WFI, also known as Water for Injection, is a high-quality purified water that meets the specifications and standards set by regulatory bodies like the United States Pharmacopeia (USP) for use in the pharmaceutical and biotechnology industries. It is a key ingredient in the manufacturing and production of various drugs, as well as the preparation of medical devices, vaccines, and parenteral solutions, where water of exceptional purity is required.
WFI is prepared through a complex process that includes distillation, reverse osmosis, deionization, and other purification methods to remove impurities and contaminants from the water supply. It undergoes extensive testing to ensure its compliance with relevant regulations, including the absence of specific microorganisms, endotoxins, heavy metals, and other substances that may be detrimental to human health.
Due to its purity, WFI is crucial for maintaining the safety, efficacy, and stability of pharmaceutical products and medical devices. It is often used as a diluent or solvent in the formulation of drugs, as well as for dissolving or diluting active pharmaceutical ingredients. Furthermore, WFI is employed as a cleaning agent for equipment and containers used in the pharmaceutical manufacturing process to prevent contamination.
Overall, WFI serves as a foundation for producing safe and reliable pharmaceutical products, playing a vital role in ensuring the quality and integrity of medications and healthcare solutions.
