ISPE HVAC 国际制药工程协会对空调系统的基准指南（中文翻译）【完整版】

1INTRODUCTION简介..................................................................................................................................71.1BACKGROUND背景....................................................................................................................................71.2SCOPEOFTHISGUIDE指南范围.................................................................................................................71.3OBJECTIVESOFTHISGUIDE指南目的........................................................................................................91.4DEFINITIONS定义.......................................................................................................................................91.5REFERENCES参考文献.............................................................................................................................102.FUNDAMENTALSOFHVAC空气净化系统的基本原则.......................................................................132.1INTRODUCTION简介.................................................................................................................................132.2WHATISHVAC?..........................................................................................................................................132.2.1Peoplecomfort人员的舒适.............................................................................................................142.2.2ProductandProcessConsiderations产品与工艺注意事项...............................................................162.2.3HowdoestheHVACsystemcontroltheseparameters?空气净化系统如何控制这些参数？.........182.2.4Whatcan’ttheHVACSystemdo?空气净化系统不能做什么？.......................................................182.3AIRFLOWFUNDAMENTALS气流基本原则...................................................................................................192.3.1Introduction简介.................................................................................................................................192.3.2VentilationFundamentals通风基本原则............................................................................................192.3.3ContaminationControl污染控制........................................................................................................202.3.4Airlocks气闸........................................................................................................................................212.3.5ClassifiedSpace分类空间.................................................................................................................212.3.6TotalAirflowVolumeandVentilationRate总风量与通风率...............................................................232.3.7RoomDistributionandQualityofincomingair房间布局和进气质量..............................................262.3.8AirflowDirectionandPressurization气流方向与增压......................................................................262.4PSYCHROMETRICS湿度测定法..................................................................................................................272.4.1Introduction简介.................................................................................................................................272.4.2BasicPropertiesofAir空气的基本性质.............................................................................................282.4.3PsychrometricPropertiesofAir空气的湿度性质...............................................................................292.5EQUIPMENT设备........................................................................................................................................302.5.1Introduction简介...............................................................................................................................302.5.2AirHandingUnit(Ahu)空气处理单元.............................................................................................302.5.3Fan风机...............................................................................................................................................302.5.4FumeExhaust/ExtractionSystem烟尘排除系统................................................................................312.5.5HeatingCoil加热旋管.........................................................................................................................312.5.6CoolingCoil冷却盘管.......................................................................................................................312.5.7Humidifier增湿器..............................................................................................................................312.5.8Dehumidifier除湿器..........................................................................................................................312.5.9AirFiltration空气过滤器..................................................................................................................312.5.10Ductwork管道系统..........................................................................................................................312.5.11DamperAndLouver风门和天窗.....................................................................................................322.5.12DiffuserandRegister扩散器和调风器...........................................................................................322.5.13Ultraviolet(UV)Light紫外灯..........................................................................................................322.6HVACSYSTEMCONFIGURATIONHVAC系统配置......................................................................................332.6.1Introduction简介...............................................................................................................................332.6.2BasicSystemTypes基本系统类型.....................................................................................................342.6.3AirHandlingUnitConfigurations空气处理单元的构造...................................................................382.6.4AIRLOCKSTRATEGIES气闸 