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1#机组编号：J12/050000-2005-021#空调净化系统与洁净室综合性能验证报告起草日期：2005年12月15日生效日期：2005年12月18日沈阳***************有限公司发布编号：J12/050000-2005-02目录1．验证报告审核单2．验证过程简介3．HVAC系统验证实施资料1——HVAC系统与洁净室综合性能验证所需文件4．HVAC系统验证实施资料2——HVAC系统与洁净室综合性能验证用仪器仪表校正确认5．HVAC系统验证实施资料3——HVAC系统与洁净室自身仪器仪表校正确认6．HVAC系统验证实施资料4——风管的安装确认7．HVAC系统验证实施资料5——空调机组主要设备确认8．HVAC系统验证实施资料6——空调机组设备结构及配置检查9．HVAC系统验证实施资料7——空调机组安装检查10．HVAC系统验证实施资料8——空调机组公用工程介质供应检查11．HVAC系统验证实施资料9——过滤器安装确认12．HVAC系统验证实施资料10——洁净区总体检查13．HVAC系统验证实施资料11——洁净区内建筑单元检查14．HVAC系统验证实施资料12——空调设备调试15．HVAC系统验证实施资料13——高效过滤器的风速测定16．HVAC系统验证实施资料14——风压测试17．HVAC系统验证实施资料15——温湿度测试18．HVAC系统验证实施资料16——自净时间测试19．HVAC系统验证实施资料17——洁净室参数测定20．验证结果的综合与评价21．验证合格单编号：J12/050000-2005-02编号：J12/050000-2005-02 1．验证过程简介该验证严格按照经批准的空调净化系统与洁净室综合性能验证方案进行验证。
由验证小组组长负责实施，主要对其进行安装确认、运行确认及性能确认，以评估和确认该系统确实符合设计要求及GMP要求。
验证条件适合，数据准确，评价科学、合理，能够准确反应该系统的实际情况。
GMP and Functional Risk Assessment for Compressed AirGMP and Functional Risk Assessment for Compressed Air Page 1 of 15DOCUMENT HISTORYThis risk assessment serves as GMP and Functional Risk Assessment for Systems, as well as traceability matrix between requirement,potential risk, and measure to control risk (e.g. specific test specification, additional requirement to mitigate risk, SOP).Risk Assessment ProcedureStep 0 – Approval Cover Page and Document History▪The section “Risk Assessment Work Session Attendance” will be used to record work session number, list of attendees, and the work session date.▪After completion of the Risk Assessment (before executing the specific measures) the Risk Assessment will be initially approved (section “Assessment”).▪In case that the approved Risk Assessment will be revised, the initial approval of the Risk Assessment is obsolete and the revised Risk Assessment requires a new approval. The Revision Number must be adapted accordingly.▪If - all defined measures and tests are completed and- in all rows the cell “Measures completed” is assessed “Yes”then the Risk Assessment is finally approved in the section “Final Assessment Approval”.Step 1 – Description of the current process / work flowGMP and Functional Risk Assessment for Compressed Air Page 2 of 15Fill out columns “Source Document”, “Function” and “Reverse Function”▪Source Documents typically encompass the System URS, block diagram, and/or functional description, but related documents must also be considered. For example, if the 21 CFR Part 11 assessment demonstrates that the system must comply with Part 11, a row must be added in thecorresponding GMP/FRA to ensure traceability to this GMP critical requirement. Other System level “umbrella” documents, egg AutomationURS and/or Electrical URS that contain Critical GMP requirements that apply to many systems, must either have their own GMP/FRAassessments, or the GMP critical requirements traced in each System level GMP/FRA.Step 2 –Risk Assessment [column “Risk Assessment”]Probability Ratingo Low (L): Due to the design failures may not occur. The design is well known and often used.o High (H): The design is new and not well known. There is a high probability that failures occur.Impact Rating▪Which impact has the described failure, independently of the probability rating?o Low (L): No impact to the product quality.o High (H): Impact to productProbability of Detection▪Which probability of failure detection is given? Is it possible to detect the failure immediately or latest during Quality Control/batch release?o High (H): The failure will be detected immediately.o