Why are there no microbial requirements included in the monographs for Purified Water and Water for Injection?
A. 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 . We recommend that you implement Alert and Action Levels no higher than, and preferably lower than, those listed in Water for Pharmaceutical Purposes based on the normal microbial performance trends of your water system. The purpose of Alert and Action Levels is to trigger additional, rather than routine, microbial control measures. These additional control measures should avoid objectionable levels and types of microorganisms for the water’s use. back to top Q.
