Ethylene Oxide (EO) is a proven and reliable sterilization process used worldwide since the 1940s. Today, EO has evolved into a sophisticated, validated process, facilitated by advanced software that delivers a sterilization cycle tailored t.
What it is:
Based on a gas diffusion process, EO is capable of sterilizing and rendering free of viable microorganisms. Sterility occurs when an EO gas
molecule reacts with and destroys the microbial DNA. The process requires the control of four variable, but interdependent parameters: gas
concentration, temperature, relative humidity and time of exposure. EO depends on its ability to freely diffuse through a product and packaging. All products must be placed in breathable packaging that allows gas to penetrate the sterile barrier and reach all surfaces of the device or product..
Best Suited For:
EO is considered the sterilization method with the broadest application for medical products due to its effectiveness at lower temperatures
and its general compatibility with a diversity of materials, resins and product types, including:
- Polymer resin-based products
- Single-use medical devices
- Procedure kits
- Surgical trays
- Synthetic gowns
- External terminal sterilization of sealed combination device/drug devices (filled syringes, drug coated stents)
The EO process delivers a wide variety of sterilization benefits:
EtO was first use in the early 20th century for the sterilisation of spices. Its use as a sterilant for medical devices really took off in the 1950ʼs with the increasing use of plastics in their construction. Today EtO continues to be the dominant technology, worldwide, for the terminal sterilisation of single use medical devices. Around 70% of single use medical devices are sterilised with EtO, and these packages bear the words Sterile EO on the back. The remaining devices are sterilised by irradiation (either Gamma or E-Beam). 70% of single use devices are sterilised with EtO.
EtO is also widely used to re-sterilise medical devices. It is uniquely good at sterilising complex shapes due to its mobility and ability to diffuse through plastics. It is also very gentle, in contrast to oxidising sterilising agents such as H2O2, causing no detectable damage to the rubber, sealants, electronics, and optics used in complex modern devices.