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EXECUTION APPROVAL SIGNATURES 批准执行签名 Thesignatures below indicate approval of this protocol and its attachments andindicate that it is ready for execution. Any changes or modifications to the intent or the acceptance criteria ofthis protocol, following approval, requires the generation of an amendmentwhich 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。 Contents
目录 1.0 SCOPE 范围....................................................................................................................................................................... 4 2.0 PURPOSE 目的...................................................................................................................................................................... 4 3.0 BACKGROUND- 背景......................................................................................................................................................... 4 4.0 INTRODUCTION 介绍........................................................................................................................................................ 4 5.0 REFERENCES 参考书目................................................................................................................................................... 5 6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任.......................................................... 6 7.0 SYSTEM DESCRIPTION 系统说明................................................................................................................................ 7 General Description 总说明..................................................................................................................................................... 7 Pretreatment Unit 预处理单元............................................................................................................................................... 8 Reverse Osmosis (RO) System 反渗透 (RO) 系统............................................................................................................... 9 Mixed Bed System 混床系统..................................................................................................................................................... 9 Monitor and Control System 监视和控制系统.............................................................................................................. 10 8.0 TESTING PROCEDURES 检验程序............................................................................................................................ 10 9.0 ACCEPTANCE CRITERIA 验收标准.......................................................................................................................... 12 Attachment 1 - Validation Test Equipment andMaterials 附件1—验证测试设备和材料......................... 13 Attachment 2 - Specification and PurchaseOrder Verification 附件2— 规范和采购单确认................... 14 Attachment 3 - Engineering Drawing List 附件３—工程图纸清单........................................................................ 15 Attachment 4 - Standard Operating ProceduresList 附件4—标准操作程序清单.......................................... 16 Attachment 5 - Operation and MaintenanceManual List 附件5—操作和维护手册清单............................ 17 Attachment 6 - Major Component Labeling List 附件6 — 主要部件标签清单................................................. 18 Attachment 7 - Critical Instrument List 附件7— 关键仪器清单......................................................................... 19 Attachment 8 - Non-Critical Instrument List 附件8—非关键仪器清单............................................................. 20 Attachment 9 - Spare Parts List 附件9—备件清单...................................................................................................... 21 Attachment 10 - Installation ProceduresVerification Data Sheet 附件10—安装程序确认数据表..... 22 Attachment 11 - Utility Data Sheet:Electrical 附件11—公用工程数据表：电............................................ 23 Attachment 12 -- Utility Data Sheet:Compressed Air 附件12—公用工程数据表：压缩空气..................... 24 Attachment 13 -- Utility Data Sheet: CityWater 附件13—公用工程数据表：自来水................................. 25 Attachment 14 -- Utility Data Sheet:Waste/Drain 附件14—公用工程数据表：废水/排水......................... 26 Attachment 15 -- PW Distribution Loop DataSheet 附件15—纯化水循环回路数据表................................... 27 Attachment 16– Chemical Tank and Dosing PumpData Sheet 附件16—化学罐和计量泵数据表............. 28 Attachment 17 – Sand Filter Data Sheet 附件17—砂滤过滤器表......................................................................... 29 Attachment 18 -- Heat Exchanger Data Sheet(Pretreatment) 附件18—热交换器数据表（预处理）... 30 Attachment 19 -- Activated Carbon Filter DataSheet 附件19—活性炭过滤器数据表............................... 31 Attachment 20 – Sterilization Pump Data Sheet附件20—灭菌循环泵数据表................................................. 32 Attachment 21 -- Softener Data Sheet 附件21—软化器数据表.............................................................................. 33 Attachment 22 -- Precision Filter Data Sheet 附件22—精密过滤器数据表....................................................... 34 Attachment 23 –Booster Pumps Data Sheet 附件23—增压泵数据表................................................................... 35 Attachment 24– RO Cleaning Tank and Pump DataSheet 附件24– RO药洗箱和泵数据表......................... 36 Attachment 25 -- Reverse Osmosis (RO) System Data Sheet 附件25 --反渗透 (RO) 系统数据表.............. 37 Attachment 26 -- Intermediate Storage TankData Sheet 附件26 -- 中间储罐数据表................................. 38 Attachment 27 -- Mixed Bed System Data Sheet 附件 27 --混床系统数据表................................................. 39 Attachment 28– Mixed Bed Regeneration Tanksand Pumps Data Sheet 附件28– 混床再生酸碱箱和泵数据表 40 Attachment 29 -- Micro Filter Data Sheet 附件29—微滤器数据表...................................................................... 41 Attachment 30 --4T Deionized Water StorageTank Data Sheet 附件30 – 4吨去离子水储罐数据表...... 42 Attachment 31 --1T PW Storage Tank Data Sheet附件31 – 1吨纯水储罐数据表........................................... 43 Attachment 32- Storage Tank Spray Ball DataSheet 附件32 –储罐喷淋球数据表...................................... 44 Attachment 33 -- UV Sanitizer Unit Data Sheet附件33 -- UV 灭菌器数据表.................................................... 45 Attachment 34 – Resin Tank Data Sheet 附件34—核子级树脂罐表...................................................................... 46 Attachment 35 --2T PW Storage Tank Data Sheet附件35 – 2吨纯水储罐数据表........................................... 47 Attachment 36 --300L PW Storage Tank DataSheet 附件36 – 300L纯水储罐数据表.................................... 48 Attachment 37 --Heat Exchanger Loop BufferTank Data Sheet 附件37 – 热交换器循环缓冲罐数据表 49 Attachment 38 -- Valve Data Sheet 附件38 -- 阀门数据表....................................................................................... 50 Attachment 39 - Sample Ports Data Sheets 附件39 - 取样口数据表..................................................................... 51 Attachment 40 - Signature Verification List 附件40 - 签名确认清单.............................................................. 52 Attachment 41 -- Protocol Deviation Log 附件41 -- 文件偏差日志...................................................................... 53 Attachment 42 -- Protocol Deviation Record 附件42 -- 文件偏差记录.............................................................. 54 Attachment 43 -- Protocol Execution ApprovalSignatures Data Sheet 附件43 --文件执行批准签名数据表 55
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发表于 2013-12-24 14:34:52
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