prop-

erty adjustments
2. Implants: residence time and thermosensitive
3. Handling, insertion, and retrieval of carrier particles with implants
4. Monitoring, recording, retrieval, and analysis of data

14.3.3 Fabricated carrier particles: Selection, design,

and relevant property adjustments
It is typically assumed that the most appropriate shape and size of the sim-
ulated or fabricated particles are those that closely mimic the shape and
maximum dimensions of the food particles being simulated. For example,
if the targeted food particles are ½-inch cubes, simulated implant carrier
particles will also typically be fabricated in the cubic shape of ½-inch size.
If the remaining relevant properties are properly controlled and imple-
mented, this approach is supposed to generate an appropriately conserva-
tive design for safe process validation.
It should be kept in mind that for some less mechanically resilient
food particles, this approach may not result in a conservative design.
For example, most fruit and vegetable particulate fruits will experience
numerous mechanical stresses on their way through the continuous flow
thermal sterilization system, especially if the particles are large and are
being treated in a conventional system of (typically tube in tube or tube
in shell) heat exchangers. These mechanical stresses can result in deg-
radation and rounding of the food particles, specifically collisions with
Chapter 14:  Aseptic processing of particulate foods 239

other particles, equipment segments, and flow obstructions like valves

and sensor implements. Some of these rounded particles may be able to
pass through the lethality-delivering system segments with less delay
caused by collisions and flow obstructions, and the simulated particles
designed to mimic the original angular format of the food particles may
get slowed in the system and lose the conservative property of provid-
ing the short residence time in the lethality-delivering system segments
(heaters and hold tubes) due to the obstructions and collisions in the sys-
tem. Additionally, food particles may be more sensitive to the mechanical
stresses and damages due to the thermal effect on change and degrada-
tion of their texture and integrity.
Therefore, in addition to the fabricated particles with the shape and
size identical to the original formats of the real food particles, it is recom-
mended that several spherically shaped carrier particles also be included
in residence time measurements to ensure that the concerns outlined ear-
lier are properly addressed.
The sphere dimensions can be selected to fit within the spatial outline
of the real particles (i.e., 12 mm radius for the 12 mm cubes), as long as
the thermal protection properties are controlled in a manner to provide
the conservative thermal protection properties to the thermosensitive
implants carried within.
Concurrently, at the processing system design and selection end,
efforts should be made to eliminate and minimize the obstructions to the
flow and other potential mechanical stress causes, to the extent possible.
Materials that have been used for the fabrication of simulated food par-
ticles by various researchers and are in current use in the industry differ
widely, depending on the method of fabrication and desired functionality.
A variety of rigid polymers such as polypropylene, polystyrene, polymeth-
ylpentene (TPX), polycarbonate, polysulfone as well as flexible polymers
such as single-component and multicomponent silicones have been imple-
mented by various researchers. Additionally, composite combinations of
epoxy adhesives with lower density additives such as hollow glass, metal,
or polymer beads have also been tested and used in some cases.
Biopolymers like alginate gels have been used in the fabrication of spore
carrier implant beads and whole particles with embedded thermosensitive
implants such as bacterial spores or chemical time–temperature integrators.
Main characteristics of the materials used need to include:

• Ability to withstand the temperatures, pressures, and other thermal

and mechanical stresses encountered during processing
• Ability to fabricate carrier particles with various wall thicknesses to
provide a targeted minimal thermal protection required for conser-
vative heat penetration characteristics
240 Handbook of aseptic processing and packaging

• Low density compared to the food particles, in order to enable fab-

rication of carrier enclosures capable of carrying implants without
causing excessive fabricated particle density and nonbuoyant, that
is, nonconservative flow characteristics

Methods of fabrication range from machining of rigid polymers and

die-casting of flexible materials like silicones and alginates for small
quantity productions to extrusion and injection molding for larger series.
Typically, simulated particles are fabricated in two-piece (top and bot-
tom) or three-piece (top, bottom, and connecting element) configurations
and can be loaded with residence time and thermosensitive implants and
sealed by using additional adhesives or gaskets to maintain particle integ-
rity and implant insulation during the exposure to the process.
Flexible, less costly materials are typically single use, whereas more
rigid and more expensive polymers produced by machining or injection
molding may be reusable if proper controls are used. Also, the low costs
of these particles may not justify reuse.

14.3.4 Achieving conservative thermal characteristics

of carrier particle enclosures
Conservative thermal characteristics for the carrier particles ensure that
any thermosensitive implant carried through the process within the par-
ticle cavity receives the level of treatment lethality required to establish a
safe process and a safe product for consumer consumption.
Conservative thermal (or heat penetration) characteristics of the car-
rier particle mean that it is constructed in such a way that the polymer
wall surrounding the carrier cavity provides to the cavity and its con-
tents at least as good (and preferably slightly higher) thermal protection
(insulation) as the related (i.e., real) food particle provides to its cold
spot (i.e., geometric center). Therefore, if it is confirmed that the ther-
mosensitive implants contained within the carrier cavity (temperature
and time–temperature detection and integration devices) have received
an appropriate and sufficient thermal lethality/microbial inactivation
cumulative treatment. The claim can be made that all other product ele-
ments (i.e., all product segments contained within the food particles)
have also received at least an equivalent (and preferably somewhat
higher) thermal treatment.
This claim will be valid as long as it can be shown that the conserva-
tive thermal characteristics are applicable and maintained throughout all
cumulative lethality delivering segments of the process (with the excep-
tion of the cooling segment, which can be addressed in a variety of ways)
and as long as it is also demonstrated that the carrier particle conservative
flow properties (i.e., construction in way to ensure at least comparable and
Chapter 14:  Aseptic processing of particulate foods 241

preferably faster flow characteristics in comparison to the real food par-

ticles) have also been designed and implemented.
Conservative thermal characteristics for conventional thermal pro-
cessing (i.e., heat-exchanger-based heating segments of the processing
systems) are achieved in three stages:

1. Design
2. Fabrication
3. Experimental confirmation and adjustment

Design is performed using the CPD (Conservative Particle Design)

software (ThermaLytics Inc., Raleigh, North Carolina). Required numeric
input values include the shape and dimensions of the targeted food (and
subsequently fabricated simulated) particles, density, heat capacity, ther-
mal conductivity and thermal diffusivity of both targeted food and the
carrier particle/polymer material, as well as assumed heat transfer coeffi-
cient between the carrier fluid and the particulates. Finally, final targeted
cumulative lethality is defined and input. Typically, this would be an Fo of
3 minutes, achieved within the hold tube segment of the system.
The CPD computer program takes the provided input values and
simulates the heat penetration into both real and simulated food parti-
cles, until the food particle has been appropriately treated, that is, until
it achieves the minimum cumulative lethality (i.e., Fo = 3 minutes) in its
geometric center (i.e., cold spot), which also results in generally higher
cumulative treatments in all other segments of the particle.
Concurrently, heat penetration into a theoretical particle with an
identical shape and size fabricated from a selected polymer (or several
different polymers) is also simulated and cumulative thermal treatment
delivered to each node in the heat penetration spatial matrix calculated
and recorded for each time increment used in the calculation.
Once the targeted lethality has been achieved for the food particle,
lethality levels accumulated by the nodes within the simulated particle are
examined and the minimum wall thickness of the simulated particle
selected is based on the penetration of the targeted cumulative lethality
level within the simulated particle fabricated from the selected polymer
material (Figure 14.4). Once the minimum wall thickness required to pro-
tect the implants that is to be carried within the cavity of the carrier particles
is determined, the next stage of particle—fabrication—can be implemented.
Once the particle material (polymer), shape, dimensions, and the min-
imum wall thickness protecting the internal cavity have been defined,
fabrication can proceed in order to obtain the carrier particles. Figure 14.5
illustrates some of the shapes and sizes available for the two-piece parti-
cles (Figure 14.5, left, injection molded) and three-piece (Figure 14.5, right,
machined) simulated particles.
 242
F0 Map for Cubic Particle Construction
B C
42. 43. 45. 48. 53. 59. 68. 81. 100. 132.
14. 15. 16. 18. 21. 26. 33. 44. 63. 100.
6.1 6.4 7.1 8.4 10. 13. 18. 27. 44. 81.
B C 2.9 3.1 3.6 4.3 5.7 7.9 11. 18. 33. 68.
1.5 1.7 2. 2.5 3.4 5. 7.9 13. 26. 59.
L
A .9 1. 1.2 1.5 2.2 3.4 5.7 10. 21. 53.
D

Handbook of aseptic processing and packaging

.6 .7 .8 1.1 1.5 2.5 4.3 8.4. 18. 48.
.4 .5 .6 .8 1.2
3 3.6 7.1 16. 45.
Center
.3 .4 .5 .7 1. 1.7 3.1 6.4 15. 43.
of
Particle .3 .3 .4 .6 .9 1.5 2.9 6.1 14. 42.
Center of
Particle A D

Center of Real Food Particle Simulated Particle Implant

Carrier Cavity

(Arced line on the right marks the conservative particle wall thickness)

Figure 14.4  Design of the conservative thermal properties of the carrier particle using computer modeling.
 Chapter 14:  Aseptic processing of particulate foods
1. 2. 3.

C
Implant and
Ballast
B Load

Figure 14.5  Fabricated two-piece (produced using injection molding, left) with magnetic tag implants, and three-piece (machined,
right) simulated food/implant carrier particles.

243
244 Handbook of aseptic processing and packaging

14.3.5 Experimental confirmation and adjustment

of conservative thermal properties
The method for experimental confirmation and adjustment of conserva-
tive thermal properties for the simulated/implant carrier particle enclo-
sures has been described by Jasrotia et al. (2008). Specifically, several
targeted food particles and fabricated simulated particles are fitted with
thin profile temperature-sensing probes such as fine-wire type-T thermo-
couples and subjected to heating under representative temperature and
pressure conditions. Fabricated particle cavities are also loaded with any
anticipated implants to be included, such as magnetic or radio-frequency
identification (RFID) tags, ballast for effective density adjustment, and
thermosensitive implants like bacterial spore beads or time–temperature
detecting and integrating devices.
Sensing tips of the temperature probes are inserted as close as pos-
sible to the center of the real food particles and into the central cavities of
the fabricated food particles.
Both particle types (real food and simulated) are placed in a her-
metically sealed container and heated. The heating can be performed
using a small bench-top autoclave or a hermetically sealed stainless steel
chamber made from sanitary (Tri-Clover) components. Tested particles
are immersed in a representative fluid, preferably identical or similar to
the real food product carrier fluid. Figure  14.6 shows the heat penetra-
tion comparison between real and simulated particles during heating in a
small autoclave. Fabricated particle construction that results in conserva-
tive (i.e., slower compared to the real food particle centers) heating and
lethality accumulation rates, as illustrated by the figure, are acceptable.
In cases when the thermal insulation provided to the carried ther-
mosensitive implants by the wall of the carrier particle enclosure is
determined to be insufficient to establish the conservative thermal char-
acteristics of the particle, corrections can be made in some cases by add-
ing additional compatible layers or inserts of insulating polymer material
(Jasrotia et al. 2008).

14.3.6 Thermal property adjustments for

advanced heating applications
Fabricated particle characteristics need to provide the thermal protection
to the incorporated implants in order to maintain the conservative rate of
heating compared to real food particles in all lethality-accumulating seg-
ments of the processing system.
There are several methods to achieve the thermal conservative charac-
teristics of the assembled implant-carrier particles under advanced heat-
ing conditions (continuous flow microwave, radio frequency, and ohmic
Chapter 14:  Aseptic processing of particulate foods 245

High-Pressure Retort Data

118
116
Nonconservative
114 Retort Temp 1
Retort Temp 2 Thermal Characteristics
112 White - 2
Temp (deg C)

Yellow - 1
Yellow - 2
110 Carrot - 1
Carrot - 2
108 Potato - 1
Potato - 2
106
Conservative Thermal
104
Characteristics
102
100
800 850 900 950 1000 1050 1100 1150 1200
Time (s)
(a)

Fo for High-Pressure Retort Data

30
Nonconservative
Thermal Characteristics
25
Retort Temp 1
Retort Temp 2
20 White – 2
Yellow – 1
Yellow – 2
Carrot – 1
Fo

15 Carrot – 2
Potato – 1
Potato – 2
10

5
Conservative
Thermal Characteristics
0
700 750 800 850 900 950 1000 1050 1100 1150 1200
Time
(b)

Figure 14.6  (a) Comparison of heat penetration (temperature increase rates)

between real food particle centers and fabricated/simulated food particles to
verify conservative thermal characteristics. (b) Comparison of heat penetration
(lethality accumulation rates) between real food particle centers and fabricated/
simulated food particles to verify conservative thermal characteristics.

heating systems). One possibility is to select the relevant characteristics

of the polymer such that they keep the heating of the polymer at a lower
rate compared to the targeted food material. In the case of microwave and
radio frequency heating dielectric properties of the polymer need to be
measured and compared to the dielectric properties of the food particle to
246 Handbook of aseptic processing and packaging

ensure this. In the case of continuous flow ohmic heating, conductivity of

the polymer needs to be checked to make sure it is maintained at a lower
level throughout the heating elements of the processing system.
Alternatively, since dielectric and electrical conductivity proper-
ties are difficult to accurately control and adjust for polymer materials,
the internal cavity of the particle can be shielded within a thin-walled,
microwave-reflecting metal sphere for microwave and radio frequency
applications (Figure 14.7a), insulated within a thin-walled nonconductive
polymer (Figure 14.7b) for ohmic heating applications. Various potential
implants are also illustrated.
Regardless of the selected method of heating characteristics control,
comparative reduction in the rate of heating for the fabricated particles
should still be confirmed experimentally by concurrent heating experi-
ments using adjusted fabricated particles and real food particles in order
to verify the conservative properties of the fabricated particles.
The experimental measurement environment for these experiments
should be representative of the system and method used in the real ster-
ilization system, for example, microwave or the ohmic heating method
should be used at the same frequency and to the similar final temperature
levels as would be encountered in the actual systems.
Temperature probes used in these experimental measurements
should not interfere with the implemented electromagnetic or electric
means of heating. Fiber-optic temperature sensing probes are therefore
typically used.
The number and complexity of parameters that can influence the flow
characteristics of food particles, both real and simulated, are high. Particle
shape, size, surface characteristics, density, dynamics, chemical and phys-
ical changes affecting these properties, carrier fluid viscosity, density,
temperature-related density dynamics, particle load levels, size ratios of
particles versus the conduits or tubes used in the system, number and
variety of different particle subpopulations for complex heterogeneous
materials, flow geometry of the system, tube orientation, and types and
numbers of flow-through fittings like elbows and sensor wells are just a
few of the parameters that have been shown to have a significant influence
on particle flow and residence time. Consequently these parameters will
also influence time of particle exposure to sterilization treatments in dif-
ferent system segments influencing the thermal treatment received and
therefore safety of the processed food products.
However, for the purpose of constructing simulated food particles
with conservative flow characteristics, it can be assumed that most of the
processing-system-related parameters and product-related parameters
will be already established. Also, if simulated particles are to be fabri-
cated in the shape and size identical to the original shape and size of
the real food pieces to be simulated, and once the conservative thermal
 Chapter 14:  Aseptic processing of particulate foods
MW-Reflective, Magnetically Electric Insulator, Magnetically
Transparent Enclosure Transparent Enclosure
(Metal Sphere) (e.g., Hollow Polymer Sphere)

Enzymic TTI Enzymic TTI

RFID TAG RFID TAG
N N
S S
S S
Temperature N Temperature N
Microbial Recorder
Microbial Recorder
N TTI N
TTI N Magnetic Tag
Magnetic Tag S
S
Thermomagnetic Thermomagnetic
Swtich Implant Spore Load Switch Implant
Spore Load
Physical Physical TTI
TTI
Chemical TTI
Chemical TTI

(a) (b)

Figure 14.7  Protective shielding/insulation for internal cavities of carrier particles. (a) Metal hollow sphere for microwave heating
applications. (b) Polymer-encased hollow cavity for ohmic heating applications.

247
248 Handbook of aseptic processing and packaging

characteristics have been established as outlined in the previous chapters,

there is only one property to be adjusted and optimized to achieve con-
servative flow properties and that is the effective density of the particle.
Assuming the identical shape and dimensions compared to the real
food particle population, polymer material for the fabrication should be
preferably selected among the materials with relatively low density or
materials with low thermal conductivity and diffusivity characteristics
in order to maximize the implant-carrying capacity of the particles with-
out causing excessive increase in density by their inclusion. Almost all
commercially available polymers satisfy the low conductivity and diffu-
sivity characteristics. However, only a few of them have low-density char-
acteristics, with polymethylpentene (TPX) and polypropylene (PP) being
the two typical materials applicable to sterilization applications due to
their relatively high melting points as well as microwave transparency
characteristics.
Effective particle density (i.e., density of the fully assembled particle
containing all enclosure components, gaskets, seals, and implants) is one
of the most significant parameters affecting the flow properties of assem-
bled particles. Differences in residence times among the particles can be
very significant in determining the received and accumulated lethality,
especially under the advanced thermal processing conditions.
Under advanced thermal processing, high amounts of energy are
delivered to the flowing product and converted into very high rates of
temperature increase per unit time. In some cases, the temperature
difference of 100°C and more are covered in several seconds. Therefore,
difference in the length of exposure to these high heating rates caused by
the difference in flow properties and system segment residence times can
result in severe under- or overprocessing,
The effect of density on particle flow under a variety of flow rates and
particle load rates has been studied by Simunovic et al. (1998). One of the most
relevant results of these studies has been the identification of the so-called
critical density, which has been defined as the density or the density range
of the particle population (assuming identical shape and size of all particles)
with the highest statistical likelihood of containing the fastest particle.
Higher density levels will slow the particle flow in horizontal and
upward vertical flow configurations but will accelerate the flow in down-
ward configurations, whereas lower density values (higher buoyancy) will
also slow the flow in horizontal configurations and downward vertical
flow, but will accelerate the flow in upward vertical flow configurations.
Neutrally buoyant density (i.e., density identical to the carrier fluid) is
the critical density for perfectly horizontal flow conditions, density of zero
(i.e., perfectly buoyant) is the critical density for upward vertical flows,
and an infinite density would be the critical density for downward verti-
cal flows, maximizing the particle velocity.
Chapter 14:  Aseptic processing of particulate foods 249

Since most of the relevant elements of the continuous flow steriliza-

tion systems in the food industry tend to implement slightly upwardly
inclined horizontal flow regimes (typical examples are the aseptic hold
tubes, with a recommended minimal upward inclination of ¼-inch per
foot of length), critical effective density for such systems tends to be
slightly lower than the carrier fluid density under the representative pro-
cessing conditions.
Therefore, conservative flow characteristics of the fabricated particles
can be achieved by adjusting their density to a value to maintain the den-
sity level slightly below the carrier fluid density throughout the relevant
(heating and lethality-delivering) processing segments to ensure that the
cumulative exposure of the carried thermosensitive implants is below the
exposure received by the processed food particles. When appropriately
safe thermal treatment is confirmed for the thermosensitive implants
under those (conservative) flow and heating conditions, all other food
product elements will have received the appropriate treatment as well.
Properly designed and preassembled simulated particles should have
the effective density prior to adjustments lower than the associated real
food particles, as well as lower than the carrier fluid. This allows for the
adjustment of the effective density upward by including ballast materials
into the particle cavity prior to sealing. The used ballast materials will
typically be made from nonpolymer materials like glass, ceramics, or met-
als. Small magnets can also be used for added ballast, while at the same
time increasing the sensitivity of magnetic implant detection within the
flow stream.

