方案01海润精制药车间一pw iq

1、题目：海润一车间纯化水分配系统安装确认方案PW distribution system of the HAIRUN workshop one IQ protocol 共46页 第29页编码DOC No：IQP-PW2-1-01海润一车间纯化水分配系统安装确认方案PW DISTRIBUTION SYSTEM OF HAIRUN WORKSHOP ONEIQ PROTOCOL方案号 DOC No： IQP-PW2-1-01 确认地点 Location： 海润一车间 HAIRUN Workshop One 江苏奥赛康药业股份有限公司JIANGSU AOSAIKANG PHARMACEUTICAL C

2、O., LTD江苏奥赛康药业股份有限公司 江苏奥赛康药业股份有限公司 题目：海润一车间纯化水分配系统安装确认方案PW distribution system of the HAIRUN workshop one IQ protocol 共46页 第30页编码DOC No：IQP-PW2-1-01确认方案的审批 Qualification Protocol Approval:方案起草 Prepared By：部门/姓名Dep./Name签名 Signature日期 Date朗脉验证部/任雨方案审核 Reviewed By：部门/姓名Dep./Name签名 Signature日期 Date设备部/

3、史建刚生产部/冯晓明质量部/沈德龙方案批准 Approved By：职务/姓名 Title/Name签名 Signature日期 Date质量负责人/赵砚荣目 录Content TOC o 1-3 h z u HYPERLINK l _Toc410667486 1、目的 Purpose PAGEREF _Toc410667486 h 5 HYPERLINK l _Toc410667487 2、范围 Scope PAGEREF _Toc410667487 h 5 HYPERLINK l _Toc410667488 3、职责 Responsibility PAGEREF _Toc410667488

4、 h 5 HYPERLINK l _Toc410667489 4、系统描述 System Description PAGEREF _Toc410667489 h 6 HYPERLINK l _Toc410667490 5、文档化 Documentation PAGEREF _Toc410667490 h 8 HYPERLINK l _Toc410667491 6、数据收集 Data Collection PAGEREF _Toc410667491 h 8 HYPERLINK l _Toc410667492 7、安全注意事项 SHE Notice PAGEREF _Toc410667492 h

5、9 HYPERLINK l _Toc410667493 8、文件确认 Documentation Verification PAGEREF _Toc410667493 h 9 HYPERLINK l _Toc410667494 9、安装确认过程 IQ Process PAGEREF _Toc410667494 h 9 HYPERLINK l _Toc410667495 9.1 PID与平面布置图检查 PID and Layout Drawing Verification PAGEREF _Toc410667495 h 9 HYPERLINK l _Toc410667496 9.2组件检查 Co

6、mponents Verification PAGEREF _Toc410667496 h 10 HYPERLINK l _Toc410667497 9.3关键仪表确认 Critical Instruments Verification PAGEREF _Toc410667497 h 11 HYPERLINK l _Toc410667498 9.4材质与表面抛光检查 Materials and Surface Finish Verification PAGEREF _Toc410667498 h 12 HYPERLINK l _Toc410667499 9.5组件结构检查 Components

7、 Structure Verification PAGEREF _Toc410667499 h 13 HYPERLINK l _Toc410667500 9.6死角检查Dead Leg Verification PAGEREF _Toc410667500 h 14 HYPERLINK l _Toc410667501 9.7焊接文件检查 Welding Documentation Verification PAGEREF _Toc410667501 h 15 HYPERLINK l _Toc410667502 9.8排净能力检查 Drainability Verification PAGEREF

8、 _Toc410667502 h 16 HYPERLINK l _Toc410667503 9.9压力测试确认 Pressure Testing Verification PAGEREF _Toc410667503 h 16 HYPERLINK l _Toc410667504 9.10清洗、脱脂和钝化确认 Cleaning, Degreasing and Passivation Verification PAGEREF _Toc410667504 h 17 HYPERLINK l _Toc410667505 9.11公用设施检查Utilities Verification PAGEREF _T

