洁净空调季度维护保养记录-诺华制药
诺华制药洁净空调操作维护程序(双语版)
密级：保密Classification: Confidential管理体系文件Standard Operating Procedure编号( SOP NO.): QMS-U&E-SOP-005A洁净空调操作程序Clean HVAC Operation Procedure姓名Name 日期Date签名Signature编制Prepared by 年月日审核Reviewed by 年月日审核Reviewed by 年月日审核Reviewed by 年月日审核Reviewed by 年月日审核Reviewed by 年月日批准Approved by 年月日生效日期：Effective Date 年月日有效期至：Expiry Date：年月日发放编号(Issue No.):1. 目的Purpose规定空调机组启动和停止的顺序，保证气流方向正确，避免交叉污染；规定空调机组的操作，保证房间对外界的正压，避免污染物的进入。
To specify the general sequence of HVAC system starting up and shut down. To guarantee the airflow direction right, to avoid cross-contamination；To specify the general instruction on how to operate the HVAC system. To maintain positive pressure relative to the outside, to limit the ingress of contaminants.2. 范围Scope本SOP适用于下列的与生产相关的洁净空调机组。
这些空调机组位于怀柔区的奥星北京制造中心的PCM1，PCM2，RSM和BWM2。
This SOP is valid for all the following production related HVAC systems located in PCM1，PCM2，RSM and BWM2 in BJMC of Austar, HuaiRou.编号No.设备名称Function Name服务区域Servicing areas洁净等级Cleaning ZonePCM1-U-AHU011#空调机组1# Air Handling UnitPCM1操作间1，辅助房间Operation Room1, Auxiliary Room操作间1万级，辅助房间10万级Operation Room1 ISO Level 7,Auxiliary Room ISO Level 8PCM1-U-AHU022#空调机组2# Air Handling UnitPCM1操作间1，Operation Room11万级，ISO Level 7PCM1-U-AHU033#空调机组3# Air Handling UnitPCM1操作间2, Operation Room21万级，ISO Level 7PCM2-U-AHU044#空调机组4# Air Handling UnitPCM2操作间，物流通道Operation Room，Material Entrance操作间1万级，物流通道10万级Operation Room ISO Level 7，Material Entrance ISO Level 8PCM2-U-AHU055#空调机组5# Air Handling UnitPCM2操作间，Operation Room1万级，ISO Level 7PCM2-U-AHU066#空调机组6# Air Handling UnitPCM2男女一更，洗衣房等，First Change, Washing House10万级，ISO Level 8BW2-U-AHU077#空调机组7# Air Handling UnitBWM2收卷间，分切间，物流通道，辅助房间等，Rolling Room, Cutting Room, MaterialEntrance, Auxiliary RoomRolling Room, Cutting Room1万级，ISO Level 7;Material Entrance, Auxiliary Room10万级，ISO Level 8BW2-U-AHU088#空调机组8# Air Handling UnitBWM2挤出间Extraction Room1万级，ISO Level 7BW2_U_AHU09 9#空调机组软管车间1万级，ISO Level 7编号No.设备名称Function Name服务区域Servicing areas洁净等级Cleaning Zone 9# Air Handling Unit Soft tube workshopBW2_U_AHU1010#空调机组10# Air Handling Unit制袋车间Bag-Making Workshop1万级，ISO Level 7BW2_U_AHU1111#空调机组11# Air Handling UnitBWM2收卷间，分切间，物流通道，辅助房间等，Rolling Room, Cutting Room, MaterialEntrance, Auxiliary Room1万级，ISO Level 7;BW2_U_AHU1212#空调机组12# Air Handling UnitBWM2挤出间Extraction Room1万级，ISO Level 7 陈惠忠加上森星的3. 职责和权限Responsibility➢动力设备部经理负责本SOP的修订和培训；➢空调系统操作工必须培训合格；➢动力设备部运行操作必须按本SOP操作；➢动力设备部运行班长检查本SOP被正确执行，正确记录；➢动力设备部有计划的停机组必须提前3天与服务的部门主管协商一致；➢空调系统启动停止的指令只能由动力设备经理下达，其他任何人无权指示机组的操作；➢操作工在授权的范围内进行操作；➢系统参数的设定只能由动力设备经理和运行班长进行；➢机组异常停机时，操作工要马上汇报给服务部门主管和动力设备经理；➢动力设备部无权擅自改动空调系统配置，例如擅自取消加湿器等；➢如果需要改变空调系统的配置，按变更程序执行；➢Manager of Utility and Equipment Department revise and training this SOP;➢The HVAC system must be operated by trained and qualified operator.➢Operator must follow the instruction in this SOP;➢Utility foreman ensure that the work is correctly carried out. And all the activities are properly documented;➢Utility must notice the head of service function section before three days when the HVAC need planed shut-down, and get agreement.➢Only the manager of utility and equipment department can give the work order to shut-down or start-up HVAC. Nobody can give any instruction to HVAC operation;➢Operator only act in his permit;➢Only the manager of utility and equipment department or the foreman can set up the parameter.➢The manager of utility and equipment department and the head of service function section must be noticed immediately when the HVAC unexpected shut-down.➢Utility and equipment department has no power to change the HVAC system without permit, e.g. erase the humidifier.➢The change request procedure must be followed when change is necessary.4. 工作程序Procedure4.1. 空调系统的开机顺序Sequence of HVAC Systems Start-up为了避免因房间负压，保证空气流向的正确，避免交叉污染，空调机组的开机顺序必须被考虑。
GMP净化空调系统运行检查记录
GMP净化空调系统运行检查记录日期:[日期]检查人:[检查人员姓名]1.检查目的本次检查的目的是确保GMP净化空调系统能够正常运行并满足相关标准和要求。
