洁净空调日维护保养记录-诺华制药

空气净化机组日常维护记录本
净化机组日常维护记录本
空气净化系统的维护要求
1、空气处理机组、新风机组应定期检查，保持清洁。

2.新风机组粗滤网每两天清洗一次；粗效过滤器应在1月至2月更换一次；中效过滤
器每周检查一次，每三个月更换一次；亚高效过滤器应每年更换一次。

如有污染和堵塞，
应及时更换。

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.定期检查回风口滤网，每周清洗一次，每年更换一次。

如有特殊污染，应及时更换，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。

日期
名称新风机组粗效过滤网新风机组中效过滤网新风机组亚高效过滤网新风机组末端高
效过滤网回风口过滤网排风机组中效过滤器空气处理机组签名清洁检查维修更换执行者科
室备注。

标准操作规程目的：建立三十万级空气净化系统的标准操作维护保养规程，使其操作有据可依。

适用范围：适用于三十万级空气净化系统操作岗位。

责任人：工程部、三十万级空气净化系统操作人。

一、标准操作程序：1.三十万级空气净化系统岗位操作人必须经过岗位培训考核合格后才能上岗操作。

2.准备工作：检查新风阀，确保打开。

新风、回风混合比例一般为30％：70％。

根据所需运行工况，检查相应的设备（包括：组合式空调器、加湿器、风冷热泵机组、臭氧发生器、除尘器、排风机等）的机械等部分完好情况，并将相应阀门等调整到相应状态，确保连接正常，加湿器、风冷热泵水源供给正常。

打开空调控制箱，开启总电源，根据所需运行工况，开启相应设备（包括：组合式空调器、回风机、加湿器、冷冻水泵、变风量机组、吊顶空调、臭氧发生器、除尘器、排风机、通风器、轴流风机等）电源开关。

风冷热泵机组电源从低压配电室直接供给，平时一般保持通电状态。

3.开机运行：空调系统应在使用前三十分钟提前开机运行，以使净化区通过自净达到相应净化级别。

空调系统开机顺序为：空调送风机→回风机→（根据生产要求）排风箱、除尘机组（避免系统形成负压）。

并正确悬挂设备状态标志牌（正在运行）。

在空调控制箱面板上按（空调送风机）启动按钮，再按墙上组合式空调器送风机变频器控制面板上（RUN）键，送风机从0Hz上升至设定频率（一般设定频率≤50Hz），正常运行。

按（回风机）启动按钮，启动回风机。

观察初、中效压差表显示情况。

制冷时，首先选择冷冻水泵1或2，并将相应冷冻水阀打开，在空调控制箱面板上按（冷冻水泵1）或（冷冻水泵2）启动按钮，启动冷冻水系统，并观察压力表情况。

冷冻水系统运行正常后，再按组合式空调器加湿段处风冷热泵远程微电脑控制面板上（F2）（此时为制冷模式1）启动风冷热泵，开始制冷。

观察冷冻水送、回水温度。

观察送、回风及净化区温度变化（正常温度范围：18℃～26℃），及时调整制冷系统。

制热时，首先选择冷冻水泵1或2，并将相应冷冻水阀打开，在空调控制箱面板上按（冷冻水泵1）或（冷冻水泵2）启动按钮，启动冷冻水系统，并观察压力表情况。

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)。

空调卫生维护记录单(示例)日期：______________
维护人员：______________
空调维护情况
1. 清洁过滤器
- 检查过滤器是否干净，如有需要，请清洁或更换过滤器。

- 清洁过滤器的方法：______________
2. 清洁冷凝器和蒸发器
- 检查冷凝器和蒸发器是否有积尘或污垢，如有需要，请进行清洁。

- 清洁冷凝器和蒸发器的方法：______________
3. 清洁排水口
- 检查排水口是否通畅，如有需要，请进行清洁。

- 清洁排水口的方法：______________
4. 检查制冷剂压力
- 使用压力计检查制冷剂的压力，确保制冷剂处于正常范围内。

- 正常制冷剂压力范围：______________
5. 检查电气连接
- 检查空调的电气连接是否松动或损坏，如有需要，请进行修复。

- 修复电气连接的方法：______________
维护记录
备注
- 在备注中记录维护过程中的任何特殊情况或需要注意的事项。

注意：以上维护项目仅为示例，实际维护应根据具体空调型号
和使用情况进行调整。

请确保维护人员具备相关专业知识和技能，
并遵守相关安全操作规程。

空调日常维护保养记录概述本文档旨在记录空调设备的日常维护保养情况，以确保空调设备的正常运行，提高其使用寿命和性能。

日期- 维护日期：[日期]- 下次维护日期：[日期]维护人员- 维护人员：[姓名]- 联系方式：[联系方式]维护内容清洁过滤器- 检查过滤器的状况，如有污垢或损坏，及时更换或清洁。

- 使用清洁剂和软刷清洁过滤器。

注意避免使用过热水或化学溶剂进行清洗。

- 清洁后将过滤器晾干或用干净的布擦干。

清洁内外机- 使用湿布或软刷清洁内外机的表面。

注意避免使用过热水或化学溶剂进行清洗。

- 清洁时应断电，并注意避免水渗入电器部分。

检查制冷剂- 检查制冷剂的压力和液位，确保在正常范围内。

- 如发现制冷剂泄漏或液位异常，需及时联系维修人员进行处理。

检查排水系统- 检查排水管道是否畅通，如有堵塞应清洁或疏通管道。

- 检查排水桶或盘的放置情况，确保能够有效收集冷凝水。

检查电气连接- 检查电气线路连接是否松脱或腐蚀，如有问题应及时修复或更换。

检查控制器- 检查空调控制器的功能是否正常，如有异常应及时修复或更换。

其他维护事项- 记录空调运行时的异常情况，并及时联系维修人员进行排查和处理。

- 如有其他维护保养需要，应根据实际情况进行记录和处理。

维护结果- 维护情况：[维护情况描述]- 是否存在问题：[是/否]- 如有问题，请描述问题的具体情况：下次维护计划- 下次维护计划：[日期或具体时间段]- 预期维护内容：[维护内容描述]以上是本次空调日常维护保养记录，谢谢！。