ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Water for Injection (WFI) (USP)

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

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (First Edition)
Publication Date: 2001

Water for Injection (WFI) (USP)

Water purified by distillation or by reverse osmosis, it contains no added substance, and it meets the purity requirements under Purified Water. Although not intended to be sterile, it meets a test for a limit of bacterial endotoxin (less than 0.25 USP En

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

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