（41）纯化水系统安装确认验证方案 IQ006-DI water 30 03 2009

R2-GP-003 版本 / Release: 1.0 页码 / Page: 1 / 9 纯化水系统安装确认验证 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 PURE WATER SYSTEM INstallation Qualification Protocol 编号/ ID: IQ 006/1 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 version QA 经理 QA manager 批准人 Approver for bilingual version 管理者代表 Management representative 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。 The purpose of this protocol is to verify that the DI water system has been designed /constructed / installed and circulated conforming to requirements. 1 参考法规与文件 / Document references 文件编号 Reference No. 文件标题 Title URS 024 药业厂房技术要求URS for JV building VP006 纯化水系统验证DI water system Qualification  VMP 转移项目 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 EIA transfer Plan SBE-GP-003 验证主程序General Procedure for Validation 2 职责 / RESPONSIBILITIES 步骤/ Steps 部门/ Department 执行测试/Test 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 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 撰写/ Writing the report 验证部门代表 Validation representative 3 定义与缩写 / Definitions and abbreviation 缩写/Short form 定义 / Definition PW 纯化水 Purified water RO 反渗透 Reverse osmosis EDI 去离子 Electro-deionization 4 系统描述 / System description 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 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 。 Product water should reaches the standards as defined in the 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-treat——desalt(1RO) ——EDI——post treatment 5.1 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(5μm)作前级处理，去除水中的胶体、有机物、悬浮物、余氯、5μm以上的微颗粒以及有效降低水中总硬度。 Pre-treating process uses gas flush multi-storey quartz sand filter（0.5-1；1-2）, activated carbon filter (4-20mu), precise filter (5μm) to remove colloid , organs, floating circumstances, CL and particles over 5μm, and to reduce water hardness. 5.2脱盐部分采用一级反渗透的 方法 快递客服问题件处理详细方法山木方法pdf计算方法pdf华与华方法下载八字理论方法下载 ，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。 desalting process adopts 1RO, it is the most important step. The RO membrane is the most advanced assembled membrane of highest recovery and desalting rate in the world. 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。 In 1RO process 98％ ion, colony and thermal resource are removed to reach good effect, therefore, the final quality of product water is ensured. 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 is of SIEMENS GERMAN brand. In order to desalting, the device utilize resin in battery module absorb metal ion in water. 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0.5μS/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。 EDI possesses the advantages of high desalting rate, no acid or alkali regeneration for resin, product water of high quality as well as water conductivity below 0.5μS/cm（25℃） and 95% water utilizing rate. The most obvious feature is that EDI use electricity but not acid or alkali to regenerate resin. Meanwhile, EDI system also has the advantages of small floor space, stable outlet water quality, low operation cost, convenient management, and etc. 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， 0.1μm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。 