1、INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 1 / 24JOHNSON & JOHNSON CHINA LTD. 强生中国有限公司Shanghai(上海)Distribution loop of purified water纯水输送系统Installation and Operation Qualification Protocol安装和运行质量验证计划方案Pr
2、oject No 项目号： KX2007-08-001Document No 文件号: KX2007-08-001-10432 2007/10/16 YP.C YK.H Z.P1 2007/09/18 YP.C YK.H Z.PRev版本Date日期Authored编制Checked校核 Approved 批准Remark备注INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD P
3、age 2 / 24CONTENTS内容1. Introduction 简单介绍2. General Information 总体描述3. Description of the tests 测试的说明4. Tests 测试5. Documentation 文件6. Discrepancy 偏差INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 3 / 241 Intro
4、duction 简单介绍The purpose of this document is to describe Installation Qualification Procedure related to PW distribution system of JOHNSON & JOHNSON CHINA LTD(Shangahi). These tests are performed within the framework of the Installation Qualification IQ and Operating Qualification OQ. 本文件的目的是为了描述上海强生
5、制药有限公司 80-85 度热纯水分配输送系统的安装和运行验证方案.这些测试在本安装和运行验证方案的框架下进行.2 - General Information 总体描述The system is presented in process and instrument diagram (P&ID) and the components list are described in the technical documents. All procedures described below refer to the following elements of Technical Documenta
6、tion:本系统的工艺描述见工艺流程图,设备和元器件见相关的技术文件.所有下面描述的相关程序参照下面的技术文件.P&ID 工艺流程图 KX2007-08-001 LC-001/002 Rev3Equipment list 设备清单KX2007-08-001-01 Rev2Valve list 阀门清单 KX2007-08-001-02 Rev2Instrument list 仪表清单KX2007-08-001-03 Rev2Pipe isometric drawing 管道轴侧图KX2007-001 GD-001/002/003/004 Rev3Interface with VWS 和威立雅的
7、工作界面:1.Pipe 管道There is a 3-way automatic valve supplied from VWS. The valve is used for switch DI water supplying from VWS system to DI water tank or returning to VWS system. Kangxu installed pipe between VWS system and DI water tank. 威立雅提供一个三通自动阀门,该阀门用于切换来自威立雅的纯水到纯水箱或回流到威立雅的纯水系统. 康旭公司负责安装威立雅纯水系统和纯水
8、箱之间的管道.2.Level signal 液位信号There is a simulated level signal supplied from Kangxu cabinet to VWS system, which used for controlled DI water supply.康旭公司提供一个模拟的液位信号给威立雅,用来控制制水系统的供应.Interface with client 和业主的工作界面:Client supply all utility such as power and steam. It is drain directly to ditch in DI wate
9、r system room for all drain of DI distribution system in DI water room.It is out of our scope for sanitizing DI water distribution system. It is also out of our scope for water quality test of distribution loop. INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/
10、2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 4 / 24业主提供诸如电,蒸汽等的公用设施的供应, 纯水分配系统的排水直接排放到纯水房间内的地沟内 .纯水分配系统的消毒不在本公司的工作范围内,同时纯水分配系统的水的质量检查也不在本公司的工作范围内.It will install in future for OTC distribution pipe. Currently, it is used bypass pipe so that distribution loop can be recycled.液体灌装区域的分配管将来再安装,因此
11、目前利用旁通管来连接, 以便回路系统能进行循环.Summary of scope:工作范围This installation supplies purified water distribution system本安装提供纯水分配系统There is one distribution pump. The pump has frequency control by itself. Frequency of pump is controlled by the Flow Transmitter (FT/FE01). The flow transmitter should send signal to
12、 the controllers inside the cabinet, then the controller will frequency on the pump to control the working frequency of the pump. The back pressure valve will maintain minimum pressure of the loop.本系统有一台纯水输送泵,该泵变频控制,泵的频率由流量变送器(FT/FE01)控制, 流量变送器发出控制信号到控制柜里的控制器.由控制器控制泵的工作频率,背压阀将维持输送系统的最低压力.There is on
13、e PW tank. The Level switch of tank LT 01 will work as dry-run protection for the pump. That means if the purified water level is lower than the level switch then it will shut off the pumps immediately. At same time a alarm will get on the cabinet. It also control inlet valve opened to tank or close
14、d to return according tank level.本系统有一台纯水水箱,它的液位开关 LT01 用来保护纯水泵的干转保护 .即当纯水箱的液位低于低位时自动立即停运纯水泵.同时在控制柜上发出报警信号.该液位同时用来控制水箱的进水阀门的开(进纯水) 或关(回纯水).The UV disinfection unit紫外线杀菌消毒器There is one UV disinfection unit is installed after distribution pump to keep bacteria in low level. It is working together with
15、 PW pump.本系统有一台紫外线杀菌器,它安装在输送泵后,用来保持细菌在控制范围内, 它和纯水泵同时启动和停止.There are two heating systems in this purified water system. One is for heating up the purified water from 15 to 80for hot water consumption. A temperature transmitter (TT01) is installed on the purified water line between the heat exchanger
16、and the consumption. This temperature transmitter will send signal to the controller inside the cabinet then the controller will send 420MA signal to the positioner of the control valve (TRV01) to control the open rate of the control valve. Other double function of heater heat up purified water at 7
