1、題目：海潤一車間純化水分配系統(tǒng)安裝確認方案PW distribution system of the HAIRUN workshop one IQ protocol 共46頁 第29頁編碼DOC No：IQP-PW2-1-01海潤一車間純化水分配系統(tǒng)安裝確認方案PW DISTRIBUTION SYSTEM OF HAIRUN WORKSHOP ONEIQ PROTOCOL方案號 DOC No： IQP-PW2-1-01 確認地點 Location： 海潤一車間 HAIRUN Workshop One 江蘇奧賽康藥業(yè)股份有限公司JIANGSU AOSAIKANG PHARMACEUTICAL C

2、O., LTD江蘇奧賽康藥業(yè)股份有限公司 江蘇奧賽康藥業(yè)股份有限公司 題目：海潤一車間純化水分配系統(tǒng)安裝確認方案PW distribution system of the HAIRUN workshop one IQ protocol 共46頁 第30頁編碼DOC No：IQP-PW2-1-01確認方案的審批 Qualification Protocol Approval:方案起草 Prepared By：部門/姓名Dep./Name簽名 Signature日期 Date朗脈驗證部/任雨方案審核 Reviewed By：部門/姓名Dep./Name簽名 Signature日期 Date設備部/

3、史建剛生產(chǎn)部/馮曉明質(zhì)量部/沈德龍方案批準 Approved By：職務/姓名 Title/Name簽名 Signature日期 Date質(zhì)量負責人/趙硯榮目 錄Content TOC o 1-3 h z u HYPERLINK l _Toc410667486 1、目的 Purpose PAGEREF _Toc410667486 h 5 HYPERLINK l _Toc410667487 2、范圍 Scope PAGEREF _Toc410667487 h 5 HYPERLINK l _Toc410667488 3、職責 Responsibility PAGEREF _Toc410667488

4、 h 5 HYPERLINK l _Toc410667489 4、系統(tǒng)描述 System Description PAGEREF _Toc410667489 h 6 HYPERLINK l _Toc410667490 5、文檔化 Documentation PAGEREF _Toc410667490 h 8 HYPERLINK l _Toc410667491 6、數(shù)據(jù)收集 Data Collection PAGEREF _Toc410667491 h 8 HYPERLINK l _Toc410667492 7、安全注意事項 SHE Notice PAGEREF _Toc410667492 h

5、9 HYPERLINK l _Toc410667493 8、文件確認 Documentation Verification PAGEREF _Toc410667493 h 9 HYPERLINK l _Toc410667494 9、安裝確認過程 IQ Process PAGEREF _Toc410667494 h 9 HYPERLINK l _Toc410667495 9.1 PID與平面布置圖檢查 PID and Layout Drawing Verification PAGEREF _Toc410667495 h 9 HYPERLINK l _Toc410667496 9.2組件檢查 Co

6、mponents Verification PAGEREF _Toc410667496 h 10 HYPERLINK l _Toc410667497 9.3關鍵儀表確認 Critical Instruments Verification PAGEREF _Toc410667497 h 11 HYPERLINK l _Toc410667498 9.4材質(zhì)與表面拋光檢查 Materials and Surface Finish Verification PAGEREF _Toc410667498 h 12 HYPERLINK l _Toc410667499 9.5組件結(jié)構檢查 Components

7、 Structure Verification PAGEREF _Toc410667499 h 13 HYPERLINK l _Toc410667500 9.6死角檢查Dead Leg Verification PAGEREF _Toc410667500 h 14 HYPERLINK l _Toc410667501 9.7焊接文件檢查 Welding Documentation Verification PAGEREF _Toc410667501 h 15 HYPERLINK l _Toc410667502 9.8排凈能力檢查 Drainability Verification PAGEREF

8、 _Toc410667502 h 16 HYPERLINK l _Toc410667503 9.9壓力測試確認 Pressure Testing Verification PAGEREF _Toc410667503 h 16 HYPERLINK l _Toc410667504 9.10清洗、脫脂和鈍化確認 Cleaning, Degreasing and Passivation Verification PAGEREF _Toc410667504 h 17 HYPERLINK l _Toc410667505 9.11公用設施檢查Utilities Verification PAGEREF _T

9、oc410667505 h 18 HYPERLINK l _Toc410667506 9.12控制系統(tǒng)硬件組成檢查Control System Hardware Architecture Verification PAGEREF _Toc410667506 h 18 HYPERLINK l _Toc410667507 9.13控制系統(tǒng)軟件配置檢查Control System Software Configuration Verification PAGEREF _Toc410667507 h 19 HYPERLINK l _Toc410667508 9.14安裝確認過程中偏差匯總 IQ Dev