Select UV for post-processing in order to meet the users’requirements of controlling of the bacterias . The total number of the bacterias is 0 to 100 per milliliter , thus fundamentally guarantee the outlet water requirements . 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 / QuAlification Test 测试方案编号 References 测试名称 Description IQ 006/1 Test 1 设施验证 Utilities Verification IQ 006/1 Test 2 设备验证 Devices Verification IQ 006/1 Test 3 文件验证 Documentation Verification IQ 006/1 Test 4 安装验证 Installation Verification IQ 006/1 Test 5 校验验证 Tag and calibration certificates Verification IQ 006/1 Test 6 材料证明 Material Verification IQ 006/1 Test 7 盲管死角验证 Dead angle Verification IQ 006/1 Test 8 坡度验证 Slopes Verification IQ 006/1 Test 9 焊接验证 Welding Verification IQ 006/1 Test 10 压力验证 Pressure Verification IQ 006/1 Test 11 清洗和钝化验证 Verification of cleaning, passivation 5 通过标准/ Acceptance criteria 如满足以下条件，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 / Check 1. 方案已经通过This protocol has been approved FORMCHECKBOX 2. 操作人经过执行验证的相关培训Operators are trained for process validation execution FORMCHECKBOX 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 reference 1 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 installation is suitable for required use 功率 11KW 2 电压 380V（3相5线） 3 频率 50 Hz 4 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 ºC 5 流量 6m3 /h 6 管径 DN 32 7 压力 0.25Mpa 8 压缩空气 Compressed 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, 9 流量 50 l/h 10 管径 8mm 11 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 correct operation of the system and its installation is suitable for required use 压力 3 Bar 13 管径 DN25 14 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 : 前提/ Prerequisite 完成 / Check 1. 本方案已被批准This protocol has been approved FORMCHECKBOX 2.操作人已接受执行验证的培训Operators are trained for validation execution FORMCHECKBOX 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 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 reference 1 PH调节装置1 01- TV-01 01-PD-01 供应商 计量泵 Supplier 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 pump X030 序列号 Serial number 08012200370 扬程 Head 7BAR 流量 flow 4.73L/H 数量 Quantity 1套 1set 2 紫外线杀菌灯1 01-UV-01 Flowing UV LAMP 供应商 Supplier 南通海发 Nantong highfine 型号 model UV-5 数量 Quantity 1台 1set 波长 Wave length 254nm 材料 Material： 304 3 原水箱 01-TV-02 raw water tank 供应商 Supplier 南通海发 Nantong highfine 数量 Quantity 1只 1pcs 体积 volume 2m3 材料 material 304 储水罐附件 The storage tank is equiped with - 360º 喷水球/360º spraying ball 液位控制器/Level controller 空气呼吸器/Spare nozzle on top 人孔/Man hole 4 原水泵 01-PC-01 raw water pump 供应商 Supplier 丹麦格兰富 Grundfos 型号 Model CR5-9 序列号 Serial number A96517043P10849 扬程 Range 47.7m 流量大小 flow 5.8T/h 数量 Quantity 1台 1 set 5 多介质过滤器 01-FM-01 Sand filter 型号 model HF-SL-800 数量 quantity 1台 供应商 Supplier 南通海发 Nantong Highfine 尺寸 size φ800 操作压力 Operation pressure 4bar 填充物 Filling material quartz sand 石英砂 石英砂规格/数量： Quartz type/ amount 1-2mm 300Kg 0.5-1mm 600Kg 6 活性碳过滤器 01-AC-01 Activated carbon filter 供应商 Supplier 南通海发 Nantong Highfine 型号 model HF-TL-800 数量 quantity 1台 尺寸 size φ800 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 250Kg 1-2mm 150Kg 7 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 计量泵 型号 Dosage pump Model X030 序列号 Serial number 08012200364 扬程 Head 7Bar 流量 flow 4.73L/H 数量： Quantity 1套 1 set 8 精密过滤器 01-JMF-01 Precise filter 供应商 Supplier 南通海发 Nantong highfine 型号 