MARKET INSIGHT

Improving Life Science

Cleanroom Performance
 AAF Flanders has an in-depth understanding
of the challenges and opportunities for life science
manufacturing processes. This understanding and
technical ability makes AAF Flanders
the preferred partner in optimizing process performance
for protecting human health.

2
 We Test HEPA Filters Because
“
They
—Dan Milholland
Expert in HEPA Filter Certification
Leak.
”
Leaks have a dramatic effect on your business, on your bottom line.
They are a challenge for every operation. The question is, how can
you reduce them?

Loss From a Single Microglass Filter Leak: Hidden Cost of

Microglass:
Two hours of unplanned downtime:

$250,000+ /hour
1%- 3%
Documentation and meetings: microglass filters

$20,000
discovered to have leaks
during each round of testing

100 microglass filters

x 3% leak rate:

Total Cost: $520,000+ Three Filters

$20,000
PER FILTER
$3K - $20K Documentation costs
associated with a single filter leak documentation & meetings
with a single leak

EQUALS
Time to Address a Leak:
$60,000
5-10 MINUTES 2 LABOR HOURS per round of
semi-annual leak testing
planned downtime unplanned downtime
for an experienced to remove, replace, OR
certification team to
scan a filter
and retest a leaking
microglass HEPA filter $120,000/yr
Total Annual Cost

You need to understand the cost

of every leak you experience.

3
 Three Hidden Risks of Microglass HEPA Filters:
It’s Worth a Closer Look.
Some Leaks Are Harder to See Than Others.
So Are the Risks They Can Cause.
HEPA leaks affect every step in the pharmaceutical process, from construction and
production to federal compliance, unplanned downtime, and equipment failure. It’s
a major part of any company’s reputation, financial bottom line, and, ultimately,
patient safety.
Using HEPA filters with microglass media, even as a part of a Standard Operating
Procedure, can lead to decreased production time, increased repair time, and
increased energy consumption, not to mention FDA 483 Warning Letters and
potentially disastrous recalls. Are you keeping your eye on the risks that are harder to
see? And if not, have you considered the consequences?

Unscheduled Downtime:

Would It Surprise You if a Weaker Filter

Also Increased Your Risk?
The pharmaceutical industry estimates that 77% of production downtime can be
attributed to failures of equipment and environmental problems.* This downtime can be

77%
caused by HEPA filters failing. Traditional HEPA filters typically fail because of the poor
mechanical strength of the media, a failure due to physical contact or degradation from
caustic chemicals. The actions required when these failures occur include replacing the
HEPA filter, certifying the installation, investigating potentially contaminated products,
and generating a risk assessment report.
of production downtime The poor durability and low tensile strength of microglass leads to media degradation
can be attributed to when exposed to cleanroom chemicals. What’s more, high pressure drops and media
failures of equipment and offgassing result in higher energy costs and lower air quality.
environmental problems
Fragile fiberglass media can lead to unplanned and costly situations, including the need
for replacement filters, labor for installation, FDA 483’s, and even recalls.
The costs and issues associated with using microglass may be viewed as a cost of
doing business, but the ultimate risks are often unrecognized. It has been reported
that 1% to 3% of microglass filters are discovered to have leaks during each round
of testing. When leaks are found, just the documentation and meetings required in
the investigation process alone are expensive, not to mention backup stock for
filter replacement.
A company’s reputation can also be damaged by these leaks. Publicly posted warning
letters are brand killers for pharma, biotech, and medical device companies. And
reputation damage from public fear will increase these concerns exponentially.
Competitor leverage, loss of business, stockholder confidence—these are just some
of the ways that leaks affect your bottom line.