通过检查，发现和解决系统可能存在的问题，以保证室内空气质量符合GMP要求。
2.检查内容2.1空调系统基本情况-检查空调系统的类型、规格和功能。
-检查室内和室外机组的清洁度和运行状态。
-检查空调系统是否存在漏水、冷风、异响等问题。
2.2空气净化器情况-检查空气净化器的类型和数量是否满足要求。
-检查空气净化器的清洁度和运行状态。
-检查空气净化器是否存在过滤芯堵塞、损坏或需要更换的情况。
2.3空气过滤器情况-检查空气过滤器的类型和等级是否符合要求。
-检查空气过滤器是否存在脱落、破损或堵塞的情况。
-检查空气过滤器是否需要更换或清洁。
2.4气压调节情况-检查气压调节装置的清洁度和运行状态。
-检查气压调节装置是否存在漏气、失效或需要维修的情况。
2.5温湿度控制情况-检查温湿度控制系统的准确性和稳定性。
-检查温湿度控制系统是否存在故障、误差或需要校准的情况。
3.检查结果及处理3.1空调系统基本情况-室内和室外机组的清洁度和运行状态良好。
-未发现漏水、冷风、异响等问题。
3.2空气净化器情况-空气净化器的类型和数量满足要求。
-空气净化器的清洁度和运行状态良好。
-无过滤芯堵塞、损坏或需要更换的情况。
3.3空气过滤器情况-空气过滤器的类型和等级符合要求。
-无脱落、破损或堵塞的情况。
-部分空气过滤器需要更换或清洁。
3.4气压调节情况-气压调节装置的清洁度和运行状态良好。
-无漏气、失效或需要维修的情况。
3.5温湿度控制情况-温湿度控制系统的准确性和稳定性良好。
-无故障、误差或需要校准的情况。
4.处理措施4.1清洗空气过滤器-对需要清洗的空气过滤器进行清洗，确保其工作正常。
4.2更换空气过滤器-对需要更换的空气过滤器进行更换，确保其过滤效果达到标准。
4.3维修气压调节装置-对存在漏气、失效或需要维修的气压调节装置进行维修或更换。
洁净空调维护保养操作规程-诺华制药
Replaces No.: SOP-000217 version 02Reason for Change:1. All EPCP AHUs added and are in service as shown to the table of chapter 31 Regulatory Basis and Reference DocumentsThe Group Quality Manual:QM N 6.1: Facility and Equipment - Qualification and CommissioningQM N 6.2: Cleanliness ZoningIGs N6.2.2: Cleanliness Zoning Policy for The Manufacture of Non-Sterile Drug Products and the Respective Drug SubstanceBNP SOPs:SOP-000052: Work Order Management ProcessSOP-000066: Filter Replacement for HVAC InstallationSOP-000074: Cleaning of HVAC installation semi solid dosage form AHU 2.2, 2.3SOP-000117: Safety GuidelinesSOP-000124: Safety Lock Off ProcedureSOP-000214: Cleaning of HVAC Installation for Room-airSOP-000309: HVAC System Operational ProcedureSOP-000328: General Operating Procedures in case of HVAC Shut DownSOP-000390: Cleanliness ZoningSOP-000407: Replacement, Cleaning and Maintenance Return Air Filter in ProductionNB. Upon approval of the RMS SOP these SOPs will be referenced to this SOP.2 PurposeThis SOP describes the procedures for the preventive maintenance on HVAC units.The preventive maintenance program has to be established in accordance with Novartis Quality Module 6.1.This maintenance program is implemented to ensure that the equipment remains in a qualified or commissioned state after handover to the User.3 ScopeThis SOP covers the preventive maintenance of all HVAC units. The following table gives an overview of the current status of HVAC units which are operational at the moment.No. Function Servicing areas Cleaning Zone1.1 Production areaDispensing A-308, Day storage Room A-310, Blending Room A-313,Intermediate Storage A-504, Granulation Room A-506, Compressing Rooms A-508.1, Compressing ante-room A-510, Capsule filling room A-508.2,Coating Room A-514, Coating drying room A-516, Corridors 300 and 500etc.Zone 22.1 Capsule filling Encapsulating A-511, Printing A-509 and locker 507 Zone 22.2 Emugel filling Cream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2, 505.3,501.1Zone 22.3EmugelprocessingCream/Ointments Processing A-503 and locker 501, Storage room 503.1 Zone 23.0 Packaging Secondary packaging A-405,Air locker 405.1 etc. Zone 24.0 N/A N/A Zone 35.0 Lockers Offices and Production Lockers Zone 26.0 QC QC Laboratories Zone 48.0 Alu-Alu packaging Alu-Alu Blister Packing A-302, Compressing Room A-304 Zone 29.0 Sampling Sampling Cabin A-907 with Personnel Lockers 905, 906 Zone 210.0 Material lockMaterial Entry A-910Material Air-Lock A-306Zone 4Zone 313.0 Washing Washing Area A-314.1, Equipment storage room A-314, PW Plant Room A-316Zone 220 New Warehouse Receiving/Dispatch Area A-804, High Rack Storage Area A-806 Zone 421New ConditionedStorage AreaNew Conditioned Storage Area 932 Zone 4PCU1 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 1 Air Inlet Fresh-air Inlet Chamber 1 N/A PCU2 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 2 Air Inlet Fresh-air Inlet Chamber 2 N/A ------ Canteen Canteen N/AAHU11 Dispensary A-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 Emergency