EO TechTeam®

The STERIS Applied Sterilization Technologies EO TechTeam is a dedicated team of technical professionals committed to assisting our Customers in all facets of the ethylene oxide sterilization validation process. Our EO TechTeam provides Customers with a variety of services through our Total Inclusive Program.

Total Inclusive Program

The Total Inclusive Program (TIP) provides Customers with support specific to their EO sterilization needs. All programs are performed using procedures and equipment in accordance with requirements set out in ISO 11135 and guidelines published by the Association for the Advancement of Medical Instrumentation (AAMI).

Our network of EO facilities offers a wide range of chamber configurations to fit any sized load, go here to view our locations.

TIP Options Include:

Ethylene Oxide Cycle Development:

Ideal for new or updated devices, this TIP option identifies an appropriate process challenge device (PCD) by establishing the relationship of the biological indicator to that of the device’s naturally occurring bioburden. This is the first critical stage in the design and development of an ISO 11135 compliant sterilization process. To learn more about establishing an appropriate PCD and identifying ways to help reduce EO sterilant used read our Selection of  Appropriate Internal Process Challenge Devices (PCDs) TechTip.

Sustainable EO® Sterilization Program:

Our EO TechTeam supports manufacturers of healthcare products with validating Sustainable EO sterilization cycles for their products. This innovative program provides Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed sterility assurance level (SAL). Go here to learn more about the Sustainable EO sterilization program.

Ethylene Oxide Cycle Validation and Protocol/Report Generation:

Using predefined templates, our EO TechTeam can generate the validation protocol, execute the validation cycles, and document a validation report, addressing all the critical aspects of ISO 11135. These templates have been designed to allow readers to navigate the critical aspects of a sterilization validation and facilitate swift review and approval by both Customers and regulatory agencies/bodies. Protocols may address validation of a new process, product adoptions into an existing process, process equivalency studies, and periodic requalification of existing processes, to name a few.

Processing for Product Functionality and/or Package Integrity Evaluation:

This option provides scalable processing from our test vessels to our large production vessels and is used for the evaluation of product functionality and package integrity for devices exposed to the EO process. Go here to learn more about our package integrity testing services.

Small Batch Release Processing:

Single batch for release to market processing follows the requirements set out in Annex E of ISO 11135. This type of processing is typically limited to small quantities of product to be used in clinical trial submissions. This option is ideal for those requiring such processing options.

Technical Consultation:

With extensive knowledge in all aspects of EO validation and processing, our EO TechTeam is available to assist with any ethylene oxide related queries. Using our experience and flexibility, the EO TechTeam can work with Customers to provide individual processing requirements and assist in experimental design and documentation. From process development in accordance with the innovative Sustainable EO program to full sterilization validation, our team is focused on helping our Customers through all phases of the sterilization process.