In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson address some of the common questions they receive on ASTM- F1980 Accelerated Aging Testing. This is part two of the series. Please click here to view part one.
What role does relative humidity play in accelerated aging?
Accelerated aging is based on time and temperature. Humidity doesn’t play a role in the Q10 factor used to determine the amount of time required. A package should be aged at low relative humidity because as the temperature is elevated you must also mimic that same about of moisture content. For example, if you are using a test temperature of 55° with a 60% relative humidity and look at the moisture content, you will be over 100% moisture rate. In the real world you are not aging your samples at 55 to 60°C. Thus, you do not want to cause a failure you are not going to see in real time aging.
What comes after Accelerated Aging?
Accelerated aging is a conditioning step. It does not tell you if you pass or fail, it is what comes after accelerated aging that indicates a pass or fail. After accelerated aging comes package strength testing and integrity testing to make sure there isn’t a sterility breach in the package. If it is product testing, you want to go through all of the tests that you would have done at time-zero or your baseline to ensure aging hasn’t caused adverse effects and compare those results back up.
Why is Real Time Aging important?
Real time aging is critical. If you have a device and that device sits on the shelf with a three-year expiration date, by the time the three years goes by, the product may be obsolete. Accelerated aging thus allows customers to bring products to market faster. Real time aging is definitive data that you’re going to get with having your samples stored on a shelf for the same specific expiration date used for accelerated aging.
Issues seen with Accelerated Aging
Planning is the number one issue with accelerated aging. When a customer says, “I need to run a five-year expiration date before next month,” there is no physical way to do this. Even if you move the temperature to 100°C. Some may keep moving the temperature up to meet specific needs for the launch date. Putting the samples over 60°C is a red flag thought that will come up in regulatory review. As you will most likely run into problems with the product performance and packaging system failure by choosing a test temperature that’s not going to realistically mimic the real world.
Thank you for watching Part two of DDL’s PackReview series on ASTM-F1980 Accelerated Aging. If you have any questions, or would like a quote, please contact us to speak with one of our packaging engineers.