Shower,A-334Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary material store,A-928 Pallettransfer.Zone 2AHU12 Clean corridor New HVAC system is used for production area step by step Zone 2AHU14 Granulation Suite A-602 Blending room,A-604Storage,Zone 2AHU15 Compression suite Covers Corridor A-612 Compression corridor,A-608 Compression room 1,A-610 Compression room A-616 , Compression room A-618Zone 2AHU16 Coating, Covers A-628 Coating, A-628.1 PersonalAirlock, A-630 Control room, A-632Printing, A-634 Bulk storage.Zone 2 Clean Stair1 A-238, Clean Stair 2 A-240 : operated zone 2Shoe Change A-238 : operated zone 2Clean Change A-232 : operated zone 4*Rooms A-230, A-234 : operated zone 4*Rooms A-222, A-226 : operated none zone**Rooms A-224, A-228, A-228.1 : operated none zoneNote:*: AHU17 is designed for Zone 2(A-232, A-234, A-230), the operation mode of the rooms are defined as listed above.**: AHU17 is designed for Zone 3(A-222, A-226), the operation mode of the rooms are defined as listed above.Clean Stair1 A-140 : operated zone 2Shoe Change A-136 : operated zone 2AHU17 Clean ChangeClean Change A-132 : operated zone 4*Zone 2No. Function Servicing areas Cleaning Zone1.1 Production areaDispensing A-308, Day storage Room A-310, Blending Room A-313,Intermediate Storage A-504, Granulation Room A-506, Compressing Rooms A-508.1, Compressing ante-room A-510, Capsule filling room A-508.2,Coating Room A-514, Coating drying room A-516, Corridors 300 and 500etc.Zone 22.1 Capsule filling Encapsulating A-511, Printing A-509 and locker 507 Zone 22.2 Emugel filling Cream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2, 505.3,501.1Zone 22.3EmugelprocessingCream/Ointments Processing A-503 and locker 501, Storage room 503.1 Zone 23.0 Packaging Secondary packaging A-405,Air locker 405.1 etc. Zone 24.0 N/A N/A Zone 35.0 Lockers Offices and Production Lockers Zone 26.0 QC QC Laboratories Zone 48.0 Alu-Alu packaging Alu-Alu Blister Packing A-302, Compressing Room A-304 Zone 29.0 Sampling Sampling Cabin A-907 with Personnel Lockers 905, 906 Zone 210.0 Material lockMaterial Entry A-910Material Air-Lock A-306Zone 4Zone 313.0 Washing Washing Area A-314.1, Equipment storage room A-314, PW Plant Room A-316Zone 220 New Warehouse Receiving/Dispatch Area A-804, High Rack Storage Area A-806 Zone 421New ConditionedStorage AreaNew Conditioned Storage Area 932 Zone 4PCU1 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 1 Air Inlet Fresh-air Inlet Chamber 1 N/A PCU2 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 2 Air Inlet Fresh-air Inlet Chamber 2 N/A ------ Canteen Canteen N/AAHU11 Dispensary A-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 Emergency Shower,A-334Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary material store,A-928 Pallettransfer.Zone 2AHU12 Clean corridor New HVAC system is used for production area step by step Zone 2AHU14 Granulation Suite A-602 Blending room,A-604Storage,Zone 2AHU15 Compression suite Covers Corridor A-612 Compression corridor,A-608 Compression room 1,A-610 Compression room A-616 , Compression room A-618Zone 2AHU16 Coating, Covers A-628 Coating, A-628.1 PersonalAirlock, A-630 Control room, A-632Printing, A-634 Bulk storage.Zone 2 Rooms A-130, A-134 : operated zone 4*Rooms A-122, A-126 : operated none zone**Rooms A-124, A-128, A-128.1 : operated none zoneNote:*: AHU17 is designed for Zone 2(A-132, A-134, A-130), the operation mode of the rooms are defined as listed above.