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<h1><img style="display: block; margin-left: auto; margin-right: auto;" src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/screenshot-2019-09-21-at-12.58.19-1.png" alt="VALIDATION OF AN ETHYLENE OXIDE STERILIZATION CYCLE" width="800"></h1>
The effectiveness of an ethylene oxide sterilization cycle is demonstrated through the validation process, which involves commissioning and performance qualification. Commissioning ensures that the sterilization equipment can maintain operational specifications and perform within the required parameters for sterilizing the specific product item. Performance qualification provides assurance by obtaining, documenting, and interpreting results that show continued compliance with predetermined specifications.
Biological indicators (BI's) and products are often used in the validation of an EtO cycle following the half-cycle or "over-kill" method. This method demonstrates that the resistance of the microbiological challenge test system is equal to or greater than the product bioburden. The appropriateness of the Biological Indicator should be evaluated, and a half-cycle, as well as two additional half-cycle experiments, are performed to demonstrate a 6-log reduction. A full cycle, providing a 12-log reduction, is performed for product release purposes. Revalidation, usually performed annually, confirms that the original process parameters remain effective.
Routine bioburden testing monitors any changes in product components, environment, packaging, or manufacturing process that could potentially impact the product bioburden and its resistance to the sterilization process. Testing to be considered when validating an EtO sterilization cycle includes bioburden, bioburden validation for recovery efficiency, a test of sterility, bacteriostasis-fungistasis, ethylene oxide residuals, and bacterial endotoxin test.
References:
ETO Sterilization Validation Regulatory Requirements

Validation Of An Ethylene Oxide Sterilization Cycle

Publish Time：2023-10-13