净化空调系统SAT文件.docx

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1、 Site Acceptance Test_Protocol/Report系统调试文件/报告Doc. No. 文件编号:AHU-402 systemAHU-402系统Rev.版本: 001System Commissioning_Protocol/Report 系统调试文件/报告AHU-402 systemAHU-402系统Approval of the document文件批准Signature 签字Date 日期Author作者Reviewer审阅Reviewer审阅Approver批准Approver批准Approver批准*The above signature indicates t

2、hat the debugging SAT theme of the system has been reviewed and approved. 以上签字表明本系统调试方案已经审核和批准。 Index目录1. Purpose 目的32. SAT scope 范围33. Abbreviations 术语和缩略语34. System Deription 系统描述45. Reference and Regulation 参考文件及规46. Responsibilities 职责67. SAT Execution 系统调试执行77.1. Prerequisites 先决条件77.2. Personn

3、el Identification 人员确认97.3. Documents Verification 文件确认117.4. Test Equipment Calibration Verification 测试仪器确认137.5. PID Walkdown Check流程图检查167.6. HEPA Filter installation Inspection高效过滤器安装检查187.7. Room Air Volume and Air Change Rate Testing房间送风量及换次数检测207.8. Terminal HEPA Filter Integrity Testing末端高效过

4、滤器完整性检查257.9. Room Pressure Difference Testing 房间静压差检测317.10. Room Temperature and Humidity Testing房间温湿度测试367.11. Cleanroom Airborne Particle Count Test (at rest) 洁净室微粒计数浓度的检测 (静态)397.12. Illumination Level Testing照度测量467.13. Noise test噪音测量497.14. Recovery Time Testing自净时间测试528. Deviations 偏差578.1.

5、List of Deviations 偏差列表579. Site Acceptance Testing Summary 现场验收测试总结5810. List of Attachment 附件列表5911. Change Log 变更记录6012. Appendix附录611. Purpose 目的Site Acceptance Testing (SAT), to verify that the proposed testing of specific items of major equipment and system at site meets the requirement of URS

6、. To ensure the HVAC system assembling and commissioning compare with the requirement.在项目现场，测试关键系统和设备的被要求的项目符合URS的要求，保证空调系统已经按要求完成了组装和调试。2. SAT scope 范围This document records the SAT of AHU-402 system该文件记录了AHU-402系统的现场测试。AHU-402 ,the air handling unit provides air flow through the HEPA to provide cle

7、ar air to rooms :room 4063,buffer room.CNC;room 4075,PAL.CNC;room 4076,PAL,Grade C;room 4077,buffer room,Grade C;room 4078,Limit bacteria detection chamber,Grade C. AHU-402空调机组为4063房间缓冲二，4075房间C级一更，4076房间C级二更，4077房间C级缓冲3,4078房间限度菌检测室提供洁净空气。3. Abbreviations 术语和缩略语Abbreviation缩写Full Name全称QAQuality As

8、surance 质量保证FATFactory Acceptance Test 工厂验收测试SATSite Acceptance Test 现场验收测试URSUser Requirement Specification 用户需求GDPGood Documentation Practice 良好的文件管理规范GTPGood Test Practice 良好的测试规范AHUAir Handling Unit 空气处理机组MAUMakeup Air Handling Unit 新风处理机组MALMaterial Air Lock物流气闸PALPersonnel Air Lock人流气闸HVACHeat

9、ing Ventilation and Air Conditioning 暖通空调HEPAHigh Efficiency Particulate Air 高效空气过滤器MCMechanical Completion 机电完工BMSBuilding Management System 楼宇自控系统VMPValidation Master Plan 验证总计划第 65 页 共 65 页4. System Deription 系统描述AHU-402 system is composed of AHU-402 unit, Exhaust fan with fine filter EU-402-01/E

10、U-402-02，constant variable air volume with damper ,H14 terminal high efficiency filter , as well as the corresponding pipeline system.as below drawing :AHU-402系统由空调机组AHU-402、中效过滤风机箱EU-402-01/EU-402-02，定风量阀、H14末端高效过滤器等以及相应的管路系统组成。如下图所示：5. Reference and Regulation 参考文件及规Following documents form the ba

