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    Critical Parameters for Effective Ethylene Oxide Sterilization

    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. ETO 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.

    eto sterilization, eo sterilization, ethylene oxide sterilization, medical device sterilization, combination drug devices sterilization

    Ethylene Oxide Sterilization is Best Suited For

    ETO Sterilization 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)

    Key Benefits of Ethylene Oxide Sterilization

    The ETO Sterilization 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 products to market rapidly

    Supporting our Customers in Reducing EO Use
    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™.

    Learn More >

    EO Sterilization Resources

    • General guide to Ethylene Oxide Sterilization

    Contact Us To Get Your Project Started

    Contact Us or give us a call +1 (800) 472-4508