VP纯化水系统验证方桉.doc

Document No 文件编号VP Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 1 of 40 Purified Water System Validation Protocol 纯化水系统验证方案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纯化水系统验证方案的审批 Title 职务职务Name 姓名姓名Signature 签字签字Date 日期日期 Written By 起草人起草人 Reviewed By 复核人复核人 Approved By 批准人批准人 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 2 of 40 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 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 3 of 40 1 Summarize 概述概述 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 purified water storage tank Simple process as follows raw water drinking water original water tank flocculant dosing system multi medium filter activated carbon filter Soft Water systems Filters a high pressure pump reverse osmosis unit alkali dosing two high pressure pump system reverse osmosis unit purified water tank and water pumps ultraviolet disinfection Terminal filter use point 公司纯化水系统为委托嘉兴嘉美水处理工程有限公司设计安装 制水能力为 1 0m3 h 利用二 级反渗透工艺来制取纯化水 饮用水加入絮凝剂 PAC 后由原水泵增压后进多介质过滤器 活性炭过滤器的过滤和吸附处理 除去水中颗粒状杂质 胶体 余氯 有机物等 使出水游离氯含量小于 0 1ppm SDI 4 再经精 密过滤器除去水中大于 5u 的颗粒后进入二级反渗透系统 利用膜分离技术的高脱盐率 除去水中 大部份离子 SiO2 有机物胶体等杂质 二级反渗透系统产水贮存于一只纯化水贮罐 经紫外线杀 菌器杀死可能存在的细菌等后由终端水泵增压并经微孔过滤器过滤 通过不锈钢管道送至各纯化水 用水点 用于配料用水 设备及容器具清洗 工作服清洗等 部份纯化水通过循环管道回至纯化水 贮罐 简易流程为 原水 饮用水 原水箱 絮凝剂加药系统 多介质过滤器 活性炭 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 4 of 40 过滤器 阻垢剂加药系统 保安滤器 一级高压泵 一级反渗透装置 碱加药系统 二级高压泵 二级反渗透装置 纯化水箱 送水泵 紫外线杀菌装置 终端微孔过滤器 使用点 2 Purpose 验证目的验证目的 Through purified water system installation operation and performance qualification to prove its ability to steady provided supply of quality and quantity qualified water 对纯化水系统的安装 运行和性能进行验证 以证明其有能力稳定地供应规定数量和质量的合 格用水 3Validation Team and Responsibilities 验证人员及职责验证人员及职责 3 1Validation Team Member 项目验证小组成员项目验证小组成员 Project validation team comprises of Production Management Department Quality Management Department Equipment Engineering Division and the operator maintenance worker QC personnel The manager of the production management department is the leader of this validation team Validation team members see attachment 2 项目验证小组由生产管理部 质量管理部 设备工程科和操作工 维修工 QA QC 组成 由 生产管理部经理任项目验证组组长 验证小组成员见附件 2 3 2 Responsibilities 职责职责 Equipment Engineering Division Draft the validation protocol Technical document qualification and implemented the validation draft the validation report Production Management Department Review the validation protocol Assist the engineering Division implementation the validation work Quality Management Department Review the validation protocol finished the relative analytical work Validation Committee Director Approved the validation protocol and the validation report 设备工程科 负责设备验证方案的起草及验证工作的具体实施 起草验证报告 生产部 复核验证方案 协助设备工程科进行验证工作的实施 质量部 负责验证文件的审核 负责相关检验任务 验证委员会主任 负责设备及公用工程系统验证方案及报告的批准 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 5 of 40 Validation process should be strictly in accordance with the approved validation protocol if need to change for special reasons they should fill out the the validation protocol change application and approval forms attachment 1 according to the original review and approval procedures for the approval before the Executive the change 验证过程应严格按照本方案规定的内容进行 若因特殊原因确需变更时 应填写 验证方案变 更申请及批准书 附件 1 按原审批程序批准后执行 4 Content Method and Criterion 验证内容 方法及合格标准验证内容 方法及合格标准 4 1Beforehand Qualification 预确认 安装前确认 预确认 安装前确认 4 1 1 Document Qualification 资料确认 Confirmed that the relevant document to support the verification is complete fill out confirm records in attachment 3 确认支持本验证的相关资料是否齐全 确认记录填写于附件 3 Document name 资料名称Confirm method 确认方法 Purified water system the detailed design requirements and technical parameters of major equipment 纯化水系统详细设计要求及主要设备技术参数 Consult equipment archives 查阅技术档案 Ordering the contract specifications and related technical information 