Learn more about the various aspects of ethylene oxide sterilization
- 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.
- 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.
- 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
- Anatomy of an Ethylene Oxide Sterilizer
Learn about the equipment used throughout the ethylene oxide sterilization process.
- 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.
- 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.
- 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.
- 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
- Selection of an EO Sterilization Facility
Learn about the factors to take into consideration when choosing an ethylene oxide contract sterilization facility.
- Written Agreement Between Product Manufacturer and Contract Sterilizer
This TechTip provides a summary of the information presented in AAMI TIR No. 14 – 2009, Contract Sterilization Using Ethylene Oxide.
- Considerations for EO Processing of Devices Containing Electronic Components
When using ethylene oxide to sterilize electrical equipment containing batteries or other energy containing components, thorough evaluation must take place to ensure the safety of those in the sterilization facility.
- Reference Load Selection for Ethylene Oxide Validation
This TechTip reviews the variables that should be considered to assure the EO sterilization process is effective each and every time.
- 2x Processing for Ethylene Oxide Sterilization
Click here to view this TechTip as a PDF When validating an ethylene oxide process, it is advantageous for both the Customer and the sterilization facility to qualify a 2X process. A 2X process is the ability to subject the validated routine load confi…
- Product Adoption for Ethylene Oxide Sterilization
Click here to view this TechTip as a PDF Introduction Medical device manufacturers are constantly developing new products or improving the design, packaging and/or load configurations of their current products. Adoption of a new product into a device f…
- Selection of Appropriate Internal Process Challenge Devices (PCDs)
Click here to view this TechTip as a PDF Introduction This TechTip outlines a practical approach to establishing an appropriate internal PCD (IPCD) to minimize over-processing while still meeting a minimum sterility assurance level (SAL) of 10-6. Histo…