14.3.7 Tags and implants used within the carrier

particle cavities for residence time and time–
temperature history measurements
A great variety of implants and tags have been used within the carrier
particles over the years of research, in an effort to improve the character-
ization of particle flows in multiphase systems. Figure 14.7 lists some of
these devices.
While it is theoretically possible to include a number of different
implants, there are practical limitations of size and weight. The implants
need to fit within the fabricated particle cavity without causing an exces-
sive increase in effective particle weight and density, reducing its buoyancy
below neutral and causing the nonconservative (i.e., slow) flow behavior.
Simulated particle populations can carry a single or multiple types of
implants and tags concurrently.
The CAPPS/NCFST approach is based on the use of two particle pop-
ulations: one with (typically magnetic) tags for flow and residence time
250 Handbook of aseptic processing and packaging

measurements; and another one used subsequently containing a thermo-

sensitive material, such as bacterial spores embedded within the particle
matrix, which is typically made by casting from a biopolymer gel, such as
alginate, which can also serve as the spore growth medium in the subse-
quent process biovalidation trials.
Conservatively designed particles, which have fast flow and slow
heating characteristics, make it possible to use multiple tags and implants
in the same population of particles. For example, a combination of resi-
dence time tags, such as miniature magnets with thermosensitive bacte-
rial spore based implants (in suspension, gel bead, or encapsulated liquid
form) enable the monitoring, detection, and selection of the fastest (or a
number of fastest) particles, as determined by residence time measure-
ments, for plating and growth enumeration on individual particle basis.
Therefore, as opposed to the bulk multiple particle incubation methods,
where the incubation yields an either positive or negative growth outcome,
without providing the quantifiable value of the lethality of delivered pro-
cess, the use of conservative carrier particles enables a more accurate esti-
mation of the process as well as the process lethality distribution over the
population of fast, average, and slow flowing particles.
At least one of the implanted tag types needs to be detectable by
remote (noncontact sensing). Magnetic implants have been the preferred
method to achieve this functionality.
Developments in increasing and maintaining the magnetic field
strength of new magnetic materials (neodymium iron boron magnets) at
high temperature levels (up to 180°C), concurrent with the development
and commercialization of new, especially giant magneto-resistive (GMR)
sensing devices, have enabled the sensitivity and detection levels for the
magnetic tag based system, which can reliably detect magnets as small
as 0.01 grams in full flow under sterilization level temperatures and flow
rates embedded within the ¼ inch and smaller sizes of simulated food
particles. Currently, no other tag type or detection sensing technology
can provide this level of sensitivity or functionality and magnetic tagging
remains the preferred method for measurement of particle residence times
both in research and development and in industrial application areas.
Other, nonmagnetic types of tags for residence time measurements
that have been used by researchers include RFID tags, and chemilumi-
nescent implants.
Among the thermosensitive implants, there have also been a variety
of alternatives. In addition to the bacterial spore-based implants (typi-
cally Clostridium sporogenes or Geobacillus stearothermophilus, depending
on the application), which may be implemented in a variety of encap-
sulated, immobilized, or free suspension/solution formats, chemi-
cal, physical, and enzymatic time–temperature integrating devices
Chapter 14:  Aseptic processing of particulate foods 251

have been tested and used with various levels of functional success.
Time–temperature integrating devices based on thermal inactivation of
enzymes derived from hyperthermophilic microorganisms are show-
ing a high degree of promise for these applications, due to the ability
to rapidly determine the postprocess retained levels of activity within
minutes and very compatible thermal inactivation kinetic param-
eters. However, all of these time–temperature integrating devices are
retrieved and quantified postprocess, and only provide an estimate
of the cumulatively delivered thermal lethality treatment, that is, the
resulting level of inactivation (or modification) of implanted thermo-
sensitive material includes accumulation during heating, holding, and
cooling segments of the process.
To improve the resolution of time-temperature detection, that is, the
ability to appropriately assign delivered lethality treatment contributions
to respective processing system stages, a real-time method for detection of
achieved temperature levels, concurrently with the detection of residence
times, is needed.
There have been several efforts to develop a method capable of detect-
ing temperature levels of freely flowing particles in real production scale
equipment under sterilization level temperatures, levels, and flow rates,
including magnetic resonance imaging (Hulbert et al. 1995; Kantt et al.
1998) and temperature-dependent magnetic field measurements of para-
magnetic materials (Ghiron and Litchfield 1996).
More recent developments of thermomagnetic switch concepts and
devices (Simunovic et al. 2004, 2006, 2007; Palazoglu et al. 2006) have
enabled the commercialization of the first real-time particle flow monitor-
ing systems capable of detecting and recording temperature levels achieved
during the process within the cavities of conservatively designed, freely
flowing simulated food particles. Figure 14.8 illustrates the basic principle
of thermomagnetic switch implants and their detection via determination
of magnetic field levels before and after the predetermined temperature
levels. Typically, the adhesive/solder used to hold the individual magnetic
implants together is a eutectic alloy or pure metal material with a melting
point within the sterilization temperature level range.
Flow monitoring, signal detection, temperature status detection,
recording, and process analysis for thermomagnetic switch systems can
be achieved using the same detection and recording system used for resi-
dence time measurements of particles with magnetic implants. Multiple
GMR-based sensors are integrated into sensor arrays (two to eight sen-
sors) for each detection location for the continuous flow sterilization sys-
tems, and these are then connected into networks of 8, 16, 32, or 64 sensing
locations, depending on system size and required spatial resolution of
flow monitoring and temperature level detection.
252 Handbook of aseptic processing and packaging

N
N S
– = Repulsion
S N N

Adhesive or Solder with a Preselected

Temperature of Melting/Thermal Release

(a)

Identical Magnets

S
Flip N
N
S
Repulsion
Attraction
N Heating
N
S S
Temperature Below Temperature At/Above
Preselected Melting Preselected Melting
Point: Net Magnetic Field Point: Net Magnetic Field
Strength Zero Strength Additive

(b)

Figure 14.8  Thermomagnetic switch temperature-sensitive implants: (a) Assembly

and magnetic field level prior to achieving the predetermined temperature switch
level. (b) Magnetic field levels and realignment of magnets during and after the
temperature switch level.

A typical sensor array location installation is illustrated in Figure 14.9

for a recently commercialized particle flow monitoring system (Clark
2010). The illustration shows a monitoring location with two sensor arrays,
each with four GMR sensor elements.
Most recent development efforts include an implantable integrated
time and temperature recording device, including a temperature-sensing
element, digital conversion, power source (battery), processor, recording
memory for data storage, and an interface for postprocess data down-
load. Development and optimization efforts are in progress to bring the
dimension and weight characteristics within limits typical of food par-
ticle characteristics.
One configuration of this device is shown in Figure 14.10.
Chapter 14:  Aseptic processing of particulate foods 253

Figure 14.9  Segment of a noncontact particle flow monitoring system installation

with two sensor arrays, each with four GMR magnetic sensors (ThermaLytics
Inc., Raleigh, North Carolina).

Figure 14.10  Prototype of a fabricated carrier particle with an implantable, high-

temperature compatible time and temperature recording circuit, recently devel-
oped by researchers at North Carolina State University.
254 Handbook of aseptic processing and packaging

14.3.8 Insertion, unobstructed flow, and retrieval of

fabricated tag and implant-carrying particles
The final but no less important set of considerations for the use of fabri-
cated implant-carrying particles are the technical issues related to their
insertion into the stream of food product or biomaterials undergoing
continuous flow thermal treatment, maintenance, and control of their
unobstructed flow through the processing system, and their retrieval for
postprocess analysis and documentation. Foods and biomaterials pro-
cessed under continuous flow conditions are exposed to high tempera-
tures and pressures during processing.
Individual (i.e., individually traceable) implant-carrying particles
need to be inserted into the flow at different intervals in order to sepa-
rate the signals from the downstream detection locations. In other words,
particles need to be separated from each other at the time of insertion
by a sufficient delay time to maintain their separation, and the ability to
identify them and properly assign the cumulative lethality treatments
received by each of the inserted particles.
The insertion can be performed at the point of product entry into the
pumping system or downstream from the material entry into the process
conduit system. Although insertion at the point of material entry into the
system requires no special equipment or procedures, depending on the
pump type used, it can lead to mechanical damage to the particles, and
depending on particle rigidity and mechanical properties, also damage to
the pump itself. Additionally, it is difficult to control the insertion delay
times when the particles are introduced into the flow stream through a
larger volume vessel. Downstream insertion into the stream of flowing
material is technically more difficult to perform due to the high-pressure
conditions within the flow (typically 150 to 300 psi, or higher, depending
on the processing system, processed material, and implemented thermal
treatment conditions). However, it is preferred, especially if the numbers
of particles to be inserted and monitored through the system are high.
The need to insert individual particles into the stream for subsequent
tracing at multiple locations downstream from the point of insertion pres-
ents the researchers with a task similar to implementing the entry and exit
of personnel from submerged vessels like submarines and spaceships.
This task is basically to enable the passage of designated material between
two significantly different pressure and atmosphere conditions with min-
imal interference and exchange of other content between the two.
A typical approach to achieve this is to construct an intermediate
space/chamber where the personnel or material is held while it is trans-
ferred between the two sets of conditions. The material to be exchanged
between the two environments is placed within the intermediate space
while exposed to the source environment, temporarily hermetically sealed
Chapter 14:  Aseptic processing of particulate foods 255

(a)

(b)

Figure 14.11  Prototype device developed at NC State University for particle

insertion into food or biomaterial product flow stream: (a) standard flow condi-
tions–top set of piping; (b) diverted flow conditions during particle insertion into
the launch chamber.

off from both environments and finally exposed to the targeted environ-
ment and launched or released into it. One version of such a system that
has been successfully used in research and industrial applications has
been developed by researchers at North Carolina State University (Kumar,
Simunovic et al. 2008) is illustrated in Figure 14.11. This device is typically
placed immediately downstream from the pump location and is exposed
to the same back pressure conditions experienced by the rest of the system.
Two manually operated high-pressure sanitary ball valves are used to
seal off the intermediate/particle launch chamber and alternatively divert
the flow between the bypass pipeline and the pipeline containing the par-
ticle launch chamber. The intermediate chamber between the external envi-
ronment and the pressurized flowing food or biomaterial consists of a third
modified ball valve. The internal chamber of the ball valve is used to hold
the inserted fabricated particle during the exchange, and the particle port
of entry is achieved via a side opening in the wall of the ball valve with
dimensions sufficient for placement of particle within the chamber.
Figure  14.12 additionally illustrates the steps of required alternat-
ing valve closures and flow diversion to enable entry of particles into
256 Handbook of aseptic processing and packaging

Figure 14.12  Sequence of operation of particle insertion assembly under full-

flow process conditions: (1) Flow-through line open, bypass line inactive; (2) flow-
through closed, bypass active; (3) particle launch port closed, cavity empty; (4)
particle launch port open, simulated particle inserted into cylindrical cavity;
(5) particle launch port closed, cavity contains particle; (6) flow-through open,
bypass inactive, particle taken by flow through the first magnetic detection/entry
port and further on through the system, launch port cavity empty.
Chapter 14:  Aseptic processing of particulate foods 257

the flowing material with minimal interference and material exchange

between the two pressure environments.
It is important to have the insertion operator protected using pro-
tective glasses, transparent shield, or similar items since an error in
the sequence of operation (opening and closing of the valves) leads to
the rapid ejection of the pumped material through the chamber open-
ing, because it is pumped under high back pressure conditions. More
recently, an automated version of this assembly has been developed,
allowing for programmed or remotely operated particle insertion and
providing increased throughput and better control of insertion times and
time delays.
Another important consideration for the implementation of fabricated
implant-carrying particles is establishing the conditions for their unim-
peded and unobstructed movement through the processing system. Since
fabricated particles are typically more rigid than the real food particles
(silicone and alginate–die cast particles are possible exceptions), and will
tend to get lodged in and temporarily slowed or completely stopped by the
flow-obstructing fitments within the flow-through system. Slowing down
of the particle flow can cause extensions of their residence time within the
thermal treatment and lethality-delivering segments of the system, thus
resulting in nonconservative flow behavior and ultimately an overestima-
tion of the delivered process potentially leading to an unsafe product. A
more drastic case is the flow stoppage of the fabricated particles, and their
accumulation at the point of obstruction, with a potential to cause full
flow obstruction and possible system failure due to the continued pump-
ing with the positive displacement pumps used in aseptic processing.
These risks need to be addressed, particularly when the ratios of particle
dimensions to internal piping diameters and passage openings are high.
Therefore, care needs to be taken to minimize and preferably eliminate the
points of possible obstruction and stoppage within the systems. Installed
systems should be examined and tested with particle samples to eliminate
the potential problems. These locations are any in-flow sensing device
wells, flow diversions, and even misaligned or overly tightened clamps
and gasket connections. This should also be considered when designing
and constructing new processing installations for thermal treatment of
foods and biomaterials containing solid product components.
There are several possible means of controlling the unobstructed
flow-through characteristics of the system, like optimization and reduc-
tion of the number of in-flow sensing locations. This however reduces the
ability to characterize the system and process treatment delivery, which is
of particular importance with new and emerging technologies and prod-
ucts like multiphase aseptically processed foods.
Another alternative is the elimination of previously installed sensor
fitments and incorporation of minimally obstructive sensors and sensing
258 Handbook of aseptic processing and packaging

Figure 14.13  Minimally obstructive in-flow keyhole sanitary sensor fitments.

(Windridge Sensors, Holly Springs, North Carolina.)

fitments in the system. In many cases these new fitments can be used
as direct replacements for the old sensor types and wells, and provide
an additional benefit of controlling and minimizing the thermal drain/
wicking effect of the previous generations of sensors, enabling the proces-
sor to characterize the processes more accurately and take appropriate
credit for the actual thermal conditions within the flow, which tend to be
typically somewhat higher than displayed and recorded by older sensing
equipment. Several examples of these minimally obstructive sensor fit-
ments have been tested by Simunovic et al. (2009) and are illustrated in
Figure 14.13.
Fabricated implant-carrying particles need to be captured and sepa-
rated from the regular product stream to enable the analyses of carried
implants, and recording and documentation of process validation. There
are several methods to achieve this. If the testing runs are performed
without subsequent filling into packages, particles can be separated cap-
tured from the outgoing product stream. Preferably, they are both tagged
magnetically and color coded, using a color recognizably different from
the remaining bulk of the product.
Provided the filling equipment can handle rigid particles with the
required dimension tolerances and clearances, they can also be filled with
the food product into the intermediate or final packages. If these packages
are small in size, it may be possible to identify the packages containing
the tagged particles using magnetic detection, similar to the method used
to determine the times of particle passage through the monitored system
flow-through pipe segments. Particles can also be diverted or retained
after the exit from the last heat-exchanging segment of the system (i.e., the
cooler).
If the magnetic strength of the implanted magnetic tags is sufficient,
in-line magnetic trap chambers can be used for their capture. Finally, an
automated tagged particle flow diversion system is currently under test-
ing, which operates in communication with the magnetic particle flow
Chapter 14:  Aseptic processing of particulate foods 259

detection system and upon detection of a tagged particle diverts the prod-
uct flow into a separate stream for accumulation of tagged particles. Upon
detection and confirmation of the flow diversion of the tagged particle,
the system reverts to the regular product stream pathway, enabling the
postprocess recovery of the tagged particles without tedious separation
from large volumes of bulk product.

14.4  Concluding remarks

Aseptic processing of low-acid particulate flows remains a major chal-
lenge for the food industry. However, numerous advantages of aseptics
(such as quality and nutrient retention improvements; superior energy
economics; reduced carbon footprint; the ability to accommodate numer-
ous shapes, sizes, and packaging materials; and superior graphic display
properties) are beginning to move these types of products into com-
mercial reality and evolving success. The first thermally sterilized and
aseptically packaged low-acid shelf-stable foods with large particles are
currently present in consumer markets in Europe, Australia, Asia, and
North America.
Increased interest in products containing real fruit and vegetable par-
ticles, in combination with new regulations and process evaluation meth-
ods are also driving the expansion of aseptic technologies in the high-acid
foods applications. Unique advantages of advanced thermal and aseptic
packaging technologies are also contributing to accelerated expansion of
particulate foods in the institutional products area, where the high-acid
particulate fruit products have an established presence already, especially
in Europe.
Another indication of the emergence of the new, particle-oriented
era in aseptic packaging are numerous commercial introductions of new
aseptic fillers and packages, particularly bags and pouches targeted at
institutional markets, both from long established aseptic filler companies
and new suppliers in this market.
The use of novel heating techniques, with advanced control systems,
and the advances in research are making the multiphase aseptics a com-
mercial reality in a very short time. Several products are appearing in the
European market in the last few years, but the validation of such products
is still required to meet FDA standards in order for these products to be
marketed in the United States.
Validation of aseptic processing of multiphase flows requires effort
and commitment from the research and development community as well
as the industrial food processors; and the use of advanced process design,
monitoring, and validation tools, which are now available. We expect
these tools to be the key in the implementation of aseptic processing to
multiphase products.
260 Handbook of aseptic processing and packaging

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chapter 15

Industry research and

development, and management
needs and challenges
Jairus R.D. David

15.1  Introduction
Aseptic processing is neither new nor old, but is a commercially success-
ful and robust technology. It is approximately 70 years old and began with
the invention of the first aseptic line of the hot–cool–fill (HCF) system by
Dr. C. Olin Ball. In a true sense, aseptic technology became a commercial
reality with installation of Dr. W.M. Martin’s Dole aseptic canner in 1951.
In 1981, approval from the U.S. Food and Drug Administration (FDA) of
the food additive petition for use of hydrogen peroxide as a sterilant for
food contact surfaces provided the impetus for introduction of various
aseptic filling and packaging systems into the U.S. market. It is very inter-
esting to note, using 1981 as an origin, aseptic processing technology is
only 30 years young in the United States! Basic and applied research in the
areas of sterilization microbiology, food engineering design, thermal pro-
cessing, packaging technology, and chemistry were the original driving
forces for successful commercialization of aseptic processing and packag-
ing technology in the United States and Europe. Also, the discipline and
manufacturing mechanics for aseptic processing of foods is based upon
theory, practice, and regulations originating from conventional canning,
continuous pasteurization, clean room technology, and the pharmaceuti-
cal industry.
It is axiomatic to consider aseptic processing and packaging as the
benchmark in optimization, for manufacture of sterile, shelf-stable canned
food. Contrasted with retorting or in-container sterilization, in aseptic,
the product and package are independently sterilized by optimal pro-
cesses wherein microbial inactivation and quality factor degradation are
also co-optimized given first-order kinetics. Aseptic systems permit ster-
ilizing the product and container separately and appropriately, without

263
264 Handbook of aseptic processing and packaging

the rate-limiting heat transfer modes, or the attendant thermal and pres-
sure stress to the container closure and seal integrity, and permitting
high-temperature short-time (HTST) or ultra-high temperature (UHT)
processing of very heat-labile products, without excessive quality factor
degradation, while achieving requisite commercial sterility. The pre-1981
market drivers were better quality low-acid heat sensitive products, com-
pared to retorted versions. The post-1981 basic drivers are use of alternate
packages, consumer convenience, light weighting, cost reduction, supe-
rior quality, and package sterilization by optimal methods.
The technology has been diversified in recent years and concepts of
aseptic processing and packaging that are somewhat removed from the
core of the original technologies (Figure 15.1) are slowly being adapted to
liquid and solid foods.
The future of aseptic processing will depend upon reducing the depar-
tures from process optima, as discussed in Chapters 1, 12, and 13, and cap-
turing findings from ongoing research in both basic and applied research
leading to use of both novel thermal sterilization methods coupled with

Pharmaceutical
Microwave Irradiation
At-Line and On-Line Sensors
Sous-Vide
Robotics; Computer Vision Systems
(Modified Atmospheric Packaging) Biosensors/Chemical Markers
M.A.P.
Antimicrobials
(Pasteurized–Refrigerated) Biotechnology
High-Pressure Processing
Aseptics
Pulsed Electric Field
Flash–18 Pulsed Light Field
Past Future Oscillating Magnetic Field
Canning

Pasteurization Defense Technology Spin Off

Freezing Present

Dehydration

Figure 15.1  Time line for present and future innovation in food industry. (Modified
from Cole, M.P.J., McClure, P.J., Stephens, P.J., and Davis, K.W. 1994. Model vali-
dation (and confidence in models)—An industry perspective. Applications for
Predictive Microbiology Symposium. 81st Annual Meeting of IAMFES, San Antonio,
Texas, July 31–August 3.)
Chapter 15:  Industry research and development 265

innovative nonthermal processes. Shown in Figure  15.1 is a technology/

innovation time line depicting aseptic processing technology in relation
to emerging technologies. It is important to underscore that no one sin-
gle technology can replace the shelf-stable capabilities of either classical
retorting or aseptic processing. However, many of the innovative thermal
and nonthermal processing technologies can be used either additively or
synergistically to build “hurdles” in tandem with an objective to produce
superior products with minimal heat-induced damages (Zhang et al. 2011).

