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。

一般情况下，洁净等级高的区域的空调机组先开启，洁净等级低的区域的空调机组后开启，避免脏的空气从十万级区流入万级区；To avoid negative pressure of clean room, to ensure the correct air flow direction, to avoid cross-contamination, the sequence must be considered when the HVAC system start-up. In most case, the AHU which services for high level classify clean zone should be start-up firstly; the AHU which services for sub level classify clean zone follows. To avoid the dirty air entrance into the ISO class 7 zone from ISO class 8 zone.各个区域的空调机组开机顺序如下表：The sequence of the AHUs Start-up功能区域Function Section 开机顺序Start-up SequencePCM1 AHU03→AHU02→AHU01PCM2 AHU 05 →AHU04→AHU06BWM2(H1,H2) AHU 07 →AHU 08BWM2(H3,H4) AHU 11→AHU 124.2. 空调系统的停机顺序Sequence of HVAC Systems Shut-down基于同样的原因，空调机组的停机顺序也是必须考虑的。