Inadequate general performance from the Bactec system was surprising, and our details distinction noticeably with Beforehand revealed studies, like a person from our possess laboratory in 2004 (8). The much larger obstacle set of organisms examined listed here, by using a significant deal with molds in reaction to the two failed detection gathering

As Element of the chance assessment, irrespective of whether a non-sterile drug substance is Employed in the compounding, the number of aseptic manipulations, the level of environmental control during the compounding facility, and the quantity of product injected or infused really should be viewed as within the assignment from the CSP being a lower

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