Application note: Cost review of water for injection systems
The following excerpt is the introduction from MECO’s whitepaper titled, A Cost Review of WFI Systems. You can download the full version of this whitepaper at MECO’s website.
In 2016, the European Pharmacopeia (Ph. Eur.) revised its monograph to allow “distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.” This new standard allows for water for injection (WFI) production via membrane, or ambient processes, such as reverse osmosis and other appropriate technologies.
Water is a substantial ingredient in the drug manufacturing process. It is considered a critical utility and is produced in several bulk classifications. Purified water (PW) and WFI are two of those classifications described in detail within various Pharmacopeia, including the US, European, Japanese and Chinese Pharmacopeias.
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