The presentation discussed developing a package validation protocol according to ISO 11607 to minimize time to market. Key points included common sections in a protocol, issues to avoid, choosing appropriate testing methods and acceptance criteria, and partnering with a test lab. Flexibility in protocol design and planning for potential issues can help speed validation and product launch.
The presentation discussed developing a package validation protocol according to ISO 11607 to minimize time to market. Key points included common sections in a protocol, issues to avoid, choosing appropriate testing methods and acceptance criteria, and partnering with a test lab. Flexibility in protocol design and planning for potential issues can help speed validation and product launch.
The presentation discussed developing a package validation protocol according to ISO 11607 to minimize time to market. Key points included common sections in a protocol, issues to avoid, choosing appropriate testing methods and acceptance criteria, and partnering with a test lab. Flexibility in protocol design and planning for potential issues can help speed validation and product launch.
The presentation discussed developing a package validation protocol according to ISO 11607 to minimize time to market. Key points included common sections in a protocol, issues to avoid, choosing appropriate testing methods and acceptance criteria, and partnering with a test lab. Flexibility in protocol design and planning for potential issues can help speed validation and product launch.
President & CEO Vice President Quality Manager Presenter Presenter Presenter 2 Agenda Description of a packaging system FDA requirements for package validation ISO 11607 Common sections in a package validation protocol Common issues when developing the your protocol Choosing a package test lab Partnering with your lab to minimize time to market
3 Packaging System
Sterile Barrier System
Primary package that allows for sterilization and provides an acceptable microbial barrier
Protective Packaging Secondary and tertiary packaging Contains and protects the SBS
4 FDA Requirements The packaging system must provide adequate protection against damage during shipping and maintain sterility of the device for the duration of the intended shelf-life. Prove that your packaging can do this with:
Recommends being compliant with ISO 11607 Packaging for Terminally Sterilized Medical Devices
5 ISO 11607 The guidance document for validating sterilized medical device packaging Compliance shows that your packaging system allows sterilization, provides physical protection, and maintains sterility up to the point of use. FDA Recognized Consensus Standard and required for European Regulation for a CE mark
6 ISO 11607 Just a guidance document Requirements that must be satisfied for compliance Does not identify which specific testing must be conducted
7 Common Sections in a Protocol Purpose Scope Referenced Documents Sample Size Equipment Responsibilities Sample Preparation Sterilization Package Integrity Testing Shelf-life Aging Sterile Barrier System Integrity Testing Acceptance Criteria
8 Common Sections in a Protocol Purpose - reason for the protocol Scope the extent of what the protocol applies to or deals with Responsibilities what parties are responsible for what sections of a protocol Sample Prep details on pkg configuration, numbering, live or dummy units, testing designation, etc. Sterilization details of sterilization following packaging prior to testing
9 Referenced Documents Industry standards or SOPs referenced for executing the protocol
Issues often seen
Referencing old versions of documents Consult your package test lab for information on revisions and changes. Referencing internal SOPs and not providing them to the lab.
10 Sample Size Use company SOPs for sample size and rationale
In the absence of an SOP or supporting data
Based on Attribute Sampling, use 59 samples for 95% confidence/95% reliability A total of 59 sterilized units or primary packages If you want more detailed information on this and the rationale behind it, we can assist you offline if you contact us.
