In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson discuss some of the common questions they receive on ASTM F1980 Accelerated Aging Testing:
What is Accelerated Aging?
Accelerated Aging is a process of putting packaged products into a chamber, elevating the test temperature to claim a specific expiration date for a medical device product or package. ASTM-F1980 is meant for sterile medical packaging but many companies and or organizations have been using it to claim specific expiration dates for their products.
When to use it?
Primarily medical device manufacturers will use accelerated aging in their package validation to be in compliance with ISO 11607.
How does AA work?
ASTM-F1980 is the document; the theory itself is the Q10 theory. For every 10 degree increase it doubles the reaction rate of the materials. This Q10 factor came from the food industry. This is not an exact science but the FDA allows you to use this theory to get your products to market faster. But you will need to follow it up with real time aging. In doing so, you want to have conclusive evidence that you are not going to have issues with your package or product for that specific shelf life.
Can you use any temperature for AA?
You need to understand where the softening or melting point is before you can pick a test temperature that is going to work properly. Accelerated aging is meant for homogeneous materials while most medical devices are comprised of multiple materials can lead to trouble. DDL Package Engineer Scott Levy tells a story of how early in his career at DDL he was working with a customer that wanted to use 70°C for accelerated aging for a product in a PETG tray. Scott put the trays into the chamber on a Friday and on the following Monday they were sludge and deformed on the bottom of the chamber. This was a great lesson and ever since then Scott makes sure to work with his customers to ensure they choose the proper temperature for their accelerated aging needs.
For more detail on the information, please watch our introduction video on Accelerated Aging Part 1.
If you have any questions, or need further information on Accelerated Aging or other testing services, please contact us to speak with one of our packaging engineers.