Get With the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination 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 implicate failures in primary packaging. This paper provides insight into the general requirements of a microbiological and physical testing program. It discusses how combination products pose a unique set of challenges to package validation engineers.
Unfortunately, medical device package testing is not standardized in terms of shelf-life requirements. This is because the variation of device materials requires the manufacturer to modify ASTM conditions to bracket shipment, storage, and use conditions. Physical testing is probably the best indicator of adequate sealing parameters. However, these tests do not give technicians the ability to extrapolate to real-world microbiological ingress limits. This paper discusses some of the options for package validation testing.