Validating the Packaging Process

Jyri Mäkinen, Wipak Oy

Contents of Presentation
• Why Packaging Process Validation?
• Using Pouches and Reels
– Checking the conditions in healthcare facilties
– Checking the material suitability by testing
– Choosing the right SBS – evaluation criteria
• Standards and Guiding Documents
– For manufacturers
– For healthcare facilities
Packaging Process Validation for Pouches
– IQ – Installation Qualification
– OQ – Operational Qualification
– PQ - Performance Qualification
• Wipak Validation Service
• Routine Control for Checking the Pack Integrity and Documentation
• Corrective Actions
Why Packaging Process Validation?
• For the safety of patients: to reduce number of infections that happen due to
lost barrier or bad aseptic presentation
• SBS (primary package) is a minimum package that prevents ingress of
microorganisms and allows aseptic presentation at the point of use
• Only intact packaging can serve as sterile barrier
• ISO 11607-2 states that there needs to be a documented validation program in all
healthcare facilities where medical devices are packed and sterilized.
• To prove that the sealer makes proper seal and that sealed package can really
serve as sterile barrier
– To prove that SOPs for sealing, wrapping, self-seal and container packing are
in place and provide sterile barrier repeaditely
– To prove that packaging works in the environment it is used
Packaging Process Validation Results in

1 2 3 4
Less claims, less Good reputation Better Lower
repacking, less broken for hospitals. material choice. infection rates.
packages, lower risks
 saves money.
Checking the environment Validating the Sealing Checking the pack
Choosing the right
and conditions Filling the pouch process (plan, IQ, OQ, intergrity at different Aseptic Presentation
pouch
PQ) stages of supply cycle
Choosing Right Sterile Barrier System
or Packaging System
For example choosing the right pouch or double pouch or tray wrap

Material performance testing

• Evaluating intended processes
• Making a plan for testing and a table for evaluation criteria
• Testing materials in those processes and using also worst case scenarios
• If using the same packaging system for multiple medical devices or a family of
medical devices, then a rationale should be developed
• The healthcare facility should follow a plan or criteria for evaluating the choice of
sterile barrier systems
• Results of testing should be compared to the acceptance criteria
• The results of the evaluation should be documented

Material stability testing

• Manufacturer documents, third party studies
• Evaluation of pack integrity in the facility according to storage, transportation,
handling and other conditions
• Evaluate pack dryness
• Think also about the possibility of extractables that may leach out of
packaging materials over time. (ASTM D4754)
Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

• Holes often come when packed items or trays are stacked,

when stored and/ or when pulled out from shelves.
• Sometimes SBSs break already during the autoclave
process, handling or transportation
• Hole in the pack means that the items inside are unsterile
– This increases the packaging related costs in OR
– This reduces the productivity of OR team
– Holes may lead into delays in operations
– Hole in the pack creates significant risk for the
patient safety
– Holes also increases the number of claims CSSD is
getting
Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

HOLES
Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

!
Loose particles can
contaminate the sterile
item upon opening.

Bad Peel, fibers coming out. Loose particles. Risk for the patient! Happens due to bad material choices or due
to wrong sealing parameters either at the manufacturer facilities or in the hospital.
 Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

• LEAKAGE IN THE SEALING AREA

LEAKAGE
– This allows a path for microbes to
enter
• DYE PENETRATION TEST FAILING
– SEALS ARE NOT INTEGRITY
– Leakage may be due to wrong
material choice or due to wrong
sealing paramaters or defected
sealer. Leakage may occur also after
sterilization as autoclave vacuum
pulses are very powerful
Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

• Too low Seal Strength levels (EN868-5, ASTM F88 or as reasonable for the process)
• RISK OF OPENING PACKAGE DURING THE AUTOCLAVE PROCESS AND AFTER WHEN
TRANSPORTING OR HANDLING THE PACKAGE
 Choosing Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

WET LOADS (PACKS)

• Moisture in the pack after sterilization means it is unsterile
• Moisture can also create water path for microbes to enter
into the pack
• Moisture is good growth place for the microbes
– May create significant infection risk for the patients
– Wet loads increase the packaging related costs in OR
– Wet packs decrease the productivity of OR team
– May lead to delays in operations
– Increases the number of claims to CSSD
Choosing
. Right Sterile Barrier System
or Packaging System
Failures that we want to avoid – Evaluation Criteria

