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What is sterile vs gamma irradiated?

April 26, 2017Gamma irradiated sterile vs

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What is sterile vs gamma irradiated?

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Sterile refers to a product that is validated sterile. ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with quarterly audits being performed to monitor bioburden levels and dose. The Sterility Assurance Level (SAL) can be determined and is 10 -6 (which is the chance of 1 non-sterile unit in 1,000,000) Gamma Irradiated refers to a product that has been irradiated at some predetermined dose which is felt to kill the bioburden. Sterility testing is usually not performed nor quarterly audits for continued validation. The SAL cannot be predicted.