胶塞清洗机运行确认.doc

1、OQ Document 运行确认文件运行确认文件Objectives 目的：目的： Use this document as the stream line guidelines to verify that the system is operated in accordance with the URS and the associated design specifications.使用该文件作为生产线的指导方针，以确认系统是否按照 URS 和相关设计说明进行运行。Customer Name客户名称客户名称: Document No 文件号：文件号：OQ1-20131468Author

2、编制：编制：Name 姓名Company/Title 公司/职务Signature 签名Date 日期Reviewed By 审核审核:Name 姓名Company/Title 公司/职务Signature 签名Date 日期Approved By 批准批准:Name 姓名Company/Title 公司/职务Signature 签名Date 日期Attention: The expiry date of a paper copy of this document is the day it was printed.注意：复印件无效 Revision History： Revision 版本号

3、版本Date 日期Name 名称Description 描述TABLE OF CONTENTS1.NOMENCLATURE AND ABBREVIATIONS 术语和缩写术语和缩写 .42.SYSTEM DESCRIPTION 系统描述系统描述.52。1.PROJECT CONFIGURATION项目配置.52.2.ACCEPTANCE CRITERIA验收标准.63。 EXECUTION REQUIREMENTS 实施要求实施要求.73。1。 EXECUTION RULES & PRACTICES实施规则惯例.73.2。EXCEPTIONAL CONDITIONS异常情况.94。 P

4、RE-TEST VERIFICATION 预测试验证预测试验证 .104。1。 TEST EQUIPMENT CALIBRATION REVIEW设备测试校验审核.105。 HARDWARE OPERATING VERIFICATION 硬件确认硬件确认.125。1.HARDWARE OPERATING ENVIRONMENT VERIFICATION硬件运行环境确认.126。 PLC LOGICS VERIFICATION PLC 逻辑确认逻辑确认.136.1.ALARM LIST VERIFICATION 报警清单验证.136.2。MANUAL CONTROL VERIFICATION手动

5、控制确认.156。3。 CYCLE SEQUENCE VERIFICATION 循环顺序的确认.177。 PERFORMANCE VERIFICATION 性能确认性能确认.247.1.CIP COVERAGE VERIFICATION (CIP OPTION) CIP 覆盖确认.247.2 SIP EFFECTIVENESS VERIFICATION (SIP OPTION） SIP 有效性确认 .267。3VACUUM INTEGRITY TEST真空完整性测试.278。 EXCEPTIONAL CONDITIONS 偏差偏差.291.Nomenclature and Abbreviati

6、ons 术语和缩写术语和缩写The following nomenclature and abbreviations are allowed to be used in this document and the appendices （where applicable)AGT Wenzhou Yaguang Science Technology Industry co。 ， Ltd。温州亚光科技实业有限公司RSC Rubber stopper cleaner 胶塞清洗机BOMBill Of Material 材料一览表CIPClean In Place 在线清洗COCCertificate

7、Of Conformance 一致性确认DPDifferential Pressure 压差ECDElectrical Circuit Diagrams 电路图E-StopEmergency Stop 急停FATFactory Acceptance Test 工厂验收测试GAGeneral Arrangement 总装图HDSHardware Design Specifications 硬件设计说明H/WHardware 硬件HMIHuman Machine Interface 人机界面HzHertz 赫兹I/OInput / Output 输入/输出IDIdentification 识别IQ

8、Installation Qualification 安装确认MTRMaterial Tracking Records 材料N/ANot Applicable 无此项N/TNot Tested 没有经过检验的No。Number 序号OQOperation Qualification 操作确认P/NPart Number 零件号P&I D Piping and Instrumentation Diagrams 管路仪表图PLCProgrammable Logic Controller 可编程逻辑控制器S/NSerial Number 序列号S/WSoftware 软件SIPSterili

9、zation In Place 在线灭菌T/CThermocouple 热电阻barMicrobar （unit measure of vacuum level）微巴WFIWater For Injection 注射用水2.System Description 系统描述系统描述2.1.Project Configuration 项目配置项目配置A.Main chamber, Inner diameter DN1500mm. 主箱体，内直径 DN1500mmB.Front obturation discharge system。 前密闭出料系统C.Inner cleaning barrel/di