model HF-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 5μm -滤芯规格数量： Amount 20英寸*3根 20ft*3pcs 9 高压泵 01-PC-03 pressure pump 供应商： Supplier 丹麦格兰富 Grundfos 类别 Type CR5-29 型号： Model A96513392P10844 扬程： 160m Head 流量大小： 5.0t/h flow 数量： 1台 Quantity 1 pcs 10 反渗透膜 01-RO-01 RO membranes 供应商： Supplier 陶氏 DOW 型号： model BW30-4040 数量： Quantity 15根 15pcs 工作压力： pressure 15bar 11 PH调节装置2 01-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 Model X030 序列号 Serial number 08012200390 扬程 Head 7Bar 流量 flow 4.73L/H 数量： Quantity 1套 1 set 12 RO水箱 02-TV-01 RO water tank 供应商 Supplier 南通海发 Nantong highfine 体积： volume 1m3 数量： Quantity 1台 1 set 材料： material 304 储水罐附件 The storage tank is equiped with: 360º 喷水球 360º spraying ball 液位控制器 Level controller 空气呼吸器 Spare nozzle on top 人孔 Man hole 13 EDI水泵 02-PC-01 EDI water pump 供应商： Supplier： 丹麦格兰富 Grundfos 型号 Model CHI4-40 序列号 Serial number C4J518004P10832 材料： Material 316 扬程 Head 28m 流量 flow 4.5t/h 14 EDI膜块 02-EDI-01 EDI module 供应商 supplier IONPURE 型号 model IP-LXM30Z-1 数量： Quantity 1个 1pcs 工作压力 pressure ≤5bar 序列号 Serial number 81704 15 纯水箱 02-TV-02 Storage tank of purified water 供应商： Supplier 南通海发 Nantong highfine 数量： Quantity 1只 1pcs 体积： volume 6m3 材料： material 316L 储水罐附件 The storage tank is equiped with： 360º 喷水球/360º spraying ball 液位控制器/Level controller 空气呼吸器/Spare nozzle on top 人孔/Man hole 16 纯水泵 02-PC-02 Purified water pump 供应商： Supplier 丹麦格兰富 类别： Typw CHI12-25 型号 Model D4F518025P10914 材料： Material 316 扬程： Head 42m 流量大小： flow 10t/h 17 紫外线杀菌灯2 02-UV-01 Flowing UV LAMP 供应商： Supplier 南通海发 Nantong highfine 型号： model UV-10 数量： Quantity 1台 1set 波长： Wave length 254nm 材料： Material： 316L 紫外线系统附件 计时器 18 0.1μm精密过滤器 02-JMF-01 0.1μm microhole filter 供应商 Supplier 南通海发 Nantong highfine 型号 ： Model： JMF407 数量 ： Quantity： 1台 1set 结构： 可自由更换滤芯 外壳材质 material 316L 滤芯材质 material PTEF 过滤精度 precision 0.1μm -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: 签名/Signature 日期/Date 合格 / Conform ( 不合格 / Non conform ( 备注 / Comments : 前提/ Prerequisite 完成 / Check 2. 本方案已被批准This protocol has been approved FORMCHECKBOX 3. 操作人已接受执行验证的培训Operators are trained for validation execution FORMCHECKBOX 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 reference 1 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 drawings (P&IDs and Isometrics ) 编号Ref : BJY-PW-PID---3页 BJY-PE-PMT---1页 2 所有设备的技术规格 Technical specifications of all equipments 编号Ref BJY-PW-SBGG---1页 3 电气，气动图表 Electric & pneumatic diagrams 编号Ref : HF-R=E-03---33页 BJY-PW-QL---1页 4 操作和维护手册 Operation and maintenance manuals 编号Ref : …………… 5 建议零件清单 Recommended spare parts list 编号Ref : BJY-PW-BPQD---1页 6 相关部件合格证明文件 编号Ref : …………… 步骤/No. 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 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 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 reference 1 获取一个 “竣工图”。 Obtain 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 are identified 2 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 drawings 3 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 tags 4 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 read 5 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 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 reference 1 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 remarks PHT-0101 原水PH变送器 是 yes 5-8 0-14 2.5 TT-0101 原水温度变送器 是 yes 0-50℃ 0-100℃ 2.5 LT-0101 原水箱液位变送器 否no 0.