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WFI in bulk is obtainedfrom water that complies with the regulation on water intended for human consumption laid down by the competent authority, or from purified water, by distillation in an apparatus of which the parts inc ontact with the water are of neutral glass, quartz or suitable metal and which is fitted with an effective device to prevent the entrainment of droplets. The correct maintenance of the apparatus is essential. During production and storage, appropriate measures are taken to ensure that the total viable aerobic count is adequately controlled and monitored. WFI complies with the tests for Purified water with additional requirements for bacterial endotoxins (not more than (nmt) 0.25 IU endotoxins per ml), conductivity and Total Organic Carbon.
Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (First Edition)
Publication Date: 2001
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