Package Validation Requirements for Medical Devices and Combinatory Products

A white paper by Stephen Richter, Ph.D, RAC, SM(NRM) of Accuratus Lab Services.

FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs. In this paper Dr. Richter provides insight on the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to the package validation engineer.