Validated ethylene oxide sterilization cycles and sterile barrier packaging support the release of single-use medical devices.
Sterilization
Sterilization and Sterile Packaging
Sterilization Method
Select a method to review its control points and validation scope.
EtO
Ethylene Oxide Sterilization and Sterile Packaging Management
Bioteque publicly lists E.O. sterilization equipment and sterilization management, and multiple single-use products are supplied in sterile pouches or blister packaging with ethylene oxide sterilization. A validated cycle should be established for product/package compatibility, including preconditioning, gas exposure, aeration, and release. Applicable validation covers bioburden, sterility assurance, EO/ECH residuals, package integrity, and shelf life.