ON LINE PRODUCTION OF ULTRAPURE WATER FOR DIALYSIS

在网上生产大量无菌、无热源的水 由于缺乏技术，低成本受到了阻碍。我们有 论证了我们第一阶段开发这项技术的可行性。 研究。我们建议将这项技术应用于透析 治疗。以下领域为目标：准备透析液、水 用于重复使用程序和置换液。以上所有内容都可以 由于可获得低成本的超纯水而得到改善。我们的目标是 为了证明设备处理过的水和透析液至少是 与传统药物一样安全，不含内毒素的溶质可减少副作用 做透析剂。我们建议开发水和透析液的原型 治疗设备：a.)满足法规要求b.)演示 好处，c.)这项技术的安全性，D.)和缩小的边 效果。这项技术有我们所拥有的更广泛的应用 概述，包括腹膜透析、家庭血液透析、生产 医院、药店和制药行业的WFI级解决方案 公司。前景看好的产品市场潜力巨大 在五年的时间里增加了1亿美元。商业广告 所提议的设备的潜力在于解决大型 患者群体。 建议的商业应用： 商业应用包括去除水中的内毒素、透析液、 和不同的解决方案。无内毒素水的使用在 临床级溶液的制备。这项技术还提供了 有机会从内毒素中清除现成溶液的用户， 在不改变原始离子组成的情况下。

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.