Low (L): The failure can not be detected immediately. The failure may not be detected during Quality Control tests.GMP criticality▪Assess the risk in regard to product quality and patient safety. Note: GMP criticality is not the same as GMP-relevance. GMP relevance will not be changed by application of specific measures and control. GMP criticality is reduced by proper design and control of the process. Forexample, sterilization process failures (e.g. temperature not reached during sterilization) have high GMP criticality, but proper design of thesterilizer and control of the process with sensors reduces GMP criticality. However, although GMP criticality has been reduced, the GMPrelevance of a compliant sterilization cycle remains unchanged.o High (H): There is an impact on product quality and/or patient safety and/or the impact is not under control / not acceptable.o Low (L): There is insignificant impact on product quality and/or patient safety and/or the impact is under control / acceptable.▪Record the unique URS ID number in the Reference Document column for all GMP crit ical requirements (marked “H”).▪For each GMP critical requirement, insert the specific URS requirement in the Function column.GMP and Functional Risk Assessment for Compressed Air Page 3 of 15Step 3 – Definition of specific measures to mitigate risks (columns Measures, Action)The main measures are, but not limited to:▪Definition of additional design requirements (e.g. in URS, FS) to mitigate risk▪Definition and execution of additional, specific IQ, OQ and PQ tests▪Generation of specific Standard Operating Procedures (SOPs)▪Specific operational procedures▪Additional sensors for process monitoring and control▪Calibration of quality relevant/critical sensors▪Cleaning validation▪Safety measures and arrangementsDefine and document the responsible person and the due date for the specific measure.Step 4 – Risk Assessme nt [column “Risk Assessment considering defined measures”]Assessment in view of the successful execution of all defined measures to mitigate risks.Apply the same rating as in Step2:Probability RatingThe probability of occurrence if all defined measures are implementedImpact RatingThe impact of an event usually remains the same independently of the defined measures.Probability of DetectionThe probability of detection of an event if all defined measures are implementedGMP-criticalityThe GMP-criticality must be low, otherwise additional measures must be defined.Step 5 – Execution of specific measuresGMP and Functional Risk Assessment for Compressed Air Page 4 of 15The execution and documentation of specific measures are traced and controlled via test specifications, list of critical sensors, preventive maintenanceplans, and/or open item lists.Document titles and revision should be documented in column “Test Documentation / Traceability / Reference” under the corres ponding point (DQ, IQ,…). In case of to many documents or title of document to long it is possible to include a reference (e.g. a reference to a Test Specification overview)in the column.The execution completion should be documented with initials and date in the column “Action / Responsible Due Date”.Step 6 – Measures completedAfter documented execution of all specific measures and tests to mitigate risks, the completion and closure is checked and confirmed in the last cellof each row.Step 7 – Risk Assessment CompletionAfter all measures of the entire analyses are completed (step 6 for all rows) the Risk Assessment