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ISPE baseline volume4-Water and Steam System 2《制药用水及蒸汽系统 (第二版) 》:本指南的英文版出版日期为2011年12月，是市面上唯一一本用于指导新建水和蒸汽系统按照现行GMP及相关法规和指南进行设计、建造、运行和维护的指南性丛书。具体内容包括设计原理、最终处理选择、储存和分配系统、实验室用水、红锈和不锈钢、调试和确认，以及制药用水系统微生物注意事项等。第二版为如何满足中国新版GMP有关于水和蒸汽系统的要求提供了具体指导原则，具有较高的参考价值和市场推广价值。
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Table of Contents 1Introduction..........................................................................................................................9 1.1Background...................................................................................................................................................9 1.2 Scope of this Guide......................................................................................................................................9 1.3 Key Topics included in thisGuide...............................................................................................................10 1.4 GuideStructure...........................................................................................................................................12 2 Key DesignPhilosophies..................................................................................................13 2.1Introduction.................................................................................................................................................13 2.2 Pharmacopeial Water and Steam...............................................................................................................13 2.3 Specification of Pharmaceutical WaterQuality...........................................................................................14 2.4 Critical ProcessParameters.......................................................................................................................15 2.5 CGMP ComplianceIssues..........................................................................................................................16 2.6 Design Range versus OperatingRange.....................................................................................................16 3 Water Options and SystemPlanning...............................................................................19 3.1Introduction.................................................................................................................................................19 3.2 Water Quality Options.................................................................................................................................19 3.3 SystemPlanning.........................................................................................................................................25 3.4 SystemDesign............................................................................................................................................30 4 PretreatmentOptions........................................................................................................31 4.1Introduction.................................................................................................................................................31 4.2 Process Design of Pretreatment.................................................................................................................31 4.3 Feed Water to Pretreatment Quality: Testing andDocumentation.............................................................. 33 4.4 Output Water from Pretreatment: Quality of Feed Waterto Final Treatment.............................................. 34 4.5 Control of Fouling: Removal of Turbidity andParticulates..........................................................................35 4.6 Control of Scaling: Removal of Hardness andMetals................................................................................37 4.7 Organic Material andRemoval...................................................................................................................41 4.8 System Design for Control of MicrobialGrowth..........................................................................................44 4.9 Removal of Microbial ControlAgents..........................................................................................................46 4.10 Changes in AnionComposition/Concentration...........................................................................................49 4.11 The Importance of pH inPretreatment.......................................................................................................51 4.12 Materials of Construction and ConstructionPractices................................................................................51 4.13 Water Conservation....................................................................................................................................52 4.14Summary.....................................................................................................................................................52 5 Final Treatment Options: Non-Compendial Waters,Compendial Purified Water,and Compendial Highly Purified Water......53 5.1 Introduction.................................................................................................................................................53 5.2 IonExchange..............................................................................................................................................55 5.3 ReverseOsmosis........................................................................................................................................61 5.4 Continuous Electrodeionization (CEDI). 66 5.5 Polishing and Removal of SpecificContaminations...................................................................................69 6 Final Treatment Options: Water for Injection(WFI)........................................................ 77 6.1 Introduction.................................................................................................................................................77 6.2 PharmacopeialIssues................................................................................................................................77 6.3 General TechnologyDiscussion..................................................................................................................79 6.4 Process and Systems Description..............................................................................................................83 6.5 Final Treatment – General System-Wide Controls andInstrumentation.................................................... 90 6.6 Summary and Technology Comparison......................................................................................................90 7 PharmaceuticalSteam......................................................................................................93 7.1 Introduction.................................................................................................................................................93 7.2 Common Steam Terms andDefinitions......................................................................................................93 7.3 Types ofSteam...........................................................................................................................................94 7.4 Regulatory and Industry Guidance.............................................................................................................95 7.5 Background and IndustryPractices............................................................................................................96 7.6 SystemPlanning.........................................................................................................................................97 7.7 SteamGeneration.....................................................................................................................................100 7.8 Steam Attributes and CondensateSampling............................................................................................102 7.9 Materials ofConstruction..........................................................................................................................103 7.10Distribution................................................................................................................................................104 8 Storage and DistributionSystems.................................................................................107 8.1Introduction...............................................................................................................................................107 8.2Purpose.....................................................................................................................................................107 8.3 SystemComponents................................................................................................................................107 8.4 Materials ofConstruction/Finishes............................................................................................................118 8.5 Microbial ControlConsiderations..............................................................................................................123 8.6 SystemDesigns........................................................................................................................................124 9 LaboratoryWater.............................................................................................................139 9.1Introduction...............................................................................................................................................139 9.2 System DesignConsiderations.................................................................................................................139 9.3 Determining User Needs..........................................................................................................................140 9.4 Water PurificationTechnologies................................................................................................................152 9.5 Laboratory Water SupplyOptions.............................................................................................................152 9.6Maintenance.............................................................................................................................................161 9.7 Instruments andCalibration......................................................................................................................161 9.8 Commissioning and Qualification.............................................................................................................162 10 Rouge and StainlessSteel..............................................................................................165 10.1 Introduction...............................................................................................................................................165 10.2 Regulatory Stance....................................................................................................................................166 10.3 Surface Conditions andTreatments.........................................................................................................167 10.4 RougeFormation......................................................................................................................................171 10.5 Rouge Detection(Methodology)...............................................................................................................178 10.6 Risk Analysis – Rouge and itsRemediation.............................................................................................183 10.7 Rouge Remediation (Methodology)..........................................................................................................185 10.8Conclusions..............................................................................................................................................190 11 Control andInstrumentation...................................................................................................................191 11.1Introduction...............................................................................................................................................191 11.2Principles..................................................................................................................................................192 11.3 General Instrumentation Requirements....................................................................................................193 11.4 Design Conditions versus OperatingRange.............................................................................................200 11.5 InstrumentationSpikes.............................................................................................................................201 11.6 ControlSystems........................................................................................................................................201 12 Commissioning andQualification..................................................................................205 12.1Introduction...............................................................................................................................................205 12.2 Sampling for WaterSystems....................................................................................................................205 12.3 Sampling for SteamSystems...................................................................................................................206 12.4 AcceptanceCriteria..................................................................................................................................206 12.5 Change Control and Maintaining the Qualified Stateof the System......................................................... 208 13 Microbiological Considerations for PharmaceuticalWater Systems......................... 209 13.1Introduction...............................................................................................................................................209 13.2 The Microbial Growth Process in High Purity WaterSystems.................................................................. 209 13.3 Detrimental Effects ofBiofilm....................................................................................................................212 13.4 Microbial Control Strategies......................................................................................................................214 13.5 SanitizerChoices......................................................................................................................................220 13.6 Assessing Microbial ControlSuccess.......................................................................................................235 13.7 Functional Microbiological Pharmacopeial Compliance...........................................................................239 13.8 Microbial and Endotoxin Control in Pure SteamSystems........................................................................241 14 Appendix 1 – References................................................................................................243 15 Appendix 2 –Glossary....................................................................................................247 15.1 Acronyms and Abbreviations....................................................................................................................247 15.2Definitions.................................................................................................................................................249
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