洁净空调验证方案DQ

1、Validation编号:No.OQ-542-JK-1HVAC系统运行确认OQ of HVAC页码:Page37 of 37株洲千金药业股份有限公司女性健康产业基地综合厂房HVAC系统运行确认（JK-1系统）协多力验证部2009年9月HVAC系统运行确认方案OQ Protocol Of HVAC 制订人：Author 制订部门：Department 审核人：Reviewed By 审核日期：Reviewed Date 协多力公司验证部Validate Department审核人：Reviewed By 审核日期：Reviewed Date 批准人：Approved By 批准日期：Approv

2、ed Date 株洲千金药业股份有限公司分发部门：Distributed To替换文件：Replaced For修订记录：Revised Record目录1.通则QENNRAL RULE51.1目的Purpose51.2范围Scope51.3文件管理规范Good Document Practice51.4各方职责71.41协多力公司的职责The Responsibilities Of Suntec Include The Followings:71.42株洲千金药业股份有限公司的职责包括但不仅仅限于以下:The Responsibilities Of qianjin Include,But N

3、ot Limited To:72.系统的描述DESCRIPTION SYSTEM921JK-1系统的系统描述 Description for JK-1 System922JK-1系统的控制系统描述Contorl System Description for JK-1 System1023设计要求：Design Requirements1324GMP适用要求：GMP According Requirements133.测试描述和可接受标准TEST DESCRIPTION AND ACCEPTANCE CRITERIA143.1先决条件Requisites143.2验证仪器校准的确认Validat

4、ion Instrument Calibration Verification143.3口令的确认Password Verification153.4房间送风量和换气次数Room Supply Flow Rate And Air Changes153.5房间压差Room Differential Pressure163.6房间温度和相对湿度Temperature And Relative Humidity In Room173.7房间洁净度的测试（静态）Non Viable Particle Count Of Room “At Rest”183.8人员的确认PERSONNEL IDENTIFI

5、CATION204.偏差报告DEVIATION REPORT205.注释COMMENT SECTION206.偏差清单LIST OF DEVIATION207.附件清单LIST OF ATTACHMENT218.审核和批准 EXECUTION REVIEW AND APPROVAL219.改造和更改控制MODIFY AND CHANGE CONTROL2110.测试报告目录 INDEX OF TEST REPORT22TEST REPORT 1 测试报告123TEST REPORT 2 测试报告224TEST REPORT 3 测试报告325TEST REPORT 5 测试报告527TEST

6、REPORT 6 测试报告628TEST REPORT 7 测试报告729TEST REPORT 8 测试报告830TEST REPORT 9 测试报告931TEST REPORT 10 测试报告1032TEST REPORT 11 测试报告1133TEST REPORT 12 测试报告1234TEST REPORT 12 测试报告12351. 通则QENNRAL RULE1.1 目的Purpose本运行确认是为了确认位于中国湖南株洲的千金药业股份有限公司（简称“千金药业”）的生产车间的洁净空调系统的运行是否符合设计标准和工艺要求。本方案规定了运行确认的内容、测试方法和测试表格。另外运行确认也

7、被视作为在进行性能确认之前对洁净空调系统进行的质量审核。 The Operation qualification protocol is to verify that the HVAC system of production workshop of Customer Co., Ltd. (briefly called as “qianjin”) located in zhuzhou, China Has Been Properly Operation According To Design Specification And Process Requirement. The Protocol

8、 Prescribes The Content、Test Method And Test Forms Of The Operation Qualification. OQ Serves As A Quality Audit Of HVAC System Prior To PQ 1.2 范围Scope 本运行确认对位于株洲新建的综合生产车间中洁净室空调净化系统中JK-1净化空调系统的运行进行确认。本方案将包括测试规程、证明文件、参照资料、标准和可接受的限度，以说明JK-1系统的运行符合设计要求、厂家建议和当前的GMP规范。This OQ is for JK-1 HVAC Operation Qu

9、alification system in powder preparation workshop.This OQ Including testing rule ,certification documents, reference documents ,standard and the acceptable level to prove JK-1 system fits designing ,requirements by clients GMP.1.3 文件管理规范Good Document Practice 下面说明了一些进行记录测试数据工作的通用标准：Below Are Indicat

10、ed Some General Criteria For Test Data Recording: 保证每一文件是可追溯的，它应有标题，系统参考（例如项目号），文件中应有设备的系列号。 Get Assurance That Every Document Is “Traceable ” That Is: It Has A Title, System Reference (For Example : Item Number), If It Is Applicable (For Example Checks About A Tank), It Is Necessary To Report Seria