15.2 Research and development

needs and challenges
For ease, research and development needs and challenges may be grouped
under four categories: raw product, processing, aseptic filling and pack-
aging, and finished product (David 1994; 1995).

15.2.1  Raw product

Because the roots of aseptic processing and packaging are in the dairy
industry, this chapter is written with milk and dairy products as exam-
ples, but the principles can be applied easily to other food products.
Consistent quality of raw ingredients and established mix procedures
are essential for reproducible finished products. It is an established fact
that UHT-processed products have less thermal degradation compared
to that of conventionally canned products. But this can very easily be
masked by our inability to control the quality and uniformity of incoming
raw ingredients. Also, affordable quality control screening tests for check-
ing microbiological, chemical, and physical quality are needed.

15.2.1.1  Raw food quality

It is a well-established fact that raw milk quality determines the sensory
and quality characteristics of finished milk. Raw milk quality is deter-
mined by herd/udder hygiene, barn sanitation, feeding method, milk-
ing method, collecting tank storage temperature and time, refrigerated
transportation, and elapsed time between barn to plant. According to the
Pasteurized Milk Ordinance (PMO), 45°F is a recommended storage tem-
perature. Refrigeration is an effective hurdle for control of heat-resistant
toxin secretion by coagulase-positive Staphylococcus aureus. However, psy-
chrotrophs can survive refrigeration temperature, and grow and secrete
heat-resistant enzymes that can survive UHT sterilization process leading
to long-term flavor problems due to proteolysis and lipolysis. Refrigerated
storage is a short-term insurance and is not a panacea to cover a multitude
of handling problems.
266 Handbook of aseptic processing and packaging

15.2.1.2  Thermization
Often, fluid milk and probably other dairy products such as cream are
heat treated, not for elimination of pathogens, but to reduce the number of
psychrotrophic bacteria capable of secreting heat-resistant proteases and
lipases. Thermization is a less severe heat treatment process than pasteur-
ization or ultra-pasteurization; heat is applied for about 15 seconds at tem-
peratures in the range of 65°C to 70°C (149°F to 158°F), followed by cooling
to below 6°C (43°F). Chilled milk is distributed to manufacturing plants
for further formulation and heat processing and packaging.

15.2.1.3  Enzyme blockers and biotechnology

Plasmin is the major native protease in milk, which causes gelation and
flavor problems. Plasminogen is the precursor for plasmin and is present
in a larger amount and is heat resistant. Unfortunately, the heat treatment
required for inactivation of heat-stable plasminogen often exceeds that
required for control of microorganisms and their spores, and inactivation
of the plasmin system.
Research by Kohlman et al. (1991) points to the presence of heat-
resistant protease activators (PAs) and heat-sensitive protease inhibitors
(PIs) controlling the kinetics of expression of plasmin from plasminogen
in plasmin-free UHT sterilized milk. Unfortunately, PIs are susceptible
to sterilization processes and the reaction is overwhelmingly driven by
PAs. Research on enzyme blockers as proposed by S.S. Nielsen of Purdue
University (personal communication, 1994) consists of removing PIs prior
to UHT processing or bulk producing them as a biotechnology product,
filter sterilizing, and aseptically adding them back to milk after UHT
treatment. PIs can improve product quality by suppressing the expression
of plasmin from plasminogen, necessary for gelatin and off flavor.
Other heat-stable enzymes in foods that affect product quality are
pectin methyl esterase in citrus juices causing cloud loss, and amylase in
pudding causing thinning.

15.2.1.4  Economic spoilage and control

Economic spoilage due to thermophilic spores in certain sensitive ingredi-
ents was presented in Chapters 12, 13, and 14. Ingredients of concern are
cocoa, nonfat dry milk (NFDM), carboxymethylcellulose (CMC), starches,
sugar, corn, mushrooms, and spices. It is a good practice to monitor, mea-
sure, and track and control the mesophilic and thermophilic spore loads of
each batch of raw product based on ingredients in a formulation. In addi-
tion, these ingredients must be completely hydrated prior to batching to
ensure that any spores if and when present are fully exposed to a designed
and delivered thermal process via a direct or indirect method of heating.
Some pretreatment procedure such as preheating, irradiation, tyn-
dallization, proper hydration of cocoa, and H2O2 and nisin are common.
Chapter 15:  Industry research and development 267

Research is needed in the area of validation and approval of heat-stable and

encapsulated natural antimicrobials or biopreservatives at UHT and HTST
sterilization regimes.

15.2.2  Processing
Agitated retorts, “Flash 18” process, and aseptic processing represent tech-
nologies that optimize heat sterilization and product quality by reducing
heat-induced damages prevalent in still or static retorts. However, in asep-
tic processing, continuous process delivery is complex and needs to be
carefully controlled and automated.

15.2.2.1  12D “Bot Cook” for milk

Milk is one of the most fragile food systems known. A food industry goal
has been to reduce the insults during pre- and poststerilization phases
of unit operations. Currently, shelf-stable UHT milk is regulated by the
PMO and the U.S. Department of Agriculture (USDA) and is treated as a
low-acid canned food (LACF) by the FDA, with a required Fo of 3 minutes.
In reality, the Fprocess that is actually delivered without any lethality credit
is on the order of 6 to 7 minutes in direct systems and 12 to 15 minutes
in indirect systems. This is an incredible assault on a very fragile food
system leading to quality defects including “cooked flavor.” This is one
reason that UHT milk has had difficulty competing with refrigerated pas-
teurized milks in the dairy case in the United States.
Many have questioned the relevance of 12D reduction or delivery of Fo of
5 minutes for shelf-stable milks. Europeans produce shelf-stable UHT milk
using an Fo of about 1.22 to 3.87 minutes, which is equivalent to a required
heat process for ultra-pasteurized milks, retailed chilled, in the United States,
as shown in Table 15.1. Research is needed in the area of thermobacteriology
pertaining to heat resistance of C. botulinum in milk menstrum and other
foods at HTST and UHT regimes for factual design of safe thermal pro-
cesses, rather than empirical and ultraconservative design (Casolari 1994).

15.2.2.2  Lethality credit for come-up time

In classical canning, it is common but sometimes erroneous to claim
lethality credit for come-up time (CUT) and cool-down time because
transient or unsteady-state heat transfer is lengthy. In UHT processing,
sterilization is done at very high temperatures with short CUT and expo-
sure times. However, very short transient or CUT does carry a significant
amount of lethality relative to brief exposure periods of the order of a few
seconds. In the United States, traditionally one only accrues lethality due
to isothermal temperatures and residence times in the hold tube, and can-
not claim any credit for either CUT or cool-down time. Deleting thermal
lethal contributions in heaters and coolers, while consistent with safety, is
268 Handbook of aseptic processing and packaging

Table 15.1  Ultra-Pasteurization Heat Process, Approximations of Heat Processes

for Destruction of Clostridium botulinum, and Commercial Sterility as Compared
to the European Range of UHT Processes
Sterilizing
Process Storage Heat/Hold Value (z = 18°F)
Ultra-pasteurization Refrigerated 280°F, 2 seconds Fo 1.5 minutes
Minimum to destroy Nonrefrigerated 280°F, 4 seconds Fo 3.0a minutes
Clostridium botulinum
spores
Commercial sterility Nonrefrigerated 280°F, 8 seconds Fo 6.0 minutes
European UHT range Nonrefrigerated 275°F, 3 seconds Fo 1.22 minutes
284°F, 3 seconds Fo 3. 87 minutes
Source: McGarrahan, E.T., 1982, Considerations Necessary to Provide for Sterilized Milk
and Milk Products in Hermetically Sealed Non-Refrigerated Containers, Journal Dairy Science
65:2023–2034.
a Minimum for public health safety varies based on product and process.

a departure from process optimum. More recently, regulatory authorities

in the United States have become open to the lethality credit claim on a
case-by-case basis.

15.2.2.3  Control of hold time and temperature

Precise control of flow and temperature are essential for proper delivery
of an approved thermal process. Inability to control temperatures within
5°F in the UHT regime can lead to irreversible damage, because this may
correspond to a doubling or tripling of Fo, as shown in Figure 15.2.

80
Required Process Temperature: 276°F
Hold Time: 11.59 sec Fo = 69.42
Hold Tube Fo (Minutes)

60 Z: 18°F Tref: 250°F Minutes

40
Fo = 36.62
Minutes
20
Fo = 5.38 Fo = 18.6
Minutes Fo = 11.58 Minutes
0 Minutes
276°F 281°F 286°F 291°F 296°F
(276+5°F) (276+10°F) (276+15°F) (276+20°F)
Process Outlet Temperature (°F)

Figure 15.2  Effect of process outlet temperature in hold tube on Fprocess.

Chapter 15:  Industry research and development 269

Figure 15.2 depicts the effect of a step temperature increase of 5°F on

Fo or lethality delivered. This illustration is based upon a scheduled pro-
cess for milk of Fo of 5.38 minutes and hold time of 11.59 seconds at 276°F.
In reality, one can notice very significant differences between flavors of
milk sterilized for 4 and 4.7 seconds at 280°F. The small difference of 0.7
seconds can cause a big flavor difference at UHT regimes.
It is common in the pharmaceutical industry to specify both an Fo
minimum and an Fo maximum in a scheduled process. The food industry
should strive for defining the safety and quality and biofunctionality lim-
its in a scheduled process to prevent departure from process optimum.

15.2.2.4  Heat exchangers and product quality

Certain types or combinations of heat exchangers are best suited for
processing of specific products. For instant heating and cooling without
excessive transient heat for low viscosity products such as milks, it is more
appropriate to use direct steam heating. It is important to note that during
cooling there may be flashing due to the presence of vacuum, and cau-
tion needs to be exercised in order not to suck in any microbial contami-
nants, and also loss of volatiles. Most attempts to heat a viscous product
like cheese sauce yields a wonderful product but at the risk of fouling
the vacuum chamber, which may be impervious to clean-in-place (CIP)
and routine cleaning. This situation leads to anaerobic pockets within 6
to 8 hours prior to cleanup and can promote 100% spoilage in subsequent
production runs.
Shell-and-tube heat exchangers are better suited for chocolate drinks
to promote caramelization. Tubular heat exchangers are better suited for
soups. Tubular and scraped surface heat exchangers (SSHE) may be best
suited for cheese sauces and puddings.

15.2.2.5  Holding tubes

A critical phase of an aseptic process that has not received proper tech-
nical consideration is the holding of product at the sterilization tem-
perature. When the product contains particles, the temperature within
individual particles during continuous processing cannot be practically
determined, thus leaving room for potential cold (underprocessed) spots.
Moreover, temperatures are not constant from inlet to discharge of con-
ventional holding tubes due to transfer of heat from liquid to particle or
vice versa, and heat losses from the outside surface of the tube. Further, it
is not known exactly at what rate the slowest particle is moving through
the tube. From FDA regulations for milk and egg product pasteurizing
systems, a particle shall not move at a rate less than one half the maxi-
mum fluid velocity for a given mass flow rate in the tube. This is based
upon a theoretical analysis for an ideal fluid (Newtonian) in laminar flow.
This implies that if some particles are moving more slowly, then other
270 Handbook of aseptic processing and packaging

particles and/or the carrier liquid must be moving at rates greater than
the theoretical maximum velocity. Thus, the hold time for the faster por-
tion will be less than the required minimum for which the holding tube
was designed, bringing up sterility questions.

15.2.2.5.1   Flow in conventional holding tubes  A conventional hold-

ing tube consists of straight sections connected by 45°, 90°, and 180°
bends. Flow in the straight sections typically exhibits a range of veloci-
ties from the tube wall to the center; this is significant in laminar flow,
which is likely to prevail in viscous products. In the bends, a swirling
motion called secondary flow, caused by centrifugal forces, is initiated.
This secondary flow, depending upon its intensity, acts much like turbu-
lence in reducing the velocity spread in the tube. However, this advan-
tage is quickly lost in the next straight section where the original flow
pattern resumes.
A condition that may develop with products containing particles flow-
ing in straight tubes is partial adhesion of some of the particles to the tube
wall, effectively reducing the area available for flow. While these adher-
ing particles will be held for longer than twice the designed holding time,
some other particles and portions of the liquid may be going through the
tube in less than one half the calculated holding time. This has not been
recognized by the FDA as a problem with homogeneous liquid products
in that the overall product is “safe.” However, significant holding time
reduction has been experienced in processing chocolate syrup, which
does not contain discrete particles. At the start of syrup production, the
specified hold is achieved. As time elapses, the chocolate coats the tube
wall, gradually reducing the actual holding time. At the end of the day,
the effective diameter of the holding tube may be only half of the tube ID,
which would cut the holding time to a quarter of the specified time for
which the holding tube was designed. Bacteriological analyses through
the day correlate well with the reduction of time of hold; that is, as the
holding time decreases, the bacterial count increases. This phenomenon
is also evident from the work of certain investigators with more viscous
products, for example, eggs, which tend to coagulate or burn at the walls
of the holding tube (Carlson 1994).
Considering some of the questions that have come about regarding
the conventional holding tube, a holding tube should be designed in such
a manner that everything possible is done to “stack the cards in favor of
the consumer and public health,” which will render a product commer-
cially sterile.

15.2.2.5.2    Proper holding tube design  To take advantage of the

velocity-leveling effect of the secondary flow in curved tubes, the holding
tube should be designed as one continuous helical coil with an adequate
Chapter 15:  Industry research and development 271

coil radius-to-tube diameter ratio. The secondary flow is effective in mix-

ing the phases and keeping the particles in uniform suspension without
adhesion to the tube wall. The fluid agitation also helps considerably
during CIP. Further, the holding tube should be insulated from the envi-
ronment to minimize heat loss and drop in temperature. This approach
eliminates the need to oversize the holding tube to account for the wide
variation in velocities in straight tubes. A properly designed holding tube
will act significantly toward providing the best-quality aseptic product.
HydroCoil® holding tubes are designed based on the aforementioned
principles.

15.2.2.6  Cooling cycle and leak detection

Prompt cooling of UHT heated product to 50°F to 60°F is an important
part of optimization. Thermal process equipment design should incor-
porate adequate cooling. Inadequate cooling or slow rate of cooling can
promote economic spoilage due to nonpathogenic thermophilic spores.
Failure modes and effect pertaining to the cooling cycle were discussed
in Chapters 12 and 13. Proper equipment preparation and set-up (EPSU)
and leak detection tests are essential for control and prevention. There is a
need to develop a reliable leak test to check system integrity.

15.2.2.7  Surge tank

Certain viscous products, such as puddings and cheese sauces, foul the
processing equipment, which must be cleaned at frequent intervals. To
contend with this requirement aseptic surge tanks are used. The surge
tank is filled at the same time fouling is anticipated. The surge tank is
large enough so that the processing system can be cleaned, resterilized,
and put back on stream before the surge tank is empty. Also, as mentioned
in Chapter 9, some operations do include aseptic surge tanks, because filler
speeds do not correlate with upstream processing flow rates.
Surge tanks are expensive. They are usually some of the first places
considered as contamination points if contamination exists, and they
are complicated to operate, which is somewhat simplified through the
use of programmable logic controllers (PLCs) and proper program-
ming. Therefore, someone knowledgeable in electronic hardware is
required to be available. It would be advantageous if processing equip-
ment could be developed that could be cleaned easily or inexpensively
so the operation and delivery of the product to the packaging system is
not interrupted.

15.2.2.8  Aseptic processing of low-acid particulate foods

To aid processors in developing a validated process schedule for low acid
particulate foods, a series of industry, university, and government work-
shops on aseptic processing of multiphase foods were conducted by the
272 Handbook of aseptic processing and packaging

National Center for Food Safety and Technology in Chicago, University of

California at Davis, and the Center for Aseptic Processing and Packaging
Studies at North Carolina State University at Raleigh. This resulted in the
publication of the “Case Study for Condensed Cream of Potato Soup from
the Aseptic Processing of Multiphase Foods Workshop” (Anon. 1996).
Other results of the workshop were summarized in a series of articles that
appeared in Food Technology magazine (Damiano et al. 1997). Based on the
recommendations of the workshops, Tetra Pak, Inc. (with the assistance of
the National Food Processors Association [NFPA]) developed the neces-
sary data required for filing a scheduled process for aseptic processing
of a low-acid product (cream of potato soup). The filing resulted in a “no-
objection” letter from the FDA in May 1997. It was thus demonstrated that
it was indeed possible for processors to adopt the recommendations of
the workshop to gain the “approval” of the FDA for aseptically process-
ing low-acid foods containing large particulates. A detailed description of
process filing using the FDA form 2541c (for aseptic processing of low-acid
foods) has been described by Sastry and Cornelius (2002).
Prior to producing aseptically processed and packaged foods contain-
ing particles, a processor is required to demonstrate that the food is com-
mercially sterile by the regulatory agencies (FDA or USDA, depending
on the type of food). FDA regulations are contained in Title 21 CFR 108
and 113, and USDA regulations are contained in Title 9 CFR 318 and 381.
General FDA requirements for establishment registration, thermal pro-
cess filing, and good manufacturing practices for low-acid canned foods
are covered in 21 CFR 108, 21 CFR 110, 21 CFR 113, and 21 CFR 114. These
and other listed regulations and forms are also accessible through contact
with FDA directly or from its Web site (www.cfsan.fda.gov).
Also, Chapter 14 of this book focuses on aseptic processing of particu-
late foods.

15.2.2.8.1    Thermal process design  A typical thermal process design

basically consists of a process temperature and a process time. For asepti-
cally processed foods containing particles, the temperature of the interior
of the particles cannot be monitored and must be estimated mathemati-
cally. Process calculation methods should take into consideration the
three-dimensional nature of the food particles if possible. Process time
for these products cannot be estimated from flow dynamics due to the
two-phase flow phenomena. Thus, it must be determined experimentally,
under normal processing conditions if at all possible. If the food contains
more than one type of particle, such as meat and vegetables, then it may
be necessary to conduct experiments with each type and size of particle in
the food. Ultimately, a process developed may need to be confirmed with
a biological validation test, as discussed in Chapter 9.
Chapter 15:  Industry research and development 273

15.2.2.8.2    Biological validation test  A biological validation test is a

confirmation test meant to ensure that the process developed by calcula-
tion is effective in commercially sterilizing the food of interest. The test
should be designed such that the test organism selected is appropriate
for the type of food under test and the temperature used to process the
food. In addition, the food may need to be supplemented with nutrients
such that any surviving test organisms, which may be in an injured state,
would be able to recover and grow out. This would ensure that no growth
of the test organisms represents actual destruction of the organism.
Any procedure used to establish an aseptic process for a low-acid
food product containing particulates should include a biological valida-
tion step. Actual biological validation is complicated by the need to docu-
ment the particle residence time distribution throughout the system and
the enumeration of control mechanisms for the critical heating rate fac-
tors. Traditional biological enumeration methods used for canned food
products are not directly applicable to continuous aseptic particulate sys-
tems (Larkin 1993).
It is strongly recommended that any processor pursuing low-acid
aseptic particulate processing should maintain a continuing dialogue
with the appropriate regulatory agency and a competent process author-
ity. A continuous dialogue will help resolve any confusion that may occur
before a final process submission is prepared.

