EO GAS STERILIZATION
Ethylene oxide (EO) is a gas commonly used to sterilize medical devices and products chemically. Ethylene oxide is a potent and highly penetrating alkylating agent. These characteristics make it an extremely effective sterilizing agent. However, at certain levels, ethylene oxide is also capable of causing cancer. Sterilization by ethylene oxide kills microorganisms through exposure to ethylene oxide gas under vacuum and humidity. EO is used either as 100% EO or in combination with carbon dioxide.
Key Benefits
Product Compatibility
Effectively sterilizes a broad range of polymers, resins, natural materials, and metals as well as dual drug-device combination products that require external contact surface sterilization.
Flexibility and Versatility
Effectively sterilizes a wide range of products with different variations in dose requirements, densities, and packaging/box sizes.
Sterility Assurance and Treatment Efficacy
Consistently meets product and regulatory requirements.
Main advantage
the main advantage is that it can sterilize heat- or moisture-sensitive medical equipment without deleterious effects on the material used in the medical devices.
Parametric Release
Allows for the release of products directly after processing which results in fast turn times to help get product to market rapidly.
Sterilization at Low Temperatures
Ensures the integrity of both the product and packaging.
Why eo gas
sterilization?
Overall, sterilization by ethylene oxide is alternative to traditional heat sterilization methods. Ethylene oxide sterilization uses a combination of vacuum, humidity, temperature, and gas to sterilize materials at lower temperatures than dry heat or steam sterilization methods. While effective, ethylene oxide can result in toxic residuals. Thus, any ethylene oxide sterilized medical devices or products must undergo ethylene oxide residual testing to meet FDA requirements. All in all, ensure you choose a contract testing organization that can provide appropriate sterilization validations and ethylene oxide residual testing for your product needs.