10、ameter DN1200mm ,aperture diameter 10mm. 内清洗筒直径 DN1200mm，孔径 10mmD.Vacuum feeding， air flushing and central spray washing， vacuum and electric-heat drying， Interchange the hot air in the chamber by 100 degree clean air and heater-exchanger cooling , automatic discharge .真空进料，气冲和中心喷淋清洗,真空和电加热干燥，吸入百级新风

11、置换箱体内热空气和换热器冷却，自动出料E.SK-3。8 vacuum pump. SK3。8 真空泵F.GRUNDFOS CM103 circular pump 格兰富循环水泵G.Domestic fresh air filter with integrality test nozzle， 国产新风过滤器，带完整性检测口。H.Sujing hightemperature effective filter 苏净耐温高效过滤器I.Differential Pressure Gage made by DWYER 美国 DWYER 生产的微压差计J.Integrated Clean In Place

12、(CIP） 。在线清洗K.Integrated Steam In Place (SIP)在线灭菌L.The control system adopts Touch screen +PLC . Friendly human-machine interface, easy operation and maintenance。控制系统采用触摸屏+PLC，人机界面紧凑，容易操作和维护M.The printer is also provided. 提供打印机N.Adopt SIEMENS S7-200CN PLC。 采用西门子 S7200CN 的 PLCO.SIEMENS 6SE6 440 transd

13、ucer。 西门子 6SE6 440 变频器P.Vessel code In accordance with GB150。符合 GB150 规范2.2.Acceptance Criteria 验收标准验收标准Acceptance criteria 验收标准验收标准Specification 说明说明Vessel 罐体罐体Design pressure (MPa)设计压力0。1/0.2Working pressure (MPa）工作压力-0。0960.17Design temperature （）设计温度133Working temperature （)工作温度20129Inner barrel

14、 aperture diameter 内清洗筒孔径10Inner barrel diameter (mm)内清洗筒直径1200Chamber diameter (mm）箱体直径1500Total volume （m3)容积2.28Capacity 生产能力105，000 /Batch(15ml Freeze drying Rubber Stopper） 15ml 冻干胶塞 105，000 只/批Vacuum value 真空度0。09MPaChamber Temperature Uniformity when steaming蒸汽灭菌时箱体内温度均匀性1Steam Sterilizing Te

15、mperature 灭菌温度122Equipment Dimension (mm)设备外形尺寸298022502500Filter dryer empty weight (kg)空重42003.Execution Requirements 实施要求实施要求3.1.Execution Rules & Practices 实施规则惯例实施规则惯例Each test will be performed according to the established testing procedure. Initials of the person performing the test and t

16、he date in which the data was collected will be used to certify that the test was executed. If any additional information needs to be documented， the comments section will be used。 After the completion of each test， the data obtained will be reviewed by a second person to certify that the test was p

17、erformed completely， that the testing plan was followed and to assure adequate documentation has been provided。 This person will initial and date each data form (Reviewed By)。文档为个人收集整理，来源于网络文档为个人收集整理，来源于网络每一个测试应当根据建立的测试程序执行。执行测试的人名和日期应被填写,用于确认测试已被执行.如有任何额外的信息需要备有证明文件，文件项将被使用。每一个测试执行完后,所获得数据应当被另一个人确认

18、测试完全执行,测试计划已执行，确保足够的文件已被提供.个人签名用首字母,日期用数据形式。The acceptance criteria are considered to be met when the collected data demonstrate that the equipment condition and/or operation are consistent with the requirements and acceptance criteria described in this protocol. Any deviation from the protocols tes

19、ting procedure or acceptance criteria must be evaluated immediately， in order to determine the impact on normal operation of the equipment。 A corrective action （resolution) should be assigned before completion of this protocol。 The exceptional condition and assigned resolution shall be documented in

