Accelerated Aging
Definition
Accelerated Aging is commonly used in the medical device industry to “speed up” 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 and is approximated by the Arrhenius (wiki citation?) Equation.Meaning of Test
Properly applied in a package validation test plan (within guidelines of ANSI/AAMI/ISO 11607-1:2006) this can result in a decreased time to market. For example, a Sterile Barrier System that is subjected to 40 days of accelerated aging at +55° Celsius can be considered as 1 year equivalent time period. 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” samples.
Typical Range
Accelerated aging temperatures typically range from 45 to 60 degrees C. Relative Humidity is typically ambient or uncontrolled, but some companies do specify relative humidity as high as 75%.
Associated Standards
Accelerated aging for medical packaging purposes is most often referenced by ASTM F1980 - Accelerated Aging of Sterile Barrier Systems for Medical Devices. Test parameters that must be addressed in the protocol include the Accelerated Aging Temperature (for example +55C), the Q10 or Aging Factor, Ambient Temperature, Accelerated Aging Time.
What We Provide
Westpak provides a range of Accelerated Aging conditions with and without humidity control in chambers in our two facilities which accommodate the largest pallet or the smallest package.
Standards at a glance
- ASTM F1980
How Westpak can help