11、sis of the Site Acceptance Testing:以下是现场验收测试的基础文件：No.编号Document/Regulation Name文件/规范名称Document/Regulation Number文件/规范编号Version版本1Technical Specification of Air Handling Units空调机组技术规格书CHTBIO-01-05-TS-001_空调机组技术规格书0012Technical Specification of FAN风机技术规格书CHTBIO-01-05-TS-002_风机技术规格书 0013Technical Speci

12、fication of HVAC Installation暖通空调安装技术说明CHTBIO-01-05-TS-003_暖通空调安装技术说明0014URS - Grade CC级洁净区用户需求说明18CT121-010-45-URS-640020015Code of acceptance for construction quality of ventilation and air conditioning works通风与空调工程施工及验收规范GB 50243-201620166Code for construction of ventilation and air conditioning

13、通风与空调工程施工规范GB 50738-201120117Code for construction and acceptance of cleanroom洁净室施工及验收规范GB 50591-201020108Code for construction and quality acceptance of industrial cleanroom洁净厂房施工及质量验收规范GB 51110-201520159Cleanrooms and associated controlled environments-Part 1: Classification of air cleanliness by

14、particle concentration洁净及相关受控环境 第一部分：空气洁净度分级ISO 14644-1201510Cleanrooms and associated controlled environments-Part 3: Test methods洁净室及相关受控环境 第三部分：测试方法ISO 14644-320196. Responsibilities 职责To identify the specific responsibilities of each side of author, executor and approver.应明确该方案起草方、执行方、批准方, 各方的具体

15、职责。Contractor 承包商：Draft Commissioning Protocols / Reports.编写调试方案和报告。Development of SAT Protocols / Reports in accordance with the SAT shedule. 根据验证的进度准备现场验收测试方案、报告。Provide appropriately resources for the completion of the testing assigned. 提供合适的资源完成约定的测试内容。Plan and qualify the equipment / systems in

16、 accordance with approved SAT Protocols.根据批准的SAT方案计划确认设备、系统。Deviation correction execution. 执行偏差的纠正。Management company管理公司Review commissioning protocol and report.审核调试方案和报告。Review commissioning test result. 审核调试测试结果。Review deviation generated during commissioning test.审核调试测试过程中产生的偏差。Project& user 项目

17、和用户Review and approve SAT Protocol and Report 审核及批准 SAT方案及SAT报告GDP/GTP training GDP/GTP 培训Deviation Handling Management training 偏差管理培训SAT execution witness and management 见证及管理现场验收测试Approve deviation record 批准偏差记录Approve deviation report .批准偏差报告7. SAT Execution 系统调试执行7.1. Prerequisites 先决条件Purpose

18、目的All prerequisites necessary to the SAT execution have been satisfied. 满足系统调试执行的所有先决条件。Procedure 方法The SAT protocol has been approved. SAT方案已完成并审批。The mechanical and electrical installation has been successfully completed. 机电安装已完成。The BMS system commissioning completed.BMS 系统调试完毕。Confirm the deviat

19、ions in prior has been closed.确认前期的偏差项已关闭。 Acceptance Criteria 接受标准Confirm all the prerequisites must be completed before the beginning of the execution of SAT. 在系统调试开始前所有的先决条件必须满足。Result 结果Fill in Form 7.1. Where requirements results “Not Applicable” fill the cell with “N/A” and explain the relevan

20、t reason within the “Note” section. 填写表7.1. 结果若为“不适用”则填写“N/A”, 并在“注释”一栏中阐述原因。Form 7.1 表7. 1Prerequisites 先决条件Prerequisites 先决条件Result 结果Yes /No 是/否The SAT protocol has been approved. SAT方案已完成并审批。The mechanical and electrical installation has been successfully completed. 机电安装已完成。The BMS system commis

21、sioning completed.BMS 系统调试完毕。Confirm the deviations in prior prophase has been closed.确认前期的偏差项已关闭。Acceptance Criteria 接受标准Yes / No 是/否Confirm all the prerequisites must be completed before the beginning of the execution of SAT. 在系统调试开始前所有的先决条件必须满足。Note 注释：Executed by 执行Date 日期Reviewed by 审核Date 日期7.

