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EDQM surveys industry on RO for WFI

This article was originally published in The Gold Sheet

Executive Summary

Should the European Pharmacopoeia let drug makers use reverse osmosis to produce water for injection? The European Directorate for the Quality of Medicines and Healthcare said April 1 that it is surveying industry on this question. EP requires distillation, while the U.S. Pharmacopeia allows reverse osmosis, although FDA imposes strict controls on it. The European Medicines Agency summarized the objections in a March 5, 2008, reflection paper: reverse osmosis cannot screen out contaminants smaller than water molecules, such as chlorine or volatile organic chemicals; and the reverse osmosis membrane can become, in effect, a bacterial fermenter by allowing a biofilm to form on its upstream side and possibly spread to the permeate side or secrete metabolic byproducts that could pass through the membrane. Reverse osmosis would be cheaper and more practical, and some say new technologies would make it safe. Responses are due May 30

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