Tyvek® Rx: June 2015
A new medical packaging study clearly demonstrates the advantages of performing microbial barrier testing in addition to package integrity testing on porous materials after sterilization and subsequent environmental conditioning and transportation testing when evaluating a packaging design.
In this study, standard chevron pouches made with either DuPont™ Tyvek® 1073B, Tyvek® 2FS™ or one of four different commonly used medical-grade papers were evaluated before sterilization and after sterilization (ethylene oxide [EO] or Gamma) and environmental conditioning and transportation testing.
You can see the extensive data generated during this study and read a discussion of the key findings in a recently published white paper titled: “Medical Packaging Study—The Impact of Sterilization and Transportation Testing on the Microbial Barrier of Different Materials.”
The bottom line is that common package integrity tests are limited in their leak detection sensitivity; therefore, microbial barrier testing will provide additional and more detailed input to assist you in judging the overall integrity and safety of a sterile package.