ISPE第四卷，水系统”中英文对照.pdf

TABLE OF CONTENTS 目录 ACKNOWLEDGEMENTS 致谢 1. INTRODUCTION 1.1 BACKGROUND 1.2 SCOPE OF THIS GUIDE 1.3 SOME APPLICABLE FDA CURRENT REGULATIONS AND GUIDES FOR PHARMACEUTICAL WATER SYSTEMS. 1.4 KEY CONCEPTS 1.5 GUIDE STRUCTURE 1. 序论 1.1 背景 1.2 本指南适用范围 1.3 一些可适用于制药用水系统的FDA 现行法规和指南 1.4 重要概念 1.5 指南结构 2. KEY DESIGN PHILOSOPHIES 2.1 INTRODUCTION 2.2 UNITED STATES PHARMACOPOEIA (USP) 2.3 SPECIFICATION OF PHARMACEUTICAL WATER QUALITY 2.4 CRITICAL PROCESS PARAMETERS 2.5 CGMP COMPLIANCE ISSUES 2.6 DESIGN RANGE VERSUS OPERATING RANGE 2. 主要设计原理 2.1 序论 2.2 美国药典 (USP) 2.3 制药用水质量技术指标 2.4 关键过程参数 2.5 cGMP 顺应性问题 2.6 设计范围与操作范围的比较 3. WATER OPTIONS AND SYSTEM PLANNING 3.1 INTRODUCTION. 3.2 WATER QUALITY OPTIONS 3.3 SYSTEM PLANNING 3.4 SYSTEM DESIGN 3. 水选项和系统计划 3.1 序论 3.2 水质选项 3.3 系统计划 3.4 系统设计 4. PRETREATMENT OPTIONS 4.1 INTRODUCTION 4.2 PROCESS DESIGN OF PRETREATMENT. 4.3 FEEDWATER TO PRETREATMENT QUALITY: TESTING AND DOCUMENTATION. 4.4 OUTPUT WATER FROM PRETREATMENT: QUALITY OF FEEDWATER TO FINAL TREATMENT. 4.5 CONTROL OF FOULING: REMOVAL OF TURBIDITY AND PARTICULATES. 4.6 CONTROL OF SCALING: REMOVAL OF HARDNESS AND METALS 4.7 REMOVAL OF ORGANICS 4.8 SYSTEM DESIGN FOR CONTROL OF MICROBIAL GROWTH 4.9 REMOVAL OF MICROBIAL CONTROL AGENTS 4.10 CHANGES IN ANION COMPOSITION / CONCENTRATION 4.11 THE IMPORTANCE OF PH IN PRETREATMENT 4.12 MATERIALS OF CONSTRUCTION AND CONSTRUCTION PRACTICES 4.13 PRETREATMENT SUMMARY 4. 预处理选项 4.1 序论 4.2 预处理的过程设计 4.3 预处理给水水质：测试和文件记录 4.4 预处理输出水：终处理给水的水质 4.5 污垢控制：颗粒和混浊的去除 4.6 结垢控制：硬度和金属的去除 4.7 有机物的去除 4.8 控制微生物生长的系统设计 4.9 微生物防治因子的去除 4.10 阴离子组份/浓度的变化 4.11 预处理中pH 的重要性 4.12 构成材料和建造 4.13 预处理摘要 5. FINAL TREATMENT OPTIONS: NON-COMPENDIAL AND COMPENDIAL PURIFIED WATER 5.1 INTRODUCTION 5.2 ION EXCHANGE 5