15.2.2.9  Ohmic heating

Ohmic or electrical resistance heating of foods to sterilization temperatures
is under intensive study with a prototype system capable of sterilizing large
particulates. As with microwave heating, there is, in principle, no upper
limit to the temperatures that can be achieved. The resulting sterile product
can be as high in quality as minimally processed foods. The technology is
a commercial success in Europe and Japan for human and pet foods. In the
United Kingdom, Sous Chef (H.J. Heinz) is commercially producing shelf-
stable meat and vegetable entrees using ohmic heating, followed by scraped
surface cooling and aseptic filling into Bosch trays. Ohmic heating has been
coupled to bulk aseptic packaging of acid foods with particulates.
Further research is needed to ensure food safety in ohmic heating, in
particular the effects of changing particle composition, particle orienta-
tion and concentration, as well as balancing conductivity between liquid
and solid phases in a liquid particulate slurry.
Pending regulatory approval for processing of low-acid particulate
foods, a U.S. company has been able to realize the benefits of ohmic heat-
ing by coupling the ohmic heater with the classical “Flash 18” process,
obviating the uncertainty of residence time distribution in hold tube and
particle breakage during the cooling leg.
274 Handbook of aseptic processing and packaging

15.2.2.10  Microwave heating

Microwave process of low acid processing of sweet potato has been
approved by the FDA. The sweet potato plant in Snow Hill, North Carolina,
is the only continuous flow low-acid process with a FDA no-objection letter
using microwave heating anywhere. This operation is looking to double
the size of the current capacity and capability. Plans are currently under-
way to produce low-acid sweet potato with particulates. The validation
system described in Chapter 9 had already been used for large particles
in Europe and is being tested by several companies in the United States.

15.2.2.11  Other nonthermal processes

The ultra-high pressure (UHP) pasteurization process may also have
application in the aseptic processing of some high-acid foods. Pressure
can inactivate vegetative microorganisms, but not the spores or enzymes,
and therefore may be used to commercially sterilize acid foods. Because
no heat is applied or generated, this method is sometimes known as cold
pasteurization.
The Institute of Food Safety and Health (IFSH) at the Moffett Center,
Illinois, lead the consortium work on pressure-assisted thermal steriliza-
tion (PATS) and was accepted by the FDA in 2009 as a new alternative to
commercially sterile low-acid canned food products. The technology uti-
lizes high pressure to produce temperatures that ensure the production of
commercially sterile low-acid food products while significantly improv-
ing food quality attributes.

15.2.2.12  Additive and synergistic processes

Nonthermal processes capable of cold pasteurization including microfil-
tration of clear thin liquids can be combined with classical heat treatments
such as pasteurization or ultra-pasteurization and other novel methods
of thermal treatment to yield superior high-acid or low-acid refrigerated
premium products with minimal heat-induced damages. Food safety is
achieved by a combination of milder hurdles technologies rather than by
delivery of a single severe one. Further progress in this area is dependent
upon a better understanding of the mechanism of action of these novel
processes (National Advisory Committee on Microbiological Criteria for
Foods 2006).

15.2.3  Aseptic filling and packaging

15.2.3.1  Line speed
It is usually desired to increase the speed of equipment. What the opti-
mum speed of aseptic packaging equipment should be is not exactly
Chapter 15:  Industry research and development 275

known. With small containers (e.g., coffee creamers), a speed of 2000

containers per minute is now possible. This is accomplished on a reliable
basis using preformed cups. An analysis must be made by a process engi-
neer considering costs, demographics, and so forth to determine the ideal
machine speed.
There is a definite need for increasing the line speed of aseptic fillers
to be competitive and comparable to dairy processing and conventional
canning. It is worthwhile to note that multiple operations such as label-
ing and packaging are done at the time of processing, justifying slower
speeds. In contrast, bright cans or jars from still retorts are staged in cages
for subsequent handling; hot water washing and air drying is used to
remove food debris from outside of glass jars prior to labeling and casing.
Higher-speed Dole canner and Bosch cup machines have been introduced
to meet the current industry demand for higher speeds, comparable to
dairy products in paperboard cartons, but do not fare well with conven-
tional canning.

15.2.3.2  At-line and on-line measurements

The current food industry trend is for integration of manufacturing with
quality assurance, thereby shifting and diffusing quality responsibility to
people involved in making of the product. To facilitate this difficult tran-
sition, several infrared and nuclear magnetic resonance  (NMR) instru-
ments at-line and on-line are available to measure solids, sugars, fat, and
so forth to validate a batch while flowing continuously. There is a definite
need for reeducating production personnel in quality control, instrumen-
tation, and continuous refinement.

15.2.3.3  Packaging issues

The consumer, to a degree, will dictate what packages are convenient and
satisfactory and which packages may be desirable. Their wishes must,
obviously, be tempered with practical realities and economics.
One of the major problems that exist today is that the package does
not adequately protect the product, the product takes on flavors from the
packaging material, or the product loses desirable flavors to the pack-
aging material; hence, the strength of the flavor may depend upon the
age of the product. Other factors can affect the packaged product quality,
including the average temperature the product is exposed to between the
time it was packed and the time it was consumed, and what competing
flavors or odors were present during the life of the product (i.e., was it
placed near a bin of onions and the onion flavor penetrated the packag-
ing material and gained entrance to the product). In other words, it would
be desirable to develop coatings or packaging materials that are more
impermeable, for example, glass or some of the coating systems used with
metal cans.
276 Handbook of aseptic processing and packaging

High-quality, glasslike transparent packaging has been achieved by

using recyclable polyethylene terepthalate (PET) bottles for water and
fruit beverages, using either preformed or blow molded-in-filler bottles.
Please refer to Chapter 6 and Appendices A and B.

15.2.3.4  Bulk packaging

The greatest growth in aseptic package has been in the realm of bulk pack-
aging into barrier flexible pouch packages. Those most commonly pro-
duced are from preformed pouches or bags incorporating valves through
which product is filled. Empty pouches are presterilized by ionizing radi-
ation—1.5 Mrad for high-acid foods and 3 Mrad for low-acid foods.
With industrial containers, a movement appears to be underway that
calls for the centralization of the majority of the producers with one or
maybe two large plants in populated areas, for example, the corridor from
Boston to Washington, the southeast area from Atlanta to Florida, Texas,
and some of the Southern states, and California and the rest of the West
Coast. The main plants appear to be in the Midwest. Obviously, there are
exceptions, but this appears to be the trend. The plants being built are
designed to package large quantities of product. Hence, processing and
packaging equipment must be able to cope with such needs. At the pres-
ent, this is possible.
Also, there appears to be a need for packaging products with par-
ticulates, which may be low acid, at fairly high rates into 2- to 300-gallon
bags. These products would be aseptically packaged during the season,
which may be quite short, and then repacked in the off-season when
they would be retort processed, frozen, prepared as a deli item, and so
forth.
The concept of packaging large-volume commodity products, for
example, tomato paste and orange juice or their concentrates, has proven
its economic value, while providing quality products to the consumer. The
same concept could be used if processing equipment existed for process-
ing low-acid products with particulates. These products could then be rep­
ackaged using techniques that were legal and performed satisfactorily.
Another machine developed and in use is a pouch or bag-in-box sys-
tem to handle institutional quantities of 1 to 2 gallons economically. This
packaging equipment is capable of packaging products containing par-
ticles, for example, soups, stews, entrees such as macaroni and cheese,
baked beans, and nacho cheese dip. Cheese dip products are now used in
convenience stores using custom-made hand-operated dispensing equip-
ment. Please refer to Chapter 7 on aseptic bulk packaging.

15.2.3.5  Pulsed light technology

Yet, another possible technology for aseptic packaging is pulsed light to
sterilize surfaces of materials used to form packages. The source is capable
Chapter 15:  Industry research and development 277

of surface effects in eliminating microbial load with virtually no energy

penetration. The lethal effect is a combination of ultraviolet (UV), visible
light-based thermal cycle, and photodynamic effect requiring oxygen and
a photochrome substrate.
A European company has produced low-acid product in a vertical
form–fill–seal machine using a pulsed light energy source in place of
H2O2 for sterilization of food contact surfaces. The energy is suitable
for sterilization of clear polypropylene but is not suitable for recyclable
PET bottles. Pulsed light technology needs to be evaluated in regard to
bulb longevity, reliability, and on-line PLC monitoring of delivery and
efficacy.

15.2.3.6  Seal integrity

The terminal retort process in canning is a de facto seal integrity tester, and
marginal seals usually do not survive the time, temperature, and pressure
of the retort scheduled process. In aseptics, not only are the product and
package decoupled, but also the final seal, made in a sterile work zone, is
not trauma tested. In aseptics, the reliability of seal inspections, manda-
tory incubation holds, and sterility tests take on additional significance.
Thus, seal integrity and maintenance of hermeticity in aseptics is a key
determinant of sterility assurance.

15.2.3.7 Aseptic filler or sterile work zone

integrity and validation
Aseptic filler is undoubtedly the heart of the aseptic system, and is crucial
to the delivery of a sterile product. Although it can be presterilized and
validated to be sterile to a sterility assurance level of 10−6, procedures and
practices to maintain or monitor its sterility are unavailable. It is assumed
to be sterile by virtue of presterilization and the use of sterile, HEPA, or
laminar flow air. Thus the work zone is at best, sterile or passive, and
not sterilizing or active, and thus not able to overcome recontamination.
The vectors of recontamination include filter failures, grow through, and
nonsterile air aspiration by the work zone due to loss of laminarity, eddy
currents at interfaces or leaks, and the discharge of finished units from the
zone. In the pharmaceutical industry, media fills have been used to vali-
date the overall sterility assurance of an aseptic system to a 10−3 level, but
this requires three successive simulated runs of a broad-spectrum growth
media of 3000 units each, with no failures. As long as the work zone
remains passive or sterile (opposed to active or sterilizing), the media fill
“lack of recontamination” is the only way to validate aseptic systems (K.S.
Purohit, Process Tek, personal communication, 2008).
As discussed in Chapters 9 and 13, 3 × 3000 media fill runs are per-
formed for validation of the aseptic zone. These runs are of short duration
278 Handbook of aseptic processing and packaging

Hurdle Validation

3 × 3000
Media fill runs

Maintenance Clean C.I.P. and Presterilization Maintenance

Room Sanitation Sterility or
Dynamic
Decontamination
Operation Sequence

Figure 15.3  Significance of a 3 × 3000 media fill runs in validation of aseptic zone.

of about 5 to 30 minutes, and are, therefore, not reflective of long produc-

tion runs (8 to 16 hours) or extended runs (24 to 120 hours). The other
limitation is that these runs are done immediately after a “severe” prester-
ilization process, and, therefore, may not be reflective of the “gentle” and
dynamic decontamination step, as depicted in Figure 15.3.
It is recommended that media fill runs be done at production start-up,
middle of run, and end of run (EOR) to be meaningful. It is good to evalu-
ate both validation and incubated spoilage data for proper evaluation of
system capability and deliverables.
It should be reemphasized that despite subsystem validation to 10−6,
overall sterility assurance is governed by the aseptic work zone, wherein
maintenance of sterility cannot be assured and monitored, and any
recontamination cannot be detected, removed, or inactivated. An excep-
tion is the active or sterilizing work zone (using superheated steam),
which is an integral part of the very first aseptic system, that is, Dole
(K.S. Purohit, Process Tek, personal communication, 2008). However, it is
important to note that the Dole aseptic system is somewhat vulnerable,
when superheated cans are “tempered down” prior to filling to avoid
product contact burn-on.
Reliable, robust aseptic systems require all product pathways, criti-
cal and direct, as well as incidental and indirect, be initially sterilized
with appropriate sterilants and maintain sterility throughout production.
While direct product (HTST/UHT, filler) and package (formers, cabinet,
sealer) pathways tend to get the required attention, sometimes the air and
its pathways that contact packages and other critical equipment surfaces
are not rigorously presterilized. The work zone, where the sterile filling
Chapter 15:  Industry research and development 279

and sealing of presterilized product into presterilized containers occurs,

is also presterilized.
The methods for presterilization of critical air pathways and air-contact
surfaces and pathways, as well as those for product and package, vary by
manufacturer but should be validated rigorously. The subtle differences
between HEPA, microfiltration, and incineration must be kept in mind dur-
ing presterilization, production monitoring, and validation. In the absence
of online monitoring of the integrity of the sterilizing filters, product release
criteria are needed to document all pathways and surfaces—direct or indi-
rect—were sterile and maintained sterility throughout production.
Quality, convenience, and economy are the drivers of activity in
aseptic processing and packaging. Although this is valid, as we move
toward low-acid particulates, we should work to enhance the reli-
ability of aseptic systems, such that they can be designed, monitored,
controlled, and validated to comparable or higher sterility assurance
levels as canning.
There is the need to develop either artificial intelligence (AI) or fuzzy
logic for real-time monitoring and control of integrity of aseptic systems
during production runs.

15.2.3.8  Cleanup and extended run

Using the same line of reasoning, packaging equipment should be
designed so it can be intermittently cleaned—at least to the point where
operation can continue after intermittent cleaning for some period of
time. This argument is equally valid for microbiological filters used for
postprocess sterile additive or HEPA filters that provide the work zone
with sterile air.
The limiting factor should be how long it takes organisms to grow
from the contaminated air, or item, or material to the sterile enclosed
area, thereby causing contamination. What the length of time should be
is not known exactly; however, it should be longer than the 1 day that is
presently used. Perhaps 2 days, 3 days, or 1 week of continuous opera-
tion should be possible. One of the considerations with aseptic packaging
equipment is that the equipment requires considerable lengths of time for
cleaning and sterilization. Hence, once these operations are completed,
and the packaging equipment put back on-line, if the equipment could
operate continuously for an extended period of time, it would be advanta-
geous and beneficial to the manufacturers.
Research is needed in validation and measurement of “repeatability”
of CIP and sanitation cycle as a function of soil, fouling, and biofilm loads.

15.2.3.9  Defect rate or sterility assurance level (SAL)

It is not correct to compare canning and aseptic processing with respect
to defect rates. However, it is not practical and profitable to run lines that
280 Handbook of aseptic processing and packaging

are prone to too many breakdowns, too many defectives, and higher
defect rates. It is possible and very common to run retorts obtaining a
defect rate of 1 in 100,000 units as shown in Table 15.2 (David 1995). A
defect rate of 1 in 10,000 holds good for all low-acid foods aseptically
packaged in rigid, semirigid, or flexible containers (C. Denny, National
Food Processors Association, personal communication 1988). However,
only 1 in 1000 or 1 in 3000 is guaranteed by vendors of aseptic filler
machines.
The safety of low-acid canned foods has been well studied, and
12D Bot-Cook is an accepted design objective for thermal processes.
In-container sterilization is a terminal process, and it is valid to extrapo-
late the probability of a nonsterile unit being one in a million or lower,
if the designed process is delivered and postprocess contamination does
not occur. It is important to note that sterility assurance of aseptically
processed and packaged foods, while similarly computed, cannot be
comparably validated. In aseptics, the overall sterility assurance is gov-
erned primarily by lack of recontamination, and even though scheduled
processes are delivered to each subsystem (food, package, closure, air,

Table 15.2  Summary of Defect Rate for Canning and

Aseptic Processes
Pdefect of System or Sterility
Assurance Level (SAL)
Thermal Processing Calculated
Operation or Standard Industry
Canning (de Morgan Theorem) 1.2 × 10−4 1 × 10−4 to 1 × 10−5
or better
Aseptic Processes (de Morgan 1.2 × 10−3 1 × 10−3 to 1 × 10−4?
Theorem)

Literature Values
United Kingdom
Hersom, 1985 2 × 10−4
Burton, 1988 1 × 10−3
United States
Pflug, 1987 1 × 10−3a
Denny, 1988 1 × 10−4 1 × 10−3
Vendors, 1982 1 × 10−3
Source: David, J.R.D., 1995, Research Needs to Ensure Safety of Shelf-Stable
Low-Acid Aseptically Packaged Products. Symposium on Current Status of
Aseptic Processing and Packaging: An Industry Perspective, Paper Nos. 4–5,
Annual IFT Meeting, Anaheim, California, June 4.
a For aseptically assembled products in the pharmaceutical industry.
Chapter 15:  Industry research and development 281

machine, etc.), the sterile work zone for filling and sealing and the main-
tenance of its sterility (with seal integrity) are key determinants of the
probability of nonsterile units.
Numerous safety and regulatory hurdles have had to be scaled, and
additional, increasingly difficult ones still need to be overcome if aseptic
processing and packaging is to live up to its potential. Safety, reliability,
and robustness as well as assurance of sterility (at least in comparison
to in-container sterilization) have all had to be nominally and direction-
ally compromised to avail of the quality and convenience that aseptics
offers. This is especially true when one compares an overall assurance
of sterility of 10−3, or perhaps 10−4 to which aseptic systems can and have
been validated, against at least 10−6 to which terminal processes have been
routinely validated. As the locus of research and development and com-
mercialization of aseptics moves toward large particulates, sterile formu-
lation, and higher throughputs, the demands for control and monitoring
will no doubt increase. Maintenance of sterility and prevention of recon-
tamination are the aseptic equivalents of postprocess contamination
(historically the canning industry’s Achilles’ heel), except that in aseptics
they are so intertwined with the system’s design and operation that they
will require constant, significant, and specialized attention to keep asep-
tic systems acceptable from public safety concerns (K.S. Purohit, Process
Tek, personal communication, 2008).

15.2.4  Finished product and package

15.2.4.1  Flavor problems
In addition to understanding bitter and rancid flavors caused by heat-
resistant enzymes in milk, there is immediate research needed in the area
of chemistry and control of flavor defects: cooked flavor, including origins
and reactions involved; other heated flavors, especially “UHT-milk” fla-
vor; stale flavor; and influence of storage conditions on flavor.

15.2.4.2  Gelation and other physical defects

Further work is needed in understanding conditions that influence gela-
tion of milk, concentrated milk, and milk-based products. It will be
important to understand the relationships between gelation and the fol-
lowing: sedimentation, protease inhibitors and activators, fat separation,
and variation in milk supply.

15.2.4.3  Rapid microbiological methods

Reliable and affordable rapid methods are needed for assessing commer-
cial sterility, and to shorten lengthy product incubation period and associ-
ated inventory buildup in warehouses.
282 Handbook of aseptic processing and packaging

During the test time of 13 to 17 days, a great deal of production can be

packed before the suspect problem is discovered. Also, there is a consider-
able time lapse before product can be shipped into commerce. The current
food industry trend is to prevent inventory buildup and to reduce ware-
house space and associated costs. A typical food industry with $1 billion
gross sales could potentially realize a one-time savings of about $1 million
to $2 million through inventory reduction and interest monies. There are
several techniques used in the food industry to optimize incubation period
from 10–14 to 3–8 days followed by 24 to 48 hours subculturing using
“gourmet media” and instrumentation systems that measure impedance,
conductivity, or ATP increase as a function of microbial growth. Further
identification and speciation via modern molecular methods is needed
for proper route cause analysis (RCA) and definitive corrective action and
preventive action (CAPA). Tracking sources of microbial contaminants has
been a concern, given the uncertainties associated with the integrity and
maintenance decontamination of “sterile working zone” or the aseptic
tunnel during normative and extended production runs. However, recent
advances in the development of molecular subtyping methods have pro-
vided tools that allow more rapid and highly accurate determinations of
these sources. Only trained individuals with a good understanding of the
molecular subtyping methods and plant floor experience can evaluate the
reliability of a link between plant ecology, food, and a spoilage incidence.
Some of the more commonly used subtyping methods are pulse field
gel electrophoresis (PFGE), ribotyping, polymerase chain reaction (PCR)
methods (RPAD and REP-PCR), DNA sequencing-based subtyping, and
other characterization methods (Kornacki 2010).

15.2.4.4  Consumer education

The food industry has the responsibility to educate consumers about the
product rather than the technological intricacies. The reason for many
premature failures of outstanding aseptic products is due to lack of
educating the consumer and providing adequate information concern-
ing product capabilities and deliverables. For example, consumers need
information in regard to UHT milk and its advantages over refrigerated
milk. Consumers are confused as to how a carton of milk can stay fresh at
ambient temperatures without refrigeration. Caution should be exercised
when using terms such as pasteurized, ultra-pasteurized, UHT, long life,
extended shelf life (ESL), and the like for marketing and advertising.