11、l Number Of The System That Is Contained In The Document. 文件中每个注解、记录等都应该清楚、易读、有日期和签名。不能使用铅笔，而应使用蓝色钢笔或水笔记录数据。 Every Annotation, Recording Etc, On A Document Must Be Clear, Readable, Dated And Signed. 每次测试须遵循以下原则：For Each Test Executed Is Necessary To: - 如果结果是某一数值时，只填写“通过/不通过”是不充分的 - It Is Not Suffici

12、ent Pass/Fail If The Result Is A Value - 如果某测试没有写明具体的测试程序，则应注明参考出处- Refer At The Procedure Used For The Test If This Is Not Described In The Body Format Used - 附上在测试过程中所产生或打印出来的图，签名并注明日期 - Attach Each Print-Out/Attachment Produced During The Test Execution, Signing And Dating It. - 每次测试应签名和注明日期（需有执行

13、人和审核人的签名） - Sign And Date Each Tests(Signature Of The People That Executes And Approves Test Must Be Present) - 如果有些测试没有进行，则应在备注或偏差记录中写明未执行的原因和预计执行的日期 - If Some Test Is Not Executed, Indicate The Reason Why It Happened, Giving, In The Deviation Form, A Possible Date For The Execution. 所有测试日期的格式为 日/月

14、/年，如12/08/2004 Format Of Date Is Dd/Mm/Yyyy. 在文件中不能使用修正液，修改错误必须使用以下正确的方式 Do Not Use Covering Liquids Or Materials On Documents, To Correct Errors, Every Writing Mistake Must Be Correct Like The Following Example: System XX 签名System YZ 日期对于不使用的部分， 必须如下面所示的划掉。或者，填写“NA”，表示不适用Pace Not Used Must Be Barre

15、d As Indicated Blow.Or Fill Out “NA”, It Means Not Applicable. 对于在执行本方案过程中所发生的每个偏差， 应填写包括以下一些内容的偏差报告 For Each Deviation That Should Occur During The Execution Of This IQOQ Protocol, Compile A Report For Non Conformity/Deviation Management (Attached To This Protocol) Recording - 偏差号 - Deviation Numbe

16、r - 偏差描述和发现人签字及日期 - Deviation Description & Sign And Date Of The People That Finder - 必要纠偏措施 - Activity Necessary To Resolve The Deviation - 纠偏措施批准人签字和日期 - Date Of Deviation Resolution . - 偏差解决的日期 Re-Check Results After Resolution 1.4 各方职责1.41 协多力公司的职责The Responsibilities Of Suntec Include The F

17、ollowings: 1. OQ方案的编制。OQ Protocol Writing 2. 提供校准测试仪器的相关证书.Supply Correlative Certificate Of Calibration Test Instrument 3. 收集原始数据并填写在OQ方案中.Collect Original Data And Fill In The OQ Protocol4. 记录发生在OQ过程中的不一致项/偏差.Record Non Conformity/Deviation Occurred During OQ5. 偏差报告的整理Deviation Reports Compilation

18、6. 编写OQ报告.OQ Report Writing1.42 株洲千金药业股份有限公司的职责包括但不仅仅限于以下:The Responsibilities Of qianjin Include,But Not Limited To: 1. 提供为此次执行本方案所必要的所有的程序、数据、手册、图纸和文件，并完成最终报告。Supply All Procedure, Data, Manuals, Drawing And Documentation Necessary For The Generation And Execution Of Protocols And The Completion O

19、f Final Report. 2. 如果需要时， 提供必要的人员协助进行系统或设备的运行。Provide Personnel, When Necessary, To A Ssist In The Operation Of Equipment Of Equipment And System. 3. 如果需要时，提供必要的人员进行校准关键和非关键的测量、记录和/或控制仪表。Provide Personnel, When Necessary, To Calib Rate Critical And Non-Critical Measuring,Recording, And Controlling I

20、nstrumentation. 4. 针对不一致项界定解决方法Define Solution For Non Conformity. 5. 审核并批准本方案和最终验证报告 The Review And Approval Of This Protocol And The Validation Final Report. 2. 系统的描述DESCRIPTION SYSTEM21 JK-1系统的系统描述 Description for JK-1 SystemJK-1系统主要服务于车间D级净化区域的温度、湿度、压差和洁净度，请见附图“JK-1空调系统流程图”。JK-1 system is solved

21、 for temperature, humidity, Press and cleaning in walkway by class D area. Details pls see the attachments “JK-1 system layout “2.1.1 空调净化系统包括洁净间、气闸和B区洁净走道等房间的净化区域。为达到最理想的空气净化效果，车间采用上送下（侧）回的空气流通方式。排风由排风机排到室外。排风需经中效过滤器处理后排出室外，如图中的PJ1.HVAC system including production material in EPO and cleaning area