will be finally approved on the cover page (section“Final Assessment Completion”).GMP and Functional Risk Assessment for Compressed Air Page 5 of 15GMP and Functional Risk Assessment for Compressed Air Page 6 of 15GMP and Functional Risk Assessment for Compressed Air Page 7 of 15GMP and Functional Risk Assessment for Compressed Air Page 8 of 15GMP and Functional Risk Assessment for Compressed Air Page 9 of 15GMP and Functional Risk Assessment for Compressed Air Page 10 of 15GMP and Functional Risk Assessment for Compressed Air Page 11 of 15GMP and Functional Risk Assessment for Compressed Air Page 12 of 15GMP and Functional Risk Assessment for Compressed Air Page 13 of 15GMP and Functional Risk Assessment for Compressed Air Page 14 of 15GMP and Functional Risk Assessment for Compressed Air Page 15 of 15。
Qualification Plan for AHU19 SystemDistribution list:AuthorLuwa Qualification Coordinator (Original)Reason for Change1. Short Description of Project / Facility / System1.1 Project DescriptionThis Qualification Plan defines the qualification activities, procedures, andresponsibilities for the secondary packing HVAC System AHU19, as part of theoverall qualification effort for the “Extension of Production Facility ChangPing” ofBeijing Luwa Pharma. Ltd., ChangPing Plant.For general information, see the following documents in its current version:Project URS Doc. No. EPCP_01_00_HLD_ URSHVAC URS Doc. No. EPCP_11_08_HVAC_URSQualification Master Plan (QMP) Doc. No. EPCP_01_00_HLD_QMPQualification Need Assessment (QNA) Doc. No. EPCP_01_00_HLD_QNA 1.2 Functional DescriptionThe secondary packing area is classified as a Luwa Zone 3 area, which comprise the following rooms:A-407 Packaging AreaA-409 Packaging Waste Air LockAHU19 is supplied with preconditioned air from PCU1. Further air treatments within the AHU19 are in the following way:∙Cooling coil (AHU)∙Heating coil (AHU)∙Fan (AHU)∙Silencer (AHU)∙Filter F9 (AHU)For the return air from AHU19 will be treated in the following way:∙Filter G4 (filter in the room)∙Fan (AHU)Then back to AHU19 and PCU1 as recirculation air.For detail information, refer to AHU19 PID (Doc. No. EPCP_11_08_AHU19_PID) and Function Specification (Doc. No. EPCP_11_08_AHU19_FS) in its currentsversion.1.3 Main Emphasis on Quality Critical Issues1.3.1 GMP Risk AssessmentIn the URS for HVAC System (Doc. No. EPCP_11_08_HVAC_URS), eachrequirement is assessed for GMP Relevance.A “GMP and Functional Risk Assessment for AHU systems” (Doc. No.EPCP_11_08_HVAC_RA) defines the critical qualification activities, which is thebasis for this qualification plan.For general information, see the overall Project “GMP Risk Assessment” (Doc. No.EPCP_11_00_HLD_GMPRA).1.3.2 Critical Measurement InstrumentsA list of instruments will be prepared for DQ and approved before IQ execution. Allcritical sensors which shall be calibrated periodically will be defined in the calibration list according to the sensor risk assessment.2 Steps Covered in this Qualification PlanDesign Qualification (DQ) Yes: No: N/A:Installations Qualification (IQ) Yes: No: N/A:Operational Qualification (OQ) Yes: No: N/A:Performance Qualification (PQ) Yes: No: N/A:3 Documentation3.1 Qualification Documents ListThe “Qualification Document List” (Doc. No. EPCP_11_08_AHU19_DL) outlines the documents to be prepared, assigned to the different Qualification Phases.The list will be updated in each qualification phase and finally completed and attached to the qualification report.3.2 Administration of