9、oc410667505 h 18 HYPERLINK l _Toc410667506 9.12控制系统硬件组成检查Control System Hardware Architecture Verification PAGEREF _Toc410667506 h 18 HYPERLINK l _Toc410667507 9.13控制系统软件配置检查Control System Software Configuration Verification PAGEREF _Toc410667507 h 19 HYPERLINK l _Toc410667508 9.14安装确认过程中偏差汇总 IQ Dev

10、iation Summary PAGEREF _Toc410667508 h 19 HYPERLINK l _Toc410667509 9.15安装确认总结 IQ Summary Report PAGEREF _Toc410667509 h 20 HYPERLINK l _Toc410667510 10、参考文献 References PAGEREF _Toc410667510 h 20 HYPERLINK l _Toc410667511 11、附录列表 Appendix Table PAGEREF _Toc410667511 h 22 HYPERLINK l _Toc410667512 附录

11、 Appendix 1 PAGEREF _Toc410667512 h 24 HYPERLINK l _Toc410667513 附录 Appendix 2 PAGEREF _Toc410667513 h 25 HYPERLINK l _Toc410667514 附录 Appendix 3 PAGEREF _Toc410667514 h 26 HYPERLINK l _Toc410667515 附录 Appendix 4 PAGEREF _Toc410667515 h 27 HYPERLINK l _Toc410667516 附录 Appendix 5 PAGEREF _Toc41066751

12、6 h 28 HYPERLINK l _Toc410667517 附录 Appendix 6 PAGEREF _Toc410667517 h 30 HYPERLINK l _Toc410667518 附录 Appendix 7 PAGEREF _Toc410667518 h 32 HYPERLINK l _Toc410667519 附录 Appendix 8 PAGEREF _Toc410667519 h 33 HYPERLINK l _Toc410667520 附录 Appendix 9 PAGEREF _Toc410667520 h 35 HYPERLINK l _Toc410667521

13、 附录 Appendix 10 PAGEREF _Toc410667521 h 36 HYPERLINK l _Toc410667522 附录 Appendix 11 PAGEREF _Toc410667522 h 37 HYPERLINK l _Toc410667523 附录 Appendix 12 PAGEREF _Toc410667523 h 38 HYPERLINK l _Toc410667524 附录 Appendix 13 PAGEREF _Toc410667524 h 39 HYPERLINK l _Toc410667525 附录 Appendix 14 PAGEREF _Toc

14、410667525 h 40 HYPERLINK l _Toc410667526 附录 Appendix 15 PAGEREF _Toc410667526 h 41 HYPERLINK l _Toc410667527 附录 Appendix 16 PAGEREF _Toc410667527 h 42 HYPERLINK l _Toc410667528 附录 Appendix 17 PAGEREF _Toc410667528 h 44 HYPERLINK l _Toc410667529 附录 Appendix 18 PAGEREF _Toc410667529 h 451、目的 Purpose本安

15、装确认用以证实海润一车间的纯化水分配系统的建造与安装符合设计标准。The IQ is to demonstrate that the construction and installation of the PW distribution system of the HAIRUN workshop one conform to the design criteria.2、范围 Scope本方案适用于海润一车间的纯化水分配系统的安装确认。This protocol is just applicable to the IQ of the PW distribution system of the

16、HAIRUN workshop one.3、职责 Responsibility所有开展的工作将按照验证管理总则（HQAM-200）执行。All activities will be executed according to the （HQAM-200）.列在方案第二页的人员负责审查和批准本方案。The personnel listed on the second page take the responsibility of the reviewing and approval of this protocol.凡是参与本方案确认测试的人员都应列在附录1“检查测试人员签字单”上。All pa

17、rticipants should be listed in the Appendix 1 “Testers Signature Form”.凡是参与本方案确认测试的人员都应经过本方案的培训，列在附表“培训记录表”（HRMR-009）中。（培训记录表原件留存于培训档案中，复印件将附于本安装确认的报告中）。All participants should be trained of this protocol and listed on the “Training Record” （HRMR-009）. (All original records should be archived by the

