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.
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.
A paper published by the Institute of Validation Technology reviews guidance from the harmonized medical packaging standard adopted by European Committee for Standardization (CEN) and International Organization for Standardization (ISO) EN ISO 11607, European Notified Bodies, and the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on revalidation of packaging. Based upon these guidances, potential changes to the package and packaging process are categorized and reviewed.
Read the full article: Sterile Barrier Systems: Managing Changes and Revalidations
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