10、iation Summary PAGEREF _Toc410667508 h 19 HYPERLINK l _Toc410667509 9.15安裝確認總結(jié) IQ Summary Report PAGEREF _Toc410667509 h 20 HYPERLINK l _Toc410667510 10、參考文獻 References PAGEREF _Toc410667510 h 20 HYPERLINK l _Toc410667511 11、附錄列表 Appendix Table PAGEREF _Toc410667511 h 22 HYPERLINK l _Toc410667512 附錄

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

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

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

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

15、裝確認用以證實海潤一車間的純化水分配系統(tǒng)的建造與安裝符合設計標準。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、范圍 Scope本方案適用于海潤一車間的純化水分配系統(tǒng)的安裝確認。This protocol is just applicable to the IQ of the PW distribution system of the

16、HAIRUN workshop one.3、職責 Responsibility所有開展的工作將按照驗證管理總則（HQAM-200）執(zhí)行。All activities will be executed according to the （HQAM-200）.列在方案第二頁的人員負責審查和批準本方案。The personnel listed on the second page take the responsibility of the reviewing and approval of this protocol.凡是參與本方案確認測試的人員都應列在附錄1“檢查測試人員簽字單”上。All pa

17、rticipants should be listed in the Appendix 1 “Testers Signature Form”.凡是參與本方案確認測試的人員都應經(jīng)過本方案的培訓，列在附表“培訓記錄表”（HRMR-009）中。（培訓記錄表原件留存于培訓檔案中，復印件將附于本安裝確認的報告中）。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、系統(tǒng)描述 System Description本純化水分配系統(tǒng)由上海朗脈潔凈技術股份有限公司設計制造與安裝，主要由儲罐、水泵、換熱器、儀器儀表、閥門以及分配管路組成。本系統(tǒng)安裝于室內(nèi)。主要用于純化水的儲存與分配。系統(tǒng)由一個循環(huán)構成：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.純化水貯存在一個豎直安放的2m3容量的不銹鋼罐內(nèi)，并通過一個水泵循環(huán)至每個使用點，最后回到該不銹鋼儲罐內(nèi)。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.分配管路系統(tǒng)由一個DN40的管道環(huán)路組成，并通過衛(wèi)生隔膜閥分配到使用點。The distribution pipe line is a DN40 piping loop, and distributed by the diaphragm valves.一個雙管板列管式換熱器安裝在分配系統(tǒng)的靠近儲罐的回路管道上，通過水罐側(cè)、換熱器前后的溫度傳感器控制系統(tǒng)溫度。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.一個液位傳感器安裝在儲罐內(nèi)，以監(jiān)控儲罐的液位。A level meter is located in the tank, aim to supervise and control the tank level.一個噴

22、淋球安裝在儲罐上方，以使儲罐內(nèi)表面保持濕潤。A spray ball is installed on the top of the internal of the tank, aim to keep the tank interior wetted.一個呼吸過濾器安裝在儲罐罐頂，以防止當水位下降時來自外界空氣的污染。該呼吸器裝有電加熱保溫裝置，以便始終保持呼吸器的濾芯處于干燥狀態(tài)。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設計了一個取樣口，以便對水進行取樣。Two sample valves are respectively installed on the supply loop and the return loop, so as to sample the PW.兩個壓力表分別安裝在儲罐上和水泵后，用于觀察罐內(nèi)與供水壓強。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.一個流量計安裝在分配系統(tǒng)的靠近儲罐的回路管路上，以通過改變水泵轉(zhuǎn)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.一個電導率儀安裝在分配系統(tǒng)的靠

25、近儲罐的回路管路上，以監(jiān)測環(huán)路上水的電導率。A conductivity transmitter is installed in the return loop, so as to supervise the conductivity of the system.在純化水循環(huán)管道回路靠近儲罐的位置安裝了2個氣動隔膜閥，用于控制循環(huán)純化水的質(zhì)量，當純化水的電導率不符合可接受標準時，回純化水儲罐的氣動閥關閉，管道對外排放氣動閥打開，將不合格水對外排放；反之回純化水儲罐的氣動閥打開，管道對外排放氣動閥關閉。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.當壓縮空氣無壓力時這兩個氣動閥應處于正常循環(huán)狀態(tài)，即回儲罐的氣動閥門應保持打開狀態(tài)，對外排放氣動閥應處于關閉狀態(tài)。When the CA pressure lost, these two valves are in normal condition that the return valve opened as the discharging valve closed.5、文檔化 Documentation安裝確認文件必須包括：IQ documentation must include:本確認方案 This qualification protocol;確認過程中所有

28、產(chǎn)生的打印文字、圖表和手寫記錄 All printed texts, charts, handwriting records from the qualification process;所有參加確認檢查的人員簽字單 All participants signature;確認過程中可能出現(xiàn)的偏差和調(diào)查方案 Deviations and investigation plan which may occur during the qualification process;最終的確認報告 Final qualification report.6、數(shù)據(jù)收集 Data Collection所有批準都要

