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A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the 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 percentÂ of failures occur due to inadequate package validation programs," said Steven Richter, PhD, founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.
Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.
Titled, "Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products," the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.
In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.
"All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions," Richter says. "The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities. This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs."