纯化水系统安装确认验证方案

1、修订记录/ revision history:10版：初始版本release 1.0 initial release部门function姓名name签名signaturefl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管理者代农man ageme nt 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 sys怕m 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 execution供

3、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 description南通海发

4、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h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 0024 use

5、r requirement specification for jv building.纯化水制备工艺流程上采用：预处理一一脫盐(一级r0) 一一edi一一后处理等步骤。process of purified water: pre-treatdesalt(iro)edi post treatment5.1初处理包括气冲式多层石英砂过滤器(0.51；、活性碳过滤器(牛20目)、蜂房式过滤器(5pm)作前级处理，去除水中的胶体、有机物、悬浮物、余氯、5pm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。本公司反渗透膜 选用国际最为先进、回

6、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屮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，达至q脱盐白勺目的。edi系统的特点直1兑盐率高，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0.5 u s/cm (25°c)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、岀水水质稳定、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

7、线杀菌器是为了满足用户对细菌控制的要求，0.1 u m微孔过滤器是将细 菌尸体有效的过滤，从而根木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 qualified7 验证测试 / qualif

8、ication test测试方案编号refere nces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材料证

9、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：instal

10、lation 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.操作人经过执行验证的相关

11、培训0perators 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 and its ins

12、tallation 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冰温8-30 qc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，调压阀）是否

13、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 system an

14、d 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a/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a/test reviewed by:签名 /signature日期/date合格 / conform 不合格 / non conform 备注 / comments :前提/ prerequisite完成/ che

15、ck1.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0perators 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 compone nts of the in stallati on verif ying that the equipme nt in stalled corresp onds with existi ng tech nica

16、l docume ntation and recordi ng the followi ng informati on for each one: desig nation, brand, model,serial nu mber an d/or other releva nt 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l01- tv-0101-pd-01供应商计量泵supplier dosag

17、e pump:美国帕斯菲达pulsaafeede溶解槽dissolved groove:苏州大白然suzhou natural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 reference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-01 flowing uv lamp供应商supplier南通海

18、发nantong highfine型号 modeluv-5数量quantity1台1set波长wave length254nm材料material：3043原水箱01-tv-02 raw water tank供应商supplier南通海发nantong highfine数量quantity1只1pcs体积 volume2m3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 reference材料 material304储水罐附件the storage tank is

19、 equiped with360q 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-01 raw water pump供应商supplier丹麦格兰富grundfos型号modelcr5-9序列号serial numbera96517043p10849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-01 sand filter型号modelhf-sl-800数量 qua ntity1台供应商suppli

20、er南通海发nantong highfine尺寸 size*800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 reference操作压力operation pressure4bar填充物filling material quartz sand右英砂石英砂规格/数量： quartz type/ amount1-2mm 300kg0.5-1 mm 600kg6活性碳过滤器01-ac-01activated carbon filter供应商supplier南通海发n

21、antong highfine型号 modelhf-tl-800数量 qua ntity1台尺寸 size©800操作压力pressure4bar填充物：filling material活性碳、石英砂activated carb on, quartz sand活性炭规格/数量： 石英砂规格/数量：4-20 冃 250kg1-2mm 150kg7阻垢剂01- tv-03 02- 01-pd-02 scale 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

22、计量泵型号dosage pump modelx030序列号serial number08012200364扬程head7bar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 reference流量flow4.73l/h数量：quantity1套1 set8精密过滤器01-jmf-01 precise 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

23、芯材质materialpp外壳材质material304过滤精度 precisi on5 n m-滤芯规格数量：amount20英寸*3根20ft*3pcs9高压泵01-pc-03 pressure pump供应商：supplier丹麦格兰富grundfos类别typecr5-29型号：modela96513392p10844扬程：160mhead流量大小：5.0t/hflow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 reference数量：1台quanti

24、ty1 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-05 01-pd-03 scale 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计量泵型号dosage pump modelx030序列号serial number08012200390扬程head7bars:4.73l/h

25、数量：quantity1套1 set12ro水箱 02-tv-01 ro water tank供应商supplier南通海发nantong highfine体积： volume1m3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 reference数量：quantity1台1 set材料： material304储水罐附件the storage tank is equiped with:360。喷水球3602 spraying ball液位控制器level con

26、troller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grun dfos型号modelchi4-40序列号serial numberc4j518004p10832材料： material316扬程head28m流量flow4.5t/h14edi膜块02-edi-01供应商 supplierionpure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anoma

27、ly referenceedi module型号 modelip-lxm30 z-1数量：quantity1个1pcs工作压力 pressurew5bar序列号serial number8170415纯水箱02-tv-02 storage 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：3609 喷水球/36(t spraying ball液位控制器/level con

28、troller空气呼吸器/spare nozzle on top人孔/man hole16纯水泵02-pc-02 purified water pump供应商：supplier丹麦格兰富类别：typwchi12-25型号modeld4f518025p10914材料： material316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 reference扬程：head42m流量大小：flow10t/h17紫外线杀菌灯202-uv-01 flowing uv lam

29、p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180um精密过滤器02-jmf-010.1 p m microhole filter供应商supplier南通海发nantong highfine型号：model：jmf407数量:quantity：1台1set结构：可白由更换滤芯外壳材质material316l滤芯材质 materialptef过滤精度 precision0.1 y m滤芯规格数量amount40英寸*7根

30、40ft*7pcs步骤/no.备注/comments测试操作a/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 :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0p

31、erators 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 reference1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杳。take each refereneed document, check

32、 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 drawings (p&ids and isometrics)编号ref:bjy-pw-pid-3 页bjy-pe-pmt1 贝所有设备的技术规格technical specifications of all equipments编号ref bjy-pw-sbgg1 m电气，气动图表electric &

