USP Water for Injection

USP Water for Injection (WFI) is required for use in anything that is injected or inserted into the human body.  This includes injected drugs, water used for irrigation or inhalation, and rinse water for anything that is inserted into the body such as catheters, pins, and screws.  Water for Injection is a bulk preparation that can be packaged in several ways.  The United States Pharmacopeia (USP) defines multiple packaged water products made with water for injection, including:  Sterile Water for Injection, Sterile Water for Irrigation, Sterile Water for Inhalation, and Bacteriostatic Water for Injection.

 

There are specific requirements listed by USP for the preparation of WFI.  It must meet requirements for total organic carbon, aka TOC (500 ppb), conductivity (1.3us @ 25 degrees Centigrade), and bacterial endotoxins (.25 eu/ml).  It must be prepared by a method equal to or superior to distillation.  Systems for the production of WFI must be validated.  Validation is an ongoing process to ensure continuous functionality of the water preparation system. The producer of the water is responsible for providing adequate control of microorganisms.  All packaged WFI products must be rendered sterile in the package.

 

The requirements for WFI are rigorous and designed to ensure that the product cannot harm a human.  Hydrx, Inc. has the experience to exceed all the requirements for production of WFI.  Furthermore, we have a patented process that is specifically designed to produce this quality of water in a robust manner on an ongoing basis.