In Search of a Nondestructive Integrity Test for Porous Packaging
Many of my fellow bloggers provide you with good and useful information for sterile medical packaging. However, today I would like to pose a challenge to our industry. Over the past decade or two we, the sterile medical device packaging industry, have advanced in great strides in the development and validation of our packaging and packaging processes. I am the first to agree that standards and regulations have been the instigators, which is a good thing. Process validation is a given, even with our preformed sterile barrier system suppliers. Package design and development have been made easier with better materials, rapid prototype development, and standardized test methods. Concerning this last matter, test methods: When the EN868 series and ISO 11607 first were approved, there were only a few methods that had been standardized with demonstrated reliability and repeatability. Since then we have gained a large selection of test methods to choose from to demonstrate compliance to regulatory standards. But, there is one very large gap, and that is a nondestructive, whole package, physical integrity test for porous medical packaging.
There are numerous nondestructive tests for film and foil packages. But what about packages made from paper and Tyvek? Most nonporous package tests deal with vacuum, pressure, or a gas-sensing method. But porous packages are designed to pass air and gases in and out. Nondestructive means you do not have to discard tested packages and the devices they contain. The only means to test a porous package now is to determine that the materials are a microbial barrier and the seals or closures maintain integrity with destructive test methods that are labor intensive, messy, and in some cases cumbersome.
Regulatory bodies have longed for whole package sterile integrity tests, but we do not have it for porous packaging. Yes, a microbial challenge and sterility test is an option, but those methods are fraught with inconsistencies, false positives and negatives, and low sensitivity. They are very difficult, if not possible, to validate. That is why we do a two-step process. I throw this challenge out to the entire industry from material and equipment suppliers to medical device manufacturers. We are in search of a nondestructive, whole package, physical integrity test for porous packaging. Where will it come from? Are you up to the challenge?'
Hal Miller, President, PACE Solutions