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....................................................................................................442.6.5Ventilation/supplystrategies通风/供风方案.....................................................................................512.6.6EXTRACT(EXHAUSTAND/ORRETURN)STRATEGIES抽气（排气和回风）方案................542.6.7DISTRIBUTION分布.........................................................................................................................552.7HVACCONTROLSANDMONITORINGHVAC控制与监测.............................................................552.7.1Introduction简介...............................................................................................................................552.7.2Controls控制.....................................................................................................................................552.7.3Actuationmethods驱动法..................................................................................................................572.7.4Instrumentation测量仪表..................................................................................................................592.7.5EnvironmentalMonitoring环境检测.................................................................................................662.7.6Equipmentmonitoring设备监测.......................................................................................................702.8SYSTEMECONOMICS系统经济...........................................................................................................712.8.1Introduction简介...............................................................................................................................712.8.2LifeCycleCostAnalysis生命周期成本分析.....................................................................................742.8.3UserRequirementsSpecification用户要求说明...............................................................................782.8.4LifeTimeOperatingCosts寿命运行成本.........................................................................................812.8.5ComparingOptions对比选择............................................................................................................812.9SUSTAINABILITY(TOBEWRITTENLATER)可持续性（以后再写）..............错误！未定义 书 关于书的成语关于读书的排比句社区图书漂流公约怎么写关于读书的小报汉书pdf 签。3THEDESIGNPROCESS 设计 领导形象设计圆作业设计ao工艺污水处理厂设计附属工程施工组织设计清扫机器人结构设计 过程..............................................................................................................833.1INTRODUCTION简介.............................................................................................................................833.1.1SystemDesignProcess系统设计工艺...............................................................................................833.1.2RegulatoryConsiderations监管事宜................................................................................................853.2DEVELOPINGTHEUSERREQUIREMENTSSPECIFICATION(URS)发展用户需求说明书..........873.2.1Introduction简介...............................................................................................................................873.2.2ReferencesforUserRequirements用户需求参考.............................................................................903.2.3HVACParametersHVAC系统参数................................................................................................913.2.4CriticalParameters关键参数...........................................................................................................933.2.5ProgrammingandLayoutConsiderations规划和布局注意事项.....................................................933.2.6ArchitecturalConsiderations建筑注意事项.....................................................................................973.3HVACSYSTEMRISKASSESSMENTHVAC系统风险评估...............................................................1003.3.1Introduction简介.............................................................................................................................1004HVACAPPLICATIONSBYPROCESSANDCLASSIFICATIONHVAC在工艺与不同洁净度分类中的运用................................................................................................................................................................1044.1INTRODUCTION简介...........................................................................................................................1044.2SYSTEMAPPLICATIONS系统的运用................................................................................................1054.2.1ISPEGrade7orISPEGrade8WithlocalprotectionorISPEgrade5含局部保护或ISPE5级的ISPE7级和ISPE8级................................................................................................................................1064.2.2ISPEGradeCNC(ControlledNotClassified)orunclassifiedISPECNC等级（受控但不分类）或未分类等级....................................................................................................................................................1074.2.3LAB实验室......................................................................................................................................1084.2.4Warehouse仓库................................................................................................................................1094.2.5Administration管理区域.................................................................................................................1094.3ROOMLEVELEXAMPLES室内等级实例...........................................................................................1104.4ACTIVEPHARMACEUTICALINGRADIENTS(API)–(WETEND)原料药-液体产品....................1164.4.1SystemSchematic(Sample)系统框图（示例）...............................................................................1164.4.2SystemDesignConsiderations系统设计注意事项..........................................................................1164.5ACTIVEPHARMACEUTICALINGRADIENTS(API)–(DRYEND)原料药-干燥产品....................1184.5.1SystemSchematic(Sample)系统框图（示例）...............................................................................1184.5.2SystemDesignConsiderations系统设计注意事项..........................................................................1184.6BIOLOGICS生物制剂............................................................................................................................1204.6.1SystemSchematic(Sample)系统框图（示例）..............................................................................1204.6.2SystemDesignConsiderations系统设计注意事项.........................................................................1204.7ORALSOLIDDOSAGE(NON-POTENTCOMPOUNDING)口服固体制剂（非活性成分）..........1214.7.1SystemSchematic(Sample)系统框图（示例）..............................................................................1214.7.2SystemDesignConsiderations系统设计注意事项.........................................................................1214.8ORALDOLIDDOSAGE(POTENTCOMPOUNDING)口服固体制剂（有效成份）.......................1244.8.1SystemSchematic(Sample)系统框图（示例）..............................................................................1244.8.2SystemDesignConsiderations系统设计注意事项.........................................................................1254.9ASPETICPROCESSINGFACILITY无菌工艺工厂.............................................................................1284.9.1SystemSchematic(Sample)系统框图（示例）..............................................................................1284.9.2SystemDesignConsideration系统设计注意事项..........................................................................1284.9.3AsepticPotentCompounds:无菌有效成分.....................................................................