15.2.4.5  “Aseptic” versus quality fresh

Also, consumers are confused by the word aseptic, which to them con-
notes a food preserved with lots of chemicals similar to an “antisep-
tic” mouthwash! Some in the industry, based on quantitative consumer
Chapter 15:  Industry research and development 283

surveys, have proposed alternative names for aseptic, such as “quality

fresh,” “shelf fresh,” and “fresh system.”

15.2.4.6  Product development

Further work is needed in introducing products specific to medical,
dietary, athletic, geriatric, and ethnic needs. Another market that needs
attention is development of mesophilic cultures for production of shelf-
stable cultured and aseptically processed fermented products such as
yogurt and yogurt drinks.
Ingredients, especially functional ones such as flavors, sweeteners,
and fat replacers, need to be thermostable at UHT processing regimes.
Research is needed in the areas of thermostable artificial sweeteners, fat
replacers, and processing aids for formulation of low-acid and high-acid
drinks, beverages, and solid foods.

15.3  Management and administrative challenges

15.3.1  Capital cost
Current aseptic packaging equipment is very expensive. Depending upon
the type of container to be packed, rate, manufacturer, and so on, the
prices can range from the equivalent of $500,000 to $3,000,000–$4,000,000
for machines to sterilize–fill–seal consumer-sized packages. Furthermore,
the equipment is not readily available, and most of it is custom made to
a given order. Hence, it may be anywhere from 6–8 months to 1–2 years
before the equipment can be obtained.
When equipment for packing in institutional- or industrial-sized
packages (bag-in-box) is considered, the prices may be reduced to $150,000
to $1,000,000. This is still quite expensive. In addition, there is cost associ-
ated with start-up validation and operations.

15.3.2  Complexity
Large aseptic packaging equipment is very complicated. Granted, more
operations are required than with conventional equipment; however, the
number of automatic operations and interlocks used seems excessive. It is
very difficult for an ordinary plant-operating person to acquire the skills
to operate a system without considerable education or training. Because
the equipment is so complicated, many users are reluctant to progress into
fields that require aseptic packaging. They do not want to undertake a
packaging system that involves operations they do not understand. Also,
there is the lead time and expenses related to validation and commission-
ing and start-up, and training and education.
284 Handbook of aseptic processing and packaging

15.3.3  Reliability
Poor aseptic packaging equipment reliability may be due to several fac-
tors. The first is improper design. One of the problems with designing
equipment is it may be initially sterilized with heat, meaning clearances
must be provided during this phase. In a later phase, that is, during opera-
tion or CIP, the equipment will be exposed to temperatures that are con-
siderably cooler; hence, shrinkage and contraction must be considered.
These dimensional differences can cause problems of proper fit during
operation and potentially impact safety.

15.3.4  Repair and maintenance

The fourth major problem with aseptic packaging machines that exist
today is the difficulty of repair and maintenance. The machines are operat-
ing in conditions that are bad to begin with (high temperatures, corrosive
atmospheric conditions, cleaning and sanitizing agents are used at times,
etc.). Designs call for precision fits so that leakage of air or contaminants
into the sterile section(s) does not occur, and everything possible is done
to operate the machines so problems will not result. The machines are first
sterilized at high temperatures and then operated at room temperature.
Aseptic machinery also is expected to operate at very high production
rates. Oftentimes the rate is a function of how fast the food product can
be placed in the container and the container can be transferred through
the machine without slopping or spilling—particularly if the machine
must be stopped because of some failure or if it is an intermittent motion
machine.
Furthermore, today’s machines are quite sophisticated from a
mechanical standpoint, and they employ state-of-the-art electronics. This
makes it very difficult for any one individual to be skilled in both areas
and be able to correct a problem. The problem may be electronic or may
be caused by a mechanical operation that is not being properly performed.
Likewise, an electrical or electronic failure may be causing mechanical
problems; hence, the first assumption of someone investigating a problem
is that it is due to mechanical failure.
These types of problems are accentuated in the United States because
many plants are eliminating or reducing the number of engineers and
maintenance personnel that are on staff. They depend more on vendors
who may or may not have qualified people or special service organiza-
tions who may or may not be qualified on a given machine.
Many times the best approach is to have the vendor provide highly
qualified technical people who can be supported by local personnel. Also,
it is not uncommon to require at least two different individuals (e.g., an
electronic and a mechanical engineer) on a given machine to resolve a
Chapter 15:  Industry research and development 285

problem. The maintenance program for any given operation involving

a specific type of machinery must be resolved by each company-plant.
However, it would not be unreasonable to see plants with individuals
on their staff skilled both in electrical and mechanical operation of the
equipment.
The needs of the industry, obviously, are to have designs available
that are simpler and equipment that is more reliable. Usually, increased
reliability is a direct function of how simple or complicated the design.
Certain equipment may be simplified if this has been stated as a primary
objective of the development group. However, if the primary objective is
to make a machine that has high speeds or develop a machine that can
handle a wide range of containers, then the design may be more com-
plicated. The basic reason is there are many more tools that the design
engineer has to work with, and these are often used. Unfortunately, many
management people do not understand the engineering details and must
make decisions based upon limited experience. It is still a requirement
that the packaging equipment be simple, reliable, and safe for both the
quality of the food being packed and the operator and maintenance per-
sonnel who are working with the machines.

15.4  Future
The trends for the future continue to look bright. Improved processing
equipment and controls will upgrade flavor profiles, which will provide
greater consumer acceptance. These new methods will include the pro-
cessing of particulates, such as meat and rice, beans, and other vegetables.
Barrier properties of container materials will continue to improve, reduc-
ing costs, and lengthening shelf life. Speeds of processing and packaging,
along with more automated controls, will be another important factor in
cost reduction.
UHT processing is energy intensive and can impart objectionable
cooked flavors. The amount of cooked flavor is often dependent on the
type of process used and the consumer’s sensitivity to it. Direct steam
injection or infusion is considered to give an improved flavor profile in
some products, such as milk. Indirect systems, however, have improved
immeasurably with the advent of hot-water sets or the use of hot water
under pressure in lieu of steam to reduce heat shock to the product. The
cooked flavor and odor tends to dissipate with age.
In order to be competitive with high-speed retort canning speeds,
aseptic canners and form–fill–seal units must operate at higher speeds in
the future. In order to accomplish this, engineers need to come up with
alternatives to heat and hydrogen peroxide as the method of sterilizing con-
tainers prior to filling. The exposure time required for heat and chemicals
makes it difficult to achieve any degree of speed. The “Flash 18” process
286 Handbook of aseptic processing and packaging

used by Nestlé Carnation is a unique hybrid alternative in that the product

is filled in the can at 255°F in a room under 18 psi pressure. This prevents
flashing, and the product and container are sterilized simultaneously.
Cans as preferred containers will continue to get a boost because of
their strength and barrier properties. Lighter-weight plate will reduce
cost, and strength can be retained by injecting nitrogen or carbon dioxide
in the headspace prior to sealing.
Form–fill–seal laminated materials may be sterilized during their
coextrusion process when sterilization temperatures are achieved. The
protective outer layer is then peeled off when entering the filler sterile
zone. This is the method employed on the ERCA aseptic units and may be
expanded to other manufacturers as the patents expire.
The development of products that take full advantage of aseptic tech-
nology has often come in conjunction with refinement or improvement
of packaging material, and packaging machines that provide enhanced
convenience, health, and wellness for the consumers.
Concerns for filling particulates and implications in seal integrity are
not trivial.

15.5  Summary
Aseptic processing and packaging is an attractive and a challenging alter-
native compared to conventional methods of canning of foods. Continuous
sterilization of heat-sensitive foods at ultra-high temperatures, followed by
prompt cooling results in a superior finished product, which can be filled
into containers of varying compositions, of different shapes, and with many
consumer-attractive features. Compared to classical canning, the definitive
market advantage of aseptically processed and packaged foods originates
from the ability to incorporate several value-added features such as substan-
tially increased sensory and nutritional qualities, microwaveability, several
user-friendly conveniences, and cost saving from use of plastics.
The future success of aseptic processing and packaging in the
United States will depend on breakthroughs in processing, packaging,
and aseptic fillers; maximizing optimization potential and minimiz-
ing departures from optima; well thought-out and top-down mandated
quality assurance and hazard analysis critical control point (HACCP)
programs; ability to validate and measure “repeatability” of CIP and san-
itation cycles; ability to validate, maintain, and measure “dynamic ste-
rility” of aseptic zones; development of reliable on-line instruments for
assuring package seal integrity; concerns for filling of legally approved
particulates and implications in seal integrity are not trivial; innovative
containers convenient to consumers; consumer education; and ability to
use novel methods of thermal processes and nonthermal technologies to
yield finished products with superior quality.
Chapter 15:  Industry research and development 287

Acknowledgment
The author expresses appreciation to Dr. Kailash Purohit of Process Tek,
Prospect Heights, Ilinois, for his useful discussion and critical review of
this chapter, and permission to use published and unpublished work.

References
Anonymous, 1996. Case study for condensed cream of potato soup from the Aseptic
Processing of Multiphase Foods Workshop. Sponsored by the National Center
for Food Safety and Technology, Summit, Argo, IL, and the Center for Aseptic
Processing and Packaging Studies, North Carolina State University, Raleigh,
NC, and the University of California at Davis, CA.
Bockelmann, V.B. 1982. Aseptic Packaging and Processing: A Collection of Lectures from
Tetra Pak Seminars, Chapters 3 and 7. Lund, Sweden: Tetra Pak.
Burton, H. 1988. Ultra-High-Temperature Processing of Milk and Milk Products.
London/New York: Elsevier Applied Science.
Carlson, V.R. March 1994. Holding TUBES. The ASTEC Report 14(1).
Casolari, A. 1994. About basic parameters of food sterilization technology. Food
Microbiology 11:75–84.
Cole, M.P.J., McClure, P.J., Stephens, P.J., and Davis, K.W. 1994. Model valida-
tion (and confidence in models)—An industry perspective. Applications for
Predictive Microbiology Symposium. 81st Annual Meeting of IAMFES, San
Antonio, Texas, July 31–August 3.
Damiano, D., Digeronimo, M., Garthwright, W., Marcy, J., and Sastry, S.K. 1997.
Workshop targets continuous multiphase aseptic processing of foods. Food
Technology 51(10):43–62.
David, J.R.D. 1994. Aseptic processing and packaging of foods: Food industry per-
spective. Part I. Presented at Canners International Permanent Committee
(CIPC) of France—Symposium, NFPA 87th Annual Convention, Los Angeles,
November 2–5.
David, J.R.D. 1995. Research needs to ensure safety of shelf stable low acid
aseptically packaged products. Symposium on Current Status of Aseptic
Processing and Packaging: An Industry Perspective. Paper Nos. 4–5, Annual
IFT Meeting, Anaheim, California, June 4.
Dunkley, W.L., and Stevenson, K.E. 1987. Ultra-high temperature process-
ing and aseptic packaging of dairy products. Journal Dairy Science
70(10):2192–2202.
Hersom, A.C. 1985. Aseptic processing and packaging of food. Food Review
International 1(2):215–270.
Kohlman, K.L., Neilsen, S.S., and Ladisch, M.R. 1991. Effects of a low concentra-
tion of added plasmin on ultra-high temperature processed milk. Journal
Dairy Science 74:1151–1156.
Kornacki, J.L. 2010. Principles of Microbiological Troubleshooting in the Industrial Food
Processing Environment. New York: Springer.
Larkin, J.W. 1993. Considerations for biological validation of aseptically processed
particulate food products. Presented at Symposium on Aseptic Processing
and Packaging Technology, FIRDI, Taiwan, R.O.C. May 19–21.
288 Handbook of aseptic processing and packaging

McGarrahan, E.T. 1982. Considerations necessary to provide for sterilized milk

and milk products in hermetically sealed non-refrigerated containers. Journal
Dairy Science 65:2023–2034.
National Advisory Committee on Microbiological Criteria for Foods (NACMCF).
2006. Requisite scientific parameters for establishing the equivalence of
alternative methods of pasteurization. Journal of Food Protection, 69(Suppl.)
(5):1190–1216.
Pflug, I.J. 1987. Endpoint of a preservation process. Journal of Food Protection
50(4):347–351.
Sastry, S.K., and Cornelius, B.D. 2002. Aseptic processing of foods containing solid
particulates. New York: Wiley-Interscience.
Zhang, H.Q., Barbosa-Canovas, G.V., Balasubramaniam, V.M., Dunne, P.C., Farkas,
D.F., and Yuan, J.T.C., eds. 2011. Nonthermal Processing Technologies for Food.
New York: IFT Press, Wiley Blackwell.
Appendices: Contract
manufacturing for aseptic
processing and packaging
Thomas Szemplenski
Contract manufacturers play a very crucial role in the introduction of
innovative and consumer-convenient new products to the market in
a timely and cost-effective manner. The high capital investment and
instinct required to run complex aseptic operations tend to preclude
many start-up companies entering aseptic operations. Contract packers
fill this void by facilitating prototyping, product sensory and specifica-
tion development and launch, and go/no-go business decisions. Shown
are aseptic filler profiles in Appendix A and a list of contract packers in
Appendix B.
Appendix A: Aseptic filler profiles
Ampack Ammann
Ampack Ammann & Co. KG
Lechfeldgraben 7
D-86343 Konigsbrunn
Germany
Tel: (49) 8231/6005-0
Fax: (49) 8231/6005-11

Ampack has no representation in the United States.

Products
Rotary indexing and linear aseptic fillers for plastic bottles and linear
cups fillers using preformed cups.

Products currently being filled using Ampack fillers

Fruit juices, milk, cream, soups, sauces, puddings, fruit conserve with
whole fruit pieces, cheese, quark, stirred and layered yogurt, infant for-
mula, sport drinks.

Equipment models
Figures A.1 and A.2.
Type Filler Models of Equipment Production Rate
Aseptic Linear preformed bottle filler 36,000 bph
Aseptic Linear preformed cup filler 65,000 cph
ESL Rotary preformed cup filler 16,000 cph
ESL Linear preformed cup filler 65,000 cph
ESL Linear preformed bottle filler 36,000 bph

291
292 Appendix A: Aseptic filler profiles

Figure A.1  Ampack linear bottle filler. (Photograph courtesy of Ampack &
Evergreen Packaging.)

Sterilization of filler—Vaporized H2O2 used in the sterile zone.

Pressurized steam in the fill system.
Packaging—PP, HDPE, and PET with foil lidding.
Sterilization of packaging—High temperature steam mixed with H2O2
followed by a hot sterile air overpressure.

Ampack aseptic fillers are currently not FDA validated for filling low-
acid foods.

Figure A.2  Ampack aseptic preformed cup filler. (Photograph courtesy of

Ampack & Evergreen Packaging.)
Appendix A: Aseptic filler profiles 293

Additional information
• Ampack Ammann has been manufacturing aseptic filling equip-
ment since 1978.
• Ampack fillers are capable of high production rates.
• Ampack has more than 130 aseptic installations.
• Ampack manufactures both rotary and linear aseptic fillers.
• The time required to change bottle sizes is very short.

Astepo S.p.A.
Via Pilastrello, 13
43044 Collecchio-Parma (Italy)
Ph: (39) 0521 800054
Fax: (39) 0521 802064
Web: www.astepo.com
E-mail: [email protected]

Product
Manufacturer of aseptic filling equipment for bag-in-box, bag-in-
drum, bag-in-bin.

Products currently being filled using Astepo fillers

High- and low-acid food and beverage products, including but not lim-
ited to: fruit purees and concentrates, tomato products, vegetables, and
dairy products.

Equipment models
See Figures A.3 and A.4.

Type Model Filling Head Package Sizes

T.A.F. Thousand liter 1H Single head 300 gallons
Up to 2″ 100 gallons 55 gallons
T.A.F. Thousand liter 2H Dual head 300 gallons
Up to 2″ 100 gallons 55 gallons
C.A.F. Compact 1H Single head 55 gallons
Aseptic Filler
Up to 2″
C.A.F. 2H Dual head 55 gallons
Up to 2″
294 Appendix A: Aseptic filler profiles

Figure A.3  Astepo T.A.F. 2H thousand liter aseptic filler. (Photograph from
Astepo literature, courtesy of VR Food Equipment.)

Filler—Fill is controlled using a flowmeter.

Filler operation—The T.A.F. filler must be loaded with the bag and
manually started. The C.A.F. filler is a continuous, automatic, web-
fed filler. After starting, the filler automatically resterilizes the
spout and cap, removes the cap, and volumetrically meters the fill-
ing of the bag. The filler then automatically replaces the cap and
ejects the filled bag.
Sterilization of filler—The presterilization of the filler is completely
automatic and is accomplished with either superheated water or
steam. During sterilization, the automatic cycling of the valves
ensures that all product contact surfaces receive enough high tem-
perature water or steam to effect sterilization. Sterilization time of
the filler is approximately 1 hour.
Packaging—Flexible bags of composite polymers with fitments. Astepo
fillers can fill bag sizes up to 1000 liters.
Sterilization of packaging—Preformed and sealed bags are sterilized
by gamma radiation. The cap and spout are resterilized just before
filling by steam or hydrogen peroxide.

Astepo fillers are FDA validated for aseptically filling low-acid foods.
Appendix A: Aseptic filler profiles 295

Additional information
• The Astepo aseptic filler is one of the most popular bag-in-box fillers
for filling low-acid food and beverages in the United States.
• The Astepo filler is manufactured in all 304 stainless steel, except the
filling heads, which are constructed of 316 stainless steel.
• Control panel contains PLC with interface video for the operator and
electrical components for the filler operation.
• Control panel also includes a diagnostics printer.
• The fillers have automatic presterilization and CIP circuits.

Robert Bosch GmbH

PA-PH/PJM3
Postfach 11 27
D 71301 Waibingen
Germany
Ph: 49 711 811-57133
Fax: 49 711 811-57230

Sales and service office in the United States:

Robert Bosch Packaging Technology, Inc.

8700 Wyoming Avenue North
Brooklyn Park, MN 55445
Ph: (941) 373-9130
Fax: (941) 373-9130
Web: www.boschpackaging.com

Product
Manufacturer of aseptic filling equipment for form–fill–seal plastic cups,
bottles, coffee creamers, and multilaminar pouches.

Products currently being aseptically filled using Bosch fillers

Infant formulas, pureed baby food, fruit juices, milk, cream dishes, cof-
fee creamers, puddings, cheese sauces, fruit gels, tomato products, conve-
nience foods, and pet food.

Equipment models
See Figure A.5 to Figure A.8.
296 Appendix A: Aseptic filler profiles

Type Filler Model Production Rate

Form-fill-seal cups TFA 4818 350 cpm
TFA 4830 720 cpm
Form-fill-seal coffee creamers TFA 2520 800 cpm
TFA 4940 1650 cpm
Form-fill-seal pouches SVA 2000 Up to 40 ppm
SVA 3000 Up to 25 ppm

Sterilization of filler—Accomplished by steam and hydrogen peroxide.

After sterilization the filler is maintained sterile by positive filtered,
sterile air pressure.
Sterilization time—Up to 1.5 hours.
Packaging—Form–fill–seal cups of various polymers (including poly-
propylene) from 5 mL up to 500 mL and form–fill–seal pouches up
to 5000 mL.
Sterilization of packaging—All packaging material is sterilized by
heated hydrogen peroxide (35%).

All four Bosch fillers are FDA validated for aseptically filling low-acid
food and beverages.

Figure A.4  Astepo C.A.F. web-fed aseptic filler. (Photograph from Astepo litera-
ture, courtesy of VR Food Equipment.)
Appendix A: Aseptic filler profiles 297

Figure A.5  Bosch TFA 4818/TFA 4830 aseptic cup filler. (Diagram from Bosch
literature.)

Dole canning systems

Division of Graham Engineering Corporation
1420 Sixth Avenue
York, PA 17403
Ph: (717) 849-4095
Fax: (717) 854-1931

Product
Manufacturer of aseptic filling equipment for cans.

