Overview of a Parametric Release Validation for EO Sterilization
Learn about the steps included in a parametric release validation, as well as special considerations for parametric release
Parametric Release for Ethylene Oxide Sterilized Devices
This TechTip provides an overview of the parametric release process, including microbiology requirements, equipment requirements, process analysis and load configuration.
Performance Qualification of Ethylene Oxide Sterilization Process Method C
Overview and detailed steps of Process Method C, the most commonly used method for an ethylene oxide performance qualification.
Overview of an Ethylene Oxide Validation
This TechTip provides a step-by-step overview of an ethylene oxide validation process that complies with the guidelines established in 11135 using a Half Cycle Overkill Approach.
Anatomy of an Ethylene Oxide Sterilizer
Learn about the equipment used throughout the ethylene oxide sterilization process.
Anatomy of an Ethylene Oxide Sterilization Process
This TechTip provides basic information on how the ethylene oxide sterilization process works, including each step of the process and items for consideration
Overview of Ethylene Oxide Residuals
Sterilizing medical devices with ethylene oxide (EO) is a common practice primarily due to its extensive material compatibility. This TechTip discusses the residues that may be found after EO processing and residual reduction methods.
Ethylene Oxide Sterilization Glossary
A Glossary list of terms that may be used in discussions of ethylene oxide (EO) sterilization as recognized by medical device manufacturers inspected by the U.S. FDA. All definitions or explanations are to be taken as applied specifically in the context of EO sterilization processing.