Ethylene Oxide (EO) Validation Services
The STERIS Isomedix Services Total Inclusive Program (TIP) is the complete turnkey program for your contract ethylene oxide sterilization needs.
The TIP program provides the required level of process development service and complies with all regulatory requirements. All programs are performed by equipment commissioned to the guidelines published by the Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11135-1:2007).
Isomedix Services provides custom programs to fit your unique EO sterilization requirements.
Ethylene Oxide Cycle Development
Ideal for new or updated devices, this TIP option identifies the hardest-to-sterilize area within your device. It also identifies this area's relationship to the naturally occurring bioburden that is introduced during the manufacturing process. This information is critical to the design of an ANSI/AAMI/ISO 11135-1:2007 compliant sterilization process.
Ethylene Oxide Cycle Validation
Designed for process validation of industrial-sized vessels, this TIP option is for Customers who lack in-house validation resources, or prefer to use outside validation services. We also have the capability to perform small-volume validations for limited production or small lots on our premises or at your location of choice. Periodic revalidation (a single half-cycle) is available.
BI Incubation Time Reduction
This TIP option uses an FDA approved guideline to reduce the incubation period for post-exposed biological indicators. Appropriate for routine processes only, it is an acceptable way to decrease unreleased inventory time.
Note: To benefit from this program, your residual hold time must be shorter than your indicated incubation period.
EO 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 residuals that remain after sterilization. Reducing residual hold time (when it is longer that 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 improves the EO process for routine sterilization of existing devices. Through manipulation of temperature and gas concentration, EO cycle optimization can also help achieve further cycle improvements, such as reduced residual hold times, shorter total cycle times and lower temperatures for temperature-sensitive products.
Product/Package Functionality Evaluation
This TIP option gauges post-sterilization material compatibility and function. It is appropriate if you do not have in-house sterilization or small-volume capabilities.
The STERIS Isomedix Services EO Technology Center
The STERIS Isomedix Services EO Technology Center is an organization designed for and committed to the assistance of Isomedix Services Customers in all facets of the ethylene oxide sterilization validation process. The Center develops and optimizes your ethylene oxide sterilization processes. It assures that you receive the most complete, cost-effective, and high quality ethylene oxide contract sterilization services available.
The EO Technology Center can help you:
- Determine if your product can be sterilized with ethylene oxide
- Determine if ethylene oxide is the best sterilization method for your product
- Determine which ethylene oxide sterilization process is best for your product
- Validate a reduced incubation time for biological indicators
- Reduce EO residue dissipation time
- Save money by using equipment that is specifically designed for either small-volume applications or large-scale production
Our equipment delivers industrial EO sterilization processes, both 100% ethylene oxide (deep vacuum) and nitrogen "soft" cycles (shallow vacuum). It ranges in size from 30 cubic feet (24" x 36" x 60") to 2100 cubic feet (60" x 112" x 540").
Contact a STERIS Isomedix Services representative to learn more about our gamma and ethylene oxide validation services.