overview of accelerated and real time aging’s role in ... · march 2017 katie tran laboratory...
TRANSCRIPT
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
2
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
3
Terms and Definitions (cont.)
• Aseptic presentation – introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination
4
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
5
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
6
Webinar: Arrhenius Equation Demystified
www.westpak.com/page/resources/webinars
8
Accelerated Aging: ASTM F1980
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
9
Post-Aging Testing Guidance (cont.)
• Popular test inputs for evaluations
– Gross leak detection (bubble) per ASTM F2096
– Seal strength (peel) per ASTM F88
10
1 “
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.
11
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.
12
Temperature Effect on Products
14
• 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.)
15
• WESTPAK recommends accelerated aging at +55°C
Case Study #1
16
• Aging Study: Thermoformed trays deformed @ +60°C
• WESTPAK recommends Aging @ +55°C maximum whenever possible
Client Short on Time: Requested +60OC
Case Study #2
17
• 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
18
ASTM F1980-16 (cont.)
19
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
20
Normal Practice
• Zero Time (T=0) then Accelerated Aging then Real Time Aging
• One after another
Real Time Aging - cont.
21
• 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?
22
26
More Questions Later?
Submit webinar and test questions to WESTPAK via our website at
www.westpak.com/contactus.aspx
27
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
About WESTPAK
28
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