纯化水系统主要组成设备订货合同 说明书及相关技 术资料 Consult equipment archives 查阅技术档案 Mainly equipments Certificates 各设备检验合格证 Consult equipment archives 查阅技术档案 Purified water quality standards 纯化水质量标准 Consult CP 2005 查阅技术档案查阅药典 2005 版纯 化水标准 Purified Water System Flow Chart 纯化水系统工艺流程图 Consult equipment archives and attached attachment 4 查阅技术档案查阅并附于附件 4 Purified water system operation and maintenance standard operation procedures 纯化水系统操作和维护保养标准操作规程 Consult the relative SOP 查阅技术档案 Purified water system sample standard operating procedures 纯化水取样标准操作规程 Consult the relative SOP 查阅技术档案 Purified water system cleaning standard operating procedures 纯化水系统清洁标准操作规程 Consult the relative SOP 查阅技术档案 Out of the box inspection records 开箱验收记录 Consult equipment archives 查阅技术档案 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 6 of 40 Installation and commissioning records 安装调试记录 Consult equipment archives 查阅技术档案 Test Run Record 试运行记录 Consult equipment archives 查阅技术档案 Pipeline Pressure Test Record 管道试压记录 Consult equipment archives and attached attachment 5 查阅并附于附件 5 Pipe cleaning records before use 管道使用前清洗记录 Consult equipment archives and attached attachment 6 查阅并附于附件 6 Pipeline passivation Records 管道钝化记录 Consult equipment archives and attached attachment 7 查阅并附于附件 7 Pipe disinfection record before use 管道使用前消毒记录 Consult equipment archives and attached attachment 8 查阅并附于附件 8 Water purification water system network diagram 纯化水系统用水网络图 Consult equipment archives and attached attachment 9 查阅附于附件 9 Qualification proof of the equipment supplier 各设备生产企业资质证明材料 Consult equipment archives and attached attachment 10 查阅附于附件 10 The equipment inspection reports 各设备检验报告 Consult equipment archives and attached attachment 11 查阅附于附件 11 4 1 2 Instrument calibration verification 仪器 仪表的检定或校验确认 Instruments used in System such as Pressure gauges conductivity meter etc shall be calibrated and within the validity period The confirm records be filled in attachment 12 Instruments as follow must be calibrated 系统所用的压力表等及检测所用的电导率仪等须经检定或检验合格 并在检定有效期内 确认 记录填写于附件 12 下列仪器仪表必须经过校验 Instrument Name 名 称 Specification 型 号 规格 Count 数 量 Pressure gauges 耐振压力表0 2 5MPa4 Pressure gauges 耐振压力表0 1MPa7 conductivity meter 电导率 仪 1 PH meter PH 计 1 4 1 3 After service Qualification 售后服务确认 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 7 of 40 Check the purified water system supplier after service information and assure it is complete The information include supplier name address phone should filled in the attachment 13 检查各主要设备售后服务资料是否齐全 包括单位名称 地址 联系电话 保修及维修等详 细资料 确认记录填写于附件 13 4 2 Installation qualification 安装确认安装确认 4 2 1 Public Media Connect confirmation records fill in attachment 14 公用介质连接确认 确认记录填写于附件 14 4 2 1 1 Power Supply Installation confirmation 电源安装确认 Item 项目Standard 合格标准Method 确认方法 electric voltage 电压380V 20 VMultimeter test 万用表检测 Three phase five wire 三相五线On site inspection 现场检查the line of electricity demand 进线要求 YJV 4 2 5 BVR 1 2 5On site inspection 现场检查 Ground Protection 接地保 护 Grounding resistance is less than 4 接地电阻小于 4 Ohmmeter measurements 欧姆表 测量 4 2 1 2 Water supply installation confirmation 进水安装确认 Item 项目Standard 合格标准Method 确认方法 Water quality requirements 水质 要求 Should meet drinking water health standards GB 5749 2006 应符合生活饮用水卫生标准 GB 5749 2006 See Water Quality Test Report 见水质检测报告 Pressure 压力0 4Mpa Measured with pressure gauge 压力表测量 Pipe diameter 管 道管径 DN32 Measured with vernier caliper 游标卡尺测量 Pipe material 管 道材质 PPInspection by Visual 目测 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 8 of 40 4 2 2 Purified water pipeline and Valves installation confirmation the records fill in attachment 15 纯化水管道及阀门 3 路 安装确认 确认记录填写于附件 15 Item 项目Standard 合格标准Method 确认方法 Work press 操作压力 0 4Mpa Measured with pressure gauge 压力表测量 Pipe diameter 管 道管径 DN32 2 Measured with vernier caliper 游标卡尺测量 Pipe material 管 道材质 