Seven Essentials For Successful Medical Package Design and Validation
Karen Greene
Healthcare Packaging
Article Summary
Individuals responsible for medical device packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end user without incurring defect or risk to patient safety. In this article, Karen Greene of DDL, Inc. and Stuart Long of Life Packaging Technology report on best practices and insights for the design and development of the medical device packaging system.
For manufacturers of terminally sterilized medical devices, compliance to the Intl. Organization for Standardization ISO 11607:2006—“Packaging for Terminally sterilized medical devices”—Part 1 and Part 2 is a requirement. A published tool to guide and assist you in compliance with ISO 11607 is the Assn. for the Advancement of Medical Instrumentation AAMI TIR 22. TIR 22 is a technical information report published by AAMI for compliance assistance. It is not a balloted standard but is reviewed by an AAMI technical committee. This article does not address Part 2, equipment and process validation.
