USP Purified Water

USP Purified Water (PW) is required for any drug product ingested into the human body.  It is also used in the preparation of topical drugs.  It is the default water quality for nearly every use (other than Water for Injection) in the biopharmaceutical industry.  This includes rinse water for cleaning all tools and machinery used in the manufacture of ingested drugs.  Purified water is a bulk preparation that can be packaged.  The United States Pharmacopeia (USP) defines packaged products made with Purified Water including:  Sterile Purified Water and Purified Water.    

 

There are specific requirements listed by USP for the preparation of PW.  It must meet requirements for total organic carbon, aka TOC (500 ppb), and conductivity (1.3us @ 25 degrees Centigrade).  Systems for the production of PW 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.  Some packaged PW products must be rendered sterile in the package.

 

The requirements for PW are fairly rigorous and designed to ensure that the water quality is consistent.  Hydrx, Inc. has the experience to exceed all the requirements for production of PW.  Furthermore, we have a patented process that is specifically designed to produce this quality of water in a robust manner on an ongoing basis.