HMRI Translational Production & Quality Core (cGMP)

Ethylene Oxide (EtO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam/dry heat sterilization - such as devices that incorporate electronic components, plastic packaging or plastic containers.  The typical sterilization are 12 to 24 hours in length.  The services includes multiple sterilization indicators to ensure that the product is properly sterilized.  

Please note that sterilized items will be held in quarantine until confirmation of sterility is obtained.  This will take an additional 48 hours after sterilization.

This test determines the water content of the drug substance or drug product. This test is performed as per USP<921>.  If GLP testing is requested, Method Qualification may be required.

Ethylene Oxide (EtO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam/dry heat sterilization - such as devices that incorporate electronic components, plastic packaging or plastic containers.  The typical sterilization are 12 to 24 hours in length.  The services includes multiple sterilization indicators to ensure that the product is properly sterilized.  

Please note that sterilized items will be held in quarantine until confirmation of sterility is obtained.  This will take an additional 48 hours after sterilization.

This test determines the water content of the drug substance or drug product. This test is performed as per USP<921>.  If GLP testing is requested, Method Qualification may be required.