................1334.10PACKAGING/LABELING包装/标签..................................................................................................1344.10.1SystemSchematics(Sample)系统框图（示例）..........................................................................1344.10.2SystemDesignConsideration系统设计注意事项........................................................................1344.11LABS实验室.........................................................................................................................................1354.11.1SystemSchematic(Sample)系统框图（示例）..........................................................................1354.11.2SystemDesignConsiderations系统设计注意事项.....................................................................1354.11.3Vivarium动物厂房.........................................................................................................................1394.12SAMPLING/DISPENSING取样/分装.................................................................................................1414.12.1SystemSchematic(Sample)系统框图（示例）............................................................................1414.12.2SystemDesignConsideration系统设计注意事项........................................................................1414.13ADMINISTRATIONANDGENERALBUILDING管理类建筑物和一般性建筑物........................1424.13.1SystemSchematic(Sample)系统框图（示例）............................................................................1424.13.2SystemDesignConsideration系统设计注意事项........................................................................1424.14WAREHOUSE仓库..............................................................................................................................1434.14.1SystemSchematic(Sample)系统框图（示例）............................................................................1434.14.2SystemDesignConsideration系统设计注意事项........................................................................1434.15PROCESSEQUIPMENTCONSIDERATIONS工艺设备注意事项...................................................1444.15.1Dustextractsystems管道抽气系统...............................................................................................1444.15.2Granulators/Coaters/FluidBedDryers制粒机/涂料器/流化床干燥器.......................................1454.15.3Glasswaredepyrogenationtunnels玻璃去热通道........................................................................1454.15.4Isolatorsystems隔离系统..............................................................................................................1465DESIGNQUALIFICATION/DESIGNREVIEW(DQ/DR)设计验证/设计评审（DQ/DR）.............1495.1DESIGNREVIEW/DESIGNVERIFICATION/DESIGNQUALIFICATION设计评审/设计验证/设计确认................................................................................................................................................................1495.2INTRODUCTION简介...........................................................................................................................1526EQUIPMENTFUNCTION,INSTALLATION,ANDOPERATION设备功能、安装和运行..............1636.1EQUIPMENTFUNCTIONANDMANUFACTURE设备功能和制造.................................................1636.1.1Introduction简介.............................................................................................................................1636.1.2AirHandlerUnit(AHU)空气处理单元..........................................................................................1636.1.3Fans风机.........................................................................................................................................1696.1.4FumeExhaust/ExtractSystems..........................................................................................................1756.1.5HeatingandCoolingCoils加热盘管和冷却盘管...........................................................................1786.1.6Humidifiers增湿器..........................................................................................................................1806.1.7Dehumidification...............................................................................................................................1816.1.8AirFiltration空气过滤器................................................................................................................1876.1.9Ductwork管道系统..........................................................................................................................2056.1.10DampersandLouvers风门和天窗................................................................................................2066.1.11DiffusersandRegisters扩散器和调风器......................................................................................2076.1.12Ultraviolet(UV)Light紫外灯........................................................................................................2086.1.13ReliabilityandMaintenanceEnhancements提高可靠性和可维护性..........................................2096.1.14EnergyReduction节省能量.........................................................................................................2106.2EQUIPMENTINSTALLATIONANDSTARTUP设备安装与启动.....................................................2146.2.1Introduction简介.............................................................................................................................2146.2.2AirHandlingUnits(AHU)空气处理单元.......................................................................................2146.2.3Fans风机.........................................................................................................................................2166.2.4Exhaust/ExtractionSystems排气/抽气系统..................................................................................2176.2.5Heating&CoolingCoils加热&冷却盘管......................................................................................2186.2.6Humidifiers增湿器..........................................................................................................................2196.2.7Dehumidifiers除湿器.......................................................................................................................2206.2.8AirFiltration空气过滤....................................................................................................................2216.2.9Ductwork管道系统..........................................................................................................................2226.2.10Dampers&Louvers风门&天窗....................................................................................................2256.2.11DiffusersandRegisters扩散器和调风器......................................................................................2256.2.12Ultraviolet(UV)Lights紫外灯......................................................................................................2266.