SHELF LIFE VALIDATION

To demonstrate that the packaging materials can maintain the integrity of the sterile barrier during your device indicated shelf life, FDA recommends that package test methods include simulated distribution as well as simulated (and/or real-time) aging followed each by associated packaging testing, including package integrity, package strength, microbial barrier properties and so on. You should conduct device specific performance testing to determine whether storage (aging) may affect the performance of the device. Please be aware if the packaging of your device consists of a double barrier system, both internal and external packaging systems should be tested.