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No. 21 CFR 211.113(a) calls for appropriate created methods for being set up and followed throughout manufacturing to circumvent objectionable microorganisms in drug solutions not needed to be sterile. Additionally, the 2nd paragraph of USP Common Chapter Antimicrobial Success Testing reads: Antimicrobial preservatives should not be used i
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As this can be a advanced process, there are actually advantages and drawbacks to lyophilization that every producer and customer must know about.3 Biopharmaceutical firms have increasingly favoured lyophilization to the formulation in their pharmaceutical products. Generally, the driving components bringing about the greater use of lyophilizat