Get with the Program: Having a solid package validation program can prevent failure of combination products

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.

Read the new bylined article by Steven Richter, "Get with the Program: Having a solid package validation program can prevent failure of combination products," for insight into the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to package validation engineers.

Published May 2010 in MD&DI, at http://ht.ly/1P7lO