Accelerated Aging / Shelf Life Expiration Dating Studies (ASTM F 1980)
Accelerated Aging is a key component of the overall packaging validation for medical devices. Following ISO 11607, a package validation includes accelerated aging and the corresponding integrity testing as well as simulated distribution and its subsequent integrity testing.
Accelerated aging serves as key interim data to support product shelf life dating until real-time data is available. One way we would work with you would be to provide a recommendation to age additional samples—if appropriate and if chamber space would allow. This additional aging may be useful in the event of a future issue to support shelf life extension or supplemental data.