20、 the Exceptional Condition Excel Sheet. 本文为互联网收集,请勿用作商业用途本文为互联网收集，请勿用作商业用途当收集的数据证明设备的状况和/或操作与草案描述的要求和测试标准一致时，验收标准应当认为相符。任何与草案测试程序或验收标准相偏移,为了终止对设备正常操作的影响，应当立即进行评估。在该项目完成之前，一个纠正的行为（决定）应当签字。异常状况和签字后的解决方案应当填写在异常状况 Excel 表格中备份。The following are the general documentation rules that apply to this document。

21、以下是总的文件规则,将应用于该文件。1.Qualified personnel must perform all tests. 执行所有测试的人应该是有资质的。2.All entries and manual additions and notes must be initialed and dated.所有条目和手册附件和注释应当签名和注明日期。3.If a mistake (which is self evident） is made, place a singleline cross out followed by initials / date。 Include an explanat

22、ion of the change in the comment section or next to the change. 如果发生错误（是不证自明的） ，用单横线删除，并签名和注明日期。包括评论项改变下一个改变的的说明。4.All entries must be in permanent black ink.所有条目必须使用永固黑墨签写.5.All supporting documentation must be logged。所有支持文件应当做标识.6.Any individual involved in the execution on this document must regi

23、ster on the signature log.任何在该文件的执行中有关的个人都应当登记在签字栏。7.Any blank line or blank space must be fully crossed through with a single diagonal line, initialed and dated along the line。任何空白行或空白区必须完全划单斜线，沿着线签名和注明日期。8.When completing information on the various attachments， write N/A if not applicable or N/AV

24、if not available.当在不同的附件上完善信息，若不适用则用 N/A,若不可用则用 N/AV。9.Annotations and/or handwritten corrections, notes, etc。, that are made on the test protocols and test scrip must be initialed and dated by the individual making the annotation. Annotation may not obscure the original text or content of the docum

25、ent。 Annotation may be made in a variety of situations, including but not limited to 写在测试草案和便条上的注释、手写修正、注解等，必须签名和注明日期，注释不能使原文或文件内容模糊。注释适用于不同的情形,包括但不限于： a.Correction of obvious typographical errors。明显的排字错误。b.Any substantive change to pre approved protocol/test script requires review and creation of a

26、 protocol deviation。任何名词的改变为预确认草案/测试手稿要求审核以及草案偏离的编写。c.Cross reference 参照。 10. The person who executes the protocol will sign their name or initials and date in the Verified By / Date box.执行草案的人将签名并注明日期在检验/日期栏内.11. The person who reviews the protocol will sign their name or initials and date in the R

27、eviewed By / Date line。 审核草案的人将签名并注明日期在审核/日期栏内。All tests or evaluation must be performed using the manuals and any other documentation related to the equipment to be tested in order to verify if they reflect the actual configuration and functionality of the equipments。所有测试或评估必须按照手册以及其它任何反映设备真实的配置和功能

28、的为了检验设备与其测试有关的文件执行。Signature Log 签字记录签字记录All personnel entering information in this protocol must complete the signature log. 该草案中所有输入信息的人员均需要签名。Name （Print)姓名姓名Company / Dept。公司。公司/部部门门Signature 签字签字Initials 简签简签Date 日期日期3.2.Exceptional Conditions 异常情况异常情况1.The following test situations are require

29、d to be recorded as Exceptional Conditions in Excel spread sheet。以下测试情形要求记录为异常情形在 Excel 表格中。a.An acceptance criteria is not met.一处验收标准不符合。b.A drawing error is identified and annotated; thus marked “no” in the “Compliant?” column of the results table.一处图纸错误被鉴别和注解，这样标注“否”在结果表格的“适应”栏内。c.The “actual res

30、ults” do not match the “expected results” of a test script.“实际结果”不符合测试手稿的“预期结果”.d.A protocol generation error is found which is not an obvious (obvious errors may be commented, initialed dated).一个草案错误产生被发现是否是显而易见的(显而易见的错误可以被注解、签名、注明日期） 。2.For each exception, list the EC , Description， Corrective Act

