A New Method for On-Site SWFI Production

By Lixiong Li and Jean J. Renard

ION EXCHANGE PHARMACEUTICALS REVERSE OSMOSIS WFI

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Abstract

Sterile and pyrogen-free Water for Injection (SWFI) is an essential and predominant ingredient in the formation of parenteral and blood reconstitution products. Currently acceptable SWFI production methods include distillation and two-stage reverse osmosis (RO) followed by ultraviolet (UV) sterilization. There is a growing interest in on-site production SWFI using portable systems for military and a number of civilian applications. A novel hydrothermal processing concept for field production of SWFI from potable water has been developeda. Six logs of pyrogen reduction were consistently achieved with reactor residence times of a few seconds at temperatures up to 450oC and sufficient pressures to prevent water from boiling. These rapid sterilization and depyrogenation results were used as the design basis for a compact SWFI generator. The approach also enables efficient recovery of thermal energy and eliminates potential bacteria and pyrogen buildup.

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