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Diluting Fluid A is utilised as the dilution medium without the need of exposing the filter towards the product. Following addition with the minimal-amount inoculum to the final rinse, the filter is plated as over. Method-unique lack of microorganisms can be approximated by comparing the Restoration within the diluting Fluid A group towards the ino
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[19] Each time a distinction seems or within the function of the dispute, the final determination is designed dependent upon the USP compendial gel clot method Until normally indicated within the monograph with the merchandise getting tested.[20](a) For each batch of drug products purporting to get sterile and/or pyrogen-free, there shall be prope