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  No. 21 CFR 211.113(a) calls for acceptable prepared procedures to be founded and adopted during manufacturing to forestall objectionable microorganisms in drug solutions not necessary to be sterile.   Furthermore, the second paragraph of USP Common Chapter Antimicrobial Effectiveness Testing reads:   Antimicrobial preservatives really should n

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two. The volume of containers useful for media fills should be enough to enable a legitimate evaluation. For compact batches, the amount of containers for media fills should no less than equal the dimensions with the product batch. The focus on needs to be zero progress and the subsequent need to apply:Bacterial Endotoxin (Pyrogen) Testing All larg