VP纯化水系统验证方案.docx

1、VP纯化水系统验证方案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 Contents1 Summarize/概述The company commissioned the Jiaxing Jiame Water Treatment En

2、gineering Co., Ltd. for the purified water system design and installation, the system product capacity of water is 3 / 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

3、 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 syst

4、em 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

5、 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 (

6、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

7、Terminal filter use point.公司纯化水系统为委托嘉兴嘉美水处理工程设计安装，制水能力为3/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，SDI4，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

8、、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Through purified water system installation, operation and performance qualification to prove its ability to steady provided supply of quality and quan

9、tity 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3.1Validation Team Member/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, main

10、tenance 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Equipment Engineering Division: Draft the vali

11、dation 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 prot

12、ocol, 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。Validation process should be strictly in accordanc

13、e 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

14、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4.1Beforehand Qualification/预确认（安装前确认） 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

15、，确认记录填写于附件3Document 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 equipm