Aging tests, along with heat seal validation and distribution simulations, are essential elements of the medical package testing protocols required by ISO 11607. The ISO standard requires specific test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. This ensures accurate expiration dates and that products are sterile and safe when healthcare professionals are ready to use them.
When it comes to aging, many manufacturers focus on accelerated aging and successfully establishing an estimated shelf life for medical devices. But another aging test often gets overlooked – real-time aging.
Understanding how accelerated and real-time aging tests work in tandem starts with an understanding of the difference between the two processes.
Real-time aging programs provide the best data to determine shelf life and the effects of aging on materials. But it’s time-consuming. As the name implies, the tests can take years. During this time, the product sits on a shelf and is exposed to environmental changes, such as temperature and humidity fluctuations, that simulate the real-world circumstances the product may experience during its lifecycle.
Accelerated aging, on the other hand, uses a mathematical calculation based on Arrhenius’ equation to estimate the impact of various environmental conditions on the product lifecycle. There are established best practices around conducting this accelerated aging, which is covered by the ASTM F1980 standard. To calculate timelines for accelerated aging tests, use our accelerated aging calculator.
The Right Time to Start Real-time Aging
Real-time and accelerated aging are designed to be utilized in tandem, occurring after the integrity of a product and package has been determined and prior to commercialization. Accelerated aging provides a conservative estimate for product shelf life that, when done properly and with proper documentation, satisfies that portion of the ISO 11607 standard requirement. But that standard also requires real-time aging.
So, when should manufacturers begin real-time aging?
The answer is to start real-time aging at approximately the same time you begin accelerated aging.
While the ISO standard doesn’t require that aging tests start at or near the same time, it is the recommended approach. Not to mention, it’s what any auditor or inspector will expect.
It’s the best way to create a testing timeline in which you’re comparing apples to apples, and it creates the shortest time between accelerated testing results and real-time findings to support them.
Best Practices for Real-time Aging
During real-time aging, it’s critical to make sure testing conditions do not fluctuate beyond expected real-world conditions and the accelerated aging parameters designed to reflect those conditions. Facility issues caused by natural disasters, utility service interruptions, and more are all a threat to the integrity of the real-time testing that needs to take place over months and years. Additionally, it’s important to make sure all documentation and written protocols also comply with relevant standards and don’t create any additional headaches when it comes time to deliver the results of real-time aging tests.
Life Science Outsourcing has decades of experience helping device manufacturers navigate medical package testing requirements and related standards. That includes incorporating established best practices and recommended timing into real-time and accelerated aging processes.