DocumentsThe Qualification Coordinator from MAM is responsible for the entire documentation until handover to the Luwa.Documents are filed according to “Project Documentation Management System” (Doc.No. EPCP_01_00_HLD_DMS in its current version).4 Basics4.1 Basic SOP’sGPE_SOP_508_0484: Concept for Commissioning and Qualification (SOP-0019069) EPCP_PSOP_001: Commissioning for Facility and EquipmentGPE_SOP_511_0042: Specification, Execution and Deviation Resolution of Tests4.2 Project Specific Agreements4.2.1 Additional SOP’s from Luwa GPEGPE_SOP_511_0030: Handling of Changes in Engineering Projects4.2.2 TrainingTwo types of training activities will be conducted - training for qualification execution and training for operation and maintenance.Qualification execution training is mandatory for all persons taking part in thequalification work. The training will be conducted by MAM, and each test personshall complete the training before any test activities such as DQ, IQ, OQ and PQ canstart.Operation and maintenance training will be conducted by relevant supplier. The Luwa operators and maintenance technicians shall complete the training before PQ testactivities. Luwa PersoMAMl Training Record (FRM_000037) and Training Record(FRM_000039) shall be used to document the training.4.2.3 Specific indication for the qualification AHU19In order to ensure the generally project schedule, it was necessary to create severalGEP related documents earlier than this qualification plan. (e.g. duct leakage test,hydraulic test)5 Qualification Activities (Action Plan)5.1 Project Time ScheduleSee Project Time Schedule in its current version.5.2 Qualification Rules and Sequence of Activities5.2.1 General Qualification ProcessThe qualification process will be based on the URS, Risk Assessment andQualification Plan, DQ/IQ/OQ/PQ test specifications. The test results will besummarized in the Qualification Report.5.2.2 DQDQ documents that the design of HVAC system fulfills the URS and GMP RiskAssessment.The Design is qualified when all design documents are marked with a signed DQstamp or approved with approval signatures.DQ confirms the details of the technical design.Scope of DQ:All relevant design documents, are defined in the Qualification Documents List, shall be qualified and filed in the Test Binder.The DQ is completed when the DQ Release Form is signed by all relevant approvers.When DQ is completed the formal Project Change Control Procedure will be in effect,see “Project Documentation Management System” (Doc. No.EPCP_01_00_HLD_DMS).5.2.3 Installation Qualification (IQ)IQ contains a series of tests which documents that the system has been appropriatelyinstalled on Site.IQ pre-requisites:∙The DQ release form have to be signed by all relevant approvers∙All documents on the Qualification Documents List must be available and filed in the Test Binder∙All IQ Test Specifications have to be approved by Luwa before test activities can begin∙All test instruments shall be calibrated and have calibration certificates IQ tests are listed in the IQ Test Specification.All deviations found during IQ execution will be handled according to the deviationmanagement concept described in section 5.2.6.The IQ is complete when the IQ Release Form is signed by all relevant approvers.5.2.4 Operation Qualification (OQ)OQ contains a series of tests which documents that the system’s function performs asdescribed in the Functional Specification.OQ pre-requisites:∙The IQ release form has to be signed by all relevant approvers.