Application Brief: The Use Of Cartridge Filtration In The Production Of Pharmaceutical Grade Water

As an ingredient or solvent, water is the most frequently used component in the manufacture of virtually all pharmaceuticals. Water is a major component in many parenteral and non-perenteral drugs, and is used in numerous washing, blending, rinsing, and process steps. Pharmaceutical grade water is classified by the U.S. Pharmacopeia (USP) into 8 different catego- ries, 5 of which are packaged water. Of the remaining three, USP Purified Water (PW) and USP Water for Injection (WFI) are considered primary or bulk waters used for most pharmaceutical water applications. USP Purified Water and Water for Injection are the primary topics of this Ap- plication Brief.

The types and quality of the water are closely regulated in major pharmaceutical producing re- gions by similar, although not identical, standards: European Pharmacopeia – EP, Japanese Phar- macopeia – JP, and the United States Pharmacopeia – USP. The industry is working to "harmonize" these standards so that a single standard will be available in the future. Differences in the Pharmacopeias can impact how a pharmaceutical manufacturer constructs and operates their water systems. For instance, the EP does not allow the use of reverse osmosis (RO) for WFI production, nor does it recognize the U.S. EPA drinking water standard as a basis for raw water entering a system. The discussion in this brief is applicable to waters produced under all three Pharmacopeias, although some variation in filter selection may be required to meet specific local regulations.