29、用黑色水筆填寫。All approval should be written by black ink pen.報告須用黑色水筆填寫。Report should be filled with a black ink pen.方案或報告不得撕毀和任意涂改，確需更改時應把原內(nèi)容用橫線劃去（原有信息仍清晰可辨）后，在旁邊書寫準確的內(nèi)容，并簽注姓名和日期，必要時應當說明更改理由。不可用刀刮，不可用橡皮擦，不可用重筆涂改。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.安裝確認結(jié)束后，收集所有的確認結(jié)果得出確認結(jié)論，形成確認報告。After finishing the IQ, all results from the qu

31、alification should come into a conclusion, and be formed into a qualification report.7、安全注意事項 SHE Notice若進入夾層，必須戴安全帽，必要時應配備安全帶與安全鞋。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，必須扶穩(wěn)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、文件確認 Documentation Verification檢查是否存在已經(jīng)批準的圖紙與設計文件以指導整個安裝確認測試，過程中有關該系統(tǒng)的確認必須嚴格依據(jù)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.列出每一個文件并檢查其有效性，將檢查結(jié)果記錄在附錄2 “文件確認表”。List each document and verify its validity, and record the test results into the Appendix 2 “Documentation Verification Form”.9、安裝確認過程 IQ Process9.1 PID與平面布置圖檢查 PID and Lay

34、out Drawing Verification9.1.1測試目的 Purpose核實系統(tǒng)安裝與PID以及布局圖是一致的，并反映了系統(tǒng)的竣工狀態(tài)。Verify the installation of the system is in accordance with P&ID/Lay-out Drawing and reflect the as-built situation.9.1.2測試方法 Test Procedure進行系統(tǒng)和圖紙（P&ID/布局圖）的比較。按照相關圖紙使用黃色的熒光筆標出每一臺設備、裝置、元件、尺寸、標簽（設備識別號）和儀表。使用紅筆更新圖紙的內(nèi)容，以準確地反映系統(tǒng)安裝

35、的最終狀態(tài)。將結(jié)果記錄于附錄3“PID與平面布置圖檢查”。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可接受標準 Acceptance Criteria所有組件和管道都是按照PID進行安裝的。All components and pipes are installed in accordance to the P&ID.設備和儀表的型號、位置和標識與PID一致。The type, location and ID o

37、f equipment and instrument are in accordance with the P&ID.9.2組件檢查 Components Verification9.2.1測試目的 Purpose檢查安裝的主要組件符合設計和采購要求。檢查主要組件與已安裝的系統(tǒng)相一致，并是竣工狀態(tài)。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測試方法 Test Procedure收集主要組件的廠家、型號和技術參數(shù)，檢查是否符合設計、采購要求并與實際竣工情況一致。將結(jié)果記錄于附錄4“組件檢查”。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可接受標準Acceptance Criteria主要組件是按照設計和采購要求所供應的。主要組件符合竣工狀態(tài)。The main components are supplied in accordance with Design and Procurement requirements. The main components correspond to the As-Built system.9.3關鍵儀表確認 Critical Instruments Ve

40、rification9.3.1測試目的 Purpose確認關鍵儀表與已安裝的系統(tǒng)相一致，儀表已經(jīng)過校準。Verify that the critical Instruments conform to system installed and that instruments have been calibrated.9.3.2測試方法 Test Procedure列出關鍵儀表以及其型號、材質(zhì)、精度與量程，檢查關鍵儀表的選型是否符合用戶要求和GMP要求。確認儀表已經(jīng)得到校準， 并在它們的校準有效期內(nèi)。將結(jié)果記錄于附錄5“關鍵儀表確認”。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可接受標準 Acceptance Criteria主要儀表是按照設計和采購要

42、求所供應的。所有關鍵儀表已經(jīng)得到確認和校準， 并在它們的校準有效期內(nèi)。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材質(zhì)與表面拋光檢查 Materials and Surface Finish Verification9.4.1測試目的 Purpose 確認與純

43、化水接觸的材質(zhì)和表面拋光符合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測試方法 Test Procedure通過材質(zhì)證書、廠家聲明或說明書，檢查與純化水接觸的材料材質(zhì)是否符合GMP要求。檢查是否有表面拋光證書，并符合衛(wèi)生型管道標準。將結(jié)果記錄于附錄6“材質(zhì)與表面拋光檢查”。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可接受標準 Acceptance Criteria與純化水接觸的主要組件的材質(zhì)符合設計要求，并符合GMP要求。（材料無毒，不釋放顆粒，易于清洗）。與產(chǎn)品接觸的金屬必須是316L不銹鋼。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.表面拋光符合衛(wèi)生型管道標準。Surface finish of the main components is in accordance with sanitary piping specification.9.5組件結(jié)構檢查 Components Structure Verification9.5.1測試目的 P