*Pharmaceutical Manufacturing Magazine (2004)

4
 Excessive PAO Testing:
Twice the Testing Offers Twice the Reliability. Right?
Microglass may be PAO compatible, but it is also fragile. Very fragile. This fragility means
that any interaction with this media entails a greater risk of damage—which CAN mean
more testing, which WILL mean more risk of failure. That’s a risk you just can’t take.
HEPA filter testing has had a long and complex history. But the FDA requires this
regular testing. It is an integral part of any cleanroom protocol. In fact, filters utilizing
microglass require more testing than any other media. Microglass requires more testing
because it is more fragile. It requires more testing because it can’t be trusted to keep
your cleanroom safe.
Obviously, it is critical that filter integrity is maintained throughout the entire manu-
facturing and testing process. Even though overcertification may seem like a solution,
it is actually just another leak waiting to happen. Testing is a key part of any cleanroom
validation, but every test includes specific risks.
Although additional testing may be appropriate when air quality is found to be
unacceptable, testing less may mean testing smart. Over-testing may make you feel
FDA Testing Guidance better about leaks in microglass filters, but it won’t make the filters any better or
stronger.

2x a year Overcertification
Overcertification in non-critical environments can cause significant problems for
Critical Areas pharmaceutical production, such as additional costs for certification services, longer
(ISO 5; Class A and B) shutdown time, and greater exposure to damage, gel liquefaction, and leakage.
However, while the FDA requires critical room leak testing twice a year, non-critical
rooms only require the test once a year. But many companies still test twice a year due
1x a year to the fragile nature of microglass and their well-founded concerns and fears associated
with it.
Non-Critical Gel Degradation
Areas Extra testing may help to find leaks, but there are inherent risks associated with these
(ISO 7 and 8) tests. One of the lesser-known risks is gel degradation. PAO can and does affect
these gels. And the ensuing gel liquefaction can dramatically compromise cleanroom
processes, in addition to damaging the filter itself and causing devastating cleanroom
damage. Contamination and premature replacement, along with associated costs and
concerns, not to mention lost production time, could cost millions of dollars. Testing
only as required will improve the integrity of your filters, the performance of your
cleanrooms, and your bottom line.

Financial Impact:

Do You Understand the Cost of Every Leak

You Experience?
Maintaining filter integrity is a challenge for every cleanroom operation, and because
of this, you need to understand the significant impact of inferior microglass media on
your business.
The FDA has increased emphasis on enforcement and validation. While compliance
may be expensive, it is nothing compared to the catastrophic expense of warnings,
recalls, and unplanned downtime. What does that really mean? Is the continuous use
of microglass worth the risk?

5
 Three Hidden Risks of Microglass HEPA Filters (continued)

The status quo, a misplaced belief that this old media is sufficient, is a recipe for disas-
ter. How could any faith remain in something that could properly be called “outdated”?
There is very little discussion in the pharma industry as a whole about what’s really going
on here. Your competitors could also be listening to manufacturers about a product that
will work “good enough” to keep them in business. The truth is, it may not. This provides
a great opportunity for a competitive advantage, as well as protecting your reputation
and improving your financial fundamentals.

Hidden Costs of Microglass HEPA Filters

We’re calling the costs of microglass use in cleanrooms “hidden,” but with every day
that passes it becomes more and more apparent that the cost to individual companies
and the pharma industry is staggering.
Let’s take a look at what it costs you EVERY TIME a microglass HEPA filter leaks. These
are not theoretical numbers. These are the hard facts about this media and the price
you’re paying for continuing with this outmoded technology.

Here is what you need to know:

The time it takes to address a filter leak:

Five to ten minutes planned time for an experienced team to scan a filter
 At least two labor hours unplanned downtime to remove, replace, and retest
a leaking filter

Loss from a single microglass HEPA filter leak:

$250,000+ hr. (two hours of unplanned downtime)
$20,000 (documentation and meetings)
$520,000+ Total cost for a single microglass HEPA filter leak

$3,000 to $20,000 Documentation costs associated with a single filter leak


1% - 3% of microglass HEPA filters are discovered to have leaks during each
round of testing.
100 filters x 3% leak rate:
3 filters x $20,000 per filter (documentation and meetings with a single leak)
Cost: $60,000 (per round of semi-annual leak testing)
OR
$120,000/yr Total Annual Cost

It should be obvious at this point that a closer look at the use of microglass HEPA
filters exposes the disturbing financial risks and extraordinary damage to reputations
associated with its use. These expenses will continue to compound in future years.
Microglass is unlikely to find a “fix” for its fragility. This fragility is inherent within the media
itself. Add to that the fact that HEPA filters cannot be repaired inside critical areas and
have to be replaced. Doesn’t it make sense to do it right the first time, for your company
and for a public that depends on your end product?

