ON LINE PRODUCTION OF ULTRAPURE WATER FOR DIALYSIS

透析用超纯水的在线生产

• 批准号: 2539775
• 负责人: PETER GRANDICS
• 金额: $ 36.91万
• 依托单位: CLARIGEN, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2000-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2539775
• 关键词: antiseptic sterilization; biomedical equipment development; clinical biomedical equipment; clinical research; dialysis; endotoxins; hemodialysis; human subject; pyrogens; surgery material /equipment; water quality; water treatment

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.

在线生产大量无菌无热原水， 由于缺乏技术，低成本受到阻碍。 我们有 我们的第一阶段已经证明了开发这种技术的可行性。 Research. 我们建议将这项技术应用于透析 治疗。 目标区域如下：准备透析液、水 用于重复使用程序和置换液。 上述所有内容都可以 通过低成本的超纯水的可用性而得到改善。 我们的目标是 证明器械处理水和透析液至少 安全如传统，无内毒素的溶质减少副作用 透析。 我们建议开发水和透析液的原型 处理装置：a.）符合法规要求B.）展示 的好处，C。该技术的安全性，d.）和降低的副 方面的影响. 这项技术的应用范围比我们更广 概述，包括腹膜透析，家庭血液透析，生产 医院、药房和制药行业的WFI级解决方案 企业 未来产品的市场潜力巨大 在五年内投入一亿美元。 商业 所提出的设备的潜力在于解决大的需求， 患者人群。 拟定商业应用： 商业应用包括从水、透析液 不同的解决方案。 无内毒素水的使用在 制备临床级溶液。 这项技术还提供 使用者有机会清除准备好的溶液中的内毒素， 而不改变原始离子组成。