**: AHU17 is designed for Zone 3(A-122, A-126), the operation mode of the rooms are defined as listed above.AHU18Primarypackaging areaPrimary packaging room A-710, A-720, A-730, A-740. Zone 2AHU19Secondarypackaging areaPackaging Area, A-407, Packaging Waste Air Lock, A-409. Zone 3AHU20WarehouseWarehouse Receiving Area, A-804 and the High Rack Storage Area, A-806.Zone 4AHU21Warehouse Conditioned Storage, A-932. Zone 4AHU22Process area New wash bay, Rooms A-624 Equipment drying room, A-620 Dirtyequipment room. Zone 2No. Function Servicing areas Cleaning Zone1.1 Production areaDispensing A-308, Day storage Room A-310, Blending Room A-313, Intermediate Storage A-504, Granulation Room A-506, Compressing Rooms A-508.1, Compressing ante-room A-510, Capsule filling room A-508.2,Coating Room A-514, Coating drying room A-516, Corridors 300 and 500etc.Zone 22.1 Capsule filling Encapsulating A-511, Printing A-509 and locker 507 Zone 22.2 Emugel fillingCream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2, 505.3,501.1Zone 22.3EmugelprocessingCream/Ointments Processing A-503 and locker 501, Storage room 503.1 Zone 23.0 Packaging Secondary packaging A-405,Air locker 405.1 etc. Zone 24.0 N/A N/A Zone 35.0 Lockers Offices and Production Lockers Zone 26.0 QC QC Laboratories Zone 48.0 Alu-Alu packaging Alu-Alu Blister Packing A-302, Compressing Room A-304 Zone 29.0 Sampling Sampling Cabin A-907 with Personnel Lockers 905, 906 Zone 210.0 Material lockMaterial Entry A-910Material Air-Lock A-306Zone 4Zone 3 13.0 WashingWashing Area A-314.1, Equipment storage room A-314, PW Plant Room A-316Zone 220 New Warehouse Receiving/Dispatch Area A-804, High Rack Storage Area A-806 Zone 421New ConditionedStorage AreaNew Conditioned Storage Area 932 Zone 4 PCU1 Inlet to AHU Central fresh-air pre-conditioning unit N/AAIC 1 Air Inlet Fresh-air Inlet Chamber 1 N/APCU2 Inlet to AHU Central fresh-air pre-conditioning unit N/AAIC 2 Air Inlet Fresh-air Inlet Chamber 2 N/A------ Canteen Canteen N/AAHU11 DispensaryA-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 Emergency Shower,A-334Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary material store,A-928 Pallettransfer.Zone 2 AHU12 Clean corridor New HVAC system is used for production area step by step Zone 2 AHU14 Granulation SuiteA-602 Blending room,A-604Storage,Zone 2 AHU15 Compression suiteCovers Corridor A-612 Compression corridor,A-608 Compression room 1,A-610 Compression room A-616 , Compression room A-618Zone 2 AHU16 Coating,Covers A-628 Coating, A-628.1 PersonalAirlock, A-630 Control room, A-632Printing, A-634 Bulk storage.Zone 2AHU24Process areaGranulation, Covers A-638 Material Airlock, A-640 Personal Airlock, A-636 Granulation room, A-642 Emergency Shower. Zone 2 AHU 25 Sampling Rooms A 820, A 821, A 822, A823, A 8244 Procedures4.1 GeneralAll maintenance activities in Production, Packaging and warehouse areas can only be performed after fulfillment of the cleanliness Zone conditions required. If it is necessary to shut down the HVAC during the preventive maintenance, the steps described in the SOP-000328 must be followed strictly.Preventive Maintenance on HVAC units will be performed on all HVAC units which are in operation and usage. For each HVAC unit, a unique maintenance manual (activity list) must be available, to ensure that specific preventive maintenance activities (e.g. measurements) are carried out appropriately. The PM works (Tasks) are stated in FRM-000363 / FRM-000386 / FRM-000387 / FRM-000388 / FRM-000392 (Related FRM to this SOP) and manufacturer recommendations.4.2 Start preventive maintenanceThe PM (Head of Utilities) Engineering Department informs the Head ofProduction and/or Production Supervisors, if possible 3 working days in advance (only AHU need to be shut down), about the preventive maintenance activities currently managed on a excel base task tracking. The schedule and work orders of HVAC AHUs maintenance is followed by SAP-PM system (SOP-000052: Work Order Management Process).In case of full or partial shut-down of HVAC system, please refer to SOP-000328in its current revision.Production notifies PM (Head of Utilities) in writing (e.g. e-mail) about "ProductionReadiness" for HVAC preventive maintenance.PM engineering starts PM works as soon as the written release for PM works fromproduction is received based on the specific maintenance