Dear All,
Currently i am in-charge on the New Product Sterilization Validation and Annual Sterilization Re-verification study on EtO Sterilization.
Our customer wish to delay the Annual Re-Verification study on the sterilization cycle parameter, and request me to come out with a justification report to justified the sterilization parameters are still perform in acceptable range and are able to show SAL value of 10-6. Beside than the information of below, which documents is relevant to justified?
- Biological Indicator used on routine cycle
- Operational Qualification (OQ) of the Sterilization Chamber
The load pattern and product pallet configuration stay the same.
Thank you.
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Winson Teng
Regulatory Affairs Engineer
Singapore
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