Start Updating international standards for pharmaceutical waters

Updating international standards for pharmaceutical waters

There have been a number of technological advancements in high-purity pharmaceutical-grade water.

Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications.

WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.

Outside of being used as an ingredient, pharmaceutical water has multiple other applications, including container and equipment cleaning, intravenous fluids, product contact of ingredient, product contact of medical device (cleaning), and reagent or solvent in drug manufacturing (but not in final product).

Treated UPW that meets requirements for a power station would be unacceptable for a pharmaceutical plant.

USP Purified Water meets USP grade specifications and can be purchased as a 20L sealed container or 200L sealed drum.

USP Purified Water is intended for use as an ingredient of official preparations and in tests and assays.

And purified water meeting pharma plant quality standards does not meet the stricter requirements found in the microelectronics industry.