22、2. Personnel Identification 人员确认Purpose 目的Identify all people involved in the protocol execution. 识别参与该方案执行的所有人员。Procedure 方法List and identify all personnel involved in the execution of the present protocol (Name, Signature and Responsibility)列出并识别所有参与该方案执行的所有人（包括姓名，签字，职责）。All personnel involved in

23、the execution of the present protocol should be appropriately trained (GDP/GTP, Validation Deviation Management and SAT Protocol training) in order to execute the protocol.参与该方案执行的所有人应接受过恰当的培训（GDP/GTP，验证偏差管理及SAT方案的培训）以便于该方案的执行。Acceptance Criteria 接受标准All the operators are recorded by Name, Signature

24、 and Responsibility. 所有的操作者都已记录姓名、签字及职责。All the operators have been trained (GDP/GTP, Validation Deviation Management and SAT Protocol training). 所有的操作者都已受过培训（GDP/GTP，验证偏差管理及SAT方案的培训）。Result 结果Fill in Form 7.2. Where requirements results “Not Applicable” fill the cell with “N/A” and explain the rele

25、vant reason within the “Note” section. 填写表7.2. 结果若为“不适用”则填写“N/A”, 并在“注释”一栏中阐述原因。Form 7.2 表7. 2Personnel Identification 人员确认Name姓名Responsibility职责Trained 培训?Yes /No是/否Signature签名Date日期Acceptance Criteria 接受标准Yes / No 是/否All the operators are identified by Name, Signature and Responsibility. 所有的操作者都已记

26、录姓名、签字及职责。All the operators have been trained (GDP/GTP, Validation Deviation Management and SAT Protocol training). 所有的操作者都已受过培训（GDP/GTP，验证偏差管理及SAT方案的培训）。Note 注释：Executed by 执行Date 日期Reviewed by 审核Date 日期7.3. Documents Verification 文件确认Purpose 目的To provide documented evidence that documents and draw

27、ings required in SAT, are available. 提供记录证明系统调试中使用的文件及图纸是有效的。Procedure 方法Record the document and drawing title, version and number. 记录文件及图纸的名称、版本、文件/图纸编号。Verify the availability of documents and drawings. 确认文件及图纸的有效性。Verify the availability of inspection, testing, record and certification related re

28、ference. 确认检查、测试、记录及证书相关的文件的有效性。Acceptance Criteria 接受标准All required documents and drawings must be available. 所有要求的文件及图纸必须有效。Result 结果Fill in Form 7.3. Where requirements results “Not Applicable” fill the cell with “N/A” and explain the relevant reason within the “Note” section. 填写表7.3 . 结果若为“不适用”则

29、填写“N/A”, 并在“注释”一栏中阐述原因Form 7.3表 7.3Documents Verification 文件确认Document/Drawing Title文件/图纸名称Doc/drawing No.文件/图纸编号Version版本Available?是否有效Yes /No 是/否Document/Drawing Title文件/图纸名称Doc/drawing No.文件/图纸编号Version版本Available?是否有效Yes /No 是/否Acceptance Criteria 接受标准Yes / No 是/否All reference documents and draw

30、ings are available. 所有相关文件及图纸是有效的。Note 注释：Executed by 执行Date 日期Reviewed by 审核Date 日期7.4. Test Equipment Calibration Verification 测试仪器确认Purpose 目的To verify that test equipment are in calibration at the time testing take place and validated. 确认测试仪器在使用期间已校验且在有效期内。To verify that the accuracy of the test

31、 equipment meet the specifications.确认测试仪表精度满足规范要求精度Procedure 方法Verify that the equipment have been calibrated. 确认仪器已校验。Verify the availability of the calibration certificates. 确认校验证书有效。To verify that the accuracy of the test equipment meet the specifications.确认测试仪表精度满足规范要求精度Type A：Name: anemograph A

32、:名称：风速仪Type B:Name: digital pressure gauge B:名称：数字压力计 Type C: Name: air hood air rate testerC:名称：电子式风量罩Type D: Name: temperature &humidity gaugeD:名称：温湿度表Type E: Name: multimeterE:名称：声级计Type F: Particle CounterF:名称：粒子计数器Type G: luxmeterG:名称：照度计Photometer光度计Smoke generator烟雾发生器Acceptance Criteria 接受标准

33、All the equipment have been calibrated. 所有仪器已校验。All calibration certificates are available. 所有校验证书有效。All test equipment meet the requirements of specifications.所有测试仪表精度满足规范要求。Result 结果Fill in Form 7.4. Where requirements results “Not Applicable” fill the cell with “N/A” and explain the relevant reas