18、 in the training document, and the copies will be attached to the qualification report).4、系统描述 System Description本纯化水分配系统由上海朗脉洁净技术股份有限公司设计制造与安装，主要由储罐、水泵、换热器、仪器仪表、阀门以及分配管路组成。本系统安装于室内。主要用于纯化水的储存与分配。系统由一个循环构成：This PW distribution system is designed, manufactured and installed by the SHANGHAI MACROPROCE

19、SS LUSTRATION TECHNOLOGY Co., Ltd. The main components are tank, pump, heat exchanger, instruments, valves and piping. The system is indoor-installed, and used to storage and distribution the Purified Water.纯化水贮存在一个竖直安放的2m3容量的不锈钢罐内，并通过一个水泵循环至每个使用点，最后回到该不锈钢储罐内。The PW is stored in a vertical SS tank o

20、f 2m3, and delivered to each use point by a centrifugal pump, return to the SS tank at last.分配管路系统由一个DN40的管道环路组成，并通过卫生隔膜阀分配到使用点。The distribution pipe line is a DN40 piping loop, and distributed by the diaphragm valves.一个双管板列管式换热器安装在分配系统的靠近储罐的回路管道上，通过水罐侧、换热器前后的温度传感器控制系统温度。A double-tube-sheet heat exc

21、hanger is installed on the return loop near the tank, and to control the system temperature by the temperature transmitters which located on the tank side, before and after the heat exchanger.一个液位传感器安装在储罐内，以监控储罐的液位。A level meter is located in the tank, aim to supervise and control the tank level.一个喷

22、淋球安装在储罐上方，以使储罐内表面保持湿润。A spray ball is installed on the top of the internal of the tank, aim to keep the tank interior wetted.一个呼吸过滤器安装在储罐罐顶，以防止当水位下降时来自外界空气的污染。该呼吸器装有电加热保温装置，以便始终保持呼吸器的滤芯处于干燥状态。A vent filter is installed on the top of the tank, so as to prevent the outside contaminants in case of the

23、level drop. Electrical heating jacket is installed on the filter house, so as to keep the filter cartridge dry.在出水和回水管路上均设计了一个取样口，以便对水进行取样。Two sample valves are respectively installed on the supply loop and the return loop, so as to sample the PW.两个压力表分别安装在储罐上和水泵后，用于观察罐内与供水压强。Two pressure gauges are

24、 respectively installed on the tank and after the pump, so as to watch the pressure of the tank and the supply water.一个流量计安装在分配系统的靠近储罐的回路管路上，以通过改变水泵转速控制回路流量。A level meter is installed in the return loop, so as to control the return water velocity by modifying the pump rotational rate.一个电导率仪安装在分配系统的靠

25、近储罐的回路管路上，以监测环路上水的电导率。A conductivity transmitter is installed in the return loop, so as to supervise the conductivity of the system.在纯化水循环管道回路靠近储罐的位置安装了2个气动隔膜阀，用于控制循环纯化水的质量，当纯化水的电导率不符合可接受标准时，回纯化水储罐的气动阀关闭，管道对外排放气动阀打开，将不合格水对外排放；反之回纯化水储罐的气动阀打开，管道对外排放气动阀关闭。Two pneumatic diaphragm valves are installed on

26、 the return line which near the tank, so as to control the PW quality. When the conductivity do not conform to the acceptance criteria, the valve which return to the tank closed as the discharging valve opened to discharge the unacceptable water. Otherwise the return valve closed as the discharging

27、valve opened.当压缩空气无压力时这两个气动阀应处于正常循环状态，即回储罐的气动阀门应保持打开状态，对外排放气动阀应处于关闭状态。When the CA pressure lost, these two valves are in normal condition that the return valve opened as the discharging valve closed.5、文档化 Documentation安装确认文件必须包括：IQ documentation must include:本确认方案 This qualification protocol;确认过程中所有

28、产生的打印文字、图表和手写记录 All printed texts, charts, handwriting records from the qualification process;所有参加确认检查的人员签字单 All participants signature;确认过程中可能出现的偏差和调查方案 Deviations and investigation plan which may occur during the qualification process;最终的确认报告 Final qualification report.6、数据收集 Data Collection所有批准都要

