EO TechTeam Services
STERIS Applied Sterilization Technologies’ EO TechTeam group is designed for and committed to the assistance of our Customers in all facets of the ethylene oxide sterilization validation process.
The TechTeam experts develop and optimize your EO sterilization processes and assure that you receive the most complete, cost-effective, and highest quality EO sterilization services available.
Our team offers a variety of services through our Total Inclusive Program.
Total Inclusive Program
The Total Inclusive Program (TIP) provides true turnkey programs for all your EO sterilization needs. All programs are performed by equipment commissioned to the guidelines published by the Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11135:2014).
TIP Options Include:
Ethylene Oxide Cycle Development:
Ideal for new or updated devices, this TIP option identifies the hardest-to-sterilize area within your device, which is critical to the design of an ANSI/AAMI/ISO 11135:2014 compliant sterilization process. It also determines a plan for establishing the relationship of the biological indicator to that of the device’s naturally occurring bioburden.
Sustainable EOSM Sterilization Program:
Our EO TechTeam experts support manufacturers of healthcare products with validating Sustainable EOSM sterilization cycles for their unique 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. Go here to learn more about the Sustainable EO sterilization program.
Ethylene Oxide Cycle Validation and Protocol Generation:
Designed for process validation of industrial-sized vessels, this TIP option is for Customers without in-house validation expertise, or those who prefer to use outside validation services. Periodic revalidation is also available.
Small Volume Validations for Routine Production:
Especially for limited production or small lots, this process validation program can take place on our premises or at your location of choice. This option is ideal for those without in-house validation expertise, or those who prefer to use outside validation services. Periodic revalidation is also available.
For Customers desiring a quicker ethylene oxide sterilization turnaround, the EO TechTeam can evaluate a device or multiple devices for one-day processing solution.
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.
Ethylene Oxide Residual Reduction (Hold Time Reduction):
Through state-of-the-art equipment that removes residues during the sterilization process, this TIP option reduces the time required for dissipation (off gassing) of residues that remain after sterilization. Reducing residual hold time (when it is longer than the biological indicator incubation time) results in reduced “in-process” inventory and a faster release of products to market.
EO Cycle Optimization:
This TIP option enhances the EO process for routine sterilization of existing devices. Through management of process parameters and phases, EO cycle optimization can also identify areas of further cycle improvement: reduced residual hold times, shorter total cycle times, and lower temperatures for temperature-sensitive products.
Processing for Product/Package Functionality Evaluation:
For those who do not have in-house sterilization or small volume capabilities, 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.
For Customers without in-house EO sterilization expertise, the EO TechTeam is available to assist with any Ethylene Oxide related problem.
Single Load Validation:
Designed for validation of a single batch for release to market purposes, this load validation program can take place on our premises or at your location of choice. This TIP option is ideal for those without in-house validation expertise, or those who prefer to use outside validation services.
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 product development to sterility validation, our team of experts is focused on helping our Customers through all phases of the sterilization process.