A System to Produce Sterile Water for Injection from Potable Water

Sterile and pyrogen-free water for injection (WFI) is an essential ingredient in parenteral and blood products. Applied Research Associates recently demonstrated a novel thermal approach that can achieve fast and virtually complete sterilization anddepyrogenation of potable water, and eliminate the possibility of bacteria and pyrogen buildup within the water conversion system (Navy STTR N99-T008 Phase I Project).The first objective of the proposed Phase II effort is to design, fabricate, and field-test a compact prototype to demonstrate that such a system can be highly efficient, reliable, robust, and easy-to-operate. The second objective is to incorporate QA/QCcriteria/ procedures and cGMP guidelines into the prototype system to ensure the quality of the product water according to the WFI standards required by the U.S. Navy, USP, and U.S. FDA. The third objective is to evaluate a rapid bacteria endotoxin (ET)detection concept, which can be eventually integrated into the proposed WFI system. The fourth objective is to obtain industrial funding to continue the commercialization effort beyond the scope of this Phase II effort.BENEFITS: As a field deployable system, the proposed approach is technically superior over the currently acceptable WFI methods (i.e., distillation and reverse osmosis). The proposed WFI process and ET detection concept hold great potential in militaryand civilian applications.