Real Time Aging Testing
Real time aging testing is a requirement of ISO 11607-1 to ensure that a sterile barrier system maintains its integrity over time. For medical devices this integrity testing is critical, and that’s why we offer both accelerated and real time aging testing services to validate packaging in these industries.
Real time aging studies must be performed in conjunction with accelerated aging testing. It serves to validate the data that was gathered through the accelerated aging process. Since study duration’s are long, it can be difficult to manage, putting product lines at risk. There are several schools of thought on how real time aging should be performed. PCL offers a range of real time aging options to ensure compliance.
Frequently asked questions
Is real time aging required for medical devices?
While it is acceptable for medical device manufacturers to go to market with accelerated aging data, real time aging testing must be performed in parallel with accelerated aging testing.