22、in B clean walkway. To get a good clean effect, the airflow by supplying from the top, return by the bottom. EF exhale the wind outside the cleanroom. The wind should be filter by the middle filter, finally be out of the room.2.1.2 JK-1系统送风量为21663m3/h，回风量为16845 m3/h，新风量为4818 m3/h，新风比为22%。Wind supply

23、ing should be 21663m3/h, wind returning should 16845 m3/h, fresh air should be 4818 m3/h The rate should be 22% by the system.2.1.3 各室温湿度要求Humidity Requirements for the rooms 夏季t=（22±4），=（55±10）% summer t=（22±4），=（55±10）%冬季t=（22±4），=（50±10）% winter t=（22±4），=（50

24、77;10）%2.1.4 各室洁净等级按D级设计，相当于ISO标准7级。D级洁净室的换气次数为16次/小时。D class for the cleanroom ,it means ISO 7. air change should be 16/h for D class cleanroom2.1.5 空气流程为新风在依次经初效过滤器、中效过滤器处理后再经过空调处理室和回风混合后再经过表冷器，再由风机经过蒸汽加热器和蒸汽加湿器经中效过滤器再处理，再通过装于房间顶部的高效过滤器送入各室，然后进行重复循环，各室的送、回、排风均有风阀调节至设计风量。详见“JK-1系统控制原理图”。Air Flow pr

25、ocess as follows, fresh air by first filter and middle filter，the fresh air and return air mixed in the air-condition by coolers, heater, humidifier and middle filter send to all the rooms by the HP-Filter on the top, cycle by times . there are wind damper to adjust the wind ,see the “JK-1 Control d

26、rawing”2.1.5.1 空气冷却器，主要功能用在夏天，使空气减温、减湿，控制送风温度，使之符合设计要求，具体数据详见空调流程及控制图。air-cooler which reduce the temperature, humidity of the air, control the wind temperature. It will make all tech. accord the design requirements. Details pls see the Drawings.2.1.5.2 空调处理室的空气加热器，主要功能在冬天开启。夏天由于室外温度较高，所以一般不会使用。 the

27、 air humidifier, it used while the winter. Because of the not temperature ,it is not used while summer.2.1.5.3 初效过滤器除尘效率大于65%，初阻力为45Pa.。当终阻力达到90Pa时，说明该过滤器容尘量达到饱和，必须更换或清洗过滤器。图中压差表能反映中效过滤器的阻力。Dedusting efficiency should be more than 60%, the least resistance should be 60Pa by the middle filter. When t

28、he finally resistance reaches 120 Pa, the dust has been saturation, the filter should be clean or changed. The press dispatch form will reflect the resistance of the filter.2.1.5.4 中效过滤器除尘效率大于60%，初阻力为60Pa.。当终阻力达到120Pa时，说明该过滤器容尘量达到饱和，必须更换或清洗过滤器。图中压差表能反映中效过滤器的阻力。Dedusting efficiency should be more tha

29、n 60%, the least resistance should be 60Pa by the middle filter. When the finally resistance reaches 120 Pa, the dust has been saturation, the filter should be clean or changed. The press dispatch form will reflect the resistance of the filter.2.1.5.5 在初、中效过滤器的前后安装微压计，如图中所示，最小单位为10Pa。Install the Min

30、i pressure plan between the first fiter and middle filter as the drawing ,the unit should be 10 Pa.22 JK-1系统的控制系统描述Contorl System Description for JK-1 System2.2.1 空调处理箱中的空气加热器采用0.3Mpa的蒸汽加热，蒸汽凝结水回到蒸汽凝结水管中。Heater in the air-condition worked with 0.3Mpa steam heating ,steam coagulate as water back to t

31、he pipes.2.2.2 空调处理箱中的表冷器的冷源来自冷冻机房的7的冷冻水。冷冻水回水的温度控制在12以下，冷冻水回水电动阀的开启大小由送风管中的温湿度传感器来控制。The cold origin of the cooler in air-condition is from 7 freeze water in the freeze plant. Water back for the freeze water is down of 12, electrical valve will be controlled by temperature sensor in blast pipe.2.2.