11 Equipment Equipment used will be in current calibration Packaging test lab will provide equipment identification and calibration dates in their final report
12 Package Integrity Testing Distribution simulation to challenge your package system to the shipping and distribution environment
ASTM D4169, ASTM D7386, ISTA
sequences, or custom sequence Climatic conditioning Drop testing Compression testing Vibration testing Concentrated impacts Low pressure
13 Package Integrity Testing Test Procedure Recommendation? FDA Recognized: ASTM D4169 and ASTM 7386 Consensus standards, sequences and inputs are designed from empirical data, and are recognized by the FDA
Consult your package test lab for guidance
14 Shelf-Life Aging Real time aging Accelerated aging to accelerate the adverse of aging with increased temperature
15 Shelf-Life Aging What accelerated aging temperature to use? Based on different variables (Q, RT temperature, shelf life, etc.) in ASTM F1980 Higher the temperature = faster aging Typically 50C, 55C, 60C
Know your packaging material and
product characteristics Avoid temperatures that would damage your product or packaging
16 Sterile Barrier System Integrity Testing To identify any breaches in the SBS following package performance testing and aging Gross Leak Detection (bubble) testing, Dye Penetration Visual Inspections
To demonstrate adequate seal strength
Peel Testing Burst Testing
17 Sterile Barrier System Integrity Testing Visual Inspections, Gross Leak Detection (bubble) testing, or Dye Penetration Testing? Visual Inspections detection rate as low as 60% Dye Penetration evaluates only the seals of the SBS Gross Leak Detection evaluates the entire SBS Our internal validation demonstrated >90% detection rate with this method
18 Sterile Barrier System Integrity Testing Seal strength testing (peel) testing or Burst Testing? Peel testing measures the strength of your seals Burst testing identifies weak spots or evaluates how the seals hold up to pressure differentials
19 Speed to Market
Pitfalls in the validation process can
stall the launch of a product.
Avoiding these pitfalls can help speed
your product to market.
20 Allow Ability to Decrease Top Load Box: 24 x 12 x 12 Box: 24 x 12 x 11.5 Top load: 1,600 lb Top load: 709 lb.
H = 108 H = 54 F = 10 F = 10 Load = 1,600 lb Load = 709 lb
21 Allow Ability to Decrease Top Load Box: 24 x 12 x 12 Box: 24 x 12 x 12 Top load: 1,600 lb Top load: 800 lb.
H = 108 H = 108 F = 10 F=5 Load = 1,600 lb Load = 800 lb
22 Peel Testing Acceptance Criteria Attribute data acceptance criteria typically 1.0 lbf/in seal. Fails validation if 0.98 lbf/in? Suggest that mean should be 1.0 lbf/in, absolute min could dip to 0.8, 0.6, etc. EN 868- states minimum value for seal strength shall be 1,5N per 15mm for steam sterilization processes and 1,2N per 15mm for other sterilization processes Equates to 0.57 lbf/in for 1.0 seal
23 Flexibility in Aging Manipulation of variables can decrease test duration. Beware of glass transition point!
24 www.medicalpackagetesting.com 25 Stay Inside Your Wheelhouse In house attribute testing may save money, but it rarely saves time or more work in the long run.
Outsourcing full validation
protocol to a test lab collates all calibration, engineer and data into one report.
26 Know your Product and Protocol
Is the shipper What is the
over-packed? purpose of testing?
What is the strength of the Which surface corrugated? do you consider the base? What is the strength of the corrugated?
27 Planning for The Unforeseen While every effort is made to avoid a non- conformance, errors occur.
Memo: to file Date: 2014/10/09 Justification: re: Validation anomaly An error occurred during the testing of <Products package> which should not effect the results of testing based on x y z.
28 Summary of Discussion Decrease compression load
Understand Planning for Peel test unforeseen criteria Enable to speed to market by incorporating into protocol Know your Utilize product and accelerated protocol aging factors
compliance to management, accredited cal, conduct ISTA consistency, UoM budgets, testing documentation etc. Highest standard 30 Partnering With Your Lab Create an atmosphere of partnership with your testing lab. Learn each others purpose for testing and processes for efficiency.
31 Partnering With Your Lab Discuss early and often any urgencies you are up against.
32 Partnering With Your Lab Relay all critical information. Communicate visual inspection criteria.
33 Partnering With Your Lab Contact the lab early to set timing expectations.
34 Conclusions FDA Requirements for Package Validation ISO 11607 requirements Common Sections in a Validation Protocol Common issues and things to avoid when developing the your protocol What to look for when choosing a third party test lab to execute your protocol How you should work closely with your lab
35 About WESTPAK, INC.
Two Locations:
San Jose Laboratory San Diego Laboratory
83 Great Oaks Boulevard 10326 Roselle Street San Jose, CA 95119 San Diego, CA 92121 408-224-1300 858-623-8100 www.westpak.com projects@westpak.com
36 THANK YOU !
Please feel free to Contact Us with any questions or
assistance with your testing needs.
Herb Schueneman Nora Crivello Kevin Fernandez
President and CEO VP, San Jose Quality Manager Herb@westpak.com nora@westpak.com Kevin@westpak.com
