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诺华制药压缩空气系统的运行操作及预防性维护保养

SOP-000347 Version : 04

Effective from : 29.10.2008

Operation and Preventive Maintenance of Compressed Air System

压缩空气系统的运行操作及预防性维护保养

Approvals 批准:

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/Adm in. Production Processing Packaging Sem i Solid

Engineering

SCM BPA

other :

压缩空气系统的运行操作及预防性维护保养

Replaces No: SOP-000347 version 03

Reason for Change:升级原因

The operation and monitoring procedure of Atlas air compressor was added in section 4.1:, update the title of SOPs.

在章节4.1增加了Atlas空压机组的操作和监视程序,更新了题目。

The procedure of the air filter replacement was update in item 4.9.

在章节4.9中升级了空气过滤器的更换程序。

The new Atlas Copco air compressor was in service.

新的Atlas空压机组投入使用。

The HAUG air compressors as well as the chilled dryer retired.

两台HAUG空压机组同时退役,不再使用。

Annex 1 was deleted.

附件1被删除。

1 Regulatory Basis and Reference Documents

QM Corporate Quality System全球质量系统手册:

N 6.1: Facility and Equipment - Commissioning and Qualification

Others 其他

>Atlas Copco< Operating manual, Air compressor

2 Purpose目的

This SOP describes the procedures and responsibilities for the operation, monitoring and preventive maintenance (PM) of Compressed Air System in ChangPing Plant, Beijing Novartis Pharma Ltd.

本SOP描述了位于北京诺华制药有限公司昌平工厂的压缩空气系统的操作、监视和预防性维护保养的程序,以及相关各方的职责。

3 Scope范围

The scope of this SOP is limited to the physical boundaries of the Compressed Air System of BNP and is defined as follows:

本SOP的范围限定在北京诺华制药有限公司昌平工厂的压缩空气系统的实体层面,具体包括:

?Two Atlas Copco air compressors

?Four air tanks( two in air compressor station, two in the technology floor)

压缩空气系统的运行操作及预防性维护保养

?Two air filters

?Instruments (Central Control System ES4i, Pressure gauges, humidity instrument in-site)

?Pressure relief devices .

?Process piping up to the stop valve (before the pressure reducer or filter located the user point). For example, VH201, VH202, and so on. The monitoring and preventive maintenance of the point of use filters and pressure reducer are in the responsibility of production.

?The above components are depicted in the Compressed Air System PID, EPCP_11_03_CA_PID_01_of_04_3.1, EPCP_11_03_CA_PID_03_of_04_3.0.

?两台Atlas空气压缩机组。

?四台贮气罐(两台位于空压站,两台位于技术夹层)

?两台过滤器。

?仪表(中央控制器ES4i,压力表,在线露点仪)

?安全阀

?压缩空气管道至用户点的截止阀(用户点的减压阀或过滤器前)例如:阀门VH201,VH202,用户点的减压阀和过滤器的监视和预防性维护保养由生产部门负责。

?以上组件详见压缩空气系统的PID图,EPCP_11_03_CA_PID_01_of_04_3.1, EPCP_11_03_CA_PID_03_of_04_3.0.

4 Procedures程序

4.1 Operation and Monitoring操作和监视

There are two Atlas Copco air compressors. One is the VSD compressor >ZT37 VSD<, another is the fixed speed compressor >ZT37-8.6-IMD<. Two Atlas Copco air compressors are in continuous operation and automatically controlled by a Central Control System-ES4i. Refer to the approved function specification EPCP_11_03_CA_FS_2.0.

共有2台Atlas 空气压缩机,1台为变频机,型号ZT37 VSD ;另1台为工频机,型号ZT37-8.6-IMD 。2台空气压缩机为连续运转模式,由中央控制系统ES4i 控制,自动根据负荷变化控制运转。参考功能规范文件EPCP_11_03_CA_FS_2.0。

The operator should monitor the air compressor station three times per shift. And the air compressor running parameter should be record one time per shift. Day shift is at 10:00 o’clock, Morning shift is at 7:00 o’clock, Evening shift is at 21:00 o’clock. Record on > FRM-000306: Monitoring Logbook for Compressed Air System<