6
 Microglass HEPA Filtration:
More That You Need to Know
Microglass HEPA filters pose an enormous risk to your process environment. The air
filters used inside your HVAC system have a dramatic impact on the total cost of
ownership, the labor resources required to support the systems, product quality, and
most importantly, patient safety.
What’s more, minimizing the hidden risks and costs associated with successfully
operating pharmaceutical cleanrooms requires a continual review and updating of your
Standard Operating Procedures, particularly the selection, installation, and maintenance
of your filters.
There are other, better pharma-grade HEPA media options that are superior to
microglass. These options will operate not only at a validated state with respect to
installation and operation—but at an improved state. Before you choose your next
HEPA filter, make sure you know what you’re buying and what the actual cost in time,
performance, and ownership will be.
There are choices in cleanroom filtration. Make certain you know what they are.
Because the wrong decision could be a damaging one.

What to look for in HEPA Filters

This checklist will help you decide on the right HEPA filter for your cleanrooms.

Durability • Highest level of mechanical strength for resistance to damage and failure rate
• Chemically inert to reduce media degradation in highly corrosive environments
• Water resistance to extend the life of the filter

Performance • High PAO holding capacity for better performance and reliability
• Low to zero offgassing of chemical components for higher quality clean air
• Lowest available pressure drop to reduce energy consumption

Total Cost of Ownership • Clearly understand all of the operational risks associated with your filter selection
• Invest in a technology that will give you the greatest impact with minimal effort
• Choose a company that provides professional guidance to reduce spending,
decrease risk, and save time

Acknowledgments:
Rahul Bharadwaj is Senior Bill Kitch is Director of High Mark Renn is Product
Global Product Engineer at Purity Products, West at Manager of High Purity
AAF Flanders. He can be AAF Flanders. He can be products at AAF Flanders.
contacted via email at contacted via email at He can be contacted via
[email protected]. [email protected]. email at [email protected].

7
 Hidden Dangers of HEPA Filter Leak Testing:
The Risks are Hidden.
The Consequences are Not.
History of Leak Testing
From the 1960s to mid-1980s, dioctylphthalate (DOP) was used in
concentrations of 80 mg/m3 (µg/L) as an aerosol challenge for leak testing HEPA
filters.1 In the 1980s, the design of aerosol photometers progressed to
incorporate solid state electronics, which helped these photometers become
more sensitive instruments to identify filter leaks.
With the implementation of these more sensitive and stable units, the recommenda-
tion for DOP aerosol challenge concentrations was reduced to 10 mg DOP/m3 of air.2
The early 1990s brought a change to the challenge material, due to DOP being
labeled as a potential carcinogen. Emery 3004 polyalphaolefin (PAO) was recognized
as a non-hazardous replacement and has now become the industry standard.3
FDA regulations require regular testing, but how often testing procedures are
utilized beyond those requirements depends on the quality of the filters and how
they are used. HEPA filter integrity has to be maintained to ensure aseptic condi-
tions. Leak testing should therefore be performed at installation to detect integrity
breaches around the sealing gaskets, through the frames, or through various
points on the filter media. Thereafter, leak tests should be performed at suitable
time intervals for HEPA filters in the aseptic processing facility.
The FDA requires testing to be performed twice a year for aseptic processing
rooms, although additional testing may be appropriate when air quality is found to
be unacceptable. There can be other reasons for additional testing, such as facility
renovations, or as part of an investigation into a media fill or drug product sterility
failure. But extra testing due to the use of lower quality filters incurs the additional
cost of more filters being certified, increasing time, money and potential damage.

