One of the questions ISO 11607 asks MDMs to answer is how long a packaged medical device will last (or how quickly it will deteriorate) during storage—a/k/a real time aging. When planning your device launch, it can be frustrating to think about waiting years to prove that a packaged product will still be safe for use down the road. You understand why it’s important, but wow, years.
ISO 11607 also provides a faster way to get to market while the full validation process plays out: accelerated aging. By simulating the passage of years, scientifically compressed, accelerated aging testing predicts likely performance outcomes of your medical device packaging system. To see more about accelerated and real time aging, you may want to check out this previous post. But accelerated aging tests are optional. Under ISO 11607, real time aging is required.
It’s smart to have a plan for this slow moving iceberg that is carving out your future.
Just Put It On a Shelf
It may seem easy enough to park your packaged product on an in-house shelf and conduct your own real time aging. What’s the big deal? There are many valid reasons to call out the old disclaimer, “Do Not Try this at Home” and instead enlist the services of a quality professional lab when it comes to real time aging.
Using an ISO-certified lab is not only a stress reliever, it’s a much safer means of getting to market on time. Here are some reasons why:
Things Happen
A prime illustration of things happening is Hurricane Dorian, happening as this is published. Dorian left a wake of total destruction in Grand Bahama and Abaco islands. Now, Dorian is lumbering up the east coast of the US. While Hurricane Dorian may not affect your medical device by geography or force, it is a reminder that extreme and unpredictable events happen.
Even if you feel safe from major disasters, there are “very likely to occur” plain-jane risks that can ruin a real time aging study just as quickly. The classic power outage. A roof leak. A fire. A burst pipe. You get the idea. All kinds of unanticipated events can change the conditions of DIY real time aging. It is a scenario that usually means starting over.
We’ve Got Your Back
You may be wondering why we think negative events wouldn’t impact a lab like PCL just as easily. While surprises may happen, Packaging Compliance Labs builds in–and looks for new–ways to protect our clients’ studies. In fact, we are happy to announce a new capability to serve and protect real time aging studies and more:
- Meet the Mezzanine! We’ve completed a major expansion that will benefit our clients using PCL for real time aging studies. The Mezzanine adds new space and opportunities. Located in our temperature-controlled warehouse, the addition of the mezzanine will allow us to house more and larger lot size real time aging projects.
The Mezzanine joins two unique protections PCL already offers when you entrust your testing to our lab. Did you know about these?
- We are a Super Power. We selected our facility location to be on the same electrical grid as our international airport. As a result, our complex is served by backup generator substations. This also means our grid is slated for first-priority intervention should a major utility event occur.
- We keep a Log Library. Part of our daily operational approach is meticulous climate-control record keeping. This not only ensures the accuracy of real time test conditions, it creates a continual, detailed record of conditions. This ongoing data provides long-term evidence to support your case should any regulatory inquiries or audits come your way.
We follow a strict protocol for the setup, storage and monitoring of real time aging studies. We are equipped technically and mechanically to minimize risk of impact from outside factors.
Real Time Aging You CAN Do In-House
If you visited our earlier post on real time and accelerated aging, you saw some best practices—and worst—for aging studies. We’ve offered some insights on why real time aging testing may not be worth trying yourself. There are, however, some steps you can do in house to set the stage for best results with your test lab. The biggest risk of not following these recommended steps is literally wasting years of time, which is catastrophic in the rapidly evolving medical and pharmaceutical industries. Start here, then start a conversation for next steps.
- Identify and test your worst-case scenario product or component for which a packaging system will be used. Choosing an easy win (i.e., small and lightweight), is highly likely to result in the FDA calling for additional testing before approval.
- Establish worst-case product expiry dates. This is no time for a guess. Look at historical data and ask questions with your product and marketing departments.
- Identify and test for additional requirements such as sterile barrier and DFMEA and PFMEA testing.
- Perform baseline T-0 testing! Then, run concurrently with an accelerated aging study with, say your 5-year real time aging study. You may be able to spot an issue earlier to preserve a portion of real time testing to that point.
Interested in seeing more about the overall validation process? Download our free 3 Pillars of Packaging Validation handbook.