JUNE 11, 2009 — AGAWAM, MA — Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best utilize packaging validation programs and discusses options when testing medical device packaging.
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.
The white paper, “Package Validation Requirements For Medical Devices and Combinatory Products,” by Stephen Richter, Ph.D, RAC, SM(NRM), President and Chief Scientific Officer of Microtest Laboratories, provides insight into general requirements in microbiological and physical testing programs. It also discusses how combination products pose a unique set of challenges to the package validation
Specifically, the white paper discusses how medical device stability package validation programs should be designed to encompass overt product storage and shipment conditions and that performing accelerated aging studies does little to address liability during shipment and storage.
To download the white paper, “Package Validation Requirements For Medical Devices and Combinatory Products” visit: http://www.microtestlabs.com/package-validation-paper/
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.