SS304 Consult pipe material certificate document and attach it in attachment16 检查材质证明并附于 附件 16 Valves material 阀 门材质 SS304 Consult pipe material certificate document and attach it in attachment16 检查材质证明并附于 附件 16 Installation requirement 安装要求 Using hot melt type welding joint connecting the health quick circular layout smooth no dead ends each water point of use of diaphragm valves the water intake point and the outlet layout drawings based on design requirements 采用热熔式氩弧焊与卫生快装接头连接 循 环布置 光滑 无死角 每个用水点采用隔 膜阀 各取水点及出水口的布置依据图纸设 计要求 Inspection by Visual and check the relative records 目测及 检查相关记录 4 2 3 purified water tank installation A total of 1 water storage capacity of 1m3 纯化水储罐安装确认 一只 贮水量为 1m3 4 2 3 1 Method Inspection by Visual Measured with vernier caliper and Consult material certificate document and attach it in attachment16 records fill in attachment 17 确认方法 目测 游标卡尺测量 检查材质证明 附于附件 16 确认记录填写于附件 17 4 2 3 2 Standards 合格标准 1 Tank inside and outside surface is polished smooth surface 储罐内外表面经过抛 光 表面光洁 2 Inside surface and sealed head Material SS304 stainless steel thickness 4mm 内筒体及封头 材质 SS304 不锈钢 厚度 4mm 3 Connectors and related auxiliary equipment 连接口及相关配套设备 Purified water Inlet top 纯化水入口 顶部 DN15 Purified water Outlet bottom 纯化水出口 底部 DN20 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 9 of 40 Limber hole bottom of the lowest 排污口 底部最低位置 DN15 Clean hole at the top of the middle position DN32 With 3600 rotary cleaning ball material SS304 清洗口 顶部正中位置 DN32 配 3600旋转清洗球 材质 SS304 不锈钢 Breath hole top 呼吸口 顶部 DN15 4 2 4 purified water storage tank SCBA installation 纯化水储罐空气呼吸器安装确认 The record fill in attachment 18 确认记录填写于附件 18 Item 项目Standard 合格标准Method 确认方法 Body material 壳 体材质 SS304 Consult material certificate document and attach it in attachment16 检查材质证明 并附于附件 16 Filter material 过 滤材质 Polypropylene 聚丙烯 Consult material certificate document and attach it in attachment16 检查材质证明 并附于附件 16 Seal method 密封方法 Melt together 热熔合 Consult certificate document and attach it in attachment16 检查证明并附于附件 16 Hole Diameter 孔 径 0 22 m Consult certificate document and attach it in attachment16 检查证明并附于附件 16 4 2 5 Critical parts material qualification 关键部位材质确认 The records fill in attachment19 确认记录填写于附件 19 Requirement 要求 Parts name 部件 Body material 壳体材质 Media and requirements 介质及 要求 Method 确认方法 Original water pump 原 水泵 Stainless steel 不锈钢 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 Multi media filter 多 介质过滤器 FRP Quartz sand anthracite 石英砂 无烟煤 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 Activated carbon filters 活性炭过滤器 FRP Activated carbon 活 性炭 Consult material certificate document and Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 10 of 40 attach it in attachment16 检 查材质证明并附于附件 16 Security filters 保安 滤器 Stainless steel 不锈钢 Polyethylene fiber 聚乙烯纤维 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 High pressure pump 高 压泵 Stainless steel 不锈钢 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 Cleaning Pumps 清洗泵 Stainless steel 不锈钢 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 reverse osmosis system element 一 二级反渗透 元件 Stainless steel 不锈钢 TFC Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 UV sterilizers 紫外线 杀菌器 Stainless steel 不锈钢 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 Microporous filter the number is 2 微孔 过滤器 2 个 Stainless steel 不锈钢 0 22 m nylon filter 0 22 m 尼 龙液体过滤芯 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 Terminal pump 终端水 泵 Stainless steel 不锈钢 Consult material certificate document and attach it in attachment16 检 查材质证明并附于附件 16 4 2 6 Pipeline pressure test clean passivation and disinfect qualification 管道分配 系统的试压 清洗 钝化 消毒确认 4 2 6 1 Qualification method 确认方法 Inspect the pipeline pressure test record attachment 5 clean record before use attachment 6 pipeline passivation records attachment 7 and