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  No. 21 CFR 211.113(a) demands correct penned treatments for being recognized and adopted all through manufacturing to prevent objectionable microorganisms in drug solutions not required to be sterile.   On top of that, the 2nd paragraph of USP Basic Chapter Antimicrobial Efficiency Tests reads:   Antimicrobial preservatives really should not b

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. It may be used in other programs, which don't have particulate matter specifications, where by bulk Water for Injection or Purified Drinking water is indicated but where by usage of a validated water process will not be practical or the place fairly larger sized quantities than are provided as Sterile Water for Injection are needed. Sterile Drink

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