PurifiedWaterSystemValidationProtocol.docVIP

Purified Water System Validation Protocol 纯化水系统验证方案 Approval of the Purified Water System Validation Protocol 纯化水系统验证方案的审批 Title 职务 Name 姓名 Signature 签字 Date 日期 Written By 起草人 Reviewed By 复核人 Approved By 批准人  Table of Contents 1 Summarize/概述 3 2 Purpose/验证目的 4 3Validation Team and Responsibilities/验证人员及职责 4 3.1Validation Team Member/项目验证小组成员 4 3.2 Responsibilities/职责 4 4 Content, Method and Criterion/验证内容、方法及合格标准 5 4.1Beforehand Qualification/预确认（安装前确认） 5 4.2 Installation qualification/安装确认 7 4.3 Operation qualification/运行确认 11 4.4 Performance Qualification/性能确认 12 5 Deviation and deal with method/验证过程中的偏差及处理 14 6 Validation Conclusion/验证结果评定与结论 14 7.Revalidation Periods/再验证周期 15 8．Validation Schedule/验证时间安排 15 9.Attachment/ 附件 16 1 Summarize/概述 The company commissioned the Jiaxing Jiame Water Treatment Engineering Co., Ltd. for the purified water system design and installation, the system product capacity of water is 1.0m3 / h, using of two grade reverse osmosis process to obtain purified water. Tap water after adding coagulant (PAC) was pumped by original water pump through multimedia filters, activated carbon filter for filtration and adsorption treatment to remove particulate impurities, colloid, chlorine, organic matter, etc. The free chlorine content of the water is less than 0.1ppm, SDI ≤ 4.Then Via precision filter to remove particles greater than 5u, entered the two grade reverse osmosis system use of membrane separation technology, desalinate the majority of ions in water, SiO2, organic colloids and other impurities, water production stored in a purified water storage tank, by ultraviolet sterilizers to kill bacteria that may exist in the terminal, after the booster pumps and precision filters, through the stainless steel pipe to various purified water use points, used for ingredients, equipment and containers cleaning, washing clothes and so on. Parts of the purified water through the circulation pipe back to the puri