Overcertification In Non-Critical Environments

Excess certification can cause many problems for environments, some more
obvious than others:
• Additional costs for certification services
• Consumes valuable time during shutdowns
• Increases exposure to damage
• Premature gel liquefaction and leakage
• Media degradation
But there are steps that can be taken. While FDA Testing Guidance requires
critical room leak testing twice a year, non-critical rooms require the testing only
once a year. However, many companies still test twice a year, due to using fragile
microglass media. There are risks associated with this, though.

8
 Tensile Strength Overexposure to PAO
Flat Folded Flat Folded
One of these risks is Gel Degradation. It has been documented that
350.0
312.8 318.0 PAOs can affect the stability of this gel. In fact, at least four Fortune 500
300.0 companies have recently reported problems with gel degradation, the
250.0 liquefaction of the substance used to install and seal the filters. The
Tensile Strength (N)

200.0 integrity of the gel and the effectiveness of the filter seal are therefore
Flat: 8x Higher
150.0 compromised. Leaking issues caused by gel degradation are even more
devastating than simple damage to the filter. When the gel itself becomes
Folded: 84x Higher
100.0

50.0 41.6 liquefied and drops to the floor of a cleanroom, the cleanroom is no
0.0
3.8 longer sterile. This presents a major risk. Gel liquefaction also initiates an
Ultrafine Microglass Media ePTFE Media Technology unplanned shutdown with enormous financial ramifications. These con-
Results based on Test Standard DIN EN 29073-3. tamination failures bring about production losses and premature change-
outs—and with them, potentially millions of dollars in damages and profits.
Burst Pressure - Flat

7.0

Reducing Your Risk

6.4
6.0

Effectively managing the risks and costs associated with successful opera-
Burst Pressure (kg/cm2 )

5.0 Endlessly Higher

4.0 tion requires utilizing HEPA filters with dramatically higher tensile strength
3.0 that are highly resistant to chemical degradation, thereby eliminating
2.0 premature leaking and failure. The only HEPA filter media with these
1.0 properties is polytetrafluoroethylene (ePTFE). Utilizing ePTFE can increase
0.0
0.0 time between testing, allowing for annual certification, which results in
Ultrafine Microglass Media ePTFE Media Technology lower labor costs and reduces your risk to gel liquefaction contamination
Results based on Test Standard DIN EN 13938-2. and early changeouts.
Abrasion Resistance - Flat The strength of the HEPA filter material is critical to the success of a
pharmaceutical environment. In fact, there is no more important
20,000
20,000 component of a cleanroom. Depending on the carrier substrate, the
strength of ePTFE filters is up to 100 times stronger than microglass.
Abrasion Resistance (# rubbing cycles)

16,000
1000x Higher This creates a filtration media that does not fail under standard operating
12,000 procedures, cleaning, installing, or testing, and provides a durability to
8,000
mitigate almost all risks of contamination from airflow. The filter will not
shed, tear, puncture, or sustain pleat tip separation.
4,000
The costs associated with failed media can be staggering:
20
• Complete loss of production for unspecified periods
0
Ultrafine Microglass Media ePTFE Media Technology
Results based on Test Standard DIN EN 12947-2. • Costly FDA 483 citations, warning letters, and consent decrees
• Expensive follow up qualifications/validations
• Catastrophic recalls

