Real-Time Aging programs provide the best data to determine shelf life and the effects of aging on materials. The test is conducted by placing the test item on a shelf and allowing it to be exposed to typical storage conditions. Doing this will establish the items accurate expiration date. However this test isnt feasible in todays market conditions in which products 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 it 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 havent 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 (1 year, 2 years, etc). Simulation is achieved by varying temperature and humidity levels and thus exposing the packaged device to conditions it is expected to survive during its shelf life. The identified expiration date through Accelerated Aging is tentative until the results of Real-Time Aging are obtained.
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.