The goal of the proposed study is to design and test a water purification system, which will produce sterile, WFI grade water on demand. Such ultra pure water may be used to prepare sterile dialyzate and replacement fluids. Earlier Clarigen has developed an endotoxin removing technology. This time the focus is on sterility. The proposed research consists of the development and testing of a proprietary chemical sterilization procedure, which will be combined with Clarigens' already tested endotoxin removing process in order to satisfy WFI specifications. The scope of recent proposed study is to define the optimal parameters of this combination method, by which sterile, endotoxin free water can be prepared. Phase I study should result in a prototype of a combination purification system, and should provide test results showing efficacy and reliability of the technology on small scale. The following problems will be addressed and their solution suggested to be considered milestones marking the completion of phase one research: the achievement of sterility of the flow-through water, demonstration of the lack of residual iodine in the product, demonstration of the lack of endotoxin and other pyrogens, and demonstration of WFI quality of the product on the small scale.
The on demand production of WFI water has several potential commercial applications. In kidney dialysis with the addition of sterile online mixing technology it will provide sterile replacement fluids and sterile dialyzate for peritoneal dialysis and continuous renal replacement therapy. In pharmacies and hospitals the preparation of replacement fluids could be simplified by the availability of on line sterile water. In disaster situations it could provide consumable and usable water to the public and to the military forces.