31、ions， Performer， State, Verifier and Date. 每一个异议，须注明编号，描述，修正方式，执行者,声明，检验者,日期。3.After all the exceptions are closed, sign and attach the Exceptional Conditions sheet as appendix 1。 所有的异议完成后，标记和贴上异议情况表格作为附件 1。4.PreTest Verification 预测试验证预测试验证4.1.Test Equipment Calibration Review 设备测试校验审核设备测试校验审核Object

32、ives 目的目的To record the calibration information for the test equipment to be used to execute this protocol and to verify that all test equipment used is within its calibration dates for the duration of the testing。 为了测试设备执行该草案并且检验所有使用的测试设备在其校验日期之内，记录校验信息。Procedure 步骤步骤1.Complete a list of the instrum

33、ents used to execute this protocol, recording Instrument Name / Model / Serial No. / Calibration Date / Calibration Due Date / Certificate Attached？ / Verified By / Date。完成执行该草案所用仪表清单,记录仪表名称、型号、系列号、校验日期、校验到期日期、校验附件、检验者、日期.2.Use the spaces provided in the results table to document instruments， and ve

34、rify all Test Equipment is in a calibrated state at the time of use and calibration certification is available。使用文件仪表的结果栏提供的空间，检验所有测试设备在同一校验状态下使用并且校验证书有效。3.Attach the calibration certificate（s） for each test instrument to this test。每一个测试仪表须附上校验证书。Acceptance Criteria 检验标准检验标准All instruments used to e

35、xecute the testing in this protocol are in a calibrated state and will be for the duration of the testing。所有用于执行该草案测试的仪表应在一个校验状态下，并在整段测试时间内有效。Results Test Equipment Calibration Review 检测设备校准审核检测设备校准审核Instrument Name 仪表名仪表名Model 型号型号Serial Number 系系列号列号Calibration Date 校验日校验日期期Calibration Due Date 校验

36、到期日校验到期日期期Certificate Attached ？(Y/N）证书附）证书附件件Verified By / Date 检验检验/日日期期Comments 注解：注解：Acceptance Criteria Met？ （Yes / No):验收标准符合（是/否）_ _ If not refer to EC :若否，参考的异常情况号:_ _Reviewed By 审核审核:Date 日期：日期：5.Hardware operating verification 硬件确认硬件确认5.1.Hardware operating environment verification 硬件运行环境确

37、认硬件运行环境确认 Objectives 目的目的 Measure the temperature in the Control cabinet. The temperature for the control cabinet equipment shall not exceed 40C. 测量控制柜中的温度。控制柜设备的温度不应当超过40C Procedures 程序程序1。 Verify the rubber stopper cleaning in the normal normal state. 确认胶塞清洗机在正常工作状态。2. Measure the temperature in t

38、he Control cabinet with a thermometer 使用温度计测量控制柜内温度。3. Complete the results table.完成结果栏。Acceptance Criteria 验收标准验收标准For control cabinets without built in ventilation shall the temperature inside the control cabinet not ex-ceed 40C。 对于没有内置通风装置的控制柜来说，控制柜内温度不应当超过 40CResults 验证结果表验证结果表Hardware operating

39、 environment 硬件运行环境硬件运行环境No序号序号Test Procedure 测试程序测试程序Pass / Fail 通过通过/不通过不通过Verified By / Date 检验检验/日日期期1Shall the temperature inside the control cabinet not ex-ceed 40C. 控制柜内温度不应当超过 40CComments 注释注释:Acceptance Criteria Met？ (Yes / No）：验收标准符合（是/否）_ _ If not refer to EC #:若否，参考的异常情况号：_ _Reviewed By

40、审核审核:Date 日期：日期：6.PLC Logics verification PLC 逻辑确认逻辑确认6.1.Alarm List Verification 报警清单验证报警清单验证Objectives 目标目标To verify the following 确认以下内容：1.Correct alarm message is shown on the alarm screens and recorded when an alarm is active. 当报警激活时，正确的报警信息在报警画面显示和记录.Procedures 程序程序 1.Obtain the Alarms Verific