29、用黑色水笔填写。All approval should be written by black ink pen.报告须用黑色水笔填写。Report should be filled with a black ink pen.方案或报告不得撕毁和任意涂改，确需更改时应把原内容用横线划去（原有信息仍清晰可辨）后，在旁边书写准确的内容，并签注姓名和日期，必要时应当说明更改理由。不可用刀刮，不可用橡皮擦，不可用重笔涂改。Protocol or report shall not be torn or erased. If necessary, any corrections should be cros

30、sed out with a single line, and initialed and dated. Where the reason for a deletion is not obvious a brief explanation should be provided. There should not be any use of knife scratches, eraser, and heavy pencil erasures.安装确认结束后，收集所有的确认结果得出确认结论，形成确认报告。After finishing the IQ, all results from the qu

31、alification should come into a conclusion, and be formed into a qualification report.7、安全注意事项 SHE Notice若进入夹层，必须戴安全帽，必要时应配备安全带与安全鞋。If it is necessary to get into the ceiling, a safety helmet should be worn on, and in some cases, the harness and safety shoes are important.若使用梯子登高，必须扶稳梯子，注意跌落。If it is

32、 necessary to ascend a height with a ladder, please hold the handrail, and pay careful attention to prevent slipping or falling down.8、文件确认 Documentation Verification检查是否存在已经批准的图纸与设计文件以指导整个安装确认测试，过程中有关该系统的确认必须严格依据上述文件。Verify that the approved drawings and design documents are available to direct the

33、 whole IQ process. All relevant verification should be based on the aforementioned documents.列出每一个文件并检查其有效性，将检查结果记录在附录2 “文件确认表”。List each document and verify its validity, and record the test results into the Appendix 2 “Documentation Verification Form”.9、安装确认过程 IQ Process9.1 PID与平面布置图检查 PID and Lay

34、out Drawing Verification9.1.1测试目的 Purpose核实系统安装与PID以及布局图是一致的，并反映了系统的竣工状态。Verify the installation of the system is in accordance with P&ID/Lay-out Drawing and reflect the as-built situation.9.1.2测试方法 Test Procedure进行系统和图纸（P&ID/布局图）的比较。按照相关图纸使用黄色的荧光笔标出每一台设备、装置、元件、尺寸、标签（设备识别号）和仪表。使用红笔更新图纸的内容，以准确地反映系统安装

35、的最终状态。将结果记录于附录3“PID与平面布置图检查”。Compare the P&ID/Lay-out Drawing with the system. Use Yellow Highlight to underline each equipment, device, component, dimension, tag (equipment identification label) and instrument in accordance with the relevant drawing. Use a red pen to update the P&ID/Lay-out in orde

36、r to accurately represent the final installation of the system. Record the results into Appendix 3 “PID and Layout Drawing Verification”.9.1.3可接受标准 Acceptance Criteria所有组件和管道都是按照PID进行安装的。All components and pipes are installed in accordance to the P&ID.设备和仪表的型号、位置和标识与PID一致。The type, location and ID o

37、f equipment and instrument are in accordance with the P&ID.9.2组件检查 Components Verification9.2.1测试目的 Purpose检查安装的主要组件符合设计和采购要求。检查主要组件与已安装的系统相一致，并是竣工状态。Verify that main components installed are in accordance with requirements of design and procurement. Verify that the main components conform to system

38、 installed, which is report as-build situation.9.2.2测试方法 Test Procedure收集主要组件的厂家、型号和技术参数，检查是否符合设计、采购要求并与实际竣工情况一致。将结果记录于附录4“组件检查”。Collect the manufacturer, model and technical data of all main components and verify their correspondence with design, procurement requirements and actual as-build situati

39、on. Record the results into Appendix 4 “Components Verification”.9.2.3可接受标准Acceptance Criteria主要组件是按照设计和采购要求所供应的。主要组件符合竣工状态。The main components are supplied in accordance with Design and Procurement requirements. The main components correspond to the As-Built system.9.3关键仪表确认 Critical Instruments Ve

