A System to Produce Sterile Water for Injection from Potable Water

Limited options and capabilities are available for on-site production of sterile and pyrogen-free water for injection (WFI) by deployable systems. An ideal field unit for military and civilian use should be compact, efficient, reliable, and easy-to-operate. This proposal addresses the development of such a system for producing sterile and pyrogen-free WFI from potable water. The proposed approach is based on a high-temperature method to achieve fast sterilization and depyrogenation, and to eliminate the possibility of bacteria and pyrogen buildup in any part of the system during the operation. The focus of Phase I study is to experimentally demonstrate that six-orders of magnitude of pyrogen reduction can be achieved with contact times of a few seconds. A laboratory-scale test apparatus will be built and used to generate water samples for biological analyses. Temperature-time criteria will be established and used to size the prototype reactor for a 30-liter/hr system with overall dimensions similar to that of a household microwave oven. Commercially available pyrogen standards will be used as controls for evaluating the rates of pyrogen destruction. Limulus amebocyte lysate (LAL) tests will be used to validate the water samples. Good manufacturing practices will be followed in conducting the research. Developing the capability to produce sterile and pyrogen-free WFI from local potable water addresses the logistical problem of transporting and storing such material required by not only the U.S. Navy, but also other military branches. WFI can be used to produce intravenous (IV) fluids and reconstitute freeze-dried blood products.