Shelf Life Testing simulates the results of storage on a shelf for some period of time. While required for Medical Devices, it can be used for a variety of industries.
Oftentimes referred to as Accelerated Shelf-Life Testing – is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. The Accelerated Aging process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate.
Properly applied in a package validation test plan and within ISO 11607 guidelines, Accelerated Aging can result in a decreased time to market for a new product. For example, per the Arrhenius equation, a Sterile Barrier System subjected to 40 days of Accelerated Aging at +55° Celsius has similar aging characteristics as a 1-year-old Real Time sample. Accelerated Aging data is recognized by regulatory bodies as an acceptable means to generate data quickly; however, this data is only accepted until those tests can be correlated to “Real Time Aging” samples.
Use our Calculator to determine your Accelerated Aging duration.
Real Time Aging
Real Time Aging is exactly what the name implies. This testing is conducted at ambient conditions in actual real time in order to analyze the conditions of packages and/or products and the effects that time has on them. Real Time Aging studies can be performed to confirm the results of Accelerated Aging on test samples.