40、rification9.3.1测试目的 Purpose确认关键仪表与已安装的系统相一致，仪表已经过校准。Verify that the critical Instruments conform to system installed and that instruments have been calibrated.9.3.2测试方法 Test Procedure列出关键仪表以及其型号、材质、精度与量程，检查关键仪表的选型是否符合用户要求和GMP要求。确认仪表已经得到校准， 并在它们的校准有效期内。将结果记录于附录5“关键仪表确认”。Collect and verify the princip

41、al characteristics of instruments (manufacturer, model, operative range, accuracy and serial number). Verify that the instruments have been calibrated, are within their validity period. Record the results into Appendix 5 “Critical Instruments Verification”.9.3.3可接受标准 Acceptance Criteria主要仪表是按照设计和采购要

42、求所供应的。所有关键仪表已经得到确认和校准， 并在它们的校准有效期内。The main instruments are supplied in accordance with Design and Procurement requirements. All the critical instruments have been identified and calibrated, are within their validity period.9.4材质与表面抛光检查 Materials and Surface Finish Verification9.4.1测试目的 Purpose 确认与纯

43、化水接触的材质和表面抛光符合GMP的要求。Verify that materials and surface finish of the components which are in contact with PW conform to GMP requirement.9.4.2测试方法 Test Procedure通过材质证书、厂家声明或说明书，检查与纯化水接触的材料材质是否符合GMP要求。检查是否有表面抛光证书，并符合卫生型管道标准。将结果记录于附录6“材质与表面抛光检查”。Verify that materials of the components that are in conta

44、ct with the PW are in accordance with the design and they are, in any case, compliance to GMP, via the material certificates, declaration, and/or specifications. Verify the presence of surface finish certificates are in accordance with sanitary piping specification. Record the results into Appendix

45、6 “Materials and Surface Finish Verification”.9.4.3可接受标准 Acceptance Criteria与纯化水接触的主要组件的材质符合设计要求，并符合GMP要求。（材料无毒，不释放颗粒，易于清洗）。与产品接触的金属必须是316L不锈钢。Materials of main components that are in contact with the PW are in accordance with the design and they are, in any case, compliance to GMP (materials non to

46、xics that do not release particles and easily cleaning). Metal that is in contact with the product must be fabricates of 316L stainless steel.表面抛光符合卫生型管道标准。Surface finish of the main components is in accordance with sanitary piping specification.9.5组件结构检查 Components Structure Verification9.5.1测试目的 P

47、urpose确认与纯化水接触的主要组件的结构符合 GMP 的要求。Verify that main components structure which are in contact with PW conform to GMP requirement.9.5.2测试方法 Test Procedure检查储水罐、循环水泵、呼吸过滤器和仪器仪表的结构。检查系统的管道与管道，管道与部件的连接方式。将结果记录于附录7“组件结构检查”。Verify the structure of tank, pump, vent filter and instrument. Verify the connectio

48、n between pipes and components. Record the results into Appendix 7 “Components Structure Verification”.9.5.3可接受标准 Acceptance Criteria连接部分是焊接的或卫生型快接方式，不能使用螺纹连接。Connections are welded, sanitary clamp (tri-clamp) flanged. No threaded connections are permitted.储罐与水泵可以完全排放。Tank and pump can be completely

49、 drained.泵的转向必须正确，泵采用机械密封而不需要额外的润滑剂。Pump motors rotate in proper direction; pump is designed with mechanical seals not requiring external lubrication.呼吸过滤器滤芯为疏水性材料，完整性测试合格。Vent filter cartridge material is hydrophobic and its integrity testing is successful.压力仪器采用卫生型不锈钢膜片，使仪表内部与流体相隔离。Pressure Gauges

50、 are designed to contain a sanitary, stainless steel diaphragm to isolate the instrument internals from the process fluids.9.6死角检查Dead Leg Verification9.6.1测试目的 Purpose对系统中的管道和组件可能存在的死角进行检查。Check the potential dead legs in the piping and components of the system.9.6.2测试方法 Test Procedure测量主管外壁到支路阀门中心

