The STERIS Applied Sterilization Technologies EO TechTeam is a dedicated team of technical experts committed to the assistance of 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 turnkey programs for all your EO sterilization needs. All programs are performed using procedures and equipment in accordance with requirements set out in ISO11135 and guidelines published by the Association for the Advancement of Medical Instrumentation (AAMI).
Our network of EO facilities offers a wide range of chamber sizes 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 experts support 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 ISO11135. These templates have been designed to allow readers 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 just a few.
For Customers desiring a quicker ethylene oxide sterilization turnaround, the EO TechTeam can evaluate a device or device family for all-in-one processing solutions.
BI Incubation Time Reduction:
This TIP option offers an acceptable way to decrease unreleased inventory time by validating the use of a reduced incubation period for biological indicators.
Processing for Product/Package Functionality Evaluation:
This TIP option provides scalable processing options (from our pilot vessel to our large production vessels) for materials to be used for gauging, compatibility and functionality.
With extensive expertise 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 professionals can work with you to provide your 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 of experts is focused on helping our Customers through all phases of the sterilization process.
Small Batch Release Processing:
Single batch for release to market purposes following the requirements set out in Annex E of ISO 11135:2014. This type of processing is typically limited to small quantities of product to be used in clinical trial submissions This TIP option is ideal for those requiring such processing options.