Accelerated and Real-Time Aging Testing for Sterile Barrier Packaging

Accelerated and real-time aging testing to determine the shelf life of products is a major part of medical device manufacturers’ product development process. We recently sat down with Dylan Keane, laboratory lead for Nelipak Laboratory Services, to learn more about this testing service.

Why are aging tests important?

Aging trials are performed to ensure the sterile barrier system is still intact during the shelf life of the product. Real-time aging takes much longer, but it is the ultimate test for shelf stability and is required by the Notified Bodies in the long run. Accelerated aging reduces time to market with a good estimate of shelf life recognized by the Notified Bodies such as the FDA until your real-time aging testing is complete.

What is accelerated aging?

Accelerated aging is a theoretical calculation of how a sterile packaging system will degrade over time. Accelerated aging testing provides data that allows medical device manufacturers to go to market with their desired shelf-life claim without waiting the entire period of the real-time shelf-life testing, which can stretch into several years.

How is accelerated aging performed?

Nelipak performs the testing based on the ASTM standard F1980. This testing allows a product to be stored under a set temperature over a set period. This extra stress, which is more severe than normal environmental conditions, causes an accelerated variation in the packaging properties over time. Using the Arrhenius equation, a temperature can be selected to calculate a period for accelerated aging. For example, a product normally stored at 23°C undergoing accelerated aging at 50°C would be equivalent to a year of aging after only 57 days or five years after 281 days.

How is real-time aging tested?

For customers looking to perform real-time aging, Nelipak can store your product in ambient conditions, which are constantly monitored by our system to ensure traceability as long as the product remains in real-time storage.

How can the testing be customized?

Nelipak has several aging chambers set to various temperatures, allowing customers to select a temperature suitable to their product and aging timeframe. Nelipak also offers different humidity setpoints if a customer is looking to age a product that may be sensitive to humidity in the environment. In addition, our chambers are continuously monitored to ensure the aging process of our customers’ products is uninterrupted.

What aging-related defects do you look for?

In aging studies, Nelipak looks for time-related defects. Some examples of this are:

  • Over time, seals can soften and loosen up
  • There might be tension in a package
  • The material can delaminate
  • The packaging could change in color