51、之间的距离(L)，测量支路管道的直径（d）和主管的直径（D）。将结果记录于附录8“死角检查”。Measure the distance (L) from outside of the main pipe to the center of the valve. Measure the diameter (d) of the branch pipe and the diameter (D) of the main pipe. Record the results into Appendix 8 “Dead Leg Verification”.ddLDd9.6.3可接受标准 Acceptance C

52、riteria管道系统中无死角，满足以下条件之一：There is no dead leg in the piping which conforms to one criterion in the following:L3d; (L+D/2)6d9.7焊接文件检查 Welding Documentation Verification9.7.1测试目的 Purpose检查管道的施工达到卫生标准。Verify that the construction of pipe has been realized in compliance with the sanitary criteria.9.7.2测

53、试方法 Test Procedure检查有下列文件：带焊接点标识的轴测图；焊接者的资质文件；焊接程序；每批管道和每种直径管道的焊接样品(每日)；焊接样品的焊接报告；所使用的机器（轨道焊机）的技术数据；焊接记录；焊接点的质量检查报告（内窥镜法）。将结果记录于附录9“焊接文件检查”。Verify the availability of following documentation:Isometric drawing with Identification of Welds;Documentation of Welders Qualification;Welding Procedures;Weld

54、 Coupons (daily) of each diameter and pipe lot;Coupon Logs;Technical identification data of used machines (orbital welders);Weld Log;Quality Inspection Report of welding (Endoscopy.).Record the results into Appendix 9 “Welding Documentation Verification”9.7.3可接受标准 Acceptance Criteria以上所有焊接文件已有。Above

55、 all the documentation of welding is available.9.8排净能力检查 Drainability Verification9.8.1测试目的 Purpose检查系统的排放能力。检查管道坡度符合设计要求。Verify the drainability of system. Verify that the pipe slope conform to design requirements.9.8.2测试方法 Test Procedure检查最低点有排放点， 使用坡度尺检查水平管线有足够的坡度以保证排放，附上坡度测试报告。将结果记录于附录10“排净能力检查”

56、。Verify that the low points are provided with drain, and test horizontal lines with the slope meter to ensure that there is a sufficient slope to guarantee drainability. Record the results into Appendix 10 “Drainability Verification”.9.8.3可接受标准 Acceptance Criteria水平管线的坡度符合设计要求（不小于0.5%）。如果出现最低点，有排放口。

57、The slope of horizontal line conforms to design requirement (no less than 0.5%). If low point is present, there is device with drain.9.9压力测试确认 Pressure Testing Verification9.9.1测试目的 Purpose确认管道和组件连接无泄漏。Verify there is no any leakage of connection of pipes and/or component.9.9.2测试方法 Test Procedure检查有

58、压力测试报告及压力测试规程，并符合相关法规标准。附上压力测试报告及压力测试规程。将结果记录于附录11“压力测试确认”。Verify the Pressure Test Report and the pressure test SOP are available and confirms with relevant regulations. Attach the pressure test report and the SOP. Record the results into Appendix 11 “Pressure Testing Verification”.9.9.3可接受标准 Accep

59、tance Criteria有压力测试报告及测试规程。测试过程中，管道和组件的连接无泄漏。There is no leakage of connection of pipes and/or components during the test. The pressure test report and the SOP are available.9.10清洗、脱脂和钝化确认 Cleaning, Degreasing and Passivation Verification9.10.1测试目的 Purpose确认在启动系统前，清洗、脱脂和钝化工作得以执行。Verify the execution

60、 of treatments of cleaning, degreasing and passivation before the starting of the system.9.10.2测试方法 Test Procedure确认相关的清洗、脱脂和钝化报告以及相关测试规程存在。它必须清楚地表明处理地全过程。它必须记录时间与使用的酸的浓度。将结果记录于附录12“清洗、脱脂和钝化确认”。Verify the presence of report and SOP relating to the execution of treatments of degreasing, cleaning and