About Paul J. Sordellini Expertise Manufacturing, packaging and sterilization of medical devices. I can assist in questions regarding Quality, Regulatory and Validation in accordance with FDA, ISO and EN guidelines and standards.
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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.