∙All documents on the Qualification Documents List must be available and filed in the Test Binder∙All OQ Test Specifications have to be approved by Luwa before test activities can begin∙All test instruments shall be calibrated and have calibration certificates∙The system is commissioned and the release form signed by relevant approvers.The OQ will be executed in two phases: HVAC equipment and HVAC automationsystem.OQ tests are listed in the OQ Test Specification.All deviations found during OQ execution will be handled according to the deviationmanagement concept described in section 5.2.6.The OQ is complete when the OQ Release Form is signed by all relevant approvers.5.2.5 Performance Qualification (PQ)PQ contains a series of tests which documents that the HVAC system and thecoMAM cted rooms’ performance are in compliance with the Zoning Diagram and theURS.PQ pre-requisites:∙The OQ release form have to be signed by all relevant approvers∙All documents on the Qualification Document List must be available and filed in the Test Binder∙All PQ Test Specifications have to be approved by Luwa before test activities can begin∙All test instruments shall be calibrated and have calibration certificates∙The HVAC system and the coMAMcted rooms must be cleaned and checked according to approved cleaning SOPs.The PQ will be executed in two phases: PQ at rest and PQ in operation.5.2.5.1 PQ at restPQ at rest comprises the tests in the PQ Test Specification.All deviatio ns found during PQ “at rest” execution will be handled according to thedeviation handling SOP-000002.The PQ at rest is complete when the PQ at rest Release Form is signed by all relevant approvers.5.2.5.2 PQ in operationPQ in operation comprises the tests in the PQ Test Specification.PQ in operation shall be executed under normal operation conditions.All deviations found during PQ “in operation” execution will be handled accordingto the deviation handling SOP-000002.The PQ in operation is complete when the PQ in operation Release Form is signedby all relevant approvers.5.2.6 Qualification Deficiency / Deviation5.2.6.1 Deficiency / Deviation ListDeficiency / Deviation List is used in DQ/IQ/OQ phase.The Deficiency / Deviation List will be used to track open items which arise duringthe course of each phase.For Deviation in PQ “at rest and in operation” see 5.2.5.1 and 5.2.5.25.2.6.2 Deviation FormDeviation form is used in the IQ/OQ phase.A consecutive numbers starting at AHU19_xQ_DEV001.The proposal for corrective action must be proposed by test engineer and approvedby BNP discipline engineer.The implementation and re-inspection of corrective action must be finally approvedby the BNP discipline engineer.5.2.7 Release FormThe “Release Form” (Basic Doc. No.: EPCP_511_0067) for IQ/OQ/PQ/Productionshall be used to release each qualification phase. Without an approved release from the prior phase the next qualification phase can not begin.A copy of the test “Deficiency list” shall be attached to the “Release Form” forrespective qualification phase.5.2.8 Qualification ReportWhen the PQ “at rest” is completed, the Qualification Report (QR) will be prepared,and it will summarize all qualification activities and results from DQ, IQ, OQ and PQ “at rest“.The Qualification Report verifies that all qualification activities described in theQualification Plan, except PQ “in operation“, have been successfully performed andfulfills the accept criteria. Further more, that all observed deviations have beenhandled