医学生物实验室工艺用水输送系统的改建及应用

Modification and application of water delivery system for biological laboratory

目的:为医学生物实验室提供纯化水、注射用水,同时解决纯蒸汽灭菌所存在的弊端。方法:对原有工艺用水系统进行改建,采用不锈钢管道化输送方式,严格按照中华人民共和国卫生部《药品生产质量管理规范》(GMP)要求设计、安装。结果:解决了工艺用水的使用要求和后序工艺设备及工艺用水分配系统自身的清洗、灭菌问题,达到了预期的目的。结论:工艺用水系统采用密闭循环式输送,在线清洗与灭菌,有效地控制了微生物污染且同时控制了细菌内毒素的水平,为安全使用工艺用水提供了可靠保障。

Objective：To provide laboratory purified water, water for injection and pure steam sterilization to solve the problem. Methods：The original water system and stainless steel pipe of the conveyor was reconstructed according to the GMP requirements of the design and installation. Results：We achieved the intended purpose to solve the process water requirements. Conclusion：The use of closed loop process water system, conveyor and line cleaning and sterilization can effectively control microbial contamination and provide reliable guarantee for safe use of the water.