Expert: Paul J. Sordellini - 5/7/2004

Question
Hello,

Medical Packaging for surgical disposible devices have tyvek coverings.  From what I understand, these are not air tight.  If the products are sterilized and then left in a package that is not air tight, can't the device become unsterile and still have an untampered package?

Thanks,
Stephen Balek

Answer
Stephen

Packaging for items sterilized with gas (ethylene oxide, steam, etc.)needs to be permeable for the gas to enter the package, contact the device surfaces, and then exit the package. Sterile barrier packaging such as Tyvek and medical grade paper allows gas to permeate, but blocks any micro-organisms. Once the package goes through a terminal sterilization process, the contents are rendered sterile and remain sterile until the package is opened.