Sterile Barrier Systems: Managing Changes and Revalidations

Wagner, Thierry; Scholla, Michael H.
September 2013
Journal of Validation Technology;Sep2013, Vol. 19 Issue 3, p1
Academic Journal
The medical device package design and packaging process are critical steps for the production and distribution of terminally sterilized medical devices. Guidance on design validation and process validation is widely available, but guidance on changes that require revalidation activities is relatively limited. This paper 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.


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