Pharmaceuticals

Part 1: Technical And Regulatory Perspective On Establishing And Maintaining Microbial Purity In Pharmaceutical Water Systems

By Edward G. Helmig

BACTERIA COMPENDIAL WATER DISTILLATION DRINKING WATER EDI EP EPA GOOD PRACTICES LIFE SCIENCES MEMBRANES MICROBIALS PHARMACEUTICALS PURIFIED WATER REVERSE OSMOSIS USP WFI

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Abstract

This article series will summarize proven technologies and practices for the preparation of water for injection (WFI). It will provide perspective on the topic, a summary of United States Pharmacopeia (USP) limits for key parameters, a brief overview of important microbial groups plus prions, endotoxins. The series will also review the principle methods for endotoxin removal and Good Practices (GPs) for maintaining microbial purity. Distillation, membranes, ozone, and ultraviolet (UV) irradiation, are the key technologies addressed. We will also examine how these technologies work, and how they sometimes fail. The article will also touch on drinking water, Purified Water, Compendial Water, and the use of reverse osmosis in pharmaceutical facilities.

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