ABSTRACT
Pharmacopoeias in other countries can differ substantially from that of the United States. Some will only allow distillation as an acceptable process for producing Water for Injection (WFI). This chapter looks at the requirements that make a solution WFI. The design of a WFI system affects the long-term condition of the system itself, as well as start-up, maintainability, validation, and contamination control. WFI is intended for use as a solvent for the preparation of parenteral solutions. The WFI feedwater storage and distribution system is undergoing many changes in design and with respect to the preferred material of construction. Reverse osmosis units are often used in pretreatment, but rarely for final generation of WFI. Additional places where one might find systems identical to a WFI system are in plants manufacturing sterile ointments or diagnostics–sometimes even in oral liquids or cosmetics plants.
