Do you know what ISO 11607 package integrity testing recommends for every medical device that is heading to market, including yours? Do you know what can happen if steps are skipped or overlooked?
ISO 11607-1 requires that “packaging systems shall maintain sterility until the point of use or the expiry date.”
It doesn’t take a scholar to see why this is critical: medical devices treat medical conditions. They may even go inside the body—of someone you love. It doesn’t get any clearer than that. We are universally in favor of maintaining sterility and validating packaging to promote the efficacy of our clients’ products.
There are two methods of medical device package testing that prove a packaging system’s ability to meet one of ISO 11607 requirements:
- Accelerated aging studies (ASTM F1980) simulate the effects of storage conditions in a shorter timeframe. ISO 11607-1 requirement? No, accelerated aging is not required by ISO 11607, however if it is used, stability testing accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.
- Real time aging studies simulate the effects of storage conditions in real time! ISO 11607-1 requirement? Yes. Stability testing shall determine that the sterile barrier maintains integrity over time and shall be performed using real time aging.
By all means take advantage of the benefits of accelerated aging tests. You may get early results that your packaging performs well—or early warning of a problem that can be fixed now, before launch. Plus, your product can be approved by regulatory bodies for launch during the pendency of real time aging results; six months, a year?
Real time aging performed alongside accelerated aging serves to validate your packaging system’s ability to maintain integrity through anticipated storage conditions.. They are a double-whammy of assurance in the reliability and consistency of your methods, materials and performance. And, until industry regulators say otherwise, you can skip ASTM F1980 if you dare, but real time aging testing is an ISO 11607 package integrity testing requirement, plain and simple.
Best Practices of Real Time Aging
Starting both real time and accelerated aging tests simultaneously is the most direct path to success. If you go in another direction, know the risks you are assuming and how you would rationalize your path if asked.
Another key best practice is to anticipate and test your packaging systems under all known storage conditions that could present along the supply chain. If storage conditions are unknown, rationale should be prepared describing how ambient conditions accurately represent the MDM’s supply chain storage conditions.
Worst Practices of Real Time Aging
DON’T subject packaging systems to conditions that are not representative of (or are more extreme) than what has been established as worst case forces of sterilization and storage by the MDM.
- Cause negative results from integrity testing after aging intervals passed.
- Put you in an awkward position. If your device was distributed based on successful accelerated aging validation results, and then real time aging validation testing shows contradicting evidence that the packaging could not maintain sterility as required by ISO 11607.
- Create difficulty in proving to governing bodies that your packaging system has been properly validated through stability testing.
These principles sound so basic. Yet, so many issues that come into our lab began as nothing more than an oversight, a lower priority, or the reality that many teams operate without a regulatory consultant in house or on-call.
For more on this topic, see FDA Packaging Feedback. If you’re facing an issue or would like to connect with a regulatory expert, check out the PCL ISO 11607 Audit Microprogram. (Scroll down the page to ISO 11607 Audit)
In February, ISO published an update: ISO 11607-1:2019 that may also be of interest.
To better serve our clients Real Time Aging needs, PCL has recently made an investment in expanded capacity. To ask a question or get a quote for real time aging, please reach out here.