操作工每班次要巡视空压站3次,记录1次空压机组运行参数,记录在FRM-000306 。

压缩空气系统的运行操作及预防性维护保养

A running parameter limits list should be kept aside the machine, and the paper should be signed by the Clean Utility. The operator should compare the running parameter with the limits. To take action follow the notes:

1张运行数据列表被至于机组现场,该文件由洁净动力经理签字。操作工需要将实际运行参数与该列表比对。并根据注释采取行动。

Atlas Air Compressor Parameter

Atlas空气压缩机组参数

压缩空气系统的运行操作及预防性维护保养

4.2 Preventive maintenance activity and the frequency预防性维护保养及其频率Preventive maintenance program should be performed based on this SOP, the manufacturers suggested working practices / frequencies and the experience of the utilities engineering PM personnel (Re: Manufacturer manuals).

预防性维护保养将在本SOP的指导下进行,制造商建议的工作内容/频率,工程动力团队人员的实践经验是编写本SOP的重要依据。(参考:指导手册)

When inspections are made or problems arise, repair or part replacement work must be initiated immediately by work order, which is executed by the R+M Engineer of the utilities engineering PM. Corrective maintenance is to follow SOP-000052.

在巡视检查中发现问题,需要修理,或者更换零件时,应该立即发起1个WO,该项工作由工程动力的维修人员完成。维修工作还应遵循SOP-000052。

4.2.1 Daily日维护保养

This maintenance is carried out by Utilities Engineering personnel and comprises of the below tasks:

本维护保养工作由工程动力人员执行,具体任务如下:

?Check temperatures and pressu res. Check set Parameters as per manufacturer’s data.

?Take readings and enter them in the log book (every 8 hours of operation)

?Drain moisture from air receiver

?Check filters and drain as necessary

?Blow out drain legs

?检查压缩空气的出口压力和温度,检查机组的运转参数。

压缩空气系统的运行操作及预防性维护保养

?阅读机组的运转参数,做好记录。

?从贮气罐底部排气。

?检查过滤器,如果需要,进行排气。

?检查排凝结水管道。

All these activities are recorded in the Air System FRM-000306 and FRM-000049. Daily maintenance is performed by day shift.

以上全部的活动记录在FRM-000306和FRM-000049上。日维护保养由白班操作工完成。

4.2.2 Quarterly季度维护保养

?Clean the air compressor, wipe the surface of the >Atlas Copco< air compressor using clean cloth. Blow the outside of the air compressor using compressed air. The all electrical components, oil cooler, middle cooler, end cooler, fan, the surface of compressor and motor inside of the >Atlas Copco< air compressor need to be cleaned by blowing them with compressed air.

?清洁压缩空气,用干净的布子擦拭空压机组的外表面。使用压缩空气吹扫空压机组的外表面,电气组件,油冷却器,中间冷却器,末冷却器,再生空气冷却器,风扇,压缩机头和电动机。

?Check the inside air compressor, Watch the five automatic electrical water drain valves, the green lamp should be light. Press the “test” button, a “Paa” sound should be he ard. It’s means that the valve can be opened. Check the air pipe, oil pipe, coolers and so on, There should be no obvious leaks from pipes, joints, flanges and seals. Hear the compressor and motor, there should be no strange voice. Smell inside, there should be no strange smell.

?空压机组内部的检查,观察5个电子自动排污阀,绿灯亮,按“test”按钮,应该听到“啪”的一声,意味着阀门可以被打开。检查空气管道,油管道,冷却器等等,管道,接头,法兰和密封应该没有可以感知的泄漏。听压缩机头和电动机的运转声音,无异常声音。闻机组内部,无异常气味。

?Check air dryer for proper operation. watch the color of the dry material through the glass windows, the color should be blue, and the dry material is granule..

?检查空气干燥机,通过玻璃视窗观察干燥剂,颜色为蓝色,呈颗粒状。

?Check for possible leaks in the air compressor station. Check the ball valve, the relief valve, the air receiver tank, filters. There should be no obvious leaks from pipes, joints, flanges and seals.

?检查空压站内部的泄漏。检查球阀,安全阀,贮气罐及其附件,过滤器。管道,接头,法兰和密封应该没有可以感知的泄漏。

?Walk down the pipeline and observe for leaks in the underground tunnel.

?巡视检查地下管沟内的管道,无泄漏。

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