…printing on or in nonporous film

CONTAMINATION RISK from printing inks or The markings and prints that are in indirect
other extractables contact with the packed items may migrate
through the polymeric film construction.
• the possibility that inks may leak into the
packaging over time, potentially
contaminating the medical device or the
environment
• (ASTM D4754)

!
DO NOT USE
Standards and Guiding documents for
Manufacturers
Responsibilities of the Manufacturer
• Material conformance. Only virgin medical grade materials can
be used. No recycled paper or recycled plastics
• Print safe (outside of packing area), safe inks
• To produce in clean environment. Quality systems in place:
ISO13485, ISO 9001, ISO14001, ISO22000 etc.
• Follow minimum ISO 11607-1 and 2
– EN868 (parts 2-10)
– ISO 11140-1
• Declaration of conformity and studies for material
compatibility, microbial properties, double pouching
validation etc.
• Manufacturer’s instructions needed
– Sterilization method, safety considerations, batch visibility, barrier
properties. Mentioned in IFUs, technical specifications, MSDSs
etc.
Standards for Packaging and Validation
Packaging for terminally sterilized Published (valid) Withdrawn (expired)
medical devices

General requirements for ISO 11607-1:2006/Amd.1:2014 ISO 11607:2006

materials, sterile barrier systems
and packaging systems EN ISO 11607-1:2017 EN-ISO 11607-1:2009;
EN-ISO 11607-1:2009/A1:2014

Validation requirements for ISO 11607-2:2006 EN ISO 11607-2:2006;

forming, sealing and assembly EN ISO 11607-2:2017 EN ISO 11607-2:2006/A1:2014

• ISO TS 16775:2014 for terminally sterilized medical devices — Guidance on the application of
ISO 11607-1 and ISO 11607-2
– Under review at the moment
ISO 11607-2: IQ, OQ and PQ

According to ISO 11607 there should be a documented validation program demonstrating the efficacy
and reproducibility of all sterilization and packing processes (pouches, wrapping, containers).

Sealing Validation for pouches should include protocol and results:

• Validation Plan
• IQ: appropriate and correctly installed sealing device, defining critical process parameters,
controlling and monitoring systems for critical parameters, calibration schedules etc.
• OQ: defining correct process parameters and quality criteria, and then challenging these process
parameters
• PQ: demonstrating that the process is constantly producing acceptable quality of seal under
specified conditions (OQ), three validation runs including ”worst case –scenario”
• Procedure for addressing failures and corrective actions
• Process control and routine monitoring
• Plan for revalidation
 Validation Plan

• Validation plan checklist: Heat Sealing Process Preformed Sterile Barrier

Systems (SBS: Pouches, Reels, etc.)
– Including: Responsible persons, description of SBS systems, assembly
process, description of pouches and reels (or wrapping, containers or self-
seal), description of sealing devices, description of sterilization processes,
description of possible protective packaging, challenges of handling,
distribution and storage, acceptance criteria and qualification steps,
validation report and approval
– Extensive question lists available in ISO TS 16775:2014 guiding
document
Revalidation Considerations

Review of the process, SBS or packaging system should be considered periodically

to ensure that multiple minor changes, which did not require revalidation, have
not affected the packaging system

Sterile Process Device Sterilization

CHANGES TO: Barrier Equipment RE-VALIDATION
System
Steriking® Seal Validation Service Platform
Steriking® Validation Service helps healthcare facilities
to validate their packaging process in accordance with
the ISO 11607-2 requirements
The Wipak Validation Service for one sealing machine comprises of:
• Instructions for Validation
• Templates for documenting Installation (IQ), Operational (OQ)
and Performance Qualifications (PQ)
– Available at website http://sealvalidation.steriking.com
Also available as word files if computer not available in
CSSD
• Testing the seals of sterilized pouches/packs (Wipak laboratory)
• Pinhole testing for sterilized pouches (Wipak laboratory)
• Peel testing/evaluation (Wipak laboratory)
• One Multi Seal test kit (MS300) for routine control
• Validation report with conclusions and recommendations
Checklists for IQ, OQ & PQ Qualification steps
PQ

OQ

IQ
Actual Qualification steps: Short Checklist IQ
Sealing Device Model Serial number

Manufacturer Name Address

CE Conformity  yes  no  evidence
Service/Maintenance Company Contact details
Documentation Available Where? Archiving
Operation Manual  yes  no

