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One example is, if a product is formulated and filtered before a final sterilization, microbiological tests from the Bio-burden after filtration will offer some practical information and facts for your determination of your adequacy on the sterilization course of action. Having said that, it will eventually offer very little, if any, data pertaining into the adequacy of the process with regard to minimizing endotoxin contamination. Considering the fact that endotoxins end result from substantial levels of microorganisms, and therefore are not removed by sterilizing or microbiological filters, the subsequent reduction of the large microbiological degree won't be connected to a similar reduction of high endotoxin level.
There's been sizeable dialogue inside the literature not long ago pertaining to the Bacterial Endotoxins Exam, its significance and interpretation, and its comparison to your USP rabbit test.
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