制药工艺用水验证课件.ppt

*制药工艺用水验证*预处理PRE-TREATMENTDIAGRAMSuspendedSolidsRemoval

悬浮固体去除SuspendedSolidsRemoval

除氯SuspendedSolidsRemoval

阻垢处理SuspendedSolidsRemoval

微生物控制Dual/MultiMediaFilter介质过滤CartridgeFilter过滤器ActivatedCarbon

活性炭ChemicalInjection

加入化学剂WaterSoftener

软化水ChemicalInjection

加入化学剂Ultraviolet

紫外灯Chlorine

氯化物Ozone

臭氧Heat

加热*制药工艺用水验证*USP纯水PURIFIEDWATER

AlternativeSystems#1and#2Drinking

WaterPretreatment

预处理FinalTreatment终处理1PrimaryIonRemovalPolishingReverseosmosis1stPassReverseosmosis1stPassFinalTreatment终处理2PrimaryIonRemovalPolishingReverseosmosisElectrodeionizationIonExchangePharmaceuticalWaterStorage/Distribution#1#2WellWater

井水SurfaceWater

地表水*制药工艺用水验证*USP纯水PURIFIEDWATER

AlternativeSystems#3and#4Drinking

WaterPretreatment

预处理FinalTreatment终处理1PrimaryIonRemovalPolishingIonExchangeElectrodialysisIonExchangeUltrafiltrationMicrofiltrationUltravioletFinalTreatment终处理2IonRemovalandPolishingDistillation,VCDistillation,SEDistillation,MEPharmaceuticalWaterStorage/Distribution#3#4WellWater

井水SurfaceWater

地表水*制药工艺用水验证*典型流程TYPICALPHARMACEUTICALPROCESSWATERTYPESTYPICALPHARMACEUTICALPROCESSWATERTYPES(2)PROCESSUNITOPERATIONPRETREATMENTFINALTREATMENTPrimaryFiltrationSofteningActivatedCarbonFiltration(1)IonExchange(Cation/Anion-1ststage)RO(1stPass)RO(2ndPass)IonExchange(MixedBed-2ndPass)EDIUltrafiltrationROWaterXXXXXDIWaterXXXXRO/DIWaterXXXXXRO/DIWater(Alternative)XXXXXXRO/EDIWaterXXXXXDI/UFWaterXXXXXRO/DI/UFWaterXXXXXXUFWaterXXXXDrinkingWater*制药工艺用水验证*技术参数ParameterRange设计参数：设计者规定的参数的精度范围。如电导0.5μs/cm。正常操作参数：生产者/操作者的实际正常运行参数。如电导1.0μs/cm。最大可允许参数：生产者/操作者最大可允许的参数。如电导1.3μs/cm。设计参数正常操作参数最大可允许参数行为限度(ActionLimit)报警条件(AlertLimit)*制药工艺用水验证*

2.纯水/注射用水制备的设计要求。

2.1一般原则以水源水质特性及用水要求为依据应考虑源水一年甚至数年的水质数据选用适当的，经济的技术手段，并非运用上述所有处理技术