Water for injection
Water for Injection
Water for Injection (WFI) is a type of water that is specifically prepared for use in the production of pharmaceuticals and medical devices. It is highly purified and free from any contaminants, making it suitable for use in intravenous solutions, injections, and other medical applications where sterility and purity are critical.
Production
Water for Injection is produced through a process of distillation or reverse osmosis, followed by additional purification steps such as deionization and filtration. The goal is to remove all impurities, including bacteria, endotoxins, and particulate matter. The production process must comply with strict pharmaceutical standards to ensure the water's safety and efficacy.
Uses
WFI is primarily used in the preparation of parenteral solutions, which are administered directly into the body, bypassing the gastrointestinal tract. This includes intravenous, intramuscular, and subcutaneous injections. It is also used in the cleaning of medical equipment and as a solvent for the preparation of medications.
Quality Standards
The quality of Water for Injection is regulated by various pharmacopoeias, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These standards specify the acceptable levels of microbial contamination, endotoxins, and other impurities. WFI must be stored and handled in a manner that prevents contamination, often in sterile containers and environments.
Storage and Handling
Water for Injection must be stored in conditions that maintain its sterility and purity. It is typically kept in sealed, sterile containers made of materials that do not react with the water. The storage environment should be controlled to prevent contamination from microorganisms and particulates.
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Contributors: Prab R. Tumpati, MD