manual for each unit. 4.3 Execution of preventive maintenancePM Engineering personnel or external vendor’s personnel execute the preventive maintenance based on the specific maintenance manual (activity lists) for each unit or a specific SOP and following the work order (SOP-000052: Work Order Management Process).The maintenance personnel (internal or external) must be well trained, skilled andexperienced in terms of execution of preventive maintenance and cGMP.If the maintenance personnel observe abnormalities on HVAC units, theresponsible HVAC Engineer has to be informed in order to define suitable remedies or repair work. The abnormalities have to be documented in the logbook FRM-000289 and assessed in view of GMP impact by the HVAC Engineer.PM Engineering HVAC Engineer is responsible for evaluating the preventive maintenance results. If a part of equipment is requiring repair or servicing, an assessment will be made as to whether the needed repair is minor or major. The assessment needs to be documented in the logbook FRM-000289 and corresponding maintenance work orders will be initiated to purchase the required spare parts. The assessment also includes a statement whether GMP compliant HVAC operations can be continued before having carried out the repair. In case the assessment result reveals that a continued operation might impact a GMP compliant operation of the HVAC unit, the Production Head and QA Head have to be informed in writing (e.g. e-mail).Minor repairs (e.g. belts, dumper, actuator, sensors) will be performed during the preventive maintenance. Major repairs (e.g. fans, coils) will be planned separately depending on the availability of the spare parts.4.4 Completion of preventive maintenanceAll preventive maintenance activities (e.g. measurements, etc.), after finishing,have to be recorded in the specific HVAC logbook FRM-000289 for each HVAC unit.PM Engineering notifies Production in writing (e.g. e-mail) about "Finishingpreventive maintenance” for HVAC units.After completion of all activities, including deficiencies, a scheduling for the next execution of preventive maintenance is to be defined in accordance to the periodicity recommended on FRM-000363 / FRM-000386 / FRM-000387 / FRM-000388 / FRM-000392, separately for each HVAC unit. Re: SOP-000052: Work Order Management Process (SAP-PM)The preventive maintenance activities and records have to be documentedproperly (i.e. log-books). The Preventive Maintenance activities must be periodically reviewed by the engineering management.5 ResponsibilitiesPreventive Maintenance is performed by PM Engineering or by external vendors based on written procedures within the valid BNP SOPs and supervised by BNP personnel.The evaluation of the results has to be done by the Head of Utility and engineering management based on agreed written procedures as indicated in previous chapters.The production Head has to provide a maintenance slot for the HVAC unit for execution of preventive maintenance after request by the Site Engineering.6 Additional Instructions6.1 Safety instructionsDuring the maintenance of any air system, the supply air and exhaust air fans must be switched off and applied as regulated by the SOP-000117 and SOP-000124. Steam heated units also require the steam supply to be shut off and the Safety Lock off Procedure applied during any cleaning procedure.7 Definitions & AbbreviationsBNP Beijing Novartis PlantHVAC Heating Ventilation Air ConditioningPM Preventive MaintenanceQA Quality Assurance8 Annexes/Related FormsFRM-000363: Preventive Maintenance Record for HVAC System (Three Months)FRM-000386: Preventive Maintenance Record for HVAC System (Six Months)FRM-000387: Preventive Maintenance Record for HVAC System (Annually)FRM-000388: Preventive Maintenance Record for HVAC System (When AHU shut down)FRM-000392: Working Activities Preventive Maintenance for HVAC System (Daily)。
