Overview of Accelerated and Real Time

Aging’s Role in Package Validation

Katie Tran
Laboratory Manager
March 2017
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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Accelerated Aging: ASTM F1980
Webinar: Arrhenius Equation Demystified
www.westpak.com/page/resources/webinars

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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
1“

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Post-Aging Testing Guidance (cont.)
• 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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Post-Aging Testing Guidance (cont.)
• 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
• 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.

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Temperature Effect on Products (cont.)

• WESTPAK recommends accelerated aging at +55°C

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Case Study #1 Client Short on Time: Requested +60OC

• Aging Study: Thermoformed trays deformed @ +60°C

• WESTPAK recommends Aging @ +55°C maximum
whenever possible

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Case Study #2 Client Rushes the Shelf Life Study

• 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)

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ASTM F1980-16

• Released October
2016

• Rev History
– 2007
– 2002
– 1999 Edition 1

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ASTM F1980-16 (cont.)

WESTPAK’s Interpretation: Conduct climatic conditioning

using ASTM D4332 or ASTM F2825

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Real Time Aging (RT)
Ideal World Normal Practice
• Zero Time (T=0) • Zero Time (T=0) then
• Accelerated Aging Accelerated Aging then
• Real Time Aging Real Time Aging

• Conducted at the same • One after another

time

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Real Time Aging - cont.
• 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

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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

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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

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 About WESTPAK

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

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