17、.1m3/h purified water to 80 Degree C in 45 mins for sanitary and cool down 1m3/h purified water from 25 to max. 20 Degree C in normal operating. A temperature transmitter (TT02) is installed on line before the purified water tank. This temperature transmitter will send signal to the controller insid
18、e the cabinet then the controller will send 420MA signal to the positioner of the control valve (TRV02/03) to control the open rate of the control valve. INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 5 / 24
19、本系统有两台换热器一台用来将纯水从 15 度加热到 80 度作为热纯水的消耗.有一个温度探头 TT01 安装在热交换器和用水点之间. 温度传感器发出信号到电控箱内的控制器上,控制器发出 4 到 20mA 信号到温度控制阀上的执行器来控制阀门 TRV01 的开启度.另一台双功能的换热器在 45 分钟内将 7.1m3/hr 的纯水加热到 80 度来消毒, 同时它在正常情况下可将 1m3/hr 的纯水从 25 度冷却到 20 度. 有一个温度探头 TT02 安装在纯水回纯水箱前.温度传感器发出信号到电控箱内的控制器上, 控制器发出 4 到 20mA 信号到温度控制阀上的执行器来控制阀门 TRV02
20、的开启度.An alarm will be gotten if the temperature is higher or lower than the certain value. 当温度超过或低于一定的设定值会发出一个报警信号Level control system 液位控制系统A transmitter is installed on the bottom of the PW tank to work as a level transmitter (LT01).在纯水箱的底部安装了一个液位变送器 LT01A level controller is installed inside the
21、cabinet, it will keep the water level between 100% and 60% by control the three-way valves(TAV01) on the purified water inlet line. An alarm will be got if the level is higher than 100% or lower than 40%.液位控制器安装在控制箱内,它将保持水箱的液位在 100%到 60%之间,它是通过在纯水箱的进水管上的三通阀TAV01 来实现的.在液位高于 100%或低于 40%时将发出一个报警信号.This
22、 level controller will also control the heating system for the inlet purified water (start up and shut off).该液位控制器还控制换热器什么时候通入纯水(即启动和关闭 )Conductivity indicator 电导显示There is a conductivity transmitter to indicate both loop distribution and at the end of each transfer loop. The conductivity data will
23、be indicated on the transmitter on the cabinet. An alarm will be got if the conductivity data is higher than certain value. 本系统有一个电导变送器来显示纯水输送和回流的电导率.电导率显示在控制箱上的变送器上. 当电导率高于一定的设定值后会发出报警信号.Others 其它A “RESET” button should be installed on the cabinet to cancel the alarm and reset the system.一个:重设”按钮安装
24、在控制箱上来取消回重设系统.A light and sound alarm should be installed on the top of the cabinet to give a warning alarm.一个声光报警安装在控制箱上给出报警There is a stop switch for cabinet installed on the cabinet for emergency stop or maintenance.在控制箱上装有一个用来切断控制柜电源来进行停电或维修的按钮INSTALLATION AND OPERATION QUALIFICATION PROCEDURE F
25、OR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 6 / 24Please refer operating manual for detail control philosophy and function description详细的操作原理和步骤说明请参照操作手册Requirements from J&J and quality of treated water:强生公司处理后的纯水要求Quality of treated water 纯水水质要求Treated w
26、ater conductivity 电导率 1.3s/cm)当输送水高电导率时报警Yes No是 否Verify that loop return high conductivity alarm.检查输送回水是否低电导率报警Alarm buzzer when loop return high conductivity.( 1.3s/cm)当纯水回水高电导率时报警Yes No是 否Verify that UV alarm.检查紫外线杀菌器是否报警Alarm buzzer when UV intensity low当紫外线杀菌器强度低时报警Yes No是 否Verify that loop ret
27、urn low-flow rate alarm.检查输送系统回水是否低流量报警Alarm buzzer when loop low-flowrate.( 5m3/hr)当纯水流量低时报警Yes No是 否Note:All alarm is indicated on HMI 所有的报警都显示在触摸屏上Observations:结果Date test performed:测试日期KANGXU Name:姓名 Signature/date 签字 /日期CUSTOMEROTHERSINSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW
28、 DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 22 / 24Test 12:Analytical Data Collection Sheet 分析测试数据的整理Please see the analytical data collection sheet which done by others参见其它分包进行的测试分析数据表 Observations:结果Date test performed:测试日期KANGXU Name:姓名 Signature/date 签字 /日期CUST
29、OMEROTHERSINSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industrial Develop Co.,LTD Page 23 / 245. Documentation 文件 Description 描述 Identification 标识 Quality Certification质量文件Material Certification材料证明Factory Test Report出厂报告Doc.C/NC文件对否Obse
30、rvation观察结果 Remark 备注Tanks 纯水箱 T X X XPump 纯水泵 P XHeater 换热器 HX X X XAir filter 空气过滤器 AF XEquipment设备UV unit 紫外线杀菌器 UV X X XManual Valves 手动阀 Ref. valve list XValves阀门 Automatic Valves 自动阀 Ref. valve list XControl cabinet 控制箱 AP1/1.1/1.2 XPressure Instrumentation 压力仪表Ref. Inst. List XLevel Switch/Tr
31、ansmitter液位仪表开关LT XTemperature controller 温度控制器TT XConductivity instrument 电导仪表CT XConductivity Cell 电导探头 CE XFlow Instrumentation 流量仪表FT XInstrument仪表Flow cell 流量探头 FE XX-Supplied 提供INSTALLATION AND OPERATION QUALIFICATION PROCEDURE FOR J&J PW DISTRIBUTION SYSTEM-10/16/2007 Shanghai Kanxu Industria
32、l Develop Co.,LTD Page 24 / 246-Discrepancy 偏差报告Appended is a discrepancy report form.如下为一个偏差报告In case of a discrepancy, make a copy of this discrepancy report form, complete it and append it to this section.当出现偏差时,复印本报告并完成,然后作为本报告的附件.Deviation report No偏差报告编号Deviation description偏差描述Initials / date日期Item cleared by / Date偏差消除日期123456789101112131415161718Comments 备注:Date 日期:
