On Line Production of Ultrapure Water for Dialysis

Period of Performance: 03/15/1998 - 03/14/1999


Phase 2 SBIR

Recipient Firm

Clarigen, Inc.
Carlsbad, CA 92008
Principal Investigator


The production of large amounts of sterile, pyrogen-free water on-line at low cost has been hampered by the lack of technology. We have demonstrated the feasibility of developing such technology by our Phase I. Research. We are proposing to apply this technology for dialysis treatments. The following areas are targeted: preparing dialysate, water for reuse procedures, and substitution fluids. All the above can be improved by the availability of ultrapure water for low cost. Our goal is to demonstrate that the device-treated water and dialysate are at least as safe as traditional, and that endotoxin free solutes decrease side effects of dialysis. We propose to develop prototypes of water and dialysate treating devices: a.) meeting regulatory requirements b.) demonstrating the benefits, c.) the safety of this technology, d.) and reduced side effects. This technology has broader range of applications that we have outlined, including peritoneal dialysis, home hemodialysis, production of WFI grade solutions in hospitals, pharmacies, and pharmaceutical companies. The market potential for the prospective products is in excess of 100 million dollars over a period of five year. The commercial potential of the proposed devices lies in addressing the needs of large patient populations. PROPOSED COMMERCIAL APPLICATION: Commercial application include removal of endotoxin from water, dialysate, and different solutions. The use of endotoxin free wate is important in preparation of clinical grade solutions. This technology also provides the users with the opportunity to purge ready solutions from endotoxin, without altering the original ion composition.