Methods for the on-line, on-demand preparation of sterile, water-for-injection grade water
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United States of America Patent
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Jun 8, 2004
Grant Date -
Sep 18, 2003
app pub date -
Mar 14, 2002
filing date -
Mar 14, 2002
priority date (Note) -
Expired
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Abstract
A new method is described to produce large volumes of low cost sterile, Water-for-Injection (WFI) grade water on-line, on-demand from potable water in order to meet the needs of dialysis therapies and other biological applications for sterile, injectable grade water. The source water is processed by a combination of membrane and column chromatographic methods including reverse osmosis, chemical sterilization, reduction of iodine sterilant to iodide, deionization, endotoxin-specific adsorption and polishing filtration in order to reduce contaminant levels below those specified by the US Pharmacopoeia.
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