Figure A.6  Some of the product aseptically packaged on a Bosch aseptic cup
filler. (Photograph from Bosch literature.)
298 Appendix A: Aseptic filler profiles

Aseptically Operating Thermoform

Fill and Seal Machine TFA 4940 for Safe Packaging
of Coffee Cream

Figure A.7  Aseptically operating thermoform fill and seal machine TFA 4940 for
safe packaging of coffee cream. (Photograph from Bosch literature.)

Figure A.8  Bosch SVA 2000/3000 aseptic pouch filler. (Photograph from Bosch
literature.)
Appendix A: Aseptic filler profiles 299

Products currently being filled using Dole canners

Puddings, cheddar cheese sauces, gravies, soups, ketchup, alfredo sauce,
ice cream mix, eggnog, pumpkin, sandwich spreads, pizza sauce, dietetic
drinks, applesauce, tomato paste, banana puree, toppings and syrups.

Equipment models
See Figure A.9.

Models Can Sizes Production Rate

330 18–96 fl. oz. 70 to 100 cpm
520 4.5–46 fl. oz. 124 to 225 cpm
530 4.5–46 fl. oz. 145 to 338 cpm
540 4.5–46 fl. oz. 155 to 450 cpm
1210 S 4.5–46 fl. oz. 23 to 60 cpm
1220 L 18–96 fl. oz. 30 to 50 cpm

Filler—The basic model is a slit-type filler. With the slit filler, the
cans pass underneath a slit opening in a tube-type filler. The slit
is approximately ¼-inch wide by 6 inches long, although the size is
variable depending upon the type of product and speed of filling.
The slit filler consists of a thick-walled, stainless steel pipe that is
slit along the lower side. This pipe has a second inner pipe that has

Figure A.9  Dole aseptic canner. (Photograph courtesy of Dole.)

300 Appendix A: Aseptic filler profiles

multiple parts and provides consistent flow to the filling system. The
sterile product is fed into the inner pipe and flows out to the slit in
the outside pipe.
Sterilization of the filler—By superheated steam using electric heaters.
Sterilization time of filler—30 minutes.
Packaging—Metal cans with seam-on ends are used in all Dole sys-
tems. Can sizes range from 4.5 ounces (202 × 214) to the #10 can
(603 × 700), and all are compatible with the system. Smaller cans
are generally aluminum. The larger cans are two- or three-piece
steel. The ends/lids can be standard or easy-open types. The cans
are manufactured with heat-resistant coatings, common to the can
industry. The can is either left undecorated (or “bright”) or has
temperature-resistant lithography.
Sterilization of packaging—Cans and lids are sterilized by using super-
heated (500°F) steam with electric heaters.

The Dole canner is FDA validated for aseptically filling low-acid foods.

Additional information
• The Dole canner was the original aseptic packaging source and used
in the basis for aseptic canning.
• The Dole canner is only leased.
• A royalty based on volume is charged for the Dole canner’s use.

DuPont/Liqui-Box
6950 Worthington-Galena Rd.
Worthington, Ohio 43085
Ph: (800) 260-4376
Fax: (614) 888-0982

Product: Bag-in-box
Manufacturer of aseptic filling equipment for bag-in-box, bag-in-drum,
bag-in-bin and associated preformed packaging of various flexible pack-
aging laminates.

Products currently being filled using DuPont/

Liqui-Box bag-in-box filling equipment
Processed fruits, juices, purees and concentrates, citrus, vegetable purees,
cheese and other sauces, tofu products, sour cream and dairy products,
including condensed milk.
Appendix A: Aseptic filler profiles 301

Equipment models
See Figures A.10 and A.11.

Type/Model Operation Package Sizes Production Rate

StarAseptTM Model 1307 Semiautomatic 6–370 gallons Up to 100 gpm
Model 2000 C1T-0-A Automatic 1–5 gallons Up to 15 bpm

Filler—Programmable logic controlled filling; by flow meter; and by

weight cells depending upon the filler.
With Model 2000 C1T-0-A, the bags are automatically fed
through a sterilization tunnel where the bag spout is sterilized, the
cap is removed, and the bag is filled to a predetermined volume.
After filling the bag is recapped and ejected. The next bag then
indexes to be filled.
Sterilization of filler—Steam.
Sterilization time—Approximately 45 minutes.
Package types—Premade, presterilized bags or various flexible pack-
aging laminates with fitments.
Sterilization of packaging—Preformed, sealed bags are sterilized by
gamma radiation. The cap and spout is resterilized using either
steam (StarAsept) or hydrogen peroxide.

DuPont/Liqui-Box bag-in-box fillers are FDA validated for filling low-

acid foods.

Figure A.10  DuPont/Liqui-Box web-fed, low-acid aseptic filler. (Photograph from

DuPont/Liqui-Box literature.)
302 Appendix A: Aseptic filler profiles

Additional information
• DuPont/Liqui-Box is the second largest supplier of aseptic bag-in-
box fillers and aseptic bag-in-box packaging.
• There are more than 220 StarAsept fillers installed worldwide.

Product: Pouches
Manufacturer of aseptic filling equipment for form–fill–seal pouches and
associated packaging of various flexible packaging laminates.

Products currently being aseptically filled using DuPont/Liqui-Box

pouch filling equipment
Milk, cream, cheese and other sauces, sour cream, nutritional food sup-
plements specialty beverages, ice cream mix, and fruit juices.

Equipment models

Model Operation Package Sizes Production Rate

A-6 Automatic 200 mL up to 1 L Up to 120 ppm
DA-4000 Automatic 200 mL up to 2 L Up to 100 ppm

Figure A.11  DuPont/Liqui-Box StarAseptTM Model 1307 bulk aseptic filler.

(Photograph from DuPont/Liqui-Box literature.)
Appendix A: Aseptic filler profiles 303

Filler—Double head vertical form–fill–seal continuous filling with pro-

grammable logic controller.
Sterilization of filler—Steam.
Sterilization time—Approximately 45 minutes.
Package types—Form–fill–seal packaging with low, medium and high
barrier films.
Sterilization of packaging—Sterilization of packaging is with 35%
hydrogen peroxide.

DuPont/Liqui-Box aseptic pouch fillers are FDA validated for filling low-
acid foods.

Additional information
• Nitrogen injection can be supplied as an option.
• DuPont Liqui-Box is the second largest supplier of aseptic pouch fill-
ers in the United States.

Elpo
FBR-Elpo Sp.A.
Via Arnaldo de Brescia, 12/A
43100 Parma (Italy)
Ph: (39) 0521 267511
Fax: (39) 0521 267676
Web: www.fbr-elpo.it

Product
Manufacturer of aseptic filling equipment for bag-in-boxes, bag-in-drums,
and bag-in-cartons.

Products currently being filled using Elpo fillers

Tomato products, fruits, juices, purees, concentrates.

Equipment models
See Figure A.12.

Model Operation Package Sizes Production Rate

Bulk filler Semiautomatic 2 to 1000 liters Manual
Web-fed Automatic 5 to 30 liters 10–12 bpm
304 Appendix A: Aseptic filler profiles

Figure A.12  Elpo single-head aseptic filler. (Photograph courtesy of Elpo.)

Filler—The filler must be loaded with the bag and manually started.
Then the filler automatically resterilizes the spout and cap with
steam, removes the cap and volumetrically meters the filling of the
bag, replaces the cap, and ejects the filled bag.
Sterilization of filler—Steam.
Sterilization time—Approximately 1 hour.
Package types—Premade, presterilized, multilayer bags with “plug”-
type fitments.
Sterilization of the packaging—Preformed, sealed bags are sterilized
by gamma radiation.

Elpo fillers are currently not FDA validated for aseptically filling low-acid
food products.
Appendix A: Aseptic filler profiles 305

Additional information
• Elpo has been very successful in marketing its fillers in Europe,
Latin America, the Middle East, and Asia.
• Elpo fillers are used in these regions to fill large and small bags with
high- and low-acid products.
• Elpo has no representation in the United States.

Fenco
Fenco S.p.A.
Via Prampolini
40-43044 Lemignano
Parma (Italy)
Ph: (39) 0521 303429
Fax: (39) 0521 303428
Web: www.fenco.it

Product
Manufacturer of aseptic filling equipment for bag-in-drum and bag-in-bin.

Products currently being filled using Fenco fillers

Tomato products, processed fruits, juices, purees, concentrates.

Equipment models
See Figures A.13 and A.14.
Model Package Sizes Production Rate
154 Up to 20 liters Manual
152 bulk filler 25–1000 liters Semimanual

Filler—Fill is controlled by volumetric flow meter. The filler must be

loaded with the bag and manually started. The filler then automati-
cally resterilizes the spout and can with steam, removes the cap, and
volumetrically meters the filling of the bag. The cap is then replaced
and the bag is ejected.
Sterilization of filler—Steam.
Sterilization time—Approximately 45 minutes.
Packaging—Premade, multilayer bags with fitments. Bag sizes from 25
liters up to 1000 liters.
Sterilization of bags—By gamma radiation. The spout and cap are
resterilized with steam.
306 Appendix A: Aseptic filler profiles

Figure A.13  Fenco Model 154 aseptic bag filler. (Photograph from Fenco literature.)

Figure A.14  Fenco Model 152 aseptic bag filler. (Photograph from Fenco literature.)
Appendix A: Aseptic filler profiles 307

Fenco fillers are currently not FDA validated for aseptically filling low-
acid foods.

Additional information
• Fenco was established in 1986.
• Fenco can also supply the aseptic processing equipment to sterilize
the products prior to filling.
• Fenco does not have representation in the United States.
• The bags used for Fenco fillers use the “plug”-style fitment design.

Fres-co system
3005 State Road
Telford, PA 18969-1033
Ph: (215) 721-4600
Fax: (215) 721-4414
Web: www.fresco.com

Product
Manufacturer of aseptic filling equipment and related packaging for
form–fill–seal pouches.

Products currently being filled using Fres-co fillers

Cheese sauces, puddings, and other dairy products. The Fres-co aseptic
fillers are capable of filling foods with particulates.

Equipment models
See Figure A.15.

Type/Model Package Sizes Production Rate

FSU 1000A 10 mL–10 L Up to 30 one-gallon ppm
Up to 500 half ounce ppm
FSU 800 high acida 50 mL–10 L Up to 30 pouchesb ppm
a For products with a pH <4.6 Aseptic cold fill, ESL low acid or hot fill of high acid.
b Either flat or stand-up pouches. Fitment attachment is optional.

Filler—Options: Time/pressure/orifice filler, positive displacement piston

filler, rotary pump filler, and magnetic or mass flow metering fillers.
Sterilization of filler—By steam and H2O2.
Sterilization time—Approximately 1 hour.
308 Appendix A: Aseptic filler profiles

$XWRPDWLF)RUP)LOODQG6HDO$VHSWLF3DFNDJLQJ6\VWHP

Figure A.15  FSU-1000. (Photo courtesy of Fres-co Systems, USA.)

Packaging—Form–fill–seal, multiply high barrier laminates with and

without fitments. Pouches can be printed or unprinted.
Sterilization of packaging—Packaging material is sterilized with H2O2.

The Fres-co aseptic pouch filler is FDA validated for aseptically filling
low-acid foods and beverages.

Additional information
• Fres-co engineering has many years of experience developing and
improving aseptic form–fill–seal equipment.
• The current aseptic filling equipment being supplied by Fres-co
incorporates new technology that will surely secure Fres-co as a
leading supplier of aseptic filling equipment for pouches.
• Fres-co is already one of the leading suppliers in the world for pack-
aging material.
• Fres-co is one of the few suppliers of aseptic packaging equipment
that is manufactured in the United States.
• Fres-co can supply aseptic pouches with and without fitments.
• Fres-co also manufactures high-speed equipment for hot filling form–
fill–seal pouches (acid products) and equipment for retort pouches.
Appendix A: Aseptic filler profiles 309

HRS process technology

5035 N. 55th Ave., Suite 6
Glendale, AZ 85301
Ph: (623) 915-4328
Fax: (623) 939-6168
Web: www.hrs-america.com

Product
Manufacturer of aseptic filling equipment for bag-in-box, bag-in-
drum, bag-in-bin.

Products currently being aseptically filled using HRS fillers

Processed diced fruits, fruit concentrates, tomato products, citrus prod-
ucts, vegetables, coffee concentrates, and soups.

Equipment models
See Figure A.16.

Model Package Sizes Type Filler

HRS AF-1 Up to 6 gallons R & D Portable
HRS AF-1-A Up to 6 gallons Automatic
HRS AF-2 Up to 6 gallons and 55 gallons Automatic
HRS AF-3 55 and 300 gallons Manual

Filler—Fill controlled by flow meter or by weight.

Sterilization of filler—By steam and hot water.
Sterilization time of filler—Approximately 45 minutes to 1 hour.
Package types—Premade, presterilized bags with fitments. HRS does
not supply the bags. Scholle, Aran, Rapak, and Liqui-Box bags can be
aseptically filled on the HRS filler.
Sterilization of the bags—Preformed, sealed bags are sterilized by
gamma radiation.

HRS fillers are not FDA validated for filling low-acid foods.

Additional information
• HRS aseptic fillers are manufactured in Argentina and Spain.
• HRS has nearly 100 aseptic bag fillers in operation.
310 Appendix A: Aseptic filler profiles

Figure A.16  HRS aseptic filler for bag-in-drum. (Courtesy of HRS.)

• HRS aseptic fillers can fill food products containing particulates.

• HRS has a testing facility in Spain where interested processors can
aseptically fill products into bag-in-box.

JBT FoodTech
2300 Industrial Avenue, Box A
Madera, CA 93639
Ph: (559) 661 3200
Fax: (559) 661 3222
Web: www.jbtfoodtech.com

European office:

John Bean Technologies S.p.A.

Via Mantova 63/A
43100 Parma, Italy
Ph: 39 0521 908411
Fax: 39 0521 460897
Web: www.jbtfoodtech.com
Appendix A: Aseptic filler profiles 311

Product
Manufacturer of aseptic filling equipment for bag-in-drum and bag-in-bin
packaging. JBT FoodTech also manufactures and supplies the complimen-
tary aseptic processing systems. JBT also owns the Metal Box aseptic cup
filler.

Products currently being filled using JBT FoodTech fillers

Diced tomatoes and paste, fruit purees and concentrates, yogurt fruit
sauces, citrus juices, pulp and concentrates, cheese sauce (low acid), and
sauces into bag-in-box.

Equipment models
See Figures A.17 and A.18.

Model Operation Package Sizes Production Rate

ABF-0.200 Semiautomatic 1 to 230 liters Up to thirty 230 L bags/hr
ABF-1200 Semiautomatic 5 to 1200 liters Up to fifteen 1200 L bags/hr

Figure A.17  JBT FoodTech aseptic bag filler. (From Fran Rica literature.)
312 Appendix A: Aseptic filler profiles

Figure A.18  JBT FoodTech “compact” aseptic plant skidded aseptic processing
system and filler. (From JBT FoodTech literature.)

Filler—Bag fillers are controlled load cells (primary) and by flow

meters (optionally).
Sterilization of fillers—Steam and hot water.
Sterilization time—Approximately one hour for the various fillers.
Package types—Bag filler utilizes premade, presterilized bags with fit-
ments, including Fran Rica 63-mm and 3-inch membrane fitments,
1-inch and 2-inch snap caps and 1-inch and 2-inch plug fitments.
Sterilization of packaging—Bags are presterilized by gamma radiation.
Cups are sterilized by hydrogen peroxide.

The ABF-0.200 bag filler is FDA validated for aseptically filling low-acid
foods.

Additional information
• JBT FoodTech has many years of experience aseptic processing and
packaging food products.
• JBT FoodTech is one of the few companies that can supply both the
aseptic packaging and processing system.
• JBT FoodTech does not supply the aseptic packaging material for
their fillers.
Appendix A: Aseptic filler profiles 313

KHS AG
Juchostrasse 20
D-44143 Dortmund
Germany
Ph: (49) 231 569 0
Fax: (49) 231 569 141
Web: www.khs-ag.com

Sales and service office in the United States:

KHS USA
880 Bahcall Ct.
Waukesha, WI 53186
Ph: (262) 787-7200
Fax: (262) 787-0025

Product
Rotary aseptic bottle filler for beverages and related aseptic processing
systems.

Products currently being filled using KHS fillers

Fruit juices, juice drinks, teas, milk and other dairy products.

Equipment models
KHS Alfill rotary capable of aseptically filling up to 800 bpm of high acid
(<pH 4.6) and 600 bpm of low acid (>pH 4.6) beverages.

Filler—Electronic controlled volumetric filling by weight cells.

Sterilization of filler—Either dry vapor and H2O2 or wet peracetic
acid.
Sterilization time of filler—Approximately 90 minutes.
Packaging—HDPE and PET bottles.
Sterilization of packaging—Dry bottle sterilization with H2O2 and
warm air; or wet bottle sterilization using peracetic acid.

 he KHS bottle filler has received FDA validation for aseptically filling
T
low acid beverages.
314 Appendix A: Aseptic filler profiles

Additional information
• KHS has a manufacturing, sales, and service organization located in
Waukesha, Wisconsin.
• KHS can sterilize the packaging with either peracetic acid or hydro-
gen peroxide.
• KHS can supply the mutually dependent processing equipment for
a turnkey aseptic system.

Krones AG
Bohmerwaldstrabe 5
D-93068 Nuestraubling
Germany
Ph: (40) 94 01/70-0
Fax: (40) 94 01/70 24 88

Sales and service office in the United States:

Krones USA
9600 S. 58th St.
Franklin, WI 53132
Ph: (414) 409-4000
Fax: (414) 409-4100

Product
Manufacturer of rotary aseptic and extended shelf-life (ESL) bottle fillers
for beverages and related aseptic processing systems.

Products currently being filled using Krones fillers

Water, teas, fruit juices, and extended shelf-life dairy products.

Equipment models
Model Bottle Sizes Production Rate
VODM-PET 36,000 bph
CAF Up to 2 liters Up to 46,500 bph

Approximate delivery—6 months.

Filler—Volumetric filling valve with inductive flow meter.
Sterilization of filler—Presterilized by steam and water at up to 135°C.
The rinser, filler, and closer are in a clean room designed to comply
with Class 100 sterile room.
Appendix A: Aseptic filler profiles 315

Sterilization time of filler—Approximately 90 minutes.

Packaging—PET bottles up to 2 liters with screw cap closure, including
sports caps.
Sterilization of bottles—By means of either peracetic acid or a gaseous
hydrogen peroxide achieving a log 5 reduction.

Krones aseptic bottle fillers have not been validated by the FDA for filling
low-acid beverages.

Additional information
• Krones installed their first aseptic filler in Switzerland in April of
1999 aseptically filling iced tea.
• Krones can supply the entire aseptic processing system includ-
ing premixing (formulating), processing, filling, labeling, and
palletizing.
• Krones aseptic fillers cannot fill beverages with discrete parti­cu­lates.
• Krones has a testing facility in Germany.
• Krones has no low acid aseptic fillers installed in the United
States.

OYSTAR Hassia
Verpackungsmaschien GmbH
P.O. Box 1120
63689 Ranstadt, Germany
Ph: 49 6041 810
Fax: 49 6041 81213
Web: www.OYSTAR.hassia.de

Sales and service office in the United States:

Hassia USA Inc.

1210 Campus Drive West
Morganville, NJ 07751
Ph: (732) 536-8770
Fax: (732) 536-8850
E-mail: [email protected]

Product
Manufacturer of aseptic filling equipment for form–fill–seal plastic cups
and StickPack sachets.
316 Appendix A: Aseptic filler profiles

Products currently being filled using Hassia fillers

Baby foods, fruit juices, desserts, soups, milk, cream dishes, coffee cream-
ers, puddings, cheese sauces, fruit gels, and sour cream.

Equipment models
See Figures A.19 to A.22.

Type Model Production Rate

Form–fill–seal cups TAS 8/48 280 cups per min.
TAS 16/48 420 cups per min.
TAS 32/48 720 cups per min.
TAS16/80 840 cups per min.
TAS 32/80 1680 cups per min.
Form–fill–seal stick packs SAS 20/60 480; 2.2 oz. sticks per min.

