by Jennifer Dean
A truly thorough understanding of ISO 11607 is needed to ensure product efficacy and ultimately, patient safety. And yet, everyday medical device packagers face failures and even product recalls.
So, let’s take a look at the four basic aspects of sterile barrier system expiration dating.
- Relevant definitions
- Performance testing vs. stability evaluation
- Real time vs. accelerated aging
- Suggestions for expiration dating evaluations
A package stability evaluation demonstrates the sterile barrier system maintains integrity over time. So when we say the term “package stability/expiration,” we’re referring to the date the product should be used.
There is a difference between “performance testing” and “stability evaluation.” Performance testing evaluates the interaction between a packaging system and the product in response to the stresses imposed by the manufacturing, sterilization, handling, storage and shipping processes and environment. Whereas, stability evaluation demonstrates a package system’s ability to maintain an acceptable level of its critical characteristics after exposure to specified sterilization cycles and time. Stable testing is usually part of an overall packaging validation program.
When looking at real time vs. accelerated aging, remember that aging should be done using a real-time method. Accelerated again data is acceptable as long as it’s started in parallel with real-time testing sequences. As stated in the ISO 11607 standard, stability testing via accelerated aging protocols will be considered sufficient evidence for claimed expiration dates only until data from real-time aging studies are available.
When evaluating expiration dating evaluations, consideration should be given to worst-case as specified for sterilization cycles, as well as the number of exposures possible in the everyday production environment.
The topic of package/material stability evaluation has generated some great debates and articles from industry leaders. Watch the news wire for more updates on this sometimes tough topic.