Tyvek® Rx: December 2013
When does a change to the medical device packaging system design and/or the process require revalidation activities? Seems like an easy question, but medical device manufacturers (MDMs) know that there is no simple answer.
Although much has been written about the requirements for validation, very little has been published on revalidation requirements driven by change. There are basic revalidation requirements covered in the standards and in various guidance documents, but due to the general nature, interpretation can be challenging.
To help address this issue, two members of the DuPont Medical and Pharmaceutical Protection Team—Thierry Wagner, EMEA Regulatory Director, and Michael H. Scholla, Ph.D., Global Regulatory Director—wrote an article titled Sterile Barrier Systems: Managing Changes and Revalidations.
Published in the peer-reviewed The Journal of Validation Technology in September 2013, this article provides an overview of the regulatory requirements for sterile packaging system revalidation and discusses points to consider when applying these requirements to various typical change scenarios.