Filler—Up to three stage fillers are possible, controlled by computer.

Accurate up to ±2 grams. Fillers can fill particulates up to 12 mm.
Production Rate of Aseptic Cup Fillers
TAS 8/48 TAS 16/48 TAS 32/48 TAS 16/80 TAS 32/80
6 up 12 up 24 up 24 up 48 up
35 strokes 35 strokes 30 strokes 35 strokes 40 strokes
16,800 cph 25,200 cph 43,200 cph 50,400 cph 100,800 cph

Figure A.19  OYSTAR Hassia form–fill–seal aseptic cup filler. (Photograph

courtesy of OYSTAR Hassia, USA.)
Appendix A: Aseptic filler profiles 317

Figure A.20  Hassia aseptic stick pack filler Model SVP 20/30. (Photograph from
OYSTAR Hassia literature.)

Sterilization of filler—Accomplished by H2O2 followed by drying. After

sterilization, the filler is maintained sterile by positive filtered, ster-
ile air over pressure.
Sterilization time of filler—1 hour.
Packaging—Form–fill–seal of various barrier polymers (including
polypropylene) from 3 oz up to 8 oz.
Sterilization of packaging—Sterilization of the packaging depends
upon the material. Hassia can sterilize the packaging by:

Figure A.21  Aseptically filled products using Hassia cup filler. (Photograph from
OYSTAR Hassia literature.)
318 Appendix A: Aseptic filler profiles

Figure A.22  Products aseptically filled on the Hassia aseptic stick filler.
(Photograph from OYSTAR Hassia literature.)

• Dry heat
• Radiation
• Moist Heat (steam)
• Chemical (hydrogen peroxide)
Hassia fillers are FDA validated for aseptic filling low-acid food
products.

Additional information
• OYSTAR Hassia is the leading supplier of aseptic filling equipment
for plastic cups in the United States.
• OYSTAR Hassia has a major sales, service, and spare parts company
located in New Jersey.
• OYSTAR Hassia also owns these other aseptic and extended shelf-
life fillers:
• OYSTAR Gasti
• OYSTAR Hamba
Appendix A: Aseptic filler profiles 319

• OYSTAR Erca
• OYSTAR Hassia also manufactures aseptic coffee creamer filling
equipment.
• Hassia has many years of experience manufacturing aseptic filling
equipment.

Procomac
GEA Procomac S.p.A.
Via Fedolfi, 29
43038 Sala Baganza (Parma) Italy
Ph: 39 0521 839411
Fax: 39 0521 833879
Web: www.procomac.it

Sales and service office in the United States:

GEA Process Engineering Inc.

1600 O’Keefe Road
Hudson, WI 54016
Ph: (715) 386-9371
Fax: (715) 386-9376

Product
Manufacturer of rotary aseptic bottle fillers for beverages. Procomac
also manufactures and supplies the product preparation equipment and
mutually dependent aseptic processing system.

Products currently being filled using Procomac fillers

Fruit juices, sport drinks, dairy products, soy milk, iced tea, and nutriceu-
tical products.

Equipment models
See Figure A.23 to Figure A.26.

Model Packaging Size Production Rate

Fillstar Fx 250 mL up to 2 liters Up to 800 bpm
320 Appendix A: Aseptic filler profiles

GEA Procomac Aseptic Filling Line

Figure A.23  GEA Procomac aseptic filling line. (Photograph from Procomac
literature.)

GEA Procomac PET Bottle Filling

Figure A.24  GEA Procomac PET bottle filling. (Photograph from Procomac
literature.)
Appendix A: Aseptic filler profiles 321

Figure A.25  Procomac aseptic rotary bottle filler. (Photograph from Procomac
literature.)

Current delivery—5 to 6 months.

Filler—Counter pressure volumetric electronic filling head with mag-
netic flow meters on each filling valve. The Procomac filler is capable
of filling round, square, and rectangular bottles.
Sterilization of filler—Steam and peracetic acid: Product path is steril-
ized by steam.
Sterilization time of filler—Time for clean-in-place (CIP) followed by ster-
ilization-in-place (SIP) is approximately 4.5 hours for automated cycle.
Packaging—HDPE and PET bottles.

Figure A.26  Products aseptically filled with Procomac filler.

322 Appendix A: Aseptic filler profiles

Sterilization of packaging—By the use of peracetic acid obtaining a

log 6 reduction of reference target microorganism and with perox-
ide sterilization.
Bottle sealing—Either with screw cap or aluminum foil lined fitment
put on in sterile zone.

Procomac aseptic fillers have been FDA validated to fill low-acid

beverages.

Additional information
• Procomac can normally change bottle sizes in 30 minutes.
• Procomac has been supplying aseptic fillers since 1996.
• Procomac has installed 95 aseptic fillers worldwide, one-third are
filling low acid products; 35 of these fillers are aseptically filling low-
acid beverages.
• Procomac aseptic fillers can fill particulates up to 5 mm × 5 mm × 5 mm.
• Procomac has a test facility in Parma, Italy.
• Procomac can engineer, manufacture, and supply the mutually
dependent aseptic processing system.
• Procomac trains operators, either at its own processing plant or in Italy.
• Procomac has Internet modem based diagnostic services.

Purity

Genpak
68 Warren Street
Glens Falls, NY 12801-0727
Ph: (724) 457-3326
Fax: (724) 457-3328

Product
Manufacturer of aseptic filling equipment for preformed coffee creamers.

Equipment models

Package
Model Size Production Rate
SC 2104A 10–20 mL Up to 1500 creamers/min.
Appendix A: Aseptic filler profiles 323

Filler—Purity manufactures a linear indexing filler that fills volumetri-

cally by the use of 3A approved diaphragm pumps.
Approximate delivery—1 year.
Packaging—Multiple materials, including HIPS and high-impact
polystyrene.
Sterilization of filler—Accomplished by steam and hydrogen peroxide.
Sterilization time—30 minutes.
Sterilization of packaging—Accomplished by H2O2 spray, dried with
filtered hot air.

The Purity filler is FDA validated for aseptically filling low-acid foods.

Additional information
• Purity fillers are manufactured in Toronto, Canada.
• The aluminum lidding material is also produced in Canada.
• The cups are manufactured in Longview, Texas.

Rapak
D S Smith Plc
Beech House
Whitebrook Park
68 Lower Cookham Road
Maidenhead
Berkshire SL6 8XY
Ph: 44 1628 583 400

Offices in the United States:

Rapak USA, Division of D S Smith Plastics

1201 Windham Parkway
Romeoville, IL 60446
Ph: (630) 296-2000
Fax: (630) 296-2195
Web: www.rapak.com

and

Rapak USA
299959 Ahern Ave.
Union City, CA 94587
Ph: (510) 324-0170
Fax: (510) 324-0180
324 Appendix A: Aseptic filler profiles

Product
Manufacturer of aseptic bags and aseptic filling equipment for bag-in-box,
bag-in-drum, bag-in-bin, and supply of packaging.

Products currently being aseptically filled

using Rapak/Intasept fillers
Fruits and vegetable purees, dairy products, sauces, juices, processed
fruit, milkshake base, and ice cream mix.

Equipment models
See Figure A.27.

Model Packaging Sizes Production Rate

IntaseptTM 2400 5–10 liters Up to 4 bpm
Intasept 2600 5–20 liters 3 to 5 bpm
Intasept 2800 Manual Up to 1000 liters 4.5 to 18 bph

Filler—The manual filler must be loaded with the bag and manually
started. The filler then automatically resterilizes the fitment with
steam, punctures the film over the fitment, and volumetrically
meters the filling of the bag. The filler then reseals the film to the
backside of the fitment and ejects the filled bag.
The automatic filler feeds the preperforated webbed bags to
a guillotine that separates the bag. It then inserts the bag into the
filling chamber where the filler resterilizes the fitment with steam,

Figure A.27  Intasept aseptic fully automatic bag-in-box filler. (Photograph from
Rapak literature.)
Appendix A: Aseptic filler profiles 325

punctures the film over the fitment, volumetrically meters the filling
of the bag, and reseals the film to the backside of the fitment then
ejects the filled bag into an optional carton loading system.
Sterilization of filler—By steam and maintained by sterile water and air.
Sterilization time of filler—Approximately 1 hour.
Package types—Premade, presterilized bags with fitments. Rapak
manufactures bags up to 100 liters.
Sterilization of packaging—Bags are presterilized by gamma radi­ation.

Rapak/Intasept fillers are FDA validated for aseptically filling low-acid

food and beverages.

Rossi Catelli S.p.A.

Via Traversetolo, 2/A
43100 Parma
Italy
Ph: (39) 0521 463284
Fax: (39) 0521 463284
Web: www.rossicatelli.com

In the United States:

Process Resource, Inc.

P.O. Box 1620
Oakdale, CA 95361
Ph: (209) 499-1974
Fax: (209) 847-4821

Product
Manufacturer of aseptic filling equipment for bag-in-box, bag-in-drum,
and bag-in-bin.

Products currently being filled using Rossi Catelli Fillers

Tomato paste and diced, processed fruits, vegetables, and dairy products.

Equipment models
See Figure A.28.
Model Filling Heads Package Sizes
Macropak RVL/2T Dual Up to 230 liters
Macropak TM 2000/2 Single and dual 230–1500 liters
326 Appendix A: Aseptic filler profiles

Figure A.28  Rossi Catelli MacropakTM 2000/2 aseptic filler. (Photograph from
Rossi Catelli literature.)

Filler—Fill is controlled by electromagnetic flow meter or weight cells.

Up to 3-inch opening.
Sterilization of filler—Steam.
Sterilization time—Approximately 45 minutes.
Package types—Premade, presterilized bags with and without fit-
ments. Rossi Catelli does not supply the packaging.
Sterilization of packaging—By gamma radiation. The cap and spout
are resterilized using steam.

Rossi Catelli fillers are currently not FDA validated for aseptic filling of
low-acid foods.

Additional information
• Rossi Catelli has been manufacturing aseptic fillers for many
years.
• Rossi Catelli purchased Manzini, an Italian manufacturer of aseptic
bag-in-box fillers.
• Rossi Catelli can supply the aseptic processing system to sterilize the
product prior to filling.
• Rossi Catelli has over 265 aseptic fillers currently in operation
worldwide.
Appendix A: Aseptic filler profiles 327

Scholle
Scholle Corp.
19520 Jamboree Road
Irvine, CA 92612
Ph: (949) 955-1750
Fax: (949) 250-1462

Regional and sales office:

Scholle Corp.
200 W. North Ave.
Northlake, IL 60164
Ph: (708) 562-7290
Fax: (708) 562-6569
Web: www.scholle.com

Product
Manufacturer of aseptic filling equipment for bag-in-box, bag-in-drum,
and bag-in-bin. Also, Scholle is the world’s leading supplier of pre-steril-
ized, aseptic bags.

Products currently being filled using Scholle fillers

Processed fruits, juices, purees and concentrates, sauces, dairy products,
liquid eggs, tomato products, vegetable products, pumpkin puree, citrus
products, and coffee creamer.

Equipment models
See Figures A.29 and A.30.

Model Package Sizes Production Rate

AF10-2E (high acid) 5–200 liters Manual
AF10-2LA (low acid) 5–200 liters Manual
AF14 (high acid) 200–1150 liters Manual
AF19-A (high acid) 5–20 liters 5–7 bags/minute
Surefill 22 (high acid) 5–20 liters Web fed; up to 15 bpm
Surefill 30 LA .5–5 gallons Web fed; up to 15 bpm

Filler—Fill is controlled by flowmeter.

Sterilization of filler—By steam, chlorine, and hot water.
328 Appendix A: Aseptic filler profiles

AUTO-FILL
10-2E
SERIES
Aseptic Filling System
for High Acid Foods

Figure A.29  Scholle aseptic bag-in-box filler. (Photograph from Scholle literature.)

Sterilization time of filler—Approximately 45 minutes.

Package types—Premade bags or various polymers, manufactured
with fitments. Bag sizes are from 5 up to 1150 liters.
Sterilization of packaging—By gamma radiation.

Some Scholle aseptic fillers are FDA validated for aseptically filling low-
acid foods.

Additional information
• Scholle is the inventor of aseptic bag-in-box packaging.
• Scholle is the world’s leading supplier of aseptic filling equipment
for bag-in-box/drum/bin packaging.
Appendix A: Aseptic filler profiles 329

VHP Unit

Sterile Tunnel Bag Infeed

Electrical Enclosure Sterile Skid

AB Panel View

Figure A.30  Scholle Surefill 30 LA linear web-fed bag filler. (Diagrams from
Scholle literature.)

• Scholle is the world’s leading supplier of aseptic bags.

• Scholle has manufacturing facilities on five continents.
• Scholle fillers can be purchased or leased.

Serac
Serac Group
12 route de Mamers BP 46
72402 La Ferte Bernard Cedex
France
Ph: (33) 2 43 60 28 28
Fax: (33) 2 43 60 28 39
www.serac-group.com

Manufacturing, sales, and service office in the United States:

330 Appendix A: Aseptic filler profiles

Serac, Inc.
300 S. Westgate Dr.
Carol Stream, IL 60188
Ph: (630) 510-9343
Fax: (630) 510-9357
Web: www.serac-usa.com

Product
Manufacturer of rotary aseptic fillers for beverages into plastic bottles (see
Figures A.31 and A.32).

Products currently being filled using Serac fillers

Fruit juices, milk, milkshakes, yogurt drinks, coffees, noncarbonated drinks,
eggnog, dairy beverages, teas, sports drinks, soups, and mineral water.

Equipment models
Model Packaging Sizes Production Rate
Lab filler 75 mL up to 3 L Approx. 20 bpm
SAS 4 TF 75 mL up to 3 L Up to 600 bpm
SAS 4 TF 75 mL up to 3 L Up to 800 bpm

Figure A.31  Serac rotary bottle filler. (Photograph courtesy of Serac.)

Appendix A: Aseptic filler profiles 331

Figure A.32  Some products filled using Serac fillers. (Photograph from Serac
literature.)

Approximate delivery—7 to 8 months.

Filler—Fill is by net weight.
Sterilization of filler—By peracetic acid and super heated water at 285°F.
Sterilization time of filler—Approximately 2 hours.
Packaging—PET, HDPE, Barex, and polyethylene bottles from 75 mL
up to 3 L. Serac filler can also fill steel and aluminum cans for aero-
sol whipped cream.
Sterilization of packaging—Preformed bottles are sterilized by the use
of peracetic acid obtaining a log 6 reduction.

Serac bottle fillers are not currently FDA validated for aseptically filling
low-acid beverages.

Additional information
• Serac has a complete manufacturing, sales, and service organization,
including spare parts located in Carol Stream, Illinois.
• Serac is a leading supplier of aseptic fillers for plastic bottles with
more than 80 installations worldwide of which 50 are filling low-
acid beverages.
• Serac fillers can fill particulates up to 10 mm in diameter.
332 Appendix A: Aseptic filler profiles

• Serac also manufactures a filler (model STAS) for aseptic and ESL
filling of HDPE blow molded (sterilized and sealed in the blow
molding process) bottles.
• Serac has a fully equipped testing facility located in France.
• Comparative floor space requirement for Serac bottle fillers is small.

Shibuya Kogyo
Shibuya Kogyo Co., LTD.
Mameda-Honmachi
Kanazawa 920
Japan
Ph: 0762-62-1200
Fax: 0762-23-1921
Web: www.shibuya-int.com

Sales and service office in the United States:

Shibuya Hoppmann Corp.

13129 Airpark Drive, Suite 120
Elkwood, VA 22718
Ph: (800) 368-3582
Fax: (540) 829-1724

Product
Manufacturer of rotary aseptic filling equipment for PET, HDPE, and
other plastic bottles.

Products currently being aseptically filled using Shibuya fillers

Flavored milk beverages, apple juice, tomato juice, milk, milk tea, milk
coffee, and Japanese, Chinese, English, and barley teas.

Equipment models
Model Production Rate Package Size
NWF36-120 1200 bottles per minute Up to 16 oz.
NWF32-108 900 bottles per minute Up to 16 oz.
NWF32-81 600 bottles per minute Up to 32 oz.
NWF4390F/SR 400 bottles per minute Up to 64 oz.
Appendix A: Aseptic filler profiles 333

Current delivery—9 months.

Filler—Rotary volumetric aseptic filler for plastic bottles.
Sterilization of filler—The Shibuya filler and capping system is based
on a closed chamber principle. All the equipment for sterilizing the
incoming components, filling, and capping is contained in stainless
steel chambers that have been presterilized with H2O2 with heat.
The fully automatic presterilization is carefully controlled, making
it possible to fill sterile product into sterile containers in a sterile
environment. Once the filler and chamber are sterile, they are main-
tained in a sterile state by the use of ultra-filtered air overpressure.
See Figure A.33.
Sterilization time of filler—Approximately 2 hours.
Packaging—Standard 500 mL to 2000 mL PET bottles and other suit-
able plastic containers (i.e., HDPE). The system can handle round,
square, or rectangular bottles with minimal change parts. Other
container geometries could be handled with extra change parts.
The closure is an aseptic type screw cap without under cap foil seal.
Sterilization of packaging—H2O2 with heated air and electron beam.

The Shibuya filler is FDA validated for aseptically filling low-acid

beverages.

Additional information
• At 1200 bottles per minute, the Shibuya aseptic filler is the highest
production speed filler for low-acid beverages on the market.
• Shibuya has years of experience at installations in Asia and the Far
East.
• Shibuya is one of the world’s leading suppliers of aseptic fill-
ing equipment for plastic bottles and has over 100 aseptic filler
installations.
• Shibuya has recently introduced electron beam sterilization of PET
bottles and can obtain a log 6 reduction.
• Shibuya has a test facility in Japan where it can aseptically process
and package high- and low-acid beverages.
• Shibuya cannot aseptically fill products with particulates.
• Shibuya aseptic fillers utilize more floor space than any other aseptic
beverage filler.
• It was directly reported by a processor at an installation in the
United States that there is 4 miles of 4-inch stainless steel piping
installed just for the use of the Shibuya filler and not associated with
the processing of the product.
334 Appendix A: Aseptic filler profiles

The Aseptic System Chamber Layout

The aseptic filling system consists of a number of stainless steel chambers joined together.
Normally the chambers are arranged in a horseshoe formation. The chambers are further
subdivided by stainless steel partitions as shown below.
Note: The heavy solid lines denote the chamber walls and partitions, the light broken lines
denote equipment inside the chambers.

Reject Product Good Product

Discharge Discharge

Infeed gripper
wheel chamber
Bottle infeed conveyor

Capping, reject
and discharge
chamber

Bottle reject
Bottle box
interior/exterior
Infeed sterilization
transfer chamber
Discharge/ chamber
reject
wheel

Hot air Bottle

activation sterilizer
chamber reject
chamber
Servo
capper

Bottle
Net weight
interior/exterior
filling chamber
sterile water Note: Sterile water
rinsing
chamber rinser can be
replaced with hot
air activator as an
option

Figure A.33  Aseptic system chamber layout.

Appendix A: Aseptic filler profiles 335

Sidel
Sidel S.p.A.
Via La Spezia 241/A
43100 Parma, Italy
Ph: +39 0521 9991
Fax: +39 0521 959009
Web: www.sidel.com

Sales and service office in the United States:

Sidel
5600 Sun Court
Norcross, GA 30092
Ph: (678) 221-3000
Fax: (678) 221-3266

Product
Manufacturer of rotary aseptic and extended shelf-life fillers for filling
beverages into plastic bottles. Sidel also manufactures associated sterile
blow molders. Sidel USA is additionally responsible for LFA-20 (originally
Tetra Pak) linear aseptic bottle fillers installed in the United States.

Products currently being filled using Sidel fillers

Fruit juices, Powerade, energy drinks, teas, soy milk, milk and other dairy
products, and coffee creamers.

Equipment models
See Figure A.34 to Figure A.36.
Type Filler Package Sizes Production Rate
Combi PredisTM FMa 100–2000 mL Up to 36,000 bph
SensofillTM FMa 100–2000 mL Up to 60,000 bph
LFA-20 100 mL–1 L

Current delivery—6 months.