-1.8m 0-3.0m 2.5 TI-0101 列管式换热器出水温度表 是 yes 0-100℃ 0-200℃ 1.5 PI-.0101 列管式换热器工业蒸汽压力表 是 yes 0-0.4Mpa 0-1.6Mpa 1.5 PI-0102 多介质过滤器压力表 Pressure meter of sand filter 是 yes 0-0.5Mpa 0-0.6Mpa 2.5 PI-0103 活性炭过滤器压力表 Pressure meter of activated carbon filter 是 yes 0-0.4Mpa 0-0.6Mpa 2.5 PI-0104 精密过滤器进水压力表 Pressure meter of precise filter 是 yes 0-0.3Mpa 0-0.6Mpa 2.5 PI-0105 高压泵进水压力表 Feed water Pressure meter of pump 是 yes 0-0.3Mpa 0-0.6Mpa 2.5 PI-0106 高压泵出水压力表 Discharge water Pressure meter of pump 是 yes 0-1.6Mpa 0-2.5Mpa 2.5 PS-0101 高压泵进水压力开关 Pressure switch of pump 否no 0-0.2Mpa 0-0.3Mpa 1.5 PI-0107 反渗透膜浓水压力表 Waste water Pressure meter of RO 是 yes 0-1.4Mpa 0-2.5Mpa 2.5 PI-0108 反渗透膜纯水压力表 Waste water Pressure meter of RO 是 yes 0-0.1Mpa 0-0.6Mpa 2.5 FT-0101 反渗透膜纯水流量变送器 pure water flow meter of RO 是 yes 0-70LPM 0-100LPM 2.5 FT-0102 反渗透膜浓水流量计 waste water flow meter of RO 是 yes 0-30LPM 0-100LPM 2.5 CT-0101 原料水电导率表 Conductivity meter for RW 是 yes 0-1000μs 0-10000μs 2.5 CT-0102 反渗透膜电导率表 Conductivity meter for RO 是 yes 0-30μs 0-100μs 2.5 LT-0201 RO水箱液位传感器 Liquid level sensor LS-02 否no 0.-1.6m 0-3.0m 2.5 PI-0201 EDI纯水进水压力表 Feed pure water pressure meter of EDI 是yes 0-0.4Mpa 0-0.6Mpa 2.5 PI-0202 EDI浓水进水压力表 Dsicharge waste water pressure meter of EDI 是yes 0-0.3Mpa 0-0.6Mpa 2.5 PI-0203 EDI纯水出水压力表 Discharged pure water pressure meter of EDI 是yes 0-0.3Mpa 0-0.6Mpa 2.5 PI-0204 EDI浓水出水压力表 Discharged waste water pressure meter of EDI 是 yes 0-0.2Mpa 0-0.6Mpa 2.5 FT-0201 EDI浓水进水流量计 feed waste water flow meter of EDI 是yes 0-5LPM 0-10LPM 2.5 FT-0202 EDI纯水出水流量计 Discharged pure water flow meter of EDI 是yes 0-60LPM 0-100LPM 2.5 LT-0202 纯水箱液位传感器 Liquid level sensor 否no 0.-2.8m 0-3.0m 2.5 CT-0201 EDI出水电导率表 Conductivity meter for Discharged water of EDI 是yes 0-1μs 0-100μs 2.5 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 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 reference 1 原水箱 SS AISI 304 2 预处理 SS AISI 304 3 中间水箱 SS AISI 304 4 生产纯水管道（预处理、RO、EDI进水） Loops for making purified water（Pre-treat RO EDI inlet） SS AISI 304 5 生产纯水管道（EDI出水） Loops for making purified water（EDI outlet） SS AISI 316L 6 纯水储水罐 Storing tank for pure water SS AISI 316L 7 紫外线杀菌器 UV SS AISI 316L 8 0.1μ精密过滤器 SS AISI 316L 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 目标 objective 确认在纯水管道中没有盲管和死角 Check that there are no dead legs in Purified Water Loop using the 3D rule. 步骤No. 测试步骤 Step description 通过标准 Acceptance criteria 试验结果 Observed results 合格与否 C/NC 偏差报告编号 Anomaly reference 1 测量主管道的下壁到盲管底部的长度。 Measure the longitude from main pipe wall to the final of the leg. 测量盲管的直径 Measure the diameter of dead angle. 填写下表 Fill in table below 所有盲管满足 L < 3D, 盲管的长度小于它三倍直径的大小 All the dead legs fulfill the L < 3D rule, which means that the longitude is less than 3 times its diameter 见附表 see table below 盲管位置 Dead Leg Verified D（直径） D (Diameter Section) 3D L（长度） L( Longitude Stretch ) 评定 Evaluation (C/NC) 备注 Notes EDI纯水出水压力表 25 75 15 EDI纯水电导率表 25 75 70 EDI出水取样阀 25 75 70 纯水箱排污口 38 114 80 0.1μ精密过滤器出水取样阀 38 114 60 步骤/No. 备注/Comments 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 备注：在URS024中我们规定管道的坡度至少为0.3%。在这个测试中我们要求至少0.3%，是符合FDA和GMP法规要求的。 