Overview of Accelerated and Real Time Aging’s Role in Package Validation … · 2020. 4. 26. ·...

March 2017 v2

Katie Tran Laboratory Manager

Overview of Accelerated and Real Time Aging’s Role in Package Validation

https://goo.gl/z3vZEa

March 2017

Katie Tran Laboratory Manager

Overview of Accelerated and Real Time Aging’s Role in Package Validation


Agenda

• Terms and Definitions • Stability Testing • Time versus Temperature

– Relationship – Affects on products

• Case Studies • ASTM F1980

– Changes to 2016 revision • Real Time Aging • FAQs

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Terms and Definitions

• Sterile barrier system – minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

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Terms and Definitions (cont.)

• Aseptic presentation – introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination

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Stability Testing (ISO 11607 Part 1)

• Purpose – Demonstrate that the sterile barrier system

maintains integrity over time

• Stability Testing – Accelerated and Real Time Aging

• Stability testing and performance testing are separate entities

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Performance Testing (ISO 11607 Part 1)

• Purpose – Evaluates the interaction between the package

system and the product in response to stresses

• Manufacturing • Sterilization • Handling • Distribution

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Accelerated Aging: ASTM F1980

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Webinar: Arrhenius Equation Demystified

www.westpak.com/page/resources/webinars

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Accelerated Aging: ASTM F1980

https://goo.gl/z3vZEahttps://goo.gl/OJrJbz

Post-Aging Testing Guidance

• Sterile barrier systems that have been subjected to aging (accelerated or real time) should be evaluated for both physical properties and integrity

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Post-Aging Testing Guidance (cont.)

• Popular test inputs for evaluations – Gross leak detection (bubble) per ASTM F2096 – Seal strength (peel) per ASTM F88

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1 “



• Aging of a specific sterile barrier system is independent of the physical configuration or contents;

• Materials and seals are expected to age the same regardless of their physical configuration or contents as long as the processing of that sterile barrier system is the same, that is, sterilized to the same processes.

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• Evaluate the performance of the aged packaging system during simulated distribution, handling, and storage as well to gather evidence of the device components’ aging characteristics.

• All aging samples will include the devices, or simulated devices, and all the packaging materials that make up the packaging system.

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ASTM F1980: Time vs Temperature

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Temperature Effect on Products

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• Temperatures higher than +60°C are not recommended due to the higher probability in many polymeric systems to experience non-linear changes, such as percent crystallinity, formation of free radicals, and peroxide degradation.


Temperature Effect on Products (cont.)

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• WESTPAK recommends accelerated aging at +55°C


Case Study #1

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• Aging Study: Thermoformed trays deformed @ +60°C • WESTPAK recommends Aging @ +55°C maximum

whenever possible

Client Short on Time: Requested +60OC


Case Study #2

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• Plan A - Aging Study @ +65°C or +70°C if required Perform in parallel with Plan B

• Plan B - Aging Study @ +55°C (back-up plan)

Client Rushes the Shelf Life Study


ASTM F1980-16

• Released October 2016

• Rev History – 2007 – 2002 – 1999 Edition 1

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ASTM F1980-16 (cont.)

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WESTPAK’s Interpretation: Conduct climatic conditioning using ASTM D4332 or ASTM F2825


Real Time Aging (RT)

Ideal World

• Zero Time (T=0) • Accelerated Aging • Real Time Aging

• Conducted at the same time

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Normal Practice

• Zero Time (T=0) then Accelerated Aging then Real Time Aging

• One after another


Real Time Aging - cont.

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• Recommendation: Perform real time aging studies at a test lab, not somewhere at your office location.

• Advantage #1: Lessens the likelihood of loosing samples to team members needing samples for their tests

• Advantage #2: Legitimate test documentation


FAQ #1 – Most Popular AA Temp?

• What is the most popular accelerated aging (AA) temperature?

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FAQ #2

• Is Aging without Transit typical?

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FAQ #3 What’s First - Aging or Transit?

• Aging first or after transit?

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QUESTIONS


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More Questions Later?

Submit webinar and test questions to WESTPAK via our website at

www.westpak.com/contactus.aspx

https://goo.gl/z3vZEahttps://goo.gl/sEkHsW

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Next Webinar Topic

ASTM vs ISTA Package Testing

Which Is Better?

Presenter: Tres Wood, CPP(L), CPLP-II Test Engineer

Date: Wednesday, June 14, 2017

Register at:

www.westpak.com/page/resources/webinars

https://goo.gl/z3vZEahttp://www.westpak.com/page/resources/webinarshttps://goo.gl/BrMXCO

About WESTPAK

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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

Contact Us
https://goo.gl/z3vZEahttps://goo.gl/BrMXCOhttps://goo.gl/BrMXCOhttps://goo.gl/BrMXCOhttps://goo.gl/z3vZEahttps://goo.gl/sEkHsW

Overview of Accelerated and Real Time Aging’s Role in Package Validation … · 2020. 4. 26. ·...

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