What is Accelerated Aging?
Accelerated aging is used to simulate the effects of real-time aging by subjecting samples to elevated temperatures for specific periods of time. It also helps provide data that allows the manufacturer to accurately predict the effect of real-time aging on a package and its enclosed product.
Concurrent with the accelerated aging process, the manufacturer must also conduct real-time studies in order to substantiate the data generated during the accelerated aging process.
Why Perform Accelerated or Real-Time Aging?
The introduction of new or modified products requires the assurance that they can be stored for an extended period of time without any decrease in performance that may affect safety and efficacy when the products are used.
It is necessary to conduct accelerated aging tests and generate data to:
- Prove the packaging provides a sterile barrier for the defined lifetime of the product or up to its point of use
- Bring product to market at the earliest possible time
Accelerated aging techniques are based on the assumptions that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate function. This function states that a 10°C increase or decrease in the temperature of a homogenous process results in approximately two times or ½ time change in the rate of a chemical reaction.
At 55°C, 6.5 weeks is equivalent to one year on-the-shelf. For example, at 55°C, 13.0 weeks would be equivalent to two years, and 32.5 weeks is equivalent to five years.
STERIS provides a range of accelerated aging conditions with and without humidity control in chambers, which accommodate both large pallets and small packages.
ISO 11607 – Packaging for Terminally Sterilized Medical Devices
ASTM F1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices