Stability Testing in Medical Devices (Accelerated Aging)

Stability Testing in Medical Devices (Accelerated Aging)

Stability testing is performed to determine how the quality of a medical device changes over time as it is affected by environmental factors such as humidity, temperature, and light. Among the stability tests, accelerated stability testing is preferred because real-time stability testing takes longer.

It is stored in air conditioner cabinets for a shorter time, at high temperature, in real time. It is based on the assumption that the chemical reactions that cause the deterioration of medical devices with accelerated aging follow an Arrhenius reaction rate function. An Arrhenius reaction is one in which an increase or decrease of 10°C causes a two or half change in the rate of a chemical reaction.

Aging tests are performed on the final product and if this directly affects the quality of the product; Stability studies should be repeated if there are cases such as changing the package, changing the sterilization method. During stability tests, intermediate control tests should be performed at certain intervals. At the end of the test, the sterility of the product should be assessed.

ASTM F1980 'Accelerated Aging of Sterile Barrier Systems for Medical Devices'

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