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Accelerated Aging – ASTM F1980

Accelerated Aging – 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 ANSI/AAMI/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 that is 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, but this data is only accepted until those tests can be correlated to “Real Time” samples.

WESTPAK also offers Real Time Aging / Shelf Life services using ambient temperature and humidity conditions.

Resources

Accelerated Aging Calculator

Typical Procedures/Protocols

ASTM F1980
ISO 11607

WESTPAK Capabilities

(23) Accelerated Aging Chambers with 108 m³ (3800 ft³) capacity and a variety of temperature levels