and closed successfully.A fter the PQ “in operation“, a Final Report will be prepared, which summarizes allactivities and results from the PQ in operation phase.The approved QR and Final Report combined confirm that the qualification iscompleted and the system is fully qualified.6 Organization / Responsibility6.1 Qualification OrganizationPeople from Luwa, MAM, Sauter and Xinxing will participate in the qualification of the AHU19 system.6.2 ResponsibilityThe responsibility of the MAM Quality Engineer:∙Prepare the QP and collect corresponding documents according to the agreed responsibility matrix Doc. No. EPCP_08_00_HVAC_RM in its current version The responsibility of the MAM Project Engineer:∙Secure correct systems description and that all technical issues are correct and meet the technical requirements∙Ensure that scope and contents are adequateThe responsibility of the MAM QA:∙Secure compliance with the EPCP_HLD and cGMP∙Secure correct referencesThe BNP responsibility:∙See QMP Responsibilities Matrix Qualification Master Plan (QMP) in its current versionDoc. No. EPCP_01_00_HLD_QMPIn general, all the responsibilities of Luwa, MAM, Sauter, Xinxing are defined in theHVAC Responsibility Matrix Doc. No. EPCP_08_00_HVAC_RM in its current version.7 AbbreviationAHU Air Handling UnitBNP Beijing Luwa PharmaDMS Document Management SystemEPCP Extension Project ChangPingFRM FormGPE Luwa Global Pharma EngineeringGMP Good Manufacturing PracticeHLD High Level DocumentHVAC Heating, Ventilation and Air ConditioningIQ Installation QualificationMAM MAM (Tianjin) Co., Ltd.OQ Operation QualificationPQ Performance QualificationQA Quality AssuranceQP Qualification PlanQMP Qualification Master PlanQNA Qualification Need AssessmentQR Qualification ReportTS Test SpecificationSOP Standard Operating ProcedureURS User Requirement Specification8 AMAMxAMAMx 1 Qualification Document List (Doc No. EPCP_11_08_AHU19_DL)。
洁净厂房空调系统调试方案（中英文）目录Content一．调试说明及依据标准 (2)1). Commissioning Description and Reference Standard 二．调试概况 (3)2). Brief Introduction of Commissioning三．施工准备 (4)3). Preparation before Construction四．调试操作工艺 (6)4). Technique of Commissioning Operation五．调试质量标准 (9)5). Quality Standard for Commissioning六．成品保护 (12)6). Protection of Finished Product七、应注意的质量问题 (12)7). Quality Problems to Be Aware八、质量记录 (13)8). Quality Record九、安全标准 (13)9). Safety Standards附录 (14)Appendix一、调试说明及依据标准1). Commissioning Description and Reference Standard1、调试说明1. Commissioning Description1.1、本调试方案仅适用于改造工程空调调试工作。
1.1. This commissioning proposal is only applicable toGSKNP Flu. Facility Revamping Project for commissioning of HVAC system.1.2、本调试方案根据本项目的通风空调系统结构、施工进度和现场条件而制定。
1.2. This commissioning proposal is designed base on these, HVAC systematic structure, constructional schedule and site conditions.1.3、本调试方案依据文件：合同文件、施工图纸、业主现场要求、国家施工及验收规范等。
洁净室空调净化系统验证文件管理规定1、目的：制定本公司空调净化系统验证标准与评价方法，保证本公司生产与质量控制各环节空调净化系统验证的进行及实施的有效性。
2、概述2.1新厂空调系统概述：新厂空调净化系统分为洁净空调系统和非洁净空调净化系统两部分，洁净空调系统为生产区提供C 级、B 级(局部A 级)和D 级的洁净空气，非洁净空调系统为辅助区域（参观走廊、库房等）提供合适的空气供应。
由于洁净空调净化系统控制药品生产环境，因此本次验证中只涉及洁净空调系统部分。
z 空调系统由包含送风、回风、排风的中央空气处理单元（中央风机）及包含加热盘管、终端HEPA 的分配系统组成。
风机单元是双层绝热壁板结构，属于再循环类型。
风机单元提供经过HEPA 过滤空气给洁净生产区。
z 对于A 级区域（100级）满布HEPA ，空气通过HEPA （EU 标准H14）（99.99%）直接送入区域。
z 对于B 级区域（100级）房间，空气以50次以上的换气次数，并且空气通过网络状、安装在天花板上的HEPA（EU 标准H14）（99.99%）直接送入房间。
z 对于C 级区域（10,000级）房间，空气以25次以上的换气次数，并且空气通过网络状、安装在天花板上的HEPA EU 标准H14（99.99%）直接送入房间。
z 对于D 级（100,000级）区域房间，空气以15次的换气次数，并且空气通过网络状、安装在天花板上的HEPA（EU 标准H14）直接送入房间。
z 厂房按照EU GMP 设计，并以防止交叉污染及环境保护为关注点，不同洁净级别的相邻房间压差维持在（12.5Pa ），房间安装压差计。