41、ation Checklist with the appropriate information （not limited to） as follows：依照下文得到一份含有正确信息(不限于）的报警检查表:a.Alarm Name， ， i.e。 ， name of the alarm variable 报警名称，也就是报警变量的名称。b.Alarm Message, i。e。 ， description of the alarm variable 报警信息，也就是报警变量的说明.2.Test each alarm with the appropriate procedur es as fol

42、lows， and identify those items which have been verified noting as necessary those items in non compliance。依照以下可用程序测试每一个报警，并且在已经检验的检查表中标记出不符合项。a.PLC Generated Alarms ： create each alarm manual， correct message is shown on main and footer alarm screens, and then disappears after the alarm is de-active

43、 and acknowledged. PLC 产生的报警：对每一个报警，人工触发 PLC 产生报警，在报警主画面和报警页脚画面显示正确的信息, 并且在报警消失和确认后，信息消失3.Complete the results table. 完成结果列表。4.Attach a copy of the verified Alarms Verification Checklist to this test. 为此测试附上一份已经检验的报警检查表。Acceptance Criteria 验收标准验收标准 The alarms function correctly。 报警功能是正确的。验证结果表验证结果表:

44、报警清单验证报警清单验证 Results Alarm List Verification序号序号No测试程序测试程序 Test Procedure是否通是否通过验证过验证Pass / Fail验证人验证人/日期日期Verified By / Date1Obtain the Alarms list Verification Checklist， and record the file information here: 得到一份报警检查表，并且在这里记录文件信息：Reference: _ Rev: _ Date： _N/A2Verify that the PLC generated alarms

45、 for the system function correctly. 确认 PLC 针对系统功能产生的报警是正确的。3Verify the PLC communication alarm functions correctly. 确认 PLC 通讯报警功能是正确的。4Verified a copy of the verified Alarms Verification Checklist is signed / dated and attached.确认一份已经检验的报警检验报告已经签名，注明日期并已随附在此文件后.N/A备注备注: Comments:Acceptance Criteria

46、Met? (Yes / No)：验收标准符合（是/否)_ _ If not refer to EC #:若否,参考的异常情况号：_ _Reviewed By 审核审核:Date 日期日期:6.2.Manual Control Verification 手动控制确认手动控制确认Objectives 目标目标To verify the manual controls accessible on main screen function well。确认操作主屏上的手动控制运行良好.Procedures 程序程序1.Prior to the testing commencing verify the

47、following:检验之后请确认达到以下状况：a.Lock off the back cover of the cleaning chamber completely and close the discharge system completely 箱体后盖锁紧到位，出料系统关闭到位。b.Water supply and pressure of compressed air are normal供水和压缩空气压力正常。c.Start up the manually controlled mode启动手动控制方式。2.Obtain the Manual Control Verificatio

48、n Checklist取得一份手动控制验证检查表。3.Follow the steps listed in the checklist， and identify on the checklist those items which have been verified noting as necessary those items in non compliance. 按检查表中所列的步骤，在检查表上确认出不合格项。4.Complete the results table完成验证结果表。5.Attach a copy of the verified Manual Control Verifi

49、cation Checklist to this test.将手动控制验证检查表随附在此检验之后.Acceptance Criteria 验收标准验收标准The manual controls operate in accordance with the system specification as verified in the results table手动控制操作与验证结果表中的系统说明书部分一致.Results 结果结果 Manual Control Verification 手动控制验证手动控制验证序号序号No检验步骤检验步骤Test Procedure是否通是否通过验证过验证Pa

50、ss / Fail验证人验证人/日期日期Verified By / Date1Obtain the Manual Control Verification Checklist， and record the file information here: 取得一份手动控制验证检查表,并在此处记录文件信息Reference： _ Rev: _ Date: _N/A2Verify that the manual controls in accordance with the system specification。确认手动控制与系统说明书一致。3Verify a copy of the verif

