操作确认OQ(中英文).docVIP

EXECUTION APPROVAL SIGNATURES 批准执行签名 The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendment which must be approved prior to execution. 下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。 Department Site 单位部门 Signature Date 签名与日期 Issued by 起草 Reviewed by 审核 Authorized by 批准 Contents目录 1.0 SCOPE 范围 3 2.0 PURPOSE 目的 3 3.0 BACKGROUND 背景 3 4.0 INTRODUCTION 介绍 3 5.0 REFERENCES 参考书目 4 6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任 4 7.0 SYSTEM DESCRIPTION 系统说明 5 General Description 总说明 5 Pretreatment Unit 预处理单元 6 Reverse Osmosis (RO) System 反渗透 (RO) 系统 7 Mixed Bed System 混床系统 8 Monitor and Control System 监视和控制系统 9 8.0 TESTING PROCEDURES 检验程序 9 9.0 ACCEPTANCE CRITERIA 验收标准 9 Attachment 1 - Validation Test Equipment and Materials 附件1—验证测试设备和材料 11 Attachment 2 - Sand Filter Data Sheet 附件2 – 砂滤器数据表 12 Attachment 3 - Carbon Filter Data Sheet 附件3 - 碳滤器数据表 13 Attachment 4 - Softener Data Sheet 附件4 – 软化器数据表 14 Attachment 5 - 5.0 μm Micron Filter Data Sheet 附件5 - 5.0微米过滤器数据表 15 Attachment 6 - Reverse Osmosis Unit Data Sheet 附件6 - 反渗透单元数据表 16 Attachment 7 – Mixed Bed Unit Data Sheet 附件7 – 混床单元数据表 17 Attachment 8 - PW Circulation Pump Data Sheet 附件8 – 纯化水循环泵数据表 18 Attachment 9 - UV Unit Data Sheet 附件9 - UV 单元数据表 19 Attachment 10 - PW Unit Manual Start-UP Data Sheet 附件10 - PW 单元手动启动数据表 20 Attachment 11 - PW Unit Automatic Start-UP Data Sheet 附件11 – 纯化水单元自动启动数据表 25 Attachment 12 - Purified Water System Data Sheet 附件12 - 纯化水系统数据表 26 Attachment 13 - PW Sanitation Cycle Verification 附件13 – 纯化水系统卫生循环验证 34 Attachment 14 - Purified Water Sample Test Result Form 附件14 - 纯化水样品检验结果表 35 Attachment 15 – 4T PW Storage Tank Level Control 附件15 – 4T 纯化水储罐液位控制 36 Attachment 16 - System Monitors 附