Revalidation

Validating a sterile barrier system (SBS) is a process that involves four different types of validation activities which covers design, packaging process, sterilization, and test methods.

In order to maintain the validated state for a sterile medical device packaging system, it is important to both conduct periodic system reviews and also to critically evaluate changes to the packaging system design and/or the process. This periodic review and change management process should be risk-based and focus on the impact of change inputs that could affect the system performance, efficacy, and safety of the packaged product.