Real-time Aging and Accelerating Aging tests are often performed together to determine the shelf life and effects of aging on materials. Accelerated aging data is recognized by regulatory bodies as an acceptable means to generate data quickly, but this data is only accepted until those tests can be repeated on real-time product/package samples.
Real-time Aging tests are conducted by placing the test item on a shelf and allowing it to be exposed to typical storage conditions. Doing this will establish the item’s accurate expiration date and provide the best data to determine shelf life and the effects of aging on materials.
However, this test is not feasible in today’s market conditions in which products often become obsolete in a short time, and there is a need to shorten the product turnaround time. Time spent sitting on the shelf could prevent lifesaving devices from helping patients in need or could render the device obsolete before it reaches the market.
To work around this, Real-time Aging is performed in conjunction with Accelerated Aging tests. Accelerated Aging is a testing method used to estimate the useful lifespan of a product when actual lifespan data is unavailable. This occurs with products that are relatively new and haven’t yet gone through their useful lifespan. A product can be released to market based upon results of successful Accelerated Aging of the product/package.
Accelerated Aging is conducted by simulating the period claimed for product expiration. Simulation is achieved by varying temperature and humidity levels and thus exposing the packaged device to conditions it is expected to experience during its shelf life. The identified expiration date through Accelerated Aging is tentative until the results of Real-time Aging are obtained.
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:
Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10°C increase in temperature doubles the rate of chemical reaction. Four variables are used in calculating the accelerated aging test duration. A calculator is provided below to easily explore difference test scenarios.
This calculator generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of Sterile Medical Device Packages.