9
Hidden Dangers of HEPA Filter Leak Testing (continued)

ePTFE and Pharma

The benefits of ePTFE filters, including the significant reduction in energy cost,
enhanced chemical tolerance, and increased durability, have long been known in
critical semiconductor applications.4 However, until recently, this technology was
not available for use in pharmaceutical environments.
But now there is an ePTFE media that is specifically designed to retain at least
equivalent amounts of PAO aerosol with a pressure drop that is equivalent or lower
than that of microglass. This new dual-layer ePTFE Technology allows for the
in-depth capture of progressively smaller solid particles.
In fact, independent laboratory studies have shown that ePTFE filters possess a far
superior PAO holding capacity over traditional microglass HEPA media, as seen in
the results below.
T H E   W O R L D   L E A D E R   I N   C L E A N   A I R   S O L U T I O N S  
D I FTFHEER   EWNOT RI AL D
L     PL RE EA SDSEUR R   IEN   V
  CS L   EP A
AON     LA OI RA  DS IONLGU   T I O N S  
Test  No.1  –  TEC  Services  Photometer
1.20 D I F F E R E N T I A L   P R E S S U R E   V S   P A O   L O A D I N G  
DIFFERENTIAL  PRESSURE  ("H2O)

Test  No.1  –  TEC  Services  Photometer

1.00
1.20
DIFFERENTIAL  PRESSURE  ("H2O)

0.80
1.00 Microglass
0.60
0.80 Semiconductor ePTFE
0.40 Pharmaceutical ePTFE
0.60
0.20
0.40
0.00
0.20 0 50 100 150 200 250 300 350 400 450 500
CALCULATED  MASS  PAO  (g)  
0.00
0 50 100 150 200 250 300 350 400 450 500
CALCULATED  MASS  PAO  (g)  
Test  No.  2  -­‐  ATI  Photometer
1.20
DIFFERENTIAL  PRESSURE  ("H2O)

Test  No.  2  -­‐  ATI  Photometer

1.00
1.20
0.80
DIFFERENTIAL  PRESSURE  ("H2O)

1.00
0.60
0.80 Microglass
0.40
0.60 Semiconductor ePTFE
0.20
Pharmaceutical ePTFE
0.40
0.00
0.20 0 50 100 150 200 250 300 350 400 450 500
CALCULATED  MASS  PAO  (g)  
0.00
0 50 100 150 200 250 300 350 400 450 500
CALCULATED  MASS  PAO  (g)  
Tes%ng  Data  from  Dan  Milholland  &  Associates  

Tes%ng  Data  from  Dan  Milholland  &  Associates  

Filter failures pose a significant cost to pharmaceutical manufacturers that produce

product in a GxP critical environment. The ability to widely use ePTFE filters in pharma-
ceutical applications provides extraordinary benefits, as well as avoiding the setbacks
that almost certainly will lead to disastrous repercussions in money, risk, and time.
You can’t afford not to investigate ePTFE filters:
• Increase in cleanroom uptime
• Lower production loss and labor costs
• Increase in time between certifications
• Significant energy savings
Attention to these critical factors will lead to more than operational efficiency and risk
mitigation—it will lead to a more viable commercial enterprise.

10
 Challenges and Opportunities Concerning Testing:
Looking Back and Planning Ahead
If business can learn anything from history, it is that the past is prologue. What
we have seen before is likely to be seen again. And what we have seen is change.
Cleanroom testing has always been an integral, if expensive and sometimes
dangerous, component of the pharmaceutical industry. It has also come with its
own set of concerns, including DOP’s cancer worries, and the more recent
considerations of gel and media degradation. Decisions must be made to
continually improve. In fact, the idea of using microglass HEPA filters as part of
a standard operating procedure may very well become obsolete in the
pharmaceutical industry in the near future.
Standard operating procedures and necessary change will always be, to a degree,
in conflict. What was useful yesterday, even what is chosen as a solution today, will
quickly become an obstacle on the road to progress and innovation. But vigilance
and an openness to “what’s next” will ensure the industry its best chance of
continued growth and success.

References
1. Hale, Dean, “HEPA Filter Gel Seal Failure Study and Conclusions,” 2006 CETA Presentation.
2. Mil Standard 286, 1956 Department of Defense Test Method Standard.
3. FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good
Manufacturing Practice, September 2004.
4. Galken, Ned, and Abhishek Saxena, “Air Filtration Applications for Membranes,” AFS Web site.

