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.

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

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)


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