33、amp; pneumatic diagrams编号ref:hf-r=e-0333 页bjy-pw-ql1 贝操作和维护手册operation and maintenance manuals编号ref:建议零件清单recommended spare parts list编号ref:bjy-pw-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a/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

34、 reviewed by:签名 /signature日期/date合格 / conform 不合格 / non conform 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，和安装图上相一致。provide documentary evidence that the water sys怕m has been installed and is correctly identified in accordance with existent installation drawings (a

35、s 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”。obtain a copy of the last version ofuas built” p&id drawings.在图上用黄色标示岀己查过的部分。偏差用红色 下划线标示。indicate on drawings what has been checked (highlight in yellow). u

36、nderline in red any ano maly附上图纸。join drawings to the test.p& id图安装验证屮用到的p& id图编号能识 别 as built p& ids drawings used in installation verification are identified2管道部件竣工管道设施图中部件被确认the comp on ents are ide ntified in as built p&id drawings3标签在图屮确认的部件在安装屮用标签标识the comp on ents are ide ntif

37、ied in the installation using tags4仪表仪表安装正确，容易读出上血的数字 the instruments are correctly in stalled , 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the 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a

38、/test performed by:签名 /signature日期/date测试所用计量仪器儿ist 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 :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anoma

39、ly 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 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

40、计量 need to be calibrated (yes/no)检査计量标签 conformity of certificate (yes or no)工作范围work scale测量范围 measure scale精确度 correc tn ess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yes050°co-i oor2.5lt-0101原水箱液位变送器否no0.-1.8m0-3.0m2.5ti-0101列管式换热器出水温度表是yes0-100°c0-200°c1.5pi

41、-.0101列管式换热器工业蒸汽压力表是yes0-0.4mpa0-1.6mpa1.5pl-0102多介质过滤器压力表pressure meter of sand filter是yes0-0.5mpa0-0.6mpa2.5pl-0103活性炭过滤器压力表pressure meter of activated carb on filter是yes0-0.4mpa0-0.6mpa2.5pl-0104精密过滤器进水压力表pressure meter of precise filter是yes0-0.3mpa0-0.6mpa2.5pl-0105高压泵进水压力表feed water pressure me

42、ter of pump是yes0-0.3mpa0-0.6mpa2.5标签 tag描述 description是否需要计量 need to be calibrated (yes/no)检査计量标签 conformity of certificate (yes or no)工作范围work scale测量范围 measure scale精确度 correc tn ess合格与否 (c/nc)备注 remarkspl-0106高压泵出水压力表discharge water pressure meter of pump是yes0-1.6mpa0-2.5mpa2.5ps-0101高压泵进水压力开关 pr

43、essure switch of pump否no0-0.2mpa0-0.3mpa1.5pl-0107反渗透膜浓水压力表waste water pressure meter of ro是yes0-1.4mpa0-2.5mpa2.5pl-0108反渗透膜纯水压力表waste water pressure meter of ro是yes0-0.1 mpa0-0.6mpa2.5ft-0101反渗透膜纯水流量变送器 pure water flow meter of ro是yes0-70lpm0-100lpm2.5ft-0102反渗透膜浓水流量计waste water flow meter of ro是y

44、es0-30lpm0-100lpm2.5ct-0101原料水电导率表conductivity meter for rw是yes0-1000 u s0-10000 u s2.5ct-0102反渗透膜电导率表conductivity meter for ro是yes0-30 u s0-100 u s2.5lt-0201ro水箱液位传感器liquid level sensor ls-02否no0.-1.6m0-3.0m2.5pl-0201edi纯水进水压力表feed pure water pressure meter of edi是yes0-0.4mpa0-0.6mpa2.5pl-0202edi浓水

45、进水压力表dsicharge waste water pressure meter of edi是yes0-0.3mpa0-0.6mpa2.5pl-0203edi纯水出水压力表discharged pure water pressure meter of edi是yes0-0.3mpa0-0.6mpa2.5pl-0204edi浓水出水压力表discharged waste water pressure meter of edi是yes0-0.2mpa0-0.6mpa2.5ft-0201edi浓水进水流量计feed waste water flow meter of edi是yes0-5lpm0

46、-10lpm2.5标签tag描述 description是否需要计量 need to be calibrated (yes/no)检査计量标签 conformity of certificate (yes or no)工作范围work scale测量范围 measure scale精确度 correc tn ess合格与否 (c/nc)备注 remarksft-0202edi纯水出水流量计discharged pure water flow meter of edi是yes0-60lpm0-100lpm2.5lt-0202纯水箱液位传感器liquid level sensor否no0.-2.8

47、m0-3.0m2.5ct-0201edi出水电导率表conductivity meter for discharged water of edi是yes0-1 u s0-100 us2.5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

48、 :前提/ prerequisite完成/ checkn/a目标 objective查看所有与纯水接触材料的证书文件check the availability of certificates of materials in contact with the water.步骤no.验证项目step description验证标准acceptance criteria验证证明文件observed results合格与否c/nc偏差报告编号anomaly reference1原水箱ss aisi3042预处理ss aisi3043中间水箱ss aisi3044生产纯水管道(预处理、ro、edi进水)loops for making purified water (pre-treat ro edi inlet)ss aisi3045生产纯水管道(edi出水)loops for making purified water (edi outlet)ss aisi316l6纯水储水罐storing tank for pure waterss aisi316l7紫外线杀菌器uvss aisi 316l80.1 u椿密过滤器ss aisi 316l测试操作a/test performed by: