Water for Injection

Can On-Site Sterile Water for Injection (SWFI) Be Easily Produced?

By Lixiong Li and Jean J. Renard

BACTERIA ION EXCHANGE PHARMACEUTICALS PYROGENS REVERSE OSMOSIS WFI

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Abstract

Editor’s note: Welcome to a technical article from our archives. This article by Lixiong Li, PhD, and Jean J. Renard, PhD, was published in the March 2008 issue of Ultrapure Water Journal. This article examines the production of Sterile Water for Injection (SWFI).

Sterile and pyrogen-free Water for Injection (SWFI) is an essential and dominating ingredient in 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 developed. 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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