OQ Document运行确认文件Objectives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:Document No文件号: OQ1-20131468Reviewed By审核:Approved By批准: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:TABLE OF CONTENTS1.NOMENCLATURE AND ABBREVIATIONS术语和缩写 (4)2.SYSTEM DESCRIPTION系统描述 (5)2.1.P ROJECT C ONFIGURATION项目配置 (5)2.2.A CCEPTANCE C RITERIA验收标准 (6)3.EXECUTION REQUIREMENTS实施要求 (7)3.1.E XECUTION R ULES &P RACTICES实施规则&惯例 (7)3.2.E XCEPTIONAL C ONDITIONS异常情况 (9)4.PRE-TEST VERIFICATION预测试验证 (10)4.1.T EST E QUIPMENT C ALIBRATION R EVIEW设备测试校验审核 (10)5.HARDWARE OPERATING VERIFICATION硬件确认 (12)5.1.H ARDWARE OPERATING ENVIRONMENT VERIFICATION硬件运行环境确认 (12)6.PLC LOGICS VERIFICATION PLC逻辑确认 (13)6.1.A LARM L IST V ERIFICATION 报警清单验证 (13)6.2.M ANUAL C ONTROL V ERIFICATION手动控制确认 (15)6.3.C YCLE S EQUENCE V ERIFICATION 循环顺序的确认 (17)7.PERFORMANCE VERIFICATION 性能确认 (24)7.1.CIP C OVERAGE V ERIFICATION (CIP O PTION)CIP覆盖确认 (24)7.2SIP E FFECTIVENESS V ERIFICATION (SIP O PTION)SIP有效性确认 (26)7.3V ACUUM I NTEGRITY T EST真空完整性测试 (27)8.EXCEPTIONAL CONDITIONS偏差 (29)1. Nomenclature and Abbreviations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BOM Bill Of Material材料一览表CIP Clean In Place 在线清洗COC Certificate Of Conformance一致性确认DP Differential Pressure 压差ECD Electrical Circuit Diagrams电路图E-Stop Emergency Stop急停FAT Factory Acceptance Test工厂验收测试GA General Arrangement总装图HDS Hardware Design Specifications硬件设计说明H/W Hardware硬件HMI Human Machine Interface人机界面Hz Hertz赫兹I/O Input / Output输入/输出ID Identification识别IQ Installation Qualification安装确认MTR Material Tracking Records材料N/A Not Applicable无此项N/T Not Tested没有经过检验的No. Number序号OQ Operation Qualification操作确认P/N Part Number零件号P&I D Piping and Instrumentation Diagrams管路仪表图PLC Programmable Logic Controller可编程逻辑控制器S/N Serial Number序列号S/W Software软件SIP Sterilization In Place在线灭菌T/C Thermocouple热电阻µbar Microbar (unit measure of vacuum level)微巴WFI Water For Injection注射用水2. System Description系统描述2.1. Project Configuration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/diameter DN1200mm ,aperture diameter Φ10mm.内清洗筒直径DN1200mm，孔径Φ10mmD. Vacuum feeding, air flushing and central spray washing, vacuum and electric-heat drying, Interchange the hotair 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，吸入百级新风置换箱体内热空气和换热器冷却，自动出料E. SK-3.8 vacuum pump. SK-3.8真空泵F. GRUNDFOS CM10-3 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 high-temperature 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 (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S7-200CN的PLCO. SIEMENS 6SE6 440 transducer. 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3. Execution Requirements实施要求3.1. Execution Rules & Practices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 the 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 performed 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).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 protocol’s testing procedure or accepta nce 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 the Exceptional Condition Excel Sheet.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。