Acknowledgements:
Rahul Bharadwaj is Senior Bill Kitch is Director of Mark Renn is Product
Global Product Engineer at High Purity Products, West Manager of High Purity
AAF Flanders. His areas at AAF Flanders. He spent products at AAF Flanders.
of expertise involves 10 years in a territory sales He completed his under-
filtration, separations, position focused on air graduate and graduate
nanofibers, membranes and filtration for the pharma- studies at the University of
nonwovens. Bharadwaj is a ceutical market before Louisville, where he was
member of the AFS scientific moving to High Purity awarded a MS in Chemical
committee, and is also a member of various Manager, responsible for AAF Flanders’s Engineering. Renn has spent 30 years focused
other technical and research committees at Cleanroom Division. This project-driven market on the design, application and testing of
ASHRAE (Vice Chair of US TAG 142 and Vice included air filtration, using both glass media HEPA filters for multiple industries, including
Chair Research TC2.4). Bharadwaj received and ePTFE media. Kitch then focused on the pharmaceutical, microelectronics and
his Doctorate in chemical engineering from the development of AAF Flanders’ own media for healthcare. Renn is a member of IEST and
University of Akron, with a Master’s in use in high end filtration markets. He graduated CETA. He can be contacted via email at
Business Administration from the Institute of from Ball State University with a BS in [email protected].
Technology and Management, New Delhi. marketing, and is a member of ISPE and
He can be contacted via email at CETA. He can be contacted via email at
[email protected]. [email protected].

11
 THE WORLD LEADER IN CLEAN AIR SOLUTIONS

MEGAcel II ®

with ePTFE Filtration Technology

MINI-PLEAT HEPA FILTER

Proven Reliability With AAF Flanders ePTFE

Exceptional Performance Filtration Technology—
Today’s Alternative to Fragile
• MEGAcel II is designed to
Microglass HEPA Filters
increase cleanroom uptime and
reduce the risks associated with Designed specifically for the unique
pharmaceutical manufacturing requirements and challenges of the
pharmaceutical industry, the MEGAcel II mini-pleat HEPA filter has
• Pharmaceutical grade ePTFE
the proven durability, polyalphaolefin (PAO) compatibility, high particulate
Filtration Technology media is
filtration efficiency, and the lowest pressure drop to meet the demands of
proven to be more durable than
pharmaceutical manufacturing. It is the best choice for the most demanding
microglass, delivering superior
applications, saving both time and money, while reducing contamination risk
performance
and invasive unscheduled downtime. With the lowest Total Cost of Ownership
• Industry’s first and only ePTFE of all mini-pleat HEPA filters, the MEGAcel II will help protect your environment,
media to be Polyalphaolefin (PAO) reduce your business risk, and optimize your clean air related spending.
compatible, with a higher PAO
holding capacity compared to
microglass media

• Superior durability and tensile MEGAcel® II Overview

strength, 84 times the pleated • Patent pending, polymer-based, dual-density, expanded
strength of microglass polytetrafluoroethylene membranes – ePTFE

• Chemical-resistant capabilities • 99.99% minimum efficiency @ 0.3 μm

reduce media degradation in
• Completely Polyalphaolefin (PAO) compatible
highly corrosive environments
• Lowest pressure drop minipleat HEPA filter available
• Exceptional water resistance
compared to ultrafine microglass • 50mm pleated pack
• Extremely low offgassing of • Anodized extruded aluminum or stainless steel frame
chemical components, resulting in
the highest quality clean air available • Gel, gasket, or knife-edge seal available

• Lowest pressure drop mini-pleat • Thermoplastic hot-melt separators

HEPA filter available, reducing energy
consumption for significant savings

• MEGAcel II and ePTFE media are

manufactured, tested, and
®

packaged in ISO 7 clean facilities

to ensure the highest purity, quality,
and consistency

Less Downtime. Less Worry. Less Risk.

