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1、修订记录/ Revision history: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目的 / PURPOSE 本方案
2、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转移项目计划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/Test Execu
3、tion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 DESCRIPTIO
4、N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 URS 002
5、4 User requirement specification for JV building.5 纯化水系统工艺流程 pure water system process原水箱Raw water tank原水泵Raw water pump 多介质过滤器Sand filter活性炭过滤器Activated carbon filter5m精密过滤器5m precise filter阻垢剂Scale inhibitor高压泵High pressure pump 反渗透系统RO systemRO水箱RO water tankEDI水泵EDI water pumpEDI系统EDI systemPH调节
6、剂PH adjustor纯水箱Pure water tank纯水泵Pure water pump紫外线杀菌器UV0.1m精密过滤器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。
7、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
8、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.Make a formal comparison between the installation and the manufacturer design specifications .Element and functions with a quality impact need to be qualified 7 验证测试 / QUALIFICAT
9、ION 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 VerificationIQ 006/1 Test 6 材
10、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, passivation8 通过标准/ ACCEPTANCE CRITERIA如满足以下条件，可以通过安装验证：In
11、stallation 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 been approved2. 操
12、作人经过执行验证的相关培训Operators are trained for process validation execution步骤No.验证项目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 operation of the system a
13、nd its installation is suitable for required use 功率11KW电压380V（3相5线）频率50 Hz2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0.25Mpa3压缩空气Compressed air操作范围是否合理、安装(过滤器
14、，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4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 correct operation of the sy
15、stem 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 o不合格 / Non conform o备注 / Comments :前提/ Prerequisit
16、e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 with existing techni
17、cal 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Supplier Dosage pum
18、p: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Quantity 1台1set波长 Wave length254nm材料 Material：3043原水箱01-TV-02raw wate
19、r tank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 numberA96517043P10849扬程 Ran
20、ge47.7m流量大小 flow5.8T/h数量 Quantity 1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 1-2mm 300Kg0.5-1mm 600Kg6活性碳过滤器01-AC-01Activated carbon filter供应商 S
21、upplier 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 250Kg1-2mm 150Kg7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 na
22、tural计量泵 型号 Dosage pump Model X030序列号Serial number08012200364扬程Head7Bar流量flow4.73L/H数量： Quantity 1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： Quantity 1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precision 5m-滤芯规格数量：Amount 20英寸*3根20ft*3pcs9高压泵01-
23、PC-03pressure pump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： Quantity 15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
24、国帕斯菲达Pulsaafeede溶解槽Dissolvedgroove:苏州大自然Suzhou natural计量泵 型号 Dosage pump Model X030序列号Serial number08012200390扬程Head7Bar流量flow4.73L/H数量： Quantity 1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： Quantity 1台1 set材料： material304储水罐附件The storage tank is equiped with:3
25、60 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 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： Quantity 1个1pc
26、s工作压力 pressure5bar序列号Serial number8170415纯水箱02-TV-02Storage tank of purified water供应商： Supplier 南通海发Nantong highfine数量： Quantity 1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-02Pur
27、ified 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： Quantity 1台1set波长： Wave length254nm材料： Material：316L紫外线系统附件计时器180.1m精密过滤器02-JMF-010.1m microhole filte
28、r供应商Supplier 南通海发Nantong highfine型号 ：Model：JMF407数量 ： Quantity：1台1set结构： 可自由更换滤芯外壳材质material316L滤芯材质materialPTEF过滤精度precision 0.1m-滤芯规格数量Amount 40英寸*7根40ft*7pcs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
29、:签名/Signature日期/Date合格 / Conform o不合格 / Non conform o备注 / Comments :前提/ Prerequisite完成 / Check2. 本方案已被批准This protocol has been approved3. 操作人已接受执行验证的培训Operators are trained for validation execution步骤No.验证项目与标准Step description验证内容Acceptance criteria验证证明文件Observed results合格与否C/NC偏差报告编号Anomaly referenc
30、e1竣工文件As built documentation : 核对是否具备所有文件Verify that each document is available. 检查设备的安装是否符合每一份文件的要求。签字并注明日期以证明已经过检查。Take each referenced document, check the installation in regard with the documentation, sign and date each document attesting that the checking has been done.竣工图(管道设施和安装平面图As-built dr
31、awings (P&IDs and Isometrics )编号Ref : BJY-PW-PID-3页BJY-PE-PMT-1页所有设备的技术规格Technical specifications of all equipments编号Ref BJY-PW-SBGG-1页电气，气动图表Electric & pneumatic diagrams编号Ref : HF-R=E-03-33页BJY-PW-QL-1页操作和维护手册Operation and maintenance manuals编号Ref : 建议零件清单Recommended spare parts list编号Ref : BJY-PW
32、-BPQD-1页相关部件合格证明文件编号Ref : 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 o不合格 / Non conform o备注 / Comments :前提/ Prerequisite完成 / CheckN/A 目标 objective给出文件依据，来说明纯水系统已经被正确安装了，和
33、安装图上相一致。Provide documentary evidence that the water system has been installed and is correctly identified in accordance with existent installation drawings (As built diagrams and schemes).步骤No.测试步骤Step description验证项目Acceptance criteria验证标准Observed results合格与否C/NC偏差报告编号Anomaly reference1获取一个 “竣工图”。O
34、btain a copy of the last version of “as built” P&ID drawings.在图上用黄色标示出已查过的部分。偏差用红色下划线标示。Indicate on drawings what has been checked (highlight in yellow). Underline in red any anomaly附上图纸。Join drawings to the test.P& ID图 安装验证中用到的P& ID图编号能识别As Built P& Ids drawings used in installation verification ar
35、e identified2管道部件竣工管道设施图中部件被确认The components are identified in As Built P&ID drawings3标签在图中确认的部件在安装中用标签标识The components are identified in the installation using tags4仪表仪表安装正确，容易读出上面的数字The instruments are correctly installed , they are accessible and they can be easily read5操作各部件都可以顺利地被操作，而且可以进行维修工作T
36、he access to the different components of the system is easy so operation and maintenance works can be done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 o不合格 / Non conform o备
37、注 / Comments :前提/ Prerequisite完成 / CheckN/A步骤No.验证项目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检查所有的重要仪器的计量证书，保证计量范围和精确度符合工作需求Check that calibration certificates are available when needede and that the calibration range and precision of the calibration
38、 are adequate for the instrument range of work and precision required见下表See table below见下表See table below标签tag描述description是否需要计量Need to be calibrated (YES/NO）检查计量标签Conformity of certificate (yes or no)工作范围Work scale测量范围Measure scale精确度correctness合格与否（C/NC）备注remarksPHT-0101原水PH变送器是 yes5-80-142.5TT-0101原水温度变送器是 yes0-500-1