pipeline disinfect records attachment 8 检查纯化水管路试压记录 附件 5 纯化水管道使用前清洗记录 附件 6 纯化水管道钝化记录 附件 7 纯化水管道使用前消毒记录 附件 8 4 2 6 2 Standards 合格标准 1 Pipeline pressure test 管路试压 Pressure test with Water experimental pressure is 0 6Mpa which is 1 5 times working pressure 0 4MPa the pipeline should be no leakage under the pressure 用水 Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 11 of 40 试压 实验压力为工作压力 0 4MPa 的 1 5 倍即 0 6Mpa 整个管路在实验压力下应无渗漏发生 2 Pipeline clean passivation and disinfect 管道清洗 钝化 消毒 Purified water cycle pipeline Pre washed The purified water tank pump and pipeline to connect into a cycle path add sufficient amount of purified water to purified tank open the pump to cycle for 15 minutes open the drain valve and then continue cycle 纯化水循环预冲洗 将纯水罐 水泵与管路连接成一个循环 通路 在纯水罐中注入足够量的纯化水 开启水泵进行循环 循环 15 分钟后 打开排水 阀 边循环边排放 Alkaline Cleaning The sodium hydroxide chemically pure and above with hot water temperature 90 or above preparation of 1 w v solution 500L with the circulation pump more than 30 minutes after 30 minutes opening Each water point of the valve for 10 seconds to wash their open the drain valve discharge lye 碱液清洗 将氢氧化钠 化学纯以上 用热水 温度 90 以上 配制成 1 w v 的溶液 500L 用水泵循环 30 分钟以上 期间隔 30 分钟后开启每个用水点阀 门 10 秒钟对其进行清洗 打开排水阀 排放碱液 Rinse Add purified water to purified water storage tank start the pump open the drain valve rinse while discharge discharge time should be no less than 30 minutes until the conductivity of the water in the tank and the conductivity of outlet water is the same 冲洗 将纯化水加入纯水罐 启动水泵 打开排水阀 边冲洗边排放 排放时间应不少于 30 分钟 直至各出水口水的电导率与纯 水罐中水的电导率一致 Passivation The nitric acid chemically pure and above preparation of 5 of the acid 500kg injection of pure water tank recycling 120 minutes using sodium hydroxide adjust PH 7 and discharge 钝化 将硝酸 化学纯以上 配制成 5 的酸液 500kg 注入纯水罐 循环 120 分钟 用氢氧化钠中和后排放 Rinse Rinse with purified water no less than 30 minutes until the conductivity of import and export purified water is the same 冲洗 用纯化水冲 洗 时间不少于 30 分钟 直至进出口纯化水的电导率一致 Disinfection preparation of 3 hydrogen peroxide disinfecting solution add Document No 文件编号 Revision No 版本号00 Purified Water System Validation Protocol 纯化水系统验证方案纯化水系统验证方案 Date 日期20090301 Company Name 公司名称 Page 页码Page 12 of 40 it to the pure water tank and start the pump loop for 30 minutes every 10 minutes opening discharge valve for each water point 10 seconds of its disinfection 消毒 配制 3 的双氧水消毒液 注入纯水罐 启动水泵 循环 30 分钟 期间每隔 10 分钟开启每个用水点阀门排放 10 秒对其进行消毒 Rinse Rinse with purified water no less than 30 minutes until the conductivity of import and export purified water is the same 冲洗 用纯化水冲 洗 时间不少于30 分钟 直至进出口纯化水的电导率值一致 4 3 Operation qualification 运行确认运行确认 4 3 1 Control and safety protection performance confirmation 控制及安全保护性能确认 Records fill in attachment 20 确认记录填写于附件 20 4 3 1 1 Qualification Method 确认方法 Check and assure that the control system and the corresponding direction is normal over voltage protection function the water level automatic control functions overload and short circuit protection function STOP function is accurate and effective 检查控制系统运行及相应指示是否正常 过压保护功能 水位自动控制功能 过载及短路保护 功能 急停 功能是否准确有效 4 3 1 2 Standards 合格标准 The control system and the corresponding directions is normal over voltage protection function the water level automatic control functions overload and short circuit protection function E STOP function are accurately and efficiently 控制系统运行及相应指示正常 过压保护功能 水位自动控制功能 过载及短路保护功能 急停 功能准确有效 4 3 2 Two grade reverse osmosis low pressure cleaning qualification 二级反渗透装置低压 清洗确认 4 3 2 1Qualification method 确认方法 Measured with stopwatch and inspection by visual 用秒表测量 目测 4 3 2 2 Standard 合格标准 Every normal run automatic low pressure washing original water pump start and low pressure washing Two grade reverse osmosis systerm the high pressure pump 3 Document No 文件编号 Revision No 版本号00 Purified Water System Validatio