为了适合人员更衣，厂房安装气闸和更衣室。
风管内安装的加热盘管为控制房间提供精确的温度。
2.2 净化空调系统设计数据 2.2.1室外气象资料z 夏季：空调干球温度 31.4℃，空调湿球温度 25.4℃，通风温度28℃，室外风速2.9m/s 。
System Commissioning_Protocol/Report系统调试文件/报告AHU-402 systemAHU-402系统*The above signature indicates that 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 (3)2. SAT scope 范围 (3)3. Abbreviations 术语和缩略语 (3)4. System Deription 系统描述 (4)5. Reference and Regulation 参考文件及规 (4)6. Responsibilities 职责 (6)7. SAT Execution 系统调试执行 (7)7.1. Prerequisites 先决条件 (7)7.2. Personnel Identification 人员确认 (9)7.3. Documents Verification 文件确认 (11)7.4. Test Equipment Calibration Verification 测试仪器确认 (13)7.5. PID Walkdown Check流程图检查 (16)7.6. HEPA Filter installation Inspection高效过滤器安装检查 (18)7.7. Room Air Volume and Air Change Rate Testing房间送风量及换次数检测 (20)7.8. Terminal HEPA Filter Integrity Testing末端高效过滤器完整性检查 (25)7.9. Room Pressure Difference Testing 房间静压差检测 (31)7.10. Room Temperature and Humidity Testing房间温湿度测试 (36)7.11. Cleanroom Airborne Particle Count Test (at rest) 洁净室微粒计数浓度的检测(静态) (39)7.12. Illumination Level Testing照度测量 (48)7.13. Noise test噪音测量 (52)7.14. Recovery Time Testing自净时间测试 (55)8. Deviations 偏差 (60)8.1. List of Deviations 偏差列表 (60)9. Site Acceptance Testing Summary 现场验收测试总结 (61)10. List of Attachment 附件列表 (62)11. Change Log 变更记录 (63)12. Appendix附录 (64)1.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. To ensure the HVAC system assembling and commissioningcompare 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。
Draft 起草人signature签名Date日期（dd/mm/yyyy）Review审核人signature签名Date日期（dd/mm/yyyy）Review审核人signature签名Date日期（dd/mm/yyyy）Review审核人signature签名Date日期（dd/mm/yyyy）Approve批准人signature签名Date日期（dd/mm/yyyy）Index目录1. Purpose 目的 (4)2. Scope 范围 (4)3. Responsibilities 职责 (4)4. Regulation and Guidance 法规和指南 (4)5. System/Equipment Description 系统/设备描述 (4)6. Classroom Parameters Design Requirement房间参数设计要求 (4)7. Combined Type air Conditioning Unit Design Requirement组合式空调机组设计要求 (5)Framework And Operation Mode组合式空调机组结构与运行模式 (5)Fresh Air Design Requirement新风段设计要求 (5)Primary Filter Design Requirement初效段设计要求 (6)Secondary Filter Design Requirement中效段设计要求 (6)Table Cooler Design Requirement表冷段设计要求 (6)Draught Fan Design Requirement风机段设计要求 (6)Heat Design Requirement加热段设计要求 (7)Heat Design Requirement加湿段设计要求 (7)Heat Design Requirement亚高效段设计要求 (7)8. Ventilate System Design Requirement风系统的要求 (7)Line风管 (7)Wind Valve风阀 (8)Insulation保温 (8)Supply Apparatus 送风 (9)Cleanroom Return Air房间回风 (10)Exhaust System排风 (10)System Air Balance Requirement系统风量与风量平衡的要求 (10)CleanRoom Air Balance Requirement房间风量与风量平衡的要求 (10)FFU RequirementFFU的要求 (11)9. System Disinfection Requirement系统消毒的要求 (11)10. Cold and heat source冷热源的配置要求 (12)11. Fireproof Material Requirement风阀、墙、吊顶等材料防火要求 (12)12. Control System Requirement控制系统的要求 (13)13. Make And Installation Requirement制造与安装的要求 (13)14. File and Certificate文件和证书要求 (13)Framework And drawing结构及装配图纸 (13)Flow Chart流程图 (14)Equipment List设备清单 (14)Electrical System电气系统 (14)Meter List仪表清单 (14)The Hardware Of Control System控制系统硬件 (15)The Software Of Control System控制系统软件 (15)Filter过滤器（初效、中效、高效） (16)Air Conditioning Unit空气处理机组 (16)Utilities公用系统 (17)Install And Maintenance Manual安装、日常维护手册 (17)Manual操作手册 (17)15. Site Supervision Requirement现场监督管理的要求 (18)Site Supervision Requirement现场的监督和管理 (18)Quality Control Planning质量控制计划 (18)Quality And Quantity Check质量和数量检查 (19)Test And Validation Requirement测试与验证的要求 (19)16. Revision History修订历史 (20)1 Purpose 目的本URS的目的是描述祥XXXXXXXXXXX有限公司XXXXXXXXXXX疫苗分包装车间分装区的净化空调系统的技术要求，为空调系统的设计、施工、检测、验证等项目的实施提供依据。
