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167(a)) by confirming that the load has actually been exposed to the prescribed Bodily circumstances. This enables producers to few adherence to sterilization cycle parameters by using a load keep track of to ascertain thermal lethality, thereby directly confirming sterility and substituting with th

(a) Penned methods shall be founded and adopted prescribing a method for reprocessing batches that don't conform to requirements or specs as well as the ways for being taken to insure which the reprocessed batches will conform with all set up expectations, requirements, and traits. Instructio

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