Based on a gas diffusion process, EO is capable of sterilising 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 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.
Best Suited for:
EO is considered the sterilisation method with the broadest application available 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 sterilisation of sealed combination device/drug devices (filled syringes, drug-coated stents)
Key Benefits:
The EO process delivers a wide variety of sterilisation benefits including:
Sterilisation 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 sterilisation.
Sterility Assurance and Treatment Efficacy:
Consistently meets product and regulatory requirements.
Flexibility and Versatility:
Effectively sterilises a wide range of products with different variations in densities and packaging / box configurations.
Parametric Release:
Allows for the release of products directly after processing which results in fast turn times to help get the product to the market rapidly.