May 29, 2010
“Get with the Program -- Having a solid package validation program can prevent failure of combination products” by Steven Richter is a featured article in Medical Device & Diagnostic Industry’s May 2010 issue: http://www.mddionline.com/article/testing-validation
FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs. This article provides insight into the general requirements in a microbiological and physical testing program. It discusses how combination products pose a unique set of challenges to package validation engineers.
