ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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WFI

Water For Injection

WFI

USP Water for Injection. Prepared from water complying with the quality attributes of “Drinking Water.” Purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. Conductivity in accordance with Stage 1, 2, and 3 tests and Conductivity Tables. Total Organic Carbon limit is at 0.5 mg/l. Typically less than 10 CFU/100ml for microbiological acceptability. Less than 0.25 USP EU/ml.

Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Publication Date: 2007

See also: Bacteriostatic Water For Injection Sterile Water For Injection Sterile Water for Irrigation

WFI

USP Water for Injection. USP Water for Injection. Prepared from water complying with the quality attributes of “Drinking Water.” Prepared using Distillation or Double pass reverse osmosis. Conductivity in accordance with Stage 1, 2, and 3 tests and conductivity tables. Total Organic Carbon at 0.5 mg/l. Less than 0.1 CFU/ml (10 CFU/100ml) for FDA acceptability. Less than 0.25 USP EU/ml.

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (Second Edition)

Publication Date: 2011

See also: WFI (Water for Injection)

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