12
MEGAcel I I Filter ®

Industry-Leading Durability
Tensile Strength
Independent tests have shown that MEGAcel II HEPA filters with
Flat Folded Flat Folded
ePTFE Filtration Technology have superior mechanical strength 350.0
over filters with traditional ultrafine microglass media. 312.8 318.0
300.0

250.0

Tensile Strength (N)

200.0
Flat: 8x Higher
150.0
Folded: 84x Higher
100.0

50.0 41.6
3.8
0.0
Resilient ePTFE Filtration Fractured ultrafine microglass
Ultrafine Microglass Media ePTFE Media Technology
Technology media at fold tip media fibers at fold tip
@ 10,000x magnification. @ 10,000x magnification.
Results based on Test Standard DIN EN 29073-3.
Superior mechanical strength is demonstrated by a high tensile
strength, burst pressure, and abrasion resistance. ePTFE media
retains its integrity with a high resistance to any potential damage, Burst Pressure - Flat
such as mishaps in handling or installation. This means that the 7.0
risk of filter media failure is minimized and that fiber shedding, 6.4
6.0
which could cause contamination when entering the airstream, is
eliminated. As a result, there is a decreased risk of contaminants
Burst Pressure (kg/cm2 )

5.0 Endlessly Higher

entering cleanroom environments. Protection of sterile products
4.0
and cleanroom personnel is optimized. Improvement in quality
risk management systems of critical applications ensures a 3.0
consistent supply of quality products and a reduction of 2.0
failure rates.
1.0

Reduce Operational Risk 0.0

0.0
Ultrafine Microglass Media ePTFE Media Technology
The pharmaceutical industry estimates that 77% of production
downtime can be attributed to failures of equipment and Results based on Test Standard DIN EN 13938-2.
environmental problems*. This downtime can be caused by
HEPA filters failing. Traditional HEPA filters typically fail due to
some form of contact combined with the poor mechanical Abrasion Resistance - Flat
strength of the filter. The actions required when these failures
occur include repairing or replacing the HEPA filter, certifying the 20,000
20,000
repair or new installation, investigating potentially contaminated
Abrasion Resistance (# rubbing cycles)

product, and generation of a risk assessment report. Effectively 16,000

managing the risks and costs associated with successful 1000x Higher
operation requires utilizing HEPA filters with dramatically higher 12,000
tensile strength that are highly resistant to chemical degradation,
thereby eliminating premature leaking and failure. 8,000

Increase Uptime 4,000

20
While FDA Testing Guidance requires critical room leak-testing 0
certification twice a year, non-critical rooms require testing only Ultrafine Microglass Media ePTFE Media Technology
once a year. With the extremely high tensile strength and
durability of the ePTFE pleated filter media, 84 times stronger Results based on Test Standard DIN EN 12947-2.
than microglass, ISO 7 and 8 areas could be tested annually.
Increasing time between certifications results in less PAO
exposure to the gel seal (gel degradation), lower labor costs,
and increased production time. *Source: Pharmaceutical Manufacturing Magazine (2004).

13
MEGAcel I I Filter ®

MEGAcel® II—First and Only PAO Compliant Enhanced Chemical Tolerance

ePTFE Media HEPA Filter
High Corrosion Resistance
The purpose of installed HEPA filter integrity testing, also called ePTFE media is proven to be resistant in highly corrosive
in-situ testing, is to confirm a flawless performance during environments and will withstand attacks from common
normal operation. With AAF Flanders’ new ePTFE Filtration decontamination chemicals. Both components of the ePTFE
Technology, MEGAcel II filters can now be scan tested with media, the membrane and non-woven layers, are stable against
the industry standard photometer at standard aerosol exposure at the prescribed time and concentration for the
concentrations, as well as the low aerosol concentration above disinfectant agents.
Discrete Particle Counter (DPC) method.
Superior Water Resistance
The MEGAcel II filter contains dual-layer ePTFE media Based on AAF Flanders’ test lab results, ePTFE Media
specifically developed to retain equivalent amounts of PAO provides superior water resistance in comparison with ultrafine
aerosol with the same or lower pressure drop increases as microglass media, reducing damage risk.
ultrafine microglass. The dual-layer ePTFE media allows for the
Negligible Offgassing
in-depth capture of progressively smaller solid particles.
ePTFE media has extremely low offgassing of chemical
Independent laboratory studies have shown that MEGAcel II components, resulting in the highest quality clean air available.
filters with ePTFE media have superior PAO holding capacity
over traditional ultrafine microglass HEPA media, as seen in the
results below.
ePTFE Filtration Ultrafine
Technology Microglass Media
1st ePTFE Layer 2nd ePTFE Layer BEFORE
(Low Fibril Density) (High Fibril Density)

