New or modified medical device products require assurance they can be stored for an extended period of time without performance decrease when the products are used. This is especially true for sterile barrier performance.
Medical package testing must acquire that assurance in the form of specific testing methods.
A common question from medical device clients looking to test their packaging is “What is the difference between real time aging and accelerated aging?” That’s usually followed with, “Why do I need both?”
Continue reading for the answers.
What is real time aging?
Real time aging programs are a part of the stability testing process. They provide data to determine shelf life and the effects of aging on materials. This is especially important for medical devices and their packaging, which need to be reliable up to the point of use.
Real time aging as a test is performed in literal fashion. The medical device in its packaging is placed on a shelf to expose it to common storage conditions such as:
- Temperature fluctuations
There is one small issue: Medical devices do not have the luxury to wait around on a shelf. Patients often need them as soon as possible. Waiting for packaging data while innovative medical devices slowly gather dust could be problematic.
That leads us to accelerated aging.
What is accelerated aging?
Medical package testing accelerated aging is conducted by simulating the period claimed for product expiration. How is this simulation achieved? By exposing its packaging to temperature and humidity levels within a specific chamber. The product packaging is exposed at a much faster rate to conditions it is expected to survive during its shelf life. The accelerated aging calculation is based on Arrhenius’ equation which simply states that a 10C increase in temperature doubles the rate of chemical reaction.
Here’s where real time aging and accelerated aging overlap. The identified accelerated aging expiration date is tentative until results from real time aging are obtained. Regulatory bodies will only recognize accelerated aging data as acceptable until those tests can be repeated on real-time product packaging samples. Until then it is only viewed as a conservative estimate of shelf life.
Accelerated aging has two primary standards pertaining to medical device sterile barrier systems:
Medical device accelerated aging of sterile barrier systems: ASTM F1980
The American Society for Testing and Materials (ASTM) has developed specific guidelines for accelerated aging.
The ASTM F 1980 guide provides documentation for accelerated aging protocols to determine the effects (if any) related to passage of time on the sterile integrity of the sterile barrier system defined in ANSI/AAMI/ISO 11607-1:2019
This experimental data supports performance and shelf-life claims until real-time aged samples are available.
Getting started with medical package testing
When you’re ready to test your medical device packaging, you’ll likely engage in both testing methods at once. Your package testing resource will work with your team to establish testing needs and begin real-time testing while planning for accelerated aging testing.
There you have it! Real-time aging and accelerated aging testing are both needed to deliver your product to market in a quick, efficient way. Real-time aging takes much longer, but it is the ultimate test for shelf stability and is required by the FDA in the long run. Accelerated aging reduces your time to market with a good estimate of shelf life recognized by the FDA until your real time aging testing is complete.