胶塞清洗机运行认(OQ)

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: OQ1-20131468

Reviewed 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 CONTENTS

1.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