Review of Accelerated Aging AA per ASTM F1980-21

We discuss the key points, brief theory, and recent updates to the ASTM F1980 ‘Accelerated Aging of Sterile Barrier Systems and Medical Devices’ protocol. Explore the relationship with real-time aging and its crucial role in establishing the required expiry dates for medical devices and pharmaceuticals.
Our discussion includes:
• The typical AA temperatures.
• Use of controlled or uncontrolled RH.
• AA time calculation.
• Psychrometric chart interpretation.
• Aging plan development.
• Additional tests to consider prior and post accelerated and real-time aging.
We also review common FAQs, including the maximum temperatures advised for medical packaging polymers, how medical device products could be affected by heat and humidity, and the use of controlled humidity during AA.
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