SBIR-STTR Award

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.

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 and depyrogenation 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/QC criteria/ 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 military and civilian applications.

Keywords:
Water For Injection (Wfi) Parenteral High-Temperature Compact At-Line Endotoxin Sensor