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
Steven Richter, PhD, is founder, president, and chief scientific officer of Microtest Laboratories Inc. (Agawam, MA).