ABSTRACT
INTRODUCTION This chapter discusses distribution systems-an important part of any pharmaceutical water system. The materials of loop construction are one of the important considerations. Certainly, 316L stainless steel should be used for all Water for Injection distribution systems. It is suggested that 316L stainless steel should be considered for any system where microbial control is a consideration, including Purified Water systems and certain active pharmaceutical ingredient water systems. As indicated in an earlier chapter, the most effective method of eliminating bacteria within a storage and distribution system is to provide hot distilled water to a storage tank, maintain the stored and recirculating water at a temperature 808C continuously, and eliminate the potential for back contamination. However, the indicated conditions are not plausible for most Purified Water systems and many Water for Injection systems. Periodic thermal sanitization of Purified Water and Water for Injection systems can provide bacteria “control.” Specifically, it has been indicated that total viable bacteria destruction can be achieved, within a properly designed system, when the storage and recirculated water is heated to 908C for a time period of two hours.
