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Often during webinars and seminars, the question is raised regarding the specifications for Purified Water (PW) and Water for Injection (WFI). The USP has responded with an explanation as part of their series on Microbiological Frequently Asked Questions (FAQ). Please read below to learn more about how one should develop specifications for microbial Water for Pharmaceutical Purposes.
“Because of the various uses of these waters, microbial requirements are not included in these monographs since this would require some uses to adhere to meaningless and/or inappropriate requirements. Microbial guidelines are provided under the non-mandatory informational chapter Water for Pharmaceutical Purposes <1231>.  We recommend that you implement Alert and Action Levels no higher than, and preferably lower than, those listed in Water for Pharmaceutical Purposes <1231> based on the normal microbial performance trends in your water system. The purpose of Alert and Action Levels is to trigger additional, rather than routine microbial measures. These additional control measures should avoid objectionable levels and types of microorganisms for the water’s use.”
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