32、3 蒸汽加湿器的阀开启程度由回风管中的温湿度传感器来控制。Humidifier damper will be controlled by temperature sensor in return pipe.2.2.4 防火阀与空调风机连锁，当防火阀关闭，空调风机停止运转并报警。Fireproofing damper and fan chain, the fan stopped working and give an alarm while he fireproofing turn off.JK-1系统功能表：房间名称Room Name房间编号Room NO.净化等级Clean Class换气次

33、数(次/h)温度T()湿度RH(%)相对非洁净区压差Differential pressures to Non clean area制浆一步制粒-1D161826456510制浆一步制粒-3D161826456510工作站-1D161826456510工作站-2D161826456510溶胶-1D161826456510走道1D161826456510洁具清洗-1D161826456510洁具存放-1D161826456510工作站-3D161826456510工作站-4D161826456510洁具清洗-2D161826456510洁具存放-2D161826456510走道2D1618264

34、56510溶胶-2D161826456510工作站-5D16182645651023 设计要求：Design Requirements 客户要求该新建综合生产车间的设计能同时符合中国和欧盟的GMP认证要求。客户也要求该设计能符合中国的“药品生产质量管理规范-1998版”（以下简称“中国GMP” ）的要求和中华人民共和国国家标准：建筑设计防火规范（GB50016-2006）。中国洁净室厂房设计规范（GB50073-2001）欧洲联盟药品生产质量管理规范（EU GMP）以及美国FDA标准。The Design Should Accorded By Chinese And URP GMP. It S

35、hould Be Accorded By GB50016-2006, GB50073-2001, EU GMP And American FDA该工程的工程设计方-中国医药集团重庆医药设计院完成了工程设计。The Designer Is CPWPIDI洁净室施工单位-昆山协多力公司为施工单位。Construction Unit Suntec Cleanroom & HVAC Engineering Co.,Ltd24 GMP适用要求：GMP According Requirements要求符合标准：Requirements up to sunff- 中国：“药品生产质量管理规范”（19

36、98年修订）China: Chinese GMP (1998 edit)- 中华人民共和国国家标准：GB50073-2001 洁净厂房设计规范。National standards of the People's Republic of China: GB50073-2001 Cleanroom design specification可以参考标准： reference standards - 美国：21 CFR Part 210-211 “GOOD MANUFACTURING PRACTIC” 2000- 欧洲：GMP 20023. 测试描述和可接受标准TEST DESCRIPTIO

37、N AND ACCEPTANCE CRITERIA 3.1 先决条件Requisites 目的Purpose确认所有进行运行确认的先决条件已经得到满足 。All Prerequisites Necessary To The OQ Execution Have Been Satisfied. 程序 Procedure 确认本方案已得到批准。Verify That OQ Protocol Has Been Approved. 可接受标准 Acceptance Criteria 开始执行本方案之前，所有的先决条件必须得到满足。All The Prerequisites Must Be Satisfi

38、ed Before The Beginning Of The Execution Of IQ Test. 测试报告 Test Report 填写“测试报告1”。Fill In Test Report No.1. 在偏差报告中记录在测试过程中所发生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report.3.2 验证仪器校准的确认Validation Instrument Calibration Verification 目的 Purpose确认对每一台验证所用的仪器的校准情况。

39、Verify Calibration State Of Every Validation Instrument. 程序 Procedure 对每一台验证所用的仪器应标识出生产厂家、型号、系列号、校准日期、有效期。必须附上校 准证书。 For Every Validation Instrument Product Factory、Type、Series Code、Calibration Date、Period Of Validity Should Been Marked. Attach Calibration Certificate. 可接受标准 Acceptance Criteria 所有仪表

40、已经得到校准，并在它们的校准有效期内，校准证书是可用的并附在本方案中。 Verify That The All Instruments Have Been Calibrated, Are Within Their Calibration Period. Verify The Availability Of The Calibration Certificates And Attached This Protocol. 测试报告 Test Report 填写“测试报告2”。Fill In Test Report No.2. 在偏差报告中记录在测试过程中所发生的偏差 Recording The D

41、eviation Occurred During The Test Execution On The Deviation Report. 3.3 口令的确认Password Verification 目的 Purpose 确认只有预先授权的口令可以进入控制系统 Verify That Only The Authorized Password In Advance Can Be Allowed To Enter The Control System. 程序 Procedure 对每一个进入控制系统的人机界面和访问等级，输入相应的口令并确认允许进入控制系统，使用相同步骤输入错误的口令，拒绝进入。F

42、or Each Man-Machine Contact Surface And Visit Rank To Enter Control System，Input The Corresponding Password And Conform To Permit To Enter The Control System；Use The Same Step But Input The Wrong Password，Then Refuse To Enter. 可接受标准 Acceptance Criteria 只有在输入相应正确的口令可以进入控制系统，错误的口令将自动拒绝 Only When Input

