Pharmaceuticals

Water for Pharmaceutical Use

By William F. Harfst

BACTERIA BIOCONTROL PHARMACEUTICALS PURIFIED WATER REVERSE OSMOSIS STANDARDS USP WATER FOR INJECTION

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Abstract

Water used in pharmaceutical applications is produced by several methods designed to achieve specific quality specifications. In general, pharmaceutical water can be classified into two basic types or forms: bulk and packaged. Bulk forms are produced at the same site where they are used. Packaged forms are produced, packaged, and sterilized to assure microbial quality throughout the productï¾’s shelf life. Two basic bulk forms of pharmaceutical water include Purified Water (PW) and Water for Injection (WFI). PW is used in the preparation of some bulk pharmaceutical chemicals, but is not intended for parenteral administration. It must be protected from microbial proliferation. WFI conforms to the same standards as that of PW, but it is pyrogen-free. WFI is intended to be used in the manufacture of injectable products that are to be sterilized after their preparation. Like PW, WFI must be protected from microbial contamination during storage and distribution.

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