Spare Part –list  yes  no

Maintenance and Cleaning Schedule  yes  no

Documented Training of Users  yes  no

Written procedures  yes  no

Conditions and features Remarks

Correctly installed? Volts, Hz, etc.  yes  no Volts Hz
Free of visual and functional defects?  yes  no

Critical process parameters  Temperature  Pressure/Force  Speed/Time

Tolerance: ± °C ± N ± m/min /s
Are these monitored ?  yes  no Evidence:
Signature: Date:
Actual Qualification steps: Short Checklist OQ
Testing conditions Lower limit Upper limit Calibration /Check up

Temperature:  yes  no

Pressure:  yes  no

Speed/Time:  yes  no

Sampling quantity

Quality criteria Before and after sterilization Test method

Completely intact seal  yes  no

No channels or open seals  yes  no

No punctures or tears  yes  no

No delamination or separation  yes  no

Other: specify

Seal strength Min. Max.

Signature: Date:
OQ – Operational Qualification
With Seal Control-Sheet and/or actual pouches

• Made visually and by using for example Steriking®

Smart Dye Test or Sterking® MS300 or some
other ASTM F1929 type of Dye Penetration test
• Using seal control sheets SC250 for Steriking® or
pouches if validating other materials than
Steriking

• NOTE! Seal Control Sheet serves very well as a

document prove of a the daily test
Seal Control Sheets -
For visual check of seal quality

Seal Control sheets (SC250) are constructed of same

materials than See-Through packages.
Seal Control sheets are also available of LT-Blueline
materials (TSC200).
Seal Validation Service – PQ steps

Force in N/15mm
1

0
0 100 200 300 400 500
Path in mm

1 2
Seal the packs, by
3
Sterilize in 3
4
Take instruments
5
Analyses and report
Select 30 items
using different different cycles. out and collect made by Wipak.
and pack them.
temperatures. empty packages.

160°C, 170°C, 180°C, 190°C, 200°C

 Actual Qualification steps: Short Checklist PQ
Defined parameters (OQ) Temperature Pressure Speed / Time

Criteria Sterilization cycle (Run) A Sterilization cycle (Run) B Sterilization cycle (Run) C

Date/time of sterilization
(according to SOPs)

Visual (as per OQ) Compliance Compliance Compliance

Material A  Yes  No  Yes  No  Yes  No

Material B  Yes  No  Yes  No  Yes  No

Material C  Yes  No  Yes  No  Yes  No

Seal strengths / Intactness Test method and institute:

Material A  OK Value:  OK Value:  OK Value:

Material B  OK Value:  OK Value:  OK Value:

Material C  OK Value:  OK Value:  OK Value:

Signature: Date:
VIDEO OF THE SEALING VALIDATION WIPAK
Steriking® Seal Validation Service Platform
Steriking® Seal Validation Service Platform
Steriking® Seal Validation Service Platform
Steriking® Seal Validation Service Platform
Steriking® Seal Validation Service Platform
 Validation Report from Wipak

Giving the sealing window Should be put into files

Report of findings.
Giving and the highest and lowest or can be kept in Wipak
Giving instructions to
recommendations for seal strength limits for the Sealing validation
do corrective actions
improvements. hospital for the specific SBS platform.
when needed.
and specific sealing device.
Routine Control for Checking the Pack Integrity
and Documentation – Steriking® SC250 and MS300
Pouches shall be inspected for intact seals and barrier integrity before
and after sterilization and before use.

Routine tests available from Wipak Steriking®:

MS300
Recommended Use:
• Daily testing and reporting with Seal Control Sheets (SC250)
• Once a week dye penetration test or every time when suspecting a problem
• Works very well after sterilization. Can be done in sterile area, sterile storage or
even up at the theaters
Contents of a Kit:
• 300 pcs Seal Control Sheets
• 1 stopwatch
• 80 ml dye solution (drop flacon and pipette)
• Instructions For Use

