Sterigenics - Ethylene Oxide Sterilization Technology
From Technologies
Based on a gas diffusion process, Ethylene Oxide (EO or ETO) is capable of sterilizing and rendering products free of viable microorganisms. Sterility occurs when an EO gas molecule reacts with and destroys the microbial DNA. The process requires the simultaneous control of four variables, but interdependent parameters: gas concentration, temperature, relative humidity, and time of exposure. EO sterilization effectiveness 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.
Details
Best Suited For
EO is considered the sterilization method with the broadest application available for medical products and medical devices 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 drug-devices (filled syringes, drug-coated stents)
At Sterigenics®, our priorities are clear. We strive to keep our employees, the communities in which we operate, and the patients we serve safe. As part of our ongoing commitment to improving and protecting the public’s health, we have consistently taken voluntary steps to capture and reduce Ethylene Oxide (EO) emissions.
With that in mind, in addition to the facility equipment enhancements we are currently implementing across all North American EO facilities, in Q1 2020 Sterigenics and our sister company Nelson Labs®, launched a multi-year initiative to work with our customers to significantly reduce the concentration of EO in their cycles. Our combined actions in support of this initiative focus on The 3Rs of EO Sterilization: REDUCE, REUSE, RECLAIM™.
Benefits
The EO process delivers a wide variety of sterilization benefits including:
- Sterilization at Low Temperatures
Ensures the integrity of both the product and packaging - 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 - Sterility Assurance and Treatment Efficacy
Consistently meets product and regulatory requirements - Flexibility and Versatility
Effectively sterilizes a wide range of products with different variations in dose requirements, densities, and packaging/box sizes - Parametric Release
Allows for the release of products directly after processing which results in fast turn times to help get product to market rapidly
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