纯化水系统安装确认验证专业技术方案.docx

1、纯化水系统安装确认验证专业技术方案修订记录/ Revisionhistory:1.0版：初始版本Release 1.0 Initial Release部门Function姓名Name签名Signature日期Date制定人Author验证代表Validation representative审核人Reviewer维修保养部门代表Maintenance representative批准人Approver for English versionQA 经理QA manager批准人Approver for bilingual version管理者代表Management representative

2、目的/ Purpose本方案的目的是验证纯化水系统的设计、制造、安装、运行是否符合要求。1 参考法规与文件/Document references文件编号 Reference No.文件标题 TitleURS 024药业厂房技术要求URS for JV buildingVP006纯化水系统验证DI water system QualificationVMP转移工程计划EIA transfer PlanSBE-GP-003验证主程序General Procedure for Validation2 职责/ RESPONSIBILITIES步骤/ Steps部门/ Department执行测试/T

3、est Execution供应商进行安装确认IQ by supplier测试结果审核/ Test Verification验证部门代表Validation representative验证报告撰写/ Writing the report验证部门代表Validation representative3 定义与缩写/ Definitions and abbreviation缩写/Short form定义 / DefinitionPW纯化水 Purified waterRO反渗透 Reverse osmosisEDI去离子 Electro-deionization4 系统描述 / System de

4、scription南通海发水处理工程有限公司提供3m3/h一级反渗透+EDI药用纯化水制取装置。The supplier Highfine Co.,Ltd provides 2m3/h 1RO+EDI PW system.水源为南京市自来水公司提供的自来水.The running water supplied by HAIMEN RUNNING WATER COMPANY is the raw water.纯化水水质要求达到白敬宇厂房用户需求文件URS 0024中规定的标准。Product water should reaches the standards as defined in the

5、 URS 0024 User requirement specification for JV building.5 纯化水系统工艺流程 pure water system process纯化水制备工艺流程上采用：预处理脱盐（一级RO）EDI后处理等步骤。Process of purified water: pre-treatdesalt(1RO) EDIpost treatment5.1 初处理包括气冲式多层石英砂过滤器（0.5-1；1-2）、活性碳过滤器（4-20目）、蜂房式过滤器(5m)作前级处理，去除水中的胶体、有机物、悬浮物、余氯、5m以上的微颗粒以及有效降低水中总硬度。5.2脱盐部

6、分采用一级反渗透的方法，这是纯水制取系统中最为关键的一步。本公司反渗透膜选用国际最为先进、回收率、脱盐率最高的卷式复合膜作为组件材料。一级反渗透去除原水中98以上的阴阳离子以及各种有害菌落和热源，以保证水的脱盐效果，从而保证产品水的最终品质。5.3 EDI选用德国西门子公司生产的模堆，此装置通过填充在电池模堆中的树脂吸附水中的金属离子，达到脱盐的目的。EDI系统的特点是脱盐率高，树脂无需使用酸碱再生，具有较高的产水质量，水的电导率可达到0.5S/cm（25）以内，水的利用率最高可达95%，其最大特点是利用电能而不是酸碱化学对树脂进行再生处理。同时，EDI系统还具有占地面积小、出水水质稳定、运行

7、操作费用低、操作管理方便等优点。5.4 后处理选用紫外线杀菌器是为了满足用户对细菌控制的要求，0.1m微孔过滤器是将细菌尸体有效的过滤，从而根本上保证了出水的水质。6 验证方案设计理由/ qualification strategy将安装和厂商设计规格作比较。对纯化水质量有影响的因素和功能需要验证.Makea formal comparison between the installation and the manufacturer design specifications.Element and functions with a quality impact need to be qua

8、lified7验证测试 / QuAlification Test测试方案编号References测试名称DescriptionIQ 006/1 Test 1 设施验证 Utilities VerificationIQ 006/1 Test 2 设备验证 Devices VerificationIQ 006/1 Test 3 文件验证 Documentation VerificationIQ 006/1 Test 4 安装验证 Installation VerificationIQ 006/1 Test 5 校验验证Tag and calibration certificates Verific