洁净空调日维护保养记录-诺华制药
FRM-000392 Version : 01Effective from : 23.06.2008SOP reference : SOP-000217Working Activities Preventive Maintenance for HVAC System (Daily)空调系统的日预防性维护保养项目Approvals 批准: Name 姓名: Date 日期: Signature 签名:Author 作者:Approvers 批准人:Final Approver 最终批准人:Applicability : document applies for Beijing Novartis Pharma Ltd. 适用性：文件适用于北京诺华制药有限公司All Plant QC QA HR/Admin. Production Processing Packaging Semi SolidEngineering SCMBPAother :Replaces No. 替代: N/A Reason for Change 更改原因: New formReference SOP 参考SOP: SOP-000217SOP reference : SOP-000217 Page:1/1空调系统的日预防性维护保养项目 ItemContent 内容Acceptance Criteria接受标准Performed by执行人000 Normally check 常规检查010 Daily record of temperature, relative humidity, pressure drop of filters and fans, room pressure difference; 日记录温度,相对湿度,压差Reference: FRM-000222, FRM-000346 完成表格: FRM-000222, FRM-000346Morning and Evening Shift 大夜, 小夜011 Check if leakage from hot water and chilled water; 检查热水,冷冻水是否漏水No leakage 无泄漏 Day Shift 白班 012Check temperature of hot water and chilled water; 检查热水,冷冻水的温度The temperature of supply hot water is 60℃.The temperature of supply chilled water is 7℃. 热水温度为60℃,冷冻水温度为7℃Day Shift 白班 013 Check if abnormal noise from equipment; 检查所有设备是否有杂音There is no abnormal noise from equipment,check the supply air fan, return air fan. pump.检查送风机,回风机,水泵，没有异常声音. Morning and Evening Shift大夜, 小夜各一次014 Check status of each equipment; 检查所有设备运行状态Running 运行正常 Morning and Evening Shift 大夜, 小夜各一次 020 Check the four chillers on the roof 检查屋顶的4台制冷机021 Check the compressor, hear the noise. 检查压缩机,听声音 There is no abnormal noise from compressor 无奇怪声音 Day Shift 白班 022 Check the Fan 检查风扇Running 全部运行Day Shift 白班 023 Check the Condenser 检查冷凝器Clean, otherwise Clean them using dust collector on Thursday干净,否则安排星期四小夜清洁，使用吸尘器。
洁净空调维护及保养记录【范本模板】
净化空调维护及保养记录月份
日
期
初效过滤器
中效过滤器
高效过滤器
双签名
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广元市第一人民医院
净化空调维护及保养记录月份
日
期
初效过滤器
末端高效过滤器
每年检查(测阻力）一次、当阻力超过设计初阻力160kpa或已使用3年更换
回风口过滤网
清洁：每周一次、更换：每年一次、如遇特殊污染随时更换
中效过滤器
高效过滤器
双签名
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注明：“√”表示清洁/检查、“△”表示更换
维护
保养
要求
新风/循环机组
初效过滤器：每月清洁1次、每3—6月(或阻力超过额定初阻力60Pa）更换一次、中效过滤器每月清洁1次每6—12月（或额定初阻力80Pa）换一次。
空调设备维修保养记录
空调设备维修保养记录空调设备是现代生活中必不可少的电器设备之一、为了保证空调设备的正常运行和延长其使用寿命，定期进行维修和保养是非常重要的。
下面将以一份空调设备维修保养记录为例，详细介绍对空调设备进行维修和保养的内容和步骤。
第一部分：设备基本信息1.设备名称：空调设备2. 设备型号：xxxx3. 设备编号：xxxx4. 安装位置：xx楼xx室第二部分：维修保养内容1.清洁空气过滤器：空调设备的过滤器会随着时间的推移而积累灰尘和污垢，影响空气的质量和空调设备的工作效率。
定期（一般为每三个月）清洁过滤器，可确保空气的畅通，避免污染和细菌滋生。
维修保养步骤：（1）关闭空调设备电源。
（2）拆下过滤网，用水冲洗，并用中性洗涤剂清洗过滤网。
（3）晾干过滤网后，用轻柔的方式重新安装好。
2.清洁冷凝器和蒸发器：冷凝器和蒸发器是空调设备中发挥重要作用的零部件。
定期清洁冷凝器和蒸发器的表面，可以提高热交换效率，降低能耗，并保证空调设备的正常运行。
维修保养步骤：（1）关闭空调设备电源。
（2）用刷子或吹尘器清除冷凝器和蒸发器上的灰尘和污垢。
（3）用清水冲洗冷凝器和蒸发器，并用干布擦干。
3.检查冷媒回路系统：冷媒回路系统是空调设备的核心组成部分。
定期检查冷媒回路系统的工作状态和漏气情况，并及时进行修复和加注冷媒，可以确保空调设备的正常运行。
维修保养步骤：（1）关闭空调设备电源。
（2）使用专业的检漏仪和压力表对冷媒回路系统进行检测。
（3）如果发现漏气，及时进行维修，更换漏气点附近的密封件。
（4）根据设备规格和要求，进行冷媒的加注和更换。
4.检查电气连接：空调设备的电气连接要牢固可靠，确保电气系统的正常工作。
定期检查电气连接的接线端子和插座，松动或生锈情况，并及时进行修复。
维修保养步骤：（1）关闭空调设备电源。
（2）使用螺丝刀和扳手检查接线端子的紧固情况。
（3）检查插座的连接情况，清除插头和插座的灰尘和污物。
维修保养日期：20xx年xx月xx日维修保养人员：xxx维修保养结果：经过本次维修保养，空调设备运行正常，各项指标符合要求。
精密空调CRAC维护保养记录
16 检查加湿器运行电流
≤额定电流
季度
17 清洗室内机（冷凝器）翅片
干净、无明显结垢
半年
保养日期
保养负责人
Form:
Page 1 of 2
Effective date:
This document contains trade secrets and proprietary information of ARAMARK, Inc. Disclosure of this publication is absolutely prohibited without the express written permission of ARAMARK, Inc.
符合产品设计标准， 进出风温 月度
差 8- 12 ℃之间 ;温度、湿度控
制精度符合产品设计要求
11 检查加湿器工作情况
加湿正常
月度
12 清洁精密空调设备表面灰尘、污垢
机组表面清洁
月度
13 检查来电自启动功能
来电能够自启动
月度
14 检查风机的运行电流
≤额定电流
季度
15 检查电加热器运行电流
≤额定电流
季度
项目名称：
设备编号：
精密空调机组保养记录表
序
保养内容
保养标准
保养周
号
期
1 检查风机转动情况，轴承的运行状态， 风机运行无异常噪声、 无异常 月度
对风扇电机轴承定期加油
振动
2 检查风扇电机支座、 叶片及对皮带松紧 皮带松紧适度， 风机底座牢固 月度
度进行调校或更换
3 检查、 清理进水、 排水阀门及下水管道 无 跑、冒、滴、漏现象
月度
4 检查隔热层有无异常状况
空调设备日常检查维修保养记录
空调设备日常检查维修保养记录
日期: [填写日期]
设备: [填写设备名称]
检查人员: [填写检查人员姓名]
---
1. 记录设备基本信息
- 品牌: [填写品牌名称]
- 型号: [填写型号]
- 安装日期: [填写安装日期]
- 维修记录: [填写最近一次维修日期和内容]
2. 检查设备工作状态
- 空调制冷效果是否正常?