47、urpose確認與純化水接觸的主要組件的結(jié)構符合 GMP 的要求。Verify that main components structure which are in contact with PW conform to GMP requirement.9.5.2測試方法 Test Procedure檢查儲水罐、循環(huán)水泵、呼吸過濾器和儀器儀表的結(jié)構。檢查系統(tǒng)的管道與管道，管道與部件的連接方式。將結(jié)果記錄于附錄7“組件結(jié)構檢查”。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可接受標準 Acceptance Criteria連接部分是焊接的或衛(wèi)生型快接方式，不能使用螺紋連接。Connections are welded, sanitary clamp (tri-clamp) flanged. No threaded connections are permitted.儲罐與水泵可以完全排放。Tank and pump can be completely

49、 drained.泵的轉(zhuǎn)向必須正確，泵采用機械密封而不需要額外的潤滑劑。Pump motors rotate in proper direction; pump is designed with mechanical seals not requiring external lubrication.呼吸過濾器濾芯為疏水性材料，完整性測試合格。Vent filter cartridge material is hydrophobic and its integrity testing is successful.壓力儀器采用衛(wèi)生型不銹鋼膜片，使儀表內(nèi)部與流體相隔離。Pressure Gauges

50、 are designed to contain a sanitary, stainless steel diaphragm to isolate the instrument internals from the process fluids.9.6死角檢查Dead Leg Verification9.6.1測試目的 Purpose對系統(tǒng)中的管道和組件可能存在的死角進行檢查。Check the potential dead legs in the piping and components of the system.9.6.2測試方法 Test Procedure測量主管外壁到支路閥門中心

51、之間的距離(L)，測量支路管道的直徑（d）和主管的直徑（D）。將結(jié)果記錄于附錄8“死角檢查”。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可接受標準 Acceptance C

52、riteria管道系統(tǒng)中無死角，滿足以下條件之一：There is no dead leg in the piping which conforms to one criterion in the following:L3d; (L+D/2)6d9.7焊接文件檢查 Welding Documentation Verification9.7.1測試目的 Purpose檢查管道的施工達到衛(wèi)生標準。Verify that the construction of pipe has been realized in compliance with the sanitary criteria.9.7.2測

53、試方法 Test Procedure檢查有下列文件：帶焊接點標識的軸測圖；焊接者的資質(zhì)文件；焊接程序；每批管道和每種直徑管道的焊接樣品(每日)；焊接樣品的焊接報告；所使用的機器（軌道焊機）的技術數(shù)據(jù)；焊接記錄；焊接點的質(zhì)量檢查報告（內(nèi)窺鏡法）。將結(jié)果記錄于附錄9“焊接文件檢查”。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可接受標準 Acceptance Criteria以上所有焊接文件已有。Above

55、 all the documentation of welding is available.9.8排凈能力檢查 Drainability Verification9.8.1測試目的 Purpose檢查系統(tǒng)的排放能力。檢查管道坡度符合設計要求。Verify the drainability of system. Verify that the pipe slope conform to design requirements.9.8.2測試方法 Test Procedure檢查最低點有排放點， 使用坡度尺檢查水平管線有足夠的坡度以保證排放，附上坡度測試報告。將結(jié)果記錄于附錄10“排凈能力檢查”

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可接受標準 Acceptance Criteria水平管線的坡度符合設計要求（不小于0.5%）。如果出現(xiàn)最低點，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壓力測試確認 Pressure Testing Verification9.9.1測試目的 Purpose確認管道和組件連接無泄漏。Verify there is no any leakage of connection of pipes and/or component.9.9.2測試方法 Test Procedure檢查有

58、壓力測試報告及壓力測試規(guī)程，并符合相關法規(guī)標準。附上壓力測試報告及壓力測試規(guī)程。將結(jié)果記錄于附錄11“壓力測試確認”。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可接受標準 Accep

59、tance Criteria有壓力測試報告及測試規(guī)程。測試過程中，管道和組件的連接無泄漏。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、脫脂和鈍化確認 Cleaning, Degreasing and Passivation Verification9.10.1測試目的 Purpose確認在啟動系統(tǒng)前，清洗、脫脂和鈍化工作得以執(zhí)行。Verify the execution

60、 of treatments of cleaning, degreasing and passivation before the starting of the system.9.10.2測試方法 Test Procedure確認相關的清洗、脫脂和鈍化報告以及相關測試規(guī)程存在。它必須清楚地表明處理地全過程。它必須記錄時間與使用的酸的濃度。將結(jié)果記錄于附錄12“清洗、脫脂和鈍化確認”。Verify the presence of report and SOP relating to the execution of treatments of degreasing, cleaning and