43、 The Corresponding Correct Password，It Can Enter The Control System；The Wrong Password Will Be Automatically Reject. 测试报告 Test Report 填写在“测试报告3 Fill In Test Report No.3. 在偏差报告中记录在测试过程中所发生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report. 3.4 房间送风量和换气次数Room Supply

44、 Flow Rate And Air Changes 目的 Purpose 检查房间的送风量和均匀性 Inspect The Supply Flow Rate And The Uniformity Of The Rooms检查每个房间的换气次数 Inspect The Air Change Of Each Room. 程序 Procedure （风量罩法） (Airflow Hood)- 取得一已校准过的风量测量装置 - Take A Calibrated Instrument Of Airflow Hood. - 对每间房间的每个过滤器进行测试 - Test Every Filter Of

45、Every Room. - 在进行测试时，所有的门必须关闭，空调系统已运行 - When Process Test，All Doors Must Be Close，And The HVAC System Is Going On. - 记录测量装置的风量读数 - Record The Reading Of Air Rate Of Test Instrument. - 计算进入房间的总风量 - Calculate The Total Air Rate Entering The Room. - 记录房间的容积 - Record The Cubage Of The Room. - 计算换气次数 - C

46、alculate The Air Changes. - 附上房间的过滤器的布置图和编号 - Attach The Layout Of The Room Filters And Series Number. 可接受标准 Acceptance Criteria 换气次数设计标准的90% The Air Changes 90% Of Design Standard 测试报告 Test Report 填写在“测试报告4 Fill In Test Report No.4. 在偏差报告中记录在测试过程中所发生的偏差 Recording The Deviation Occurred During The T

47、est Execution On The Deviation Report. 3.5 房间压差Room Differential Pressure 目的 Purpose 确认不同洁净等级的不同房间的压差，确认特殊房间之间的压差 Verify The Differential Pressure Of Different Room Of Different Clean Level. Verify The Differential Pressure Between The Special Rooms. 程序 Procedure 方法一Method No.1 - 把待测试房间与参照房间连往精密压力计（

48、通过硅树脂管道），测量静态压差 - Connect The Test Room With Reference Room Toward The Precision Pressure Instrument (Through Silicone Resin Pipeline)，Measure The Differential Pressure Of Static State. - 检验所得数值是否符合可接受标准 - The Value Through Test Is Accordant With The Acceptance Criteria. 方法二Method No.2 - 利用已安装的，并且得到

49、校准的微压差计来测量不同房间的静态压差 - Test The Static Differential Pressure Of The Different Room By The Installed And Calibrated Micro-Pressure Instrument. 可接受标准 Acceptance Criteria 压差在设计标准±5Pa范围之内 The Differential Pressure Is Within ±5Pa Of Design Standard. 不同洁净度的不同房间的压差12.5Pa The Differential Pressure

50、Of Different Room Of Different Clean Level12.5Pa测试报告 Test Report 填写在“测试报告5” Fill In Test Report No.5. 在偏差报告中记录在测试过程中所发生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report. 3.6 房间温度和相对湿度Temperature And Relative Humidity In Room目的 Purpose 确认房间内的温度和相对湿度达到设计标准 Validate

51、 Temperature And Relative Humidity In Room Gets Design Requirements 程序 Procedure 测点选择高度应离地面0.8m，距设备周围0.8m以外处，并应避开出、回风口处 The Test Point Should Choice The Point That The Distance From The Test Point To The Ground Is 0.8m,The Distance Around The Equipments Is Outside 0.8m，And Should Avoid The Exhaust V

52、ent And The Return Vent. 可接受标准 Acceptance Criteria 房间内的各测点温度和相对湿度在设计范围内 The Temperature And Relative Humidity Of Each Test Point In The Room Is In Design Range. 测试报告 Test Report 填写在“测试报告6 Fill In Test Report No.6 在偏差报告中记录在测试过程中所发生的偏差 Recording The Deviation Occurred During The Test Execution On The

53、Deviation Report. 3.7 房间洁净度的测试（静态）Non Viable Particle Count Of Room “At Rest” 目的 Purpose 确认房间的洁净等级。测试是在静态的环境下进行, 即设备不运行，无工作人员 Verify The Clean Level. The Test Is Carrying On Under The Static Environment, Namely The Equipment Does Not Move, Non- Staff. 程序 Procedure 1、使用一已校准的颗粒计数器 Take A Calibrated Particle Counter. 2、保证房间已清洁过 Verify That The Room Has Been Cleaned. 3、仪器自净 The Instruments Clean Themselves. 4、确定取样点的数量： Verify The Amount Of The Sampling Point A: 表示房间面积N:表示取样点数量。指明取样点的位置。取样点的数量不少于2点。 A: Room Area N: T