It is imperative to define the packaging system in order to proceed with development and implementation. The goal of a thorough packaging system hazard analysis is to eliminate all high severity hazards and reduce as many medium and low severity hazards as possible. Today’s increasingly complex medical devices require the package designer to perform a thorough investigation of the anticipated distribution, storage and handling conditions of their medical device. For ISO 11607-2:2006 compliance, it is required to demonstrate that packaging equipment involved in forming, sealing and assembling of a sterile barrier system be validated. Sterile barrier system forming and sealing processes are directly related to the outcome of sterile barrier system integrity thus, the packaging process limits are developed to produce packages with the property of sterile barrier integrity (substrates and seals) at a high degree of statistical confidence and reliability.

Reprinted with Permission from DDL, Inc.