FDA-Industry Relations: Progress from Confrontation to Communication

Abstract

The Water for Injection (WFI) System at the Upjohn Company was placed “on stream” in July of 1981. This presentation will discuss the design and operation of it. Although the WFI System at Upjohn is similar to many other systems in the pharmaceutical industry in that it complies with GMP and 3-A guidelines, there are several distinct features. These include separate WFI Product and Rinse systems, a lower circulating temperature, and reheating of water cooled but not used at the points-of-use. Included are descriptions of these features as well as the general design of the generation, storage, and distribution systems. Finally, operating experiences, including start-up, validation, and daily operations, are discussed.