Packaging Accelerated Aging Studies

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 process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate. Following validation ISO 11607 guidelines and ASTM F1980, accelerated aging data can be generated. Accelerated Aging data is acceptable by regulatory bodies as evidence to generate data quickly, but this data is only accepted until those tests can be correlated to "Real Time" samples.

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A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives/Regualtions

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