Remark : in URS024, we mentioned that the piping slopes should be at least 1%. In this test, we will check that they are at least 0,3%, to be in compliance with FDA and GMP regulation, and to have full drainage of the system. 步骤No. 测试步骤 Step description 通过标准 Acceptance criteria 试验结果 Observed results 合格与否 C/NC 偏差报告编号 Anomaly reference 1 测量水平安置的管道坡度 Measure the slope of pipes in horizontal parts. 在最终版竣工图上用黄色标示出已检查的部分，用红色下划线标示偏差部分 On the last version of document "As Built isometric drawing”,indicate which slope has been checked (highlight in yellow). Underline in red any anomaly. 填写下表并附上完成后图纸 Fill in table below, and join the completed drawing. 不得低于0.3% Minimum 0,3% 见下表 See table below 管道位置 Pipeline verification 坡度 Gradient 评定 Evaluation 合格与否 C/NC 备注 Comments EDI出水进纯水箱管道 0.4% 纯水箱出水进纯水泵管道 0.35% 纯水箱排污管道 0.4% 0.1μ精密过滤器出水管道 0.1μ精密过滤器 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 目标 objective 确认轨道焊接被用到高纯度的金属管道焊接，而且合格的焊接工人利用正确的焊接方法和合格的焊接工具。 Check that orbital welding has been used for joining high purity metallic piping, and that certified welders have used approved weld procedures and certified equipment. 步骤No. 验证项目 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 reference 1 有经过批准的焊接步骤 There are approved welding procedures Welding procedure available Ref: BJY-PW-HJCX-01 BJY-PW-HJCX-02 2 有焊接工人有效证书 Welders are identified and certificated 电焊工证书 Welder certification available Ref: TS6JNTG71523 3 有焊接报告 There is a welding diary available (Weld Report) 焊接报告 Weld report available Ref: BJY-PW-HJBG-01 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 : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 目标 objective 确认输送分配管道的压力大于正常压力（最小的液压测试是 8 bars或者工作压力的1.5倍）条件下设备中没有漏水 Check that there are not leaks in the installation when subjected to a pressure higher than normal conditions pressure (minimum hydraulic test pressure 8 bars or 1,5 times workings pressure of the system). 步骤No. 测试步骤 Step description 通过标准Acceptance criteria 试验结果Observed results 合格与否 C/NC 偏差报告编号 Anomaly reference 1 有符合的纯化水管道压力测试步骤 There is an appropriate procedure describing the hydrostatic pressure test 编号Ref : …………… 2 静水压力测试执行的方案 There is a protocol for the execution of the hydrostatic pressure test 编号Ref : …………… 3 有静水压力测试结果的报告 There is a report with the result of the hydrostatic pressure test 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 ( 不合格 / Non conform ( 备注 / Comments : 前提/ Prerequisite 完成 / Check N/A FORMCHECKBOX 目标 objective 确认设备在安装结束后和开机之前已经进行了清洗和钝化。 Check that the installation has been cleaned and passivated once the installation is finished and before the starting up of the system. 步骤No. 测试步骤 Step description 通过标准Acceptance criteria 试验结果Observed results 合格与否 C/NC 偏差报告编号 Anomaly reference 1 有执行清洗和钝化的方案 There is a protocol for the execution of the cleaning and passivation 有相关文件 Document is available 编号 Ref : …………… 2 有清洗钝化的测试结果报告 There is a report with the result of the cleaning and passivation 有相关文件 Document is available 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 ( 不合格 / Non conform ( 备注 / Comments : 纯水箱 Pure water tank EDI系统 EDI system EDI水泵 EDI water pump RO水箱 RO water tank 反渗透系统 RO system 高压泵 High pressure pump 阻垢剂 Scale inhibitor 5μm精密过滤器 5μm precise filter 活性炭过滤器 Activated carbon filter 多介质过滤器 Sand filter 原水泵 Raw water pump 原水箱 Raw water tank 0.1μm精密过滤器 紫外线杀菌器 UV 纯水泵 Pure water pump PH调节剂 PH adjustor R2-GP-003 验证方案 QUALIFATION PROTOCOL