- [ ] 是
- [ ] 否（请详细描述问题）
- 空调加热效果是否正常?
- [ ] 是
- [ ] 否（请详细描述问题）
- 空调送风是否均匀?
- [ ] 是
- [ ] 否（请详细描述问题）
- 空调控制面板是否正常运作? - [ ] 是
- [ ] 否（请详细描述问题）
3. 清洁设备过滤器
- 进行过滤器清洁:
- [ ] 是
- [ ] 否（请在备注中解释原因）4. 检查冷凝水排放
- 冷凝水排放是否通畅?
- [ ] 是
- [ ] 否（请详细描述问题）
5. 其他维护记录
- 请记录任何其他维护或维修工作，并提供详细的描述和日期。
---
备注: [填写任何额外的备注或说明]
---
请妥善记录以上维护和检查的结果，以确保设备的正常运行和
延长设备的寿命。
空调净化系统检查维护保养、清洗记录
填表人/日期： 生效日期：2016年05月18日
KANGGU
项目
嘉兴康谷医用材料有限公司
空气净化系统检查维护保养、清洗记录
检查结果
保养清洗内容
HWR-001-00
日期
送风管道
初效过滤
中效过滤
高效过滤
送风、回风口
风机
空调冷凝液、 润滑油
备注：初效过滤器每月清洁一次，中效过滤器每三个月清洁一次，先从过滤器上小心拆下
过滤布，放入桶中用饮用水清洗两次，每次30分钟；在布上放洗衣粉，用毛刷刷去污垢，用饮用水 清洗3次，每次15分钟；用纯化水清洗过滤布2次，每次15分钟，自然晾干。高效过滤器一般情况下 每年更换一次，每月检漏一次，以保证达到洁净度要求。
洁净空调维护及保养记录
净化空调维护及保养记录月份
日
期
初效过滤器
中效过滤器
高效过滤器
双签名
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Hale Waihona Puke 1﹟2﹟3﹟4﹟
5﹟
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广元市第一人民医院
净化空调维护及保养记录月份
日
期
初效过滤器
中效过滤器
高效过滤器
双签名
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注明：“√”表示清洁/检查、“△”表示更换
维护
保养
要求
新风/循环机组
初效过滤器：每月清洁1次、每3-6月（或阻力超过额定初阻力60Pa）更换一次、中效过滤器每月清洁1次每6-12月（或额定初阻力80Pa）更换一次。
末端高效过滤器
每年检查（测阻力）一次、当阻力超过设计初阻力160kpa或已使用3年更换
空气净化机组日常维护记录本
净化机组日常维护记录本
空气净化系统维护与保养要求
1、空气处理机组、新风机组应定期检查，保持清洁。
2、新风机组粗效滤网宜每2d清洁一次；粗效过滤器宜1月～2月更换一次；中效过滤器宜每周检查，3个月更换一次；亚高效过滤器宜每年更换。
发现污染和堵塞及时更换。
3、末端高效过滤器宜每年检查一次，当阻力超过设计初阻力160Pa或已经使用3年以上时宜更换。
4、排风机组中的中效过滤器宜每年更换，发现污染和堵塞及时更换。
5、定期检查回风口过滤网，宜每周清洁一次，每年更换一次。
如遇特殊污染，及时更换，并用消毒剂擦拭回风口内表面。
6、设专门维护管理人员，遵循设备的使用说明进行保养与维护；并制定运行手册，有检查和记录。
诺华制药压缩空气系统维护保养记录
FRM-000305 Version : 02Effective from : 29.10.2008SOP reference: SOP-000347Preventive Maintenance Record for Compressed Air System压缩空气系统维护保养记录Approvals 批准人:Applicability : document applies for Beijing Novartis Pharma Ltd.All Plant QC QA HR/Admin. ProductionProcessingPackagingSemi SolidEngineering SCM BPAother :Replaces No: FRM-000305 Version 01 Reason for Change:Detailed …How to do it ‟ was added. 6 items was added. Translate to Chinese. Reference SOP : SOP-000347Preventive Maintenance Record for Compressed Air System压缩空气系统维护保养记录NB. for daily routine maintenance refer to FRM-000306: Monitoring Logbook for Compressed Air System被注：日维修记录在FRM-000306。
1 Quarterly季度维护保养Quarterly PM Checklist WO No.:Responsible Technician: Scheduled Date:SOP reference: SOP-000347 Page: 1/4压缩空气系统维护保养日志SOP reference: SOP-000347 Page: 2/4压缩空气系统维护保养日志Describe repair and maintenance if applicable during Preventive Maintenance briefly: 如果在预防性维护保养其间有其它维修工作被执行，详细记录如下：Reviewed by Clean Utility:Comments:SOP reference: SOP-000347 Page: 3/4压缩空气系统维护保养日志2 Annually年度维护保养Annually PM Checklist WO. No.:Responsible Technician: Scheduled Date Window:Describe repair and maintenance if applicable during Preventive Maintenance briefly如果在预防性维护保养其间有其它维修工作被执行，详细记录如下：SOP reference: SOP-000347 Page: 4/4压缩空气系统维护保养日志Reviewed by Clean Utility:Comments:SOP reference: SOP-000347 Page: 5/4。
空调卫生保养记录表(模板)
空调卫生保养记录表(模板)
项目信息
- 空调名称：[空调名称]
- 空调型号：[空调型号]
- 安装位置：[安装位置]
- 负责人：[负责人]
- 保养日期：[保养日期]
保养内容
- 清洁过滤网：使用吸尘器或清水清洗过滤网，确保无积尘和
污垢。
- 清洁风道：使用专用清洁剂清洁空调风道，确保无异味和污垢。
- 检查电气线路：检查空调电线连接是否牢固，无松动或损坏。
- 检查制冷系统：检查空调制冷系统的压力和冷媒量，确保正
常运行。
- 除霉处理：使用除霉剂喷洒空调内部，清除霉菌和异味。