Sufficient for testing one sealing

device for 1 year.
Routine Control for Checking the Pack Integrity
and Documentation Steriking® Smart Dye Test
Dye penetration test is easy and clean format
• Ink is packed in single dosages into special aluminum package
from where it is easy to release inside the sterilization package
without any risk of ink transmission
There are two versions of Smart Dye test:
• One for paper/laminate packs (blue ink), SDTB
• One for Tyvek/laminate packs (red ink), SDTP
• Seal integrity can be detected within 5 seconds
Typical problems found during validation
and routine testing + corrective actions
Wet Packs -> What to do?
• Checking packaging procedures:
– Check how loading the autoclave
– Decrease the number of items packed into
tray
– Use of tray liners
• Changing autoclave parameters.
– Longer drying or more vacuum pulses after the sterilization
holding time etc.
• Checking the water quality
• Maintenance of the autoclave
• Using separate steam generators for autoclaves
• Switch from container or linen to single use
wrapping or pouches
Typical problems found during validation and
routine testing + corrective actions
Avoiding Wet Packs - Load related matters
• Do not load too many heavy sets to the same load. (Check manufacturer IFU about the
limits)
• Avoid stacking containers or wrapped trays
• Leave enough space between the trays
• Put peel pouches on their edges or paper side down to allow condesate drop down
• Usually autoclave manufacturers instruct to load containers on the bottom shelves,
wrapped items on bottom or second shelve and peel pouches on top.
• Sometimes recommendation is to place the biggest and heaviest sets as far from the
drain as possible. Reason being that they create the most condensate and this way it is
easiest to get them dry
• Do not put too heavy load into containers or trays (follow IFUs or for example AAMI or
EN standard documents)
Avoiding Wet Packs – Tray Liners
Avoiding Wet Packs – Tray Liners
For absorbing moisture and for extra protection
• For use with surgical instrument trays and containers
• Absorbs excessive condensation during autoclave process
– To be placed into a tray under the instruments and/or under the tray
– Sometimes also under containers or wrapped trays
– Protects the sterilized package against damage
– Protects sharp instruments or tray edges from sticking thru the
wrapping material
• Protects items falling in between the mesh tray holes

WIPAK STERIKING® TRAY LINERS ARE:

• TL – Standard Tray-Liner - 70 g – absorbs 4 times its own weight
• TLWE – Tray-Liner with Edge – 107 g – absorbs 4 times its own weight
• TLNW – Nonwoven Tray-Liner – 45 g – absorbs 6 times its own weight
Autoclave Process
Avoiding Wet Packs
Changing autoclave process parameters

• Drying happens in last phases with residual heat • 3. Drying can be further intensified with steam
• With the heat that has been transferred from pulses in between the vacuum pulses
steam to the packed items • here items are heated with steam with purpose
• If items are wet, heat has not been enough for that items get the needed heat to dry the
drying residual water
• 1. Drying can be influenced with vacuum pulses • This is used usually for heavy instrument loads
where water boils out more easy in lower (metal)
pressure (usually good for textiles and items that
dry easy)
• 2. Drying can be intensified with air pulses in
between the vacuum pulses (usually used for
rubber, plastic and medium sized instrument
loads)
Typical problems found out during routine testing
or validation + corrective actions
Broken packages
• Checking packging procedures:
– Handle packaging with care, see critical points and
areas in the hospital. Change the way of working or try
to fix the environment when possible
– See if instrument could be packed so that sharp parts
would touch the stronger part of the package –
normally film
– Use package with stronger paper or Tyvek.
60g/m270g/m2, 59g/m275g/m2
– Use tyvek or Nonwoven if still stronger package
needed
– Crepe  Nonwoven  Synthetic (SMX)
– Use inner pouch to protect from sharp edges
– USE BETTER/ MORE SUITABLE MATERIALS
Typical problems found out during routine testing
or validation + corrective actions
Broken packages
• Checking packging procedures and quality system:
– If using linen or other reusable textiles, there might be
holes already after one use. Checking of the holes is
manadatory each time when wrapping and when
opening the pack
– Use tray liner or protective corner cards
– Use tip protectors for sharp instruments (small pouch
or special protector)
– Consider disposable materials

Linen wears out during the use

– How to identify possible pinholes
Typical problems found out during routine testing
and validation + corrective actions 3

Force in N/15mm
Weak Seals
1

• Checking packging procedures:

– Do not pack too tight. Only ¾ of the pack should 0
0 100 200
Path in mm
300 400 500

be filled. 2cm per side free space.

– See that paper side is down
– If packing pouch edge down, paper against paper
and film against film. Leave space between the
packs
– Do not pack to the trays which do not have holes
– Pack bowls and such items so that condensate
water may drop out
– Check the seal integrity by doing validation and by
doing routine control
Thank you

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