BACTERIA CALIBRATION DISTILLATION EDI ENDOTOXINS OZONE PHARMACEUTICALS PURIFIED WATER REVERSE OSMOSIS SYSTEM DESIGN USP UV WFI

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Abstract

The United States Pharmacopeia (USP) Official Monograph for Water for Injection (WFI) accepted use of reverse osmosis (RO) or distillation as the production method more than 35 years ago in USP XIX. Currently, USP accepts distillation or a “… process that is equivalent or superior to distillation in the removal of chemicals and microorganisms” (1). The European Pharmacopeia (EP) has historically limited production of WFI to distillation, including a statement that “The correct maintenance of the apparatus is essential” (2).

The future acceptance of nondistillation based systems for the production of both USP and EP WFI should consider responsive proactive preventative maintenance programs. A “Case History” is provided to demonstrate the importance of maintenance. In a follow-on article, the author will demonstrate the need for responsive system maintenance using Risk Assessment by Failure Mode and Effect Analysis.

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