9、ationIQ 006/1 Test 6 材料证明 Material VerificationIQ 006/1 Test 7 盲管死角验证Dead angle VerificationIQ 006/1 Test 8 坡度验证 Slopes VerificationIQ 006/1 Test 9焊接验证Welding VerificationIQ 006/1 Test 10压力验证Pressure VerificationIQ 006/1 Test 11清洗和钝化验证Verification of cleaning, passivation5 通过标准/ Acceptance criteria如

10、满足以下条件，可以通过安装验证：Installation Qualification is accepted if :-完成所有的测试All activities have been performed-没有不可接受偏差No blocking anomaly remains-撰写报告并批准The report is written and approved通过安装验证后方可进行操作验证。The acceptation of the IQ will allow the start of OQ.前提/ Prerequisite完成 / Check1. 方案已经通过This protocol has

11、 been approved2. 操作人经过执行验证的相关培训Operators are trained for process validation execution步骤No.验证工程Step description验证内容Acceptance criteria验证标准Observed results合格与否C/NC偏差报告编号Anomaly reference1 供配电Electricity supply / consumption操作范围是否合理、安装是否符合要求Check the operative range is appropriate to the correct operat

12、ion of the system and its installation is suitable for required use功率11KW电压380V（3相5线）频率50 Hz4 饮用水Raw water操作范围是否合理、安装是否符合要求Check the operative range is appropriate to the correct operation of the system and its installation is suitable for required use,水温8-30 C流量6m3 /h管径DN 32压力0.25Mpa8 压缩空气Compresse

13、d air操作范围是否合理、安装(过滤器，调压阀)是否符合要求Check the operative range is appropriate to the correct operation of the system and its installation(filters, valves) is suitable for required use压力6 bar,流量50 l/h管径8mm附件过滤器、调压阀12 工业蒸汽Industrial steam操作范围是否合理、安装是否符合要求Check the operative range is appropriate to the corre

14、ct operation of the system and its installation is suitable for required use压力3 Bar管径DN25附件过滤器、减压阀步骤/No.备注/Comments测试操作人/Test performed by:签名/Signature日期/Date测试所用计量仪器/List of equipments used :附件列表/List of attachments测试审核人/Test reviewed by:签名/Signature日期/Date合格 / Conform不合格 / Non conform备注 / Comments

15、 :前提/ Prerequisite完成 / Check1. 本方案已被批准This protocol has been approved2.操作人已接受执行验证的培训Operators are trained for validation execution目标 objective检查主要的部件，验证安装的部件和现有的技术文件是否一致；记录名称，品牌，型号和序列号等其他相关信息。Characterize the major components of the installation verifying that the equipment installed corresponds wit

16、h existing technical documentation and recording the following information for each one: designation, brand, model ,serial number and/or other relevant characteristics.步骤No.验证项日Step description验证内容Acceptance criteria验证标准Observed results合格与否C/NC偏差报告编号Anomaly reference1PH调节装置101- TV-0101-PD-01供应商计量泵Su

17、pplier Dosage pump:美国帕斯菲达Pulsaafeede溶解槽 Dissolved groove: 苏州大自然Suzhou natural计量泵型号Model Dosage pumpX030序列号Serial number08012200370扬程Head7BAR流量 flow4.73L/H数量Quantity1套 1set2紫外线杀菌灯101-UV-01Flowing UV LAMP供应商Supplier南通海发Nantong highfine型号modelUV-5数量Quantity1台1set波长Wave length254nm材料Material：3043原水箱01-T

18、V-02raw watertank供应商Supplier南通海发Nantong highfine数量Quantity1只1pcs体积volume2m3材料material304储水罐附件The storage tank is equiped with-360 喷水球/360 spraying ball液位控制器/Level controller空气呼吸器/Spare nozzle on top人孔/Man hole4原水泵01-PC-01raw water pump供应商Supplier丹麦格兰富Grundfos型号ModelCR5-9序列号Serial numberA96517043P108