51、ied Manual Control Verification Checklist is signed / dated and attached。 确认已验证过的手动控制检查表已经签署姓名和日期并已随附在此文件后。N/A备注备注 Comments:Acceptance Criteria Met? （Yes / No):验收标准符合(是/否）_ _ If not refer to EC ：若否，参考的异常情况号：_ _Reviewed By 审核审核:Date 日期日期:6.3.Cycle Sequence Verification 循环顺序的确认循环顺序的确认Objectives 目标目标确认

52、清洗、硅化、灭菌、干燥等操作循环的次序是否与系统说明书一致.To verify that the cleaning, Siliconizing， Sterilizing and drying Cycle sequence operates in accordance with the system specification.Procedures 程序程序1.Prior to the testing commencing verify the following 测试前应确认以下内容：a.Lock off the back cover of the cleaning chamber compl

53、etely and close the discharge system completely 箱体后盖锁紧到位，出料系统关闭到位。b.All valves are initially at their no cycle normal state 全部阀门处于设备未进行循环操作前的最初正常状态。c.Compressed air and utility are normal 压缩空气和公共供应正常。d.Set the appropriate parameter on the setting screen according the operation Instruction. 按照操作说明书在设

54、置屏上设置合适的参数e.Start up the automatically controlled mode. 启动自动控制方式。2.Start the auto cycle on the main operation screen 在操作主屏上启动自动循环过程。3.Follow the steps listed in the results table， and document the verified results遵照结果表上所列的步骤，并记录验证结果。验收标准验收标准 Acceptance CriteriaThat the auto cycle sequence operates i

55、n accordance with the system specification as verified by the results table.自动循环操作次序与经结果表验证过的系统说明书一致。Results 结果结果Cycle Sequence Verification 循环次序确认循环次序确认步骤步骤序号序号Step No步骤名称步骤名称Step Name检验步骤检验步骤Test Procedure是否通是否通过验证过验证Pass / Fail验证人验证人/日期日期Verified By / Date1Vacuum Feeding真空进料Verify the following 确

56、认以下内容:1. Correct step messages are displayed at the status screen.状态屏上显示正确的步骤信息2. The main motor rotating at setting speed, and automatic positioning 主电机以设定转速运转，并自动定位3。 The cleaning barrel strobe align to the lower pipe orifice of 17# charging cylinder automatically ， Bring out a menu with “start” “

57、Pause” and “finish button, charging cylinder down to lower limit 内清洗筒小阀门与 17进料气缸的下管口自动对齐，弹出一个“开始”“暂停”“结束的菜单，进料气缸下降到下限位4。 Click “start” botton， the 11# valve open， the vacuum pump start and the 16 valve open； click “pause” botton, the 11# valve and vacuum pump close； click “finish” botton, the 16# va

58、lve close, charging cylinder up to upper limit. 点击开始,11阀打开,真空泵运转,16#阀打开，点击暂停，11#真空阀和真空泵关闭，点击结束，16#进料阀关闭，进料气缸上升到上限位2Spraying Rough Washing喷淋粗洗Verify the following 确认以下内容：1。 Correct step messages are displayed at the status screen.状态屏上显示正确的步骤信息2. The main motor rotating at setting speed 主电机以设定转速运转3. T

59、he purified water valve， overfall valve， draining valve, normal pressure valve and steam drain valve open; after the setting time， the purified water valve close; the overfall valve， drain valve, normal pressure valve and steam drain valve close until water level detector detect no water in the drai

60、ning pipe 纯化水阀，溢流阀，排水阀,常压化阀和排蒸汽阀打开，设定时间到，纯化水阀关闭；水位传感器显示排水管道内无水时，溢流阀,排水阀,常压化阀排蒸汽阀关闭步骤步骤序号序号Step No步骤名称步骤名称Step Name检验步骤检验步骤Test Procedure是否通是否通过验证过验证Pass / Fail验证人验证人/日期日期Verified By / Date3Purified Water Rinsing纯化水漂洗Verify the following 确认以下内容:1。 Correct step messages are displayed at the status screen.状态屏上显示正