Shelf life claims validation forms part of a comprehensive range of medical device and pack testing that is available from MET. A recent article in the spring edition of Med-Tech Packaging News by Mark Turner (MET) describes the application of these tests under FDA guidance.

The FDA periodically issues Guidance documents to assist medical device manufacturers and designers conform to regulations. One such Guidance ‘Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products’ was published by the Center for Biologics Evaluation and Research on the 22nd of Feb 2008.

This extensive article, in the magazine, examines the Guidance and helps medical device engineers apply it to their own products and developments. Click here to see this article.

Contact MET for the full text of the article or to discuss your requirements for showing evidence of the maintenance of product sterility during shelf life.

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