Accelerated Aging Test for Medical Devices

Accelerated aging is the idea that a certain packing system will age at the same rate regardless of how the container is made or what is within it. Simulating real-time aging in a shorter amount of time by storing samples at a higher temperature is the essence of accelerated aging. The guide for performing accelerated aging tests on sterile medical device packages is provided in ASTM F1980.

Accelerated Aging Test for Medical Devices

To verify shelf-life claims, an accelerated aging test for medical devices is utilized to replicate real-time shelf-life aging. The guide for performing accelerated aging tests on sterile medical device packages is provided in ASTM F1980.

The theory behind accelerated aging holds that exposing a packaging system to external stress during storage that is more intense than typical environmental stress for a shorter period of time is equivalent to the normal amount of stress the same packaging system experiences during storage over a longer period of time. This theory predicts how quickly materials would deteriorate based on an Arrhenius reaction rate function. According to the Arrhenius reaction rate, a chemical reaction has a change rate that is roughly two times as fast for a temperature increase of 10°C.

A product’s stability can be determined in half the time it takes to do real-time stability testing by using the most popular accelerated aging test techniques. The evidence collected through the aging test may be utilized to justify the expiration date. This expiration date won’t be made official, though, until real-time stability testing has been completed.

The typical storage temperature for packs during an accelerated aging study is 55°C. A 6-week period at this temperature is equivalent to a year of natural storage at room temperature (23°C). Blisters, pouches, and both porous and non-porous packs can be tested using this technique. 

Video 01: ASTM F1980 Accelerated Aging

Experimental Parameters for ASTM F1980 Accelerated Aging Test:

• Number of specimens/products: to be specified
• The experimental setup must reflect the real product storage and use conditions or ambient temperature, typically between 20^oC and 25^oC.
• Accelerated aging temperature: To be specified, but typically below 60^oC since higher temperature may induce nonlinear changes.
•  Accelerated aging factor: To be specified. It is calculated by the Arrhenius equation:

Where:

T_AA: Accelerated aging temperature in ^oC.

T_RT: Ambient temperature in ^oC.

Q₁₀: Chemical reaction rate, which is typically 2.

Limitations of Accelerated Aging Tests

• Due to harsh climatic conditions like high humidity and high temperature, accelerated aging will not address environmental concerns.
• For some product packaging technologies, it is not possible to accelerate aging.