34、on within the “Note” section. 填写表7.4. 结果若为“不适用”则填写“N/A”, 并在“注释”一栏中阐述原因。Form 7.4 表7. 4Test Equipment Calibration Verification 测试仪器校验确认Equipment Name仪器名称Manufacturer生产商Series No.型号Calibration校验Acceptable? 可接受吗？Yes / No是/否Cal. Date校验日期Due Date有效期Acceptance Criteria 接受标准Yes / No 是/否All the equipments ha

35、ve been calibrated, are within their calibration period. 所有仪器已校验，且在校验有效期内。All calibration certificates are available. 所有校验证书有效。All test equipment meets the requirements of specifications.所有测试仪表精度满足规范要求Note 注释：Executed by 执行Date 日期Reviewed by 审核Date 日期7.5. PID Walkdown Check流程图检查Purpose 目的To verify t

36、hat the installation within the system is in accordance with the approved P&ID.确认该系统的安装与批准的P&ID流程图一致。Procedure 方法Take a copy of the approved P&ID and component list.复印批准的P&ID图纸及部件清单。Compare the drawing against the installation. Mark the drawing to clearly indicate areas or items that are correct wit

37、h blue pen and that are incorrect with red pen.将图纸与实际安装进行比对。在图纸上清晰标注，用蓝笔标记正确的部分，用红笔标记错误的部分。The followings will be checked:检查内容包括以下：The installation sequence of all the components is compliance with the approved P&ID.检查部件安装顺序与批准的P&ID一致。All components and equipment are installed and labelled correctly

38、 according to approved P&ID and component list.检查P&ID 图纸及部件清单中所有的部件，设备均已安装并正确标识。Acceptance Criteria 接受标准The installation sequence of components and equipment are compliance with the approved drawings and component list. 部件及设备的现场安装顺序与批准的图纸一致。All components and equipment are installed and labelled cor

39、rectly according to approved P&ID and component list.P&ID 图纸中及部件清单中所有的部件及设备均已安装并正确标识。Result 结果Fill in Form7.5. Where requirements results “Not Applicable” fill the cell with “N/A” and explain the relevant reason within the “Note” section. 填写表7.5. 结果若为“不适用”则填写“N/A”, 并在“注释”一栏中阐述原因。Form 7.5 表7.5PID dra

40、wing check流程图检查Page 页 _of _No 测试序号Test item测试内容Pass/Fail通过/失败1The installation sequence of all the components and equipment are compliance with the approved P&ID.检查部件及设备的安装顺序与批准的P&ID一致。2All components and equipment are installed and labelled correctly according to approved P&ID and component list.P&

41、ID 图纸中及部件清单中所有的部件及设备均已安装并正确标识。3Marked all components and equipment inspected by color.所检查过的所有项目均应在PID图纸上用带颜色的笔标注。Acceptance Criteria 接受标准Yes / No是/否The installation sequence of components and equipment are compliance with the approved drawings and component list. 部件及设备的现场安装顺序与批准的图纸一致。All components

42、and equipment are installed and labelled correctly according to approved P&ID and component list.P&ID 图纸中及部件清单中所有的部件及设备均已安装并正确标识。Note 注释： Executed by 执行Date 日期Reviewed by 审核Date 日期7.6. HEPA Filter installation Inspection高效过滤器安装检查 Purpose 目的Verify the installation status of HEPA filters compliance wi

43、th URS requirement. 确认高效过滤器的安装符合URS要求。Procedure 方法All HEPA filters shall be delivered incl. filter certificate with signature and date for each filter.所有高效过滤器须包含每个过滤器的证书签名以及日期Each HEPA filter shall have unique identification and location.每一个高效过滤器均应有统一的标识和位置Aluminium alloy frame, sealed with liquid.采

44、用铝合金边框，液槽式密封It is flush mounted and is flush with the top plate after installation. It is sealed with sealant.采用嵌入式安装，安装后与顶板平齐，四周用密封胶密封。The filter installed from below, it is tightly sealed and there is no loose leakage.过滤器下安装，牢固密封、无松动泄漏。Acceptance Criteria 接受标准All HEPA filters shall be delivered in

45、cl. filter certificate with signature and date for each filter.所有高效过滤器须包含每个过滤器的证书签名以及日期Each HEPA filter shall have unique identification and location.每一个高效过滤器均应有统一的标识和位置Aluminium alloy frame, sealed with liquid.采用铝合金边框，液槽式密封It is flush mounted and is flush with the top plate after installation. It is sealed with sealant.采用嵌入式安装，安装后与顶板平齐，四周用密封胶密封。The filter ins