19、49扬程Range47.7m流量大小flow5.8T/h数量 Quantity1台 1 set5多介质过滤器01-FM-01Sand filter型号modelHF-SL-800数量quantity1台供应商Supplier南通海发Nantong Highfine尺寸size800操作压力Operation pressure4bar填充物 Filling material quartz sand 石英砂石英砂规格/数量：Quartz type/ amount 1-2mm300Kg0.5-1mm600Kg6活性碳过滤器01-AC-01Activated carbon filter供应商Suppl

20、ier南通海发Nantong Highfine型号modelHF-TL-800数量quantity1台尺寸size800操作压力Pressure 4bar填充物： Filling material 活性碳、石英砂Activated carbon, quartz sand活性炭规格/数量：石英砂规格/数量：4-20目 250Kg1-2mm150Kg7阻垢剂01- TV-0302- 01-PD-02Scale inhibitor供应商计量泵Supplier Dosage pump美国帕斯菲达Pulsaafeede溶解槽Dissolvedgroove:苏州大自然Suzhou natural计量泵 型

21、号Dosage pump ModelX030序列号Serial number08012200364扬程Head7Bar流量flow4.73L/H数量： Quantity1套1 set8精密过滤器01-JMF-01Precise filter供应商Supplier南通海发Nantong highfine型号modelHF-JMF-203数量： Quantity1台 1 set结构可自由更换滤芯滤芯材质material PP外壳材质material 304-过滤精度precision5m-滤芯规格数量：Amount 20英寸*3根20ft*3pcs9高压泵01-PC-03pressure pump

22、供应商： Supplier丹麦格兰富Grundfos类别 Type CR5-29型号：ModelA96513392P10844扬程： 160mHead流量大小： 5.0t/hflow数量： 1台Quantity 1 pcs10反渗透膜01-RO-01RO membranes供应商： Supplier陶氏DOW型号： modelBW30-4040数量： Quantity15根15pcs工作压力： pressure15bar11PH调节装置201-TV-0501-PD-03Scale inhibitor供应商计量泵Supplier Dosage pump美国帕斯菲达Pulsaafeede溶解槽Di

23、ssolvedgroove:苏州大自然Suzhou natural计量泵 型号 Dosage pump ModelX030序列号Serial number08012200390扬程Head7Bar流量flow4.73L/H数量： Quantity1套1 set12RO水箱02-TV-01RO water tank供应商Supplier南通海发Nantong highfine体积： volume1m3数量： Quantity1台1 set材料： material304储水罐附件The storage tank is equiped with:360 喷水球360 spraying ball液位控

24、制器Level controller空气呼吸器Spare nozzle on top人孔Man hole13EDI水泵02-PC-01EDI water pump供应商： Supplier： 丹麦格兰富Grundfos型号ModelCHI4-40序列号Serial numberC4J518004P10832材料： Material316扬程Head28m流量flow4.5t/h14EDI膜块02-EDI-01EDI module供应商supplierIONPURE型号modelIP-LXM30Z-1数量： Quantity1个1pcs工作压力pressure5bar序列号Serial numb

25、er8170415纯水箱02-TV-02Storage tank of purified water供应商： Supplier南通海发Nantong highfine数量： Quantity1只1pcs体积：volume6m3材料：material316L储水罐附件The storage tank is equiped with：360 喷水球/360 spraying ball液位控制器/Level controller空气呼吸器/Spare nozzle on top人孔/Man hole16纯水泵02-PC-02Purified water pump供应商：Supplier丹麦格兰富类别： TypwCHI12-25型号ModelD4F518025P10914材料： Material316扬程： Head42m流量大小： flow10t/h17紫外线杀菌灯202-UV-01Flowing UV LAMP供应商： Supplier南通海发Nantong highfine型号： modelUV-10数量： Quantity1台1set波长： Wave length254nm材料： Material：316L紫外线系统附件计时器180.