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Frequently Asked Questions
Q: Why should I consider optimizing the amount of sterilant in my existing <a href="https://www.hzbocon.com/product-list/ethylene-oxide-sterilizer">EO sterilization</a> cycle? A: Ethylene oxide (EO) has been used as a sterilization method for healthcare products since the 1960s. However, there are human safety and environmental challenges associated with its use. To address these issues, STERIS AST offers the Sustainable EO&reg; sterilization services program, which provides strategies to reduce EO sterilant usage while achieving the prescribed Sterility Assurance Level (SAL). Optimizing sterilant input offers benefits such as lower product residuals, improved occupational safety, and enhanced supply chain efficiencies.
Q: Is the Sustainable EO program a validation approach using alternative bioburden-based methods? A: While bioburden-based methods per ISO 11135:2014 may be used, the focus of the Sustainable EO program is predominantly on utilizing an Overkill approach. Qualified Sustainable EO cycles using the overkill approach have demonstrated delivery of the required SAL of 10-6, minimizing overprocessing seen on legacy cycles.
Q: Does ISO 11135:2014 specify that the biological indicator (BI) should be placed within the most challenging location of the product? A: No. The standard requires the BI to be placed in a Process Challenge Device (PCD) that presents a challenge to the sterilization process equivalent or greater than the natural bioburden at the most difficult location within the product.
Q: Does my cycle need to use the same EO concentration as that used to establish the D-value of the BI? A: No. The D-value of a BI is established under specific conditions, but industrial EO processes may be qualified at a range of temperatures and EO concentrations based on product limitations.
Q: Given the criticality of the Test of Sterility on products with natural bioburden, are there particular considerations regarding sampling for this assay? A: Comparative studies should be performed using product bioburden representative of normal production. Refer to ISO 11737-2:2009 for selection of samples and assessment of test method.
Q: How do I perform a comparative resistance study? A: A comparative resistance study involves performing a sublethal fractional exposure time process to compare the relative resistance of Process Challenge Devices (PCDs) and product Test of Sterility units.
Q: What do I do if I get no growth from both the product Test of Sterility and the PCD? A: No growth from both indicates an opportunity to further reduce cycle lethality by adjusting EO concentration and/or dwell time.
Q: What do I do once I have my PCD determined and demonstrated as appropriate? A: Once a PCD is defined, the validation progresses to Performance Qualification (PQ) cycles to confirm the process can deliver the required minimum SAL of 10-6.
Q: Do I need to demonstrate that my EPCD (if used) is more challenging than my IPCD? A: A PCD, internal or external, only needs to present a challenge equivalent or greater than the natural bioburden at the most difficult location within the product.
Q: If I have a legacy process and re-design to a Sustainable EO process, is it considered a change? A: Yes. Any change needs to be reviewed and subjected to verification and/or validation. A risk assessment is recommended.
Q: What notification do I need to make to my Notified Body? A: A sterilization expert should consult with their Regulatory Affairs or their Notified Body regarding required regulatory filings.

Frequently Asked Questions Of Eo Sterilization

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Q: Why should I consider optimizing the amount of sterilant in my existing EO sterilization cycle?

Frequently Asked Questions Of Eo Sterilization

Publish Time：2024-01-18