ASTM Accelerated Aging Testing
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices For many products it’s critical that they can retain their performance and integrity over time. Packaging Compliance Labs provides ASTM F1980 testing to evaluate the long-term effects on packaging in a compressed timeline. This experimental data can be used to support shelf-life claims until data becomes available from real time aging studies.
The accelerated aging test method is a theoretical calculation of how a sterile packaging system will degrade over time. FDA and ISO 11607 permit medical device manufacturers to go to market using accelerated aging data. The caveat is that real-time aging testing must be run in parallel, to confirm accelerated aging findings. The typical temperatures used to test by most medical engineers are 50C, 55C, and 60C. It is important, however, to consider the materials of construction when determining the test specifications. Our Aging Calculator is a great tool to estimate how many days your study will require. If you have questions about accelerated aging of medical devices, we are ready to discuss your project to recommend the best course of action.
Frequently Asked Questions
Why is accelerated aging testing required for medical devices to go to market?
Section 8.3.1 of ISO 11607 states that “stability testing shall demonstrate that the sterile barrier system maintains integrity over time”. Section 8.3.3. of ISO 11607 also states that “Stability testing, using aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until real-time aging studies are available”.
What is accelerated aging?
Accelerated aging is a theoretical calculation of how a sterile packaging system will degrade over time. Accelerated aging testing provides data that allows medical device manufacturers to go to market with their desired shelf-life claim.