AFTER
Damage after use of Hydrogen Peroxide ( H2 O2 ) for cleanroom sterilization.

1 Hour Test Intervals (@15µg/l) Time vs. DP

for typical 50mm media packs
1.20

1.00
Differential Pressure (H2O)

10 years
0.80
5 years SEM photos at 5,000x magnification.
0.60

0.40

0.20

0.00
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63
Test Intervals
2 test Intervals is representative of 1 year in use

Ultrafine Microglass ePTFE Filtration Technology

14
 Lower Energy Consumption Energy Savings Calculation
Estimates show that up to 50% of a facility’s energy Average Pressure Drop
consumption is used for heating, cooling, and air handling. MEGAcel II Filter 0.25 in. w.g. (62 Pa)
With increasing utility prices and peak power billing plans,
Ultrafine Microglass HEPA 0.47 in. w.g. (117 Pa)
lowering energy consumption is a key initiative.
MEGAcel II filters with ePTFE media feature a lower pressure Airflow Rate 100 FPM – 0.5 m/sec
drop than traditional filters with ultrafine microglass media, up
to 50% lower depending on the exact conditions. At the same Annual Energy Consumption
time, the overall filtration efficiency for MEGAcel II filters has
ePTFE Media 285 kWh
proven to be higher than for filters with ultrafine microglass
media. The lower pressure drop and improved efficiency are Ultrafine Microglass HEPA 535 kWh
achieved from an evenly distributed layer of fibers with very ∆Savings 250 kWh
fine nanometer-scale diameters. Air molecules can efficiently
pass through the fibers, and airborne particles can be
captured more easily. The result: air quality is optimized
and energy costs are substantially reduced.

Performance Data Manufactured in ISO 7 Clean Facilities

Initial Resistance vs. Filter Face Velocity Both the MEGAcel II HEPA filter and ePTFE Media are
manufactured by AAF Flanders. By doing so, we can
0.5 control the quality and consistency of the media. The
media is produced in an ISO 7 cleanroom to ensure the
purity and cleanliness of the product. The filter is then
Initial Resistance (in. w.g.)

0.4
Energy assembled, tested, and packaged in an ISO 7 clean
Ultrafine Savings
0.3 Microglass HEPA manufacturing facility, resulting in unparalleled product
performance and operational efficiency.
0.2

MEGAcel® II
0.1
HEPA Filter

0
0 25 50 75 100 125
Filter Face Velocity (FPM)

99.99% HEPA Filter, 50mm Packs

AAF Flanders ePTFE Filtration Technology produced in an

ISO 7 cleanroom.

MEGAcel ® is a registered trademark of AAF International in the U.S.

and other countries.

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Proven Expertise of AAF Flanders
AAF Flanders offers the most comprehensive air filtration portfolio
in the industry, including particulate and gas-phase filters, to provide
a customized clean air solution. Each product is carefully designed,
manufactured, and tested in full compliance with all applicable
standards to meet the most challenging demands with the lowest
Total Cost of Ownership.

Contact your local AAF Flanders representative

for a complete list of AAF Flanders
Air Filtration Product Solutions.

888.223.2003
aafintl.com

AAF Flanders has a policy of continuous product

research and improvement and reserves the right to
change design and specifications without notice.

©2017 AAF International and its affiliated companies.

9920 Corporate Campus Drive, Suite 2200, Louisville, KY 40223-5690
888.223.2003 Fax 888.223.6500 | aafintl.com ISO Certified Firm AAF-1-104A 04/17