Filler—Magnetic gravity level filler with flowmeters using no mem-
brane that is capable of filling pulp.
Sterilization of filler—Presterilization is accomplished by 280°F steam.
Sterility is maintained by positive filtered, sterile air pressure.
Sterilization time of filler—70 minutes.
336 Appendix A: Aseptic filler profiles

Figure A.34  Sensofill FMa. (Diagram from Sidel literature.)

Packaging—PET, PP, and HDPE bottles with screw caps, heat-sealed

foil caps, and sports caps.
Sterilization of packaging—PredisTM, accomplished by H2O2 vapor; ster-
ilization up to 4 log; SensofillTM, accomplished with peracetic acid.

Sidel Combi and Sensofill fillers are currently not FDA validated for asep-
tic filling of low-acid beverages. The Tetra Pak designed linear fillers (LFA-
20) are FDA validated for aseptically filling low-acid beverages.

Additional information
• Sidel has approximately 200 Combi and 100 aseptic fillers installed
around the world.

Figure A.35  Combi Sensofill FMa. (Diagram from Sidel literature.)

Appendix A: Aseptic filler profiles 337

Figure A.36  Some products filled using Sidel fillers. (Photograph from Sidel
literature.)

• Sidel has testing facilities in Italy and France.

• Sidel fillers are capable of aseptically filling small particulates.
• Sidel has strong service and spare parts in the United States.
• Combi PredisTM FMa and SensofillTM FMa are suitable for high-acid
aseptic filling.
• Sidel employs approximately 5500 people around the world and is a
division of Tetra Laval.

Sig Combibloc GmbH

Rurstrasse 58
D-52441 Linnich
Germany
Ph: 49 2462 79-0
Fax: 49 2462 79-2519

Sales and service office in the United States:

SIG Combibloc, Inc

2501 Seaport Drive, Suite 100
Chester, PA 19013
Ph: (610) 546-4140
Fax: (610) 546-4340
www.sig.biz

Product
Aseptic carton packaging equipment for liquid products into preformed
paperboard cartons.
338 Appendix A: Aseptic filler profiles

Products currently being filled using Combibloc fillers

Juice and juice concentrates, nectars, milk, cream, condensed milk, rice
milk, cream soups, soups with particulates, coffee, sauces, tomato prod-
ucts, baby food, fruit toppings and purees, syrups, and teas.

Equipment models
Note: SIG Combibloc manufactures many different models of fillers.
Contact Combibloc for exact model desired. The following is the produc-
tion speeds of the fillers.
Model Production Rate Package Sizes
Small size package Up to 24,000 pph 125–150 to 200–250 mL
Medium size package Up to 12,000 pph 250–350 to 400–500 mL
Large size package Up to 9000 pph 1000–2000 mL

Approximate delivery—High-acid filler, 9 months; low-acid filler,

12 months.
Filler—Available in either single or double lane filler configurations.
Capable of filling particulates up to 15 mm. Fill is above the product
facilitating the filling of foods containing particulates.
Sterilization of filler—By steam and hot water.
Sterilization time of the filler—1 hour.
Packaging—Preformed, flat, folded sleeves, which are printed, die cut,
and flame sealed. The sleeve is fed into the Combibloc filler where
it is opened, the bottom is sealed, and the formed carton is then
filled with sterile product and sealed above the liquid contents. See
Figure A.37 to Figure A.41.

Combibloc fillers are FDA validated for aseptically filling low-acid foods.

Additional information
• Unlike Tetra Pak, there is no royalty payment assessed on packag-
ing volume.
• Offers 20 different size packages (from 150 mL up to 2 L).
• Combibloc fillers are capable of food and beverages containing dis-
crete particulates.
• Packaging provides headspace in the package to allow filling of par-
ticulates, shakeability, and to avoid spilling when opened.
• Combibloc has a testing laboratory in Germany.
• Changeover time for different size packages is approximately 2 min-
utes without changing machine parts.
Appendix A: Aseptic filler profiles 339

Printed
Design

Outer Pe
Coating

Cardboard

Middle Pe
Coating

Aluminium

Inner Pe
Coating

Figure A.37  Combibloc packaging structure. (Diagram from SIG Combibloc

literature.)

Figure A.38  Combibloc and Combifit packages. (Photograph from SIG Combibloc
literature.)
340 Appendix A: Aseptic filler profiles

Figure A.39  New package: Combibloc Combishape. (Photograph from SIG

Combibloc literature.)

• There is no loss of sterility during changeover of carton size.

• Unique patented Pour ‘n Seal CombiTop fitment available for
recloseable carton.

Stork
Stork Food and Dairy Systems B.V
Deccaweg 32
1042 AD Amsterdam
Netherlands
Ph: 31 20 634 89 11
Fax: 31 20 636 97 54

Perforations combiTop combiLift combiTwist combiSwift combiSmart shapeTwist

Figure A.40  Types of Combibloc opening options.

Appendix A: Aseptic filler profiles 341

Figure A.41  Combibloc 724 Food Filler. (Photograph from SIG Combibloc
literature.)

Sales and service office in the United States:

Stork Food & Dairy Systems

1024 Airport Parkway
P.O. Box 1258
Gainesville, GA
Ph: (770) 535-1875
Fax: (770) 532-9867
Web: www.stork-usa.com

Product
Manufacturer of linear aseptic fillers for plastic bottles and related aseptic
processing systems.
342 Appendix A: Aseptic filler profiles

Products currently being filled using Stork Fillers

Fruit juices, milk and other dairy products, stirred yogurt, soy milk, and
coffee drinks.

Equipment models
See Figures A.42 and A.43.

Model Package Size Production Rate

Asep-Tec 20 mL up to 2 liters Up to 400 bpm

Filling
Lanes Stages Nominal Capacity
1 Liter 0.5 Liter
8 1 9400 12000
8 2 12000 12000
12 1 14000 18000
12 2 18000 18000
16 1 24000

Approximate delivery—6 to 8 months.

Filler—Linear aseptic filler for various plastic bottles for high- and
low-acid beverages capable of log >6 sterility. A flow meter prin-
ciple is used and can fill particulates up to a 9-mm cube. Bottles can
be nitrogen purged after sterilization to remove air and again after
filling to enhance shelf life.
Sterilization of filler—Accomplished by steam and H2O2 followed by
drying and cooling. Sterility is then maintained by positive filtered,
sterile air pressure.

Figure A.42  Some products aseptically filled using Stork fillers.

Appendix A: Aseptic filler profiles 343

Figure A.43  Stork linear aseptic filler for plastic bottles. (Photograph from Stork
literature.)

Sterilization time of filler—Approximately 90 minutes.

Packaging—PET, HDPE, PP, and other plastic bottles 20 mL up to 2 L.
Bottles can be monolayer, three layers with light barrier, or up to
six layers with both light and oxygen barriers. Bottles can be closed
with either seals or screw cap.
Sterilization of packaging—Preformed bottles are sterilized with
hydrogen peroxide.

Stork aseptic fillers have been FDA validated for aseptically filling low-
acid beverages.

Additional information
• Stork is a leading supplier of aseptic fillers for bottles with many
installations throughout the world with more than 60 aseptic fillers
in operation.
• Stork manufactures the blow molding equipment for bottles that can
be directly coupled to the aseptic filler.
• Stork can change the container size or the product without an inter-
mediate sterilization cycle.
• The Stork linear, aseptic bottle filler has substantially reduced main-
tenance compared to rotary fillers.
• Stork can supply the mutually dependent aseptic processing systems.
344 Appendix A: Aseptic filler profiles

• Stork has a testing facility in Holland where it can aseptically process

and package beverages with direct and indirect heat exchange systems.
• The Stork filler is capable of filling beverages with discrete particu-
lates up to 9 mm × 9 mm × 9 mm cubes.
• Stork was the first aseptic bottle fillers that received FDA validation
for aseptically filling low-acid dairy beverages.
• Stork also manufactures the conveying system, secondary packag-
ing, and palletizing equipment.

Tetra Pak
Tetra Pak International S.A.
70 Avenue General-Guisan
CH-1009 Pully/Lausanne
Switzerland
Ph: 41 21 729 21 11
Fax: 41 21 729 22 88
www.tetrapak.com

Sales and service office in the United States:

Tetra Pak, Inc.

101 Vernon Hills Parkway
Vernon Hills, IL 60061
Ph: (847) 955-6000
Fax: (847) 955-6500
www.tetrapakusa.com

Product
Tetra Pak is the world’s leading manufacturer of aseptic filling equipment
for form–fill–seal paperboard cartons, and supplier of aseptic packaging
material and associated materials handling equipment. Tetra Pak is also
one of the world’s leading suppliers of aseptic processing systems.

Products currently being filled using Tetra Pak Fillers

Fruit juices, vegetable juices, milk, cream, pudding, ice cream mix, cus-
tard, cheese sauce, yogurt, wine, coffee and tea drinks, soups, milkshake
mix, broths, rice and soy beverages, and specialty sauces.

Equipment models
See Figure A.44 to Figure A.46.
Appendix A: Aseptic filler profiles 345

Figure A.44  Tetra Pak A3/Flex. (Photograph from Tetra Pak literature.)

Figure A.45  All Tetra Pak aseptic fillers generate packaging based on form–
fill–seal. (Diagram courtesy of Tetra Pak.)
346 Appendix A: Aseptic filler profiles

Figure A.46  Several configurations of Tetra Pak packaging. (From Tetra Pak
literature.)

Model Package Size Range Production Rate

A3/Flex 200 mL up to 2000 mL Up to 8000 p/h
A3/Flex Speed See following note Up to 24000 p/h

Filler—Tetra Pak has many models of Tetra Pak form-fill-seal continu-

ous fillers capable of producing a myriad of different shapes and
sizes of packages with different types of openings. See Tetra Pak
Web site for further details at www.tetrapak.com.

Note—The A3/Flex can produce 22 different Tetra Pak Aseptic and Tetra
Prisma Aseptic packages. The A3/Flex Speed can produce Tetra Brik,
Aseptic 1000 mL Baseline, Slimline, and Square Line packages.

Sterilization of filler—Accomplished by hot air and hydrogen

peroxide
Sterilization time—45 minutes.
Tetra Pak packaging—Form–fill–seal from roll stock consisting of
paper, plastic, and aluminum foil in a variety of combinations.
Package sizes range from 125 mL up to 2 L. Cartons are printed by
offset method in up to four colors.
Sterilization of packaging—Accomplished by 30% hydrogen peroxide
at 70°C for 6 seconds. Hydrogen peroxide is then removed by either
rollers or hot air.
Packaging options—Pull tab, CIP unit, cap applicator, case packer,
accumulator, straw applicator, multishrink.

All Tetra Pak aseptic fillers are FDA validated for filling low-acid food
and beverages.
Appendix A: Aseptic filler profiles 347

Additional information
• Tetra Pak is the world’s largest supplier of aseptic packaging and fillers.
• In 2009 Tetra Pak had 9115 Tetra Pak fillers in operation.
• Tetra Pak’s new A/3 Flex filler can convert from Brik to Prism and
can convert 2 volumes in 10 minutes.
• The A3 Flex filler can also produce 22 different Tetra Brik packages.
• Tetra Pak’s A3 Speed can produce Tetra Brik, Aseptic Baseline,
Slimline, and Squareline packages.
• Some Tetra Pak fillers can fill products containing discrete particu-
late matter.
• Tetra Pak has offices in 165 markets and employs more than
21,000 employees.
• Tetra Pak has 59 services centers and 19 research and development
centers worldwide.
• Tetra Pak is one of the few companies in the world that also manufac-
tures and supplies mutually dependent aseptic processing systems.
• Tetra Pak has a fully equipped and staffed testing laboratory in
Denton, Texas. This testing laboratory:
• Is validated by the FDA and conforms to the PMO for aseptically
processing and packaging product.
• Has a number of different processing options, including direct and
indirect heat exchange systems.
Appendix B: Aseptic contract
packers in the United States
Bag-in-box
• Associated Milk Producers, Inc. (AMPI)
• Bay Valley Foods
• Beverage House
• California Natural Products
• CASP
• Cutrale Citrus
• Fruit Crown
• Gehl Foods
• Gossner Foods
• Island Oasis
• Langer Juice
• Lyon’s Magnus
• Pacific Fruit
• Pacific Natural Foods
• Sabroso
• Stahlbush Farms
• Steuben Foods
• Wild Aseptics

Cans and cups

• Advanced Foods (California)
• Advanced Foods (Pennsylvania)
• Advanced Foods (Wisconsin)
• AMPI
• Bay Valley Foods
• Gehl Foods
• IFP/Leahy
• Steuben Foods

349
350 Appendix B: Aseptic contract packers in the United States

SIG Combibloc and Tetra Pak

• Advanced Foods (California)
• American Soy
• Beverage Concepts
• California Natural Foods
• Coastlog
• Cutrale Citrus
• Foods Swing
• Gossner Foods
• IFP/Leahy
• Indulac
• Island Oasis
• Jasper Foods
• Johanna Foods
• Kerry Ingredients
• Kiko Foods
• Lyon’s Magnus
• Morningstar
• NorCal
• Ocean Spray
• Pacific Natural Foods
• Pacific Nutritional Foods
• Schroeder (Michigan)
• Schroeder (Minnesota)
• Steuben Foods
• SunOpta (California)
• SunOpta (Minnesota)
• Whitlock Packaging (New Jersey)
• Whitlock Packaging (Oklahoma)

Plastic bottles
• Aseptic Solutions
• Flavors Inc.
• Gehl Foods
• HP Hood
• Jasper Foods
• Kan Pak
• Lyon’s Magnus
• Steuben Foods
Appendix B: Aseptic contract packers in the United States 351

Pouches
• Advanced Foods (California)
• Advanced Foods (Pennsylvania)
• Advanced Foods (Wisconsin)
• AMPI
• Bay Valley Foods
• Gehl Foods
• Kan Pak
• Morningstar
• Steuben Foods
 352
Plastic Cups Tetra Pak and
Processor Location Bottles and Cans Bag-in-Box Pouches Combibloc
Advanced Foods 402 S. Custer Ave. L L
New Holland, PA 17557
Ph. (717) 355-8667
600 First Ave. West L L
Clear Lake, WI 54005

Appendix B: Aseptic contract packers in the United States

Ph. (715) 263-2956
1211 E. Nobel Ave. L L L
Visalia, CA 93277
Ph. (559) 627-2070
American Soy 1474 N. Woodland Dr. L
Saline, MI 48176
Ph. (734) 736-9230
AMPI E. Highway 212 L L L
Dawson, MN 56232
Ph. (320) 769-2994
Aseptic Solutions 4848 Alcoa Circle H
Corona, CA 92880
Ph. (951) 736-9230
Bay Valley Foods 820 Palmyra Ave L L L
Dixon, IL 61021
Ph. (815) 288-4097
 Appendix B: Aseptic contract packers in the United States
Beverage Concepts 30322 Esperanza H
Rancho Santa Margarita, CA
92688
Ph. (949) 459–2922
Beverage House 107 North Ave. H
Cartersville, GA 30120
Ph. (770) 387-0451
California Natural Products 1250 Lathrop Road L L
Lathrop, CA 95330
Ph. (209) 858-2525
CASP 105 Horizon Park Dr. L
Penn Yan, NY 14527
Ph. (315) 531-8080
Coastlog 209 Theodore Rice Rd. L
New Bedford, MA 02745
Ph. (248) 344-9556
Cutrale Citrus 602 S. McKean Street H H
Auburndale, FL 33823
Ph. (863) 965-5000
Flavors, Inc. 575 Alcoa Circle H
Corona, CA 92880
Ph. (949) 459-2660 (Continued)

353
 354
Plastic Cups Tetra Pak and
Processor Location Bottles and Cans Bag-in-Box Pouches Combibloc
Food Swing 904 Woods Road L
Cambridge, MD 21613
Ph. (410) 228-1644
Fruit Crown 250 Adams Blvd. H
Farmingdale, NY 11735

Appendix B: Aseptic contract packers in the United States

Ph. (518) 694-5800
Gehl Foods N116 W15970 Main St. L L L L
Germantown, WI 53022
Ph. (262) 251-8572
Gossner Foods 1105 N. 1000 West L L
Logan, UT 84321
Ph. (435) 752-9365
HP Hood 160 Hood Way L
Winchester, VA 22602
Ph. (540) 969-0045
IFP/Leahy 401 N. Main Street H H
Rosendale, WI 54974
Ph. (920) 872-2181
Indulac 198 Chardon Ave. L
Hato Rey, Puerto Rico 00918
Ph. (787) 753-0974
 Appendix B: Aseptic contract packers in the United States
Island Aseptic 100 Hope Road H L
Byesville, OH 43723
Ph. (740) 685-2548
Island Oasis 141 Norfolk St. H L
Walpole, MA 02081
Ph. (800) 999-5674
Jasper Foods 3877 E. 27th St. L L
Joplin, MO 64804
Ph. (417) 206-3333
Johanna Foods Johanna Farms Rd. H
Flemington, NJ 08822
Ph. (908) 788-2200
Kan Pak 1016 Summitt St. L L
Arkansas City, KS 67005
Ph. (800) 378-1265
Kerry Ingredients 11 Artley Road L
Savannah, GA 31408
Ph. (912) 330-7955
Kiko Foods 5510 Jefferson Hwy. L
Jefferson, LA 70123
Ph. (504) 736-0220
Langer Juice Co. 16195 Stephens St. H
City of Industry, CA 91745
Ph. (626) 336-1666
(Continued)

355
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Plastic Cups Tetra Pak and
Processor Location Bottles and Cans Bag-in-Box Pouches Combibloc
Lyon’s Magnus 1636 S. Second St. H H H
Fresno, CA 93702
Ph. (559) 268-5966
Morningstar 6364 Valley Park L
Mt. Crawford, VA 22841

Appendix B: Aseptic contract packers in the United States

Ph. (540) 434-1948
500 Jackson St. N L
Sulphur Springs, TX 75482
Ph. (903) 885-7573
NorCal 2286 Stone Blvd. H
Sacramento, CA 95691
Ph. (916) 372-0660
Ocean Spray 7800 S. 60th Ave. H
Kenosha, WI 53142
Ph. (262) 942-5351
Pacific Fruit 121 Center Street H
South Gate, CA 90280
Ph. (562) 531-1770
Pacific Natural 19480 SW 97th Ave. L L
Tualatin, OR 97062
Ph. (503) 692-9666
 Appendix B: Aseptic contract packers in the United States
Pacific Nutritional 9960 SW Potano L
Tualatin, OR 97062
Ph. (503) 692-3498
Rio Bravo 36889 Hwy. 58 H
Buttonwillow, CA 93206
Ph. (661) 764-9000
Sabroso 690 S. Grape St. H
Medford, OR 97502
Ph. (541) 772-5653
Schroeder 2080 Rice St. L
Maplewood, MN 55113
Ph. (561) 855-6418
5252 Clay Ave. L
Grand Rapids, MI 49548
Ph. (616) 538-3822
Stahlbush Farms 3122 Stahlbush Island Rd. L
Corvalis, OR 97333
Ph. (541) 757-1497
Steuben Foods 150 Maple Rd. L L L L L
Elma, NY 14059
Ph. (716) 291-9484
SunOpta 3915 Minnesota St. L
Alexandria, MN 5630
Ph. (320)763-9822
(Continued)

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Plastic Cups Tetra Pak and
Processor Location Bottles and Cans Bag-in-Box Pouches Combibloc
SunOpta 555 Mariposa Rd. L
Modesto, CA 95354
Ph. (209) 818-0032
Whitlock Packaging 1701 S. Lee H
Ft. Gibson, OK 74434

Appendix B: Aseptic contract packers in the United States

Ph. (918) 478-4300
92 Main Street H
Wharton, NJ 07885
Ph. (973) 361-9794
Wild Aseptics 2924 Wyetta Drive H
Beloit, WI 53511
Ph. (608) 362-5012
Note: H = high acid; L = low acid.