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Wherever sterility and/or pyrogen tests are done on certain batches of shortlived radiopharmaceuticals, these batches could be released before completion of sterility and/or pyrogen screening, furnished these kinds of testing is finished as quickly as possible.(e) Returned labeling shall be managed and stored in a very manner to forestall mixups an
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In APS batches, the figures of colony-forming units recorded on the environmental monitoring plates in Grade A (LAF, RABS, or isolator) and Grade B places need to be recorded. An isolate must be taken from Every single visually distinctive microbial colony and determined by species employing readily available biochemical and/or nucleic acid identif
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