- 检查排水系统：检查空调排水管道是否通畅，无堵塞或漏水。
- 检查遥控器：检查空调遥控器是否正常工作，按键是否灵敏。
保养结果
- 清洁过滤网：[清洁情况]
- 清洁风道：[清洁情况]
- 电气线路：[正常/需要修复]
- 制冷系统：[正常/需要修复]
- 除霉处理：[除霉情况]
- 排水系统：[通畅/需要清理]
- 遥控器：[正常/需要更换]
保养建议
- 建议定期清洁过滤网和风道，以保持空调的正常运行。
- 若发现电气线路或制冷系统存在问题，建议尽快联系维修人员进行修复。
- 需要注意除霉处理和排水系统的清理，以防止霉菌滋生和漏水问题。
- 若遥控器功能有异常，建议更换新的遥控器。
备注
[其他备注信息]
---
以上为空调卫生保养记录表的模板，根据实际情况填写具体内容，并保存记录以供参考和跟踪维护空调的状况。
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Operate the all manual valves that can be
opened or closed by slightly moving their
Valve handles move smoothly.
212 handles left or right
M3 可轻松转动
用手操作手动阀门
Check the insulation 检查保冷层
Check the flexible rubber connection 检查挠性接头
Re-Heater (air/hot water) 再加热器 Check the hot water pump 检查热水泵
SOP reference : SOP-000217
Preventive Maintenance Record for HVAC System (Three Months) 空调系统的预防性维护记录(3 月周期)
FRM-000363 Version : 03 Effective from : 14.07.2008
M3
No crack, No deterioration 无裂纹,无变形
221 Cooler (air/cold water) 冷却器
SOP reference : SOP-000217
Page: 1/3
Preventive Maintenance Record for HVAC System (Three Months) 空调系统的预防性维护记录(3 月周期)
213
Check the insulation of the hot water piping 检查热水管道的保温
M3
No damage, No deterioration 无损坏,无变形,无开裂
Check the soft rubber connection of the hot
214 water piping 检查热水管道的挠性接头
Check the tube of the pressure switch 检查压力开关的接管.
Interval 周期
M3 M3
Acceptance Criteria 接受标准
There is no crack in the belts, the belts do not sway and jump. There is no strange noise. 皮带没有裂纹,皮带不摇摆,不跳动,没有杂 音. The tube connection tight, no leakage. 接管紧固,没有泄漏.
Quarterly 3M (Inspection when AHU in operation)
Item 项目 222
222
223 224 230 231
232
233 234
Content 内容
Check water outlet and trap function 检查排水功能
Operate the entire valve that can be opened or closed by slightly moving their handles left or right 用手操作手动阀门
FRM-000363 Version : 03 Effective from : 14.07.2008
HVAC System No.: Operator’s Name:
PID and Tag No.: Personnel No.:
Date: Started on:
Work Order No.: Finished at:
HVAC System No.: Operator’s Name:
PID and Tag No.: Personnel No.:
Quarterly 3M (Inspection when AHU in operation)
Date: Started on:
Work Order No.: Finished at:
Resu名/日期
Remark 备注
200 Heat exchanger 加热器
210 Heater (air/hot water) 加热器
Check the hot water pump 211 检查热水泵
Running smoothly, no strange noise.*1 M3 运行,无杂音
Item 项目 100 110
111
112
Content 内容
Air processing facility Fan
Visual check the belts through the glass window, Hearing the noise of belt and fan. 通过玻璃窗户目视检查皮带,听皮带和风机的声音
FRM-000363 Version : 03 Effective from : 14.07.2008
Preventive Maintenance Record for HVAC System (Three Months) 空调系统的预防性维护记录(3 月周期)
Approvals 批准:
Name 姓名: Author 作者:
QC
QA
HR/Admin.
Production
Processing
Packaging
Semi Solid
Engineering
SCM
BPA
other :
Replaces No. 替代: FRM-000363 version 02
Reason for Change 更改原因: Adjusting the Intervals Adaptations to fit SAP-PM scheduling, setting Acceptance Criteria. Reference SOP 参考 SOP: SOP-000217
Date 日期:
Signature 签名:
Approvers 批准人:
Final Approver 最终批准人:
Applicability : document applies for Beijing Novartis Pharma Ltd. 适用性：文件适用于北京诺华制药有限公司
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