CARBON CHLORINE CHLORAMINES CONDUCTIVITY DISTILLATION ION EXCHANGE MEMBRANES PHARMACEUTICALS PURIFIED WATER REVERSE OSMOSIS USP UV

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Abstract

T his edition of Ultrapure Water is devoted to pharmaceutical water treatment. This Back To Basics article provides a brief overview of pharmaceutical water treatment. The pharmaceutical industry in most countries is regulated. In the United States, the industry is regulated by the U.S. Food and Drug Administration (FDA), and takes its guidance from several sources, including the Pharmaceutical Research and Manufacturers of America (PhRMA), and the United States Pharmacopeial Convention (USP). Each country has its own governing and guiding agencies. The information in this article will refer to the standards in the United States. A pharmaceutical water treatment plant takes treated raw water, which meets drinking water quality as per U.S. Environmental Protection Agency (EPA) guidelines, and removes sufficient contaminants from the water to meet the standards required for Compendial Waters. Compendial waters include any water intended to be used for final drug dosage forms, including Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile Water for Irrigation (e.g., used to rinse, or irrigate, internal organs during surgery), and Sterile Water for Inhalation.

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