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PharmaceuticalPharmaceuticalWaterSystemsWaterSystemsPharmaceuticalPharmaceuticalWaterSystemsWaterSystems制药用水系统制药用水系统--------PrePre--Treatment&PurificationTreatment&Purification预处理和纯化部分预处理和纯化部分JohnsonZhang/张劲松Content内容内容1、WaterSystemDesignProcessImpact影响水系统设计工艺的因素2、Pre-TreatmentTechnologies预处理技术3、PurificationTechnologies纯化技术4、PurificationDesignOptions纯化设计选项JohnsonZhang/张劲松1WaterSystem1、WaterSystemDesignProcessImpact影响水系统设计工艺的因素JohnsonZhang/张劲松SystemPlanning系统计划编制JohnsonZhang/张劲松WaterQuality水质GetQualityAssuranceinvolvedbeforeproceeding在行动之前就要获得相关的质量保证在行动之前就要获得相关的质量保证JohnsonZhang/张劲松WaterQualityFactors考虑水质的因素6Productqualityrequirements产品质量要求6ProductchemicalµbiologicalWaterQuality6Productchemicalµbiologicalrequirements产品理化和微生物的要求6Dosage&deliveryform剂型y6Regulatorycommitments符合法规6Service&SOP’s服务和SOPJohnsonZhang/张劲松WaterUsedforfor...CleaningManufacturingLaboratoryResearch&gforManufactureManufacturingSterileBulkParenteralNon-ParenteralBulkLaboratoryResearch&PilotAnalyticalResearch&Pilot(seenote2)streamFinalRinseWashStepsSterileBulkAPIorBPCParenteralDosageFormNonParenteralDosageFormBulkAPIorBPCResearch&Pilot(seenote2)Analytical(seenote1)tispurifieddownsreviousrevision,nterpretation.cGMPNon-cGMPWFIWhereproductSeeNote1SeeNote4deletedfromaproncernsovermisiWFISeeNote1ThislinewasbecauseofcoSitblNUSPPurifiedJohnsonZhang/张劲松SuitableNon-Compendial(seenote3)ABCBiotechCompanyWaterrequirementsformanufacturingaparenteraldosageform−Bathrooms−DrinkingPotableWaterg−Safetyshowers−HVACPltWt−Plantsteam−Processcooling−CleansteamPlantWater−Cleansteam−Processcleaning−InitialrinsesSuitableNon-Compendial/USP−Finalrinses−Media&bufferfWFIJohnsonZhang/张劲松−FinalformulationSystemPlanning系统计划编制Chapter3ofISPEBaselineVolume4Chapter3ofISPEBaselineVolume4JohnsonZhang/张劲松Use-PointCriteria使用点的要求DeliveryTemperature温度−Isitdesirabletosupplyhotcoldorambientwaterhot,coldorambientwatertotheprocess?工艺要求是热地、冷的或是常温的水？IthttfUsePointCriteria−Isthetemperatureofwatercriticaltotheprocess?水温是否是工艺中关键点关键点？−Whatrangeoftemperatureispacceptable?什么温度范围可接受？JohnsonZhang/张劲松Use-PointCriteria使用点的要求DeliveryPressure压力−Processequipment,sprayProcessequipment,sprayorfillnozzlesmayhaveminimumormaximumpressuresforproperUsePointCriteriapressuresforproperoperation工艺设备、喷淋球或喷嘴正常工作的最小/大压力？力？−Desiredwaterfeedratestoequipmentmaydictateillii期望供inletpressurelimits期望供水压力指的是设备进口压力JohnsonZhang/张劲松Use-PointCriteria使用点的要求DeliveryFlowRate流量−Whatvolumeofwatermustbesuppliedinwhatperiodoftime?是么时间段内必须要多大流量？UsePointCriteria多大流量？−Howfastorslowlyshouldequipmentbefilled?充满设备要多快/慢？备要多快/慢？−Isflowratecritical,andifsowhatrangeisacceptable?流量是否是关键点？什么范围可接受？JohnsonZhang/张劲松Use-PointCriteria使用点的要求UtilizationSchedule使用情况−Howfrequentlyandonwhatscheduledoesthisusepointusewater?用水点的使用频率？UsePointCriteriausewater?用水点的使用频率？−Doestheusepointalwaysconsumefullflowrates?用水点是否要直满流量消耗点是否要一直满流量消耗？−Whichoperationsarecritical?关键点是？关键点是JohnsonZhang/张劲松Use-PointCriteria使用点的要求SystemDemandCharacteristics系统要求的特性Whichlargeconsumersof−Whichlargeconsumersofwaterwillusewaterconcurrently?最大用水点同时使用的几率？UsePointCriteria使用的几率？−Isitpossibletorestrictsimultaneoususebylargeygusers?是否可能限制用水量大的使用点同时使用？−WhatifdemandexceedsWhatifdemandexceedssupplyforashortperiod?短时间的需求超过供给会怎么样？JohnsonZhang/张劲松Use-PointCriteria使用点的要求Automatedversusmanualflowcontrol自动还是手动控制−AutomatedsystemscouldhelpcontroloutflowandUsePointCriteriahelpcontroloutflow,andpreventoverflow自动系统可以控制流量和防止上限情况Attdtb−Automatedsystemsmaybesensitivetounderflowconditions自动系统可以感应下限情况限情况JohnsonZhang/张劲松Use-PointMatrix用水点矩阵LocatiLocationEquipmentWorkingHours123456789101112131415161718192021222324No.PWsoliddosesloopQFQQFQFQFFJohnsonZhang/张劲松TimelineJohnsonZhang/张劲松Histogram柱状图1600180.0120.0140.0160.060.080.0100.0LPM0020.040.00.004812162024283236404448525660646872768084889296100104108112116120124128132136140144148152156160164168TIME(HR)JohnsonZhang/张劲松CommonMistake常见错误Underestimatingwaterconsumption低估了用水量Allowfor:Alld所有工艺所需−Allprocessneeds所有工艺所需−Cleaning,bothCIPandCOP清洁−Equipmentflushingparticularlymembranes设备冲洗，特别是膜Equipmentflushing,particularlymembranes设备冲洗，特别是膜−Point-of-useflushing使用点的冲洗−Sampling(includingflushes)取样−Downtimeforsanitization消毒的停工−Futureexpansion将来的扩展JohnsonZhang/张劲松SystemPlanning系统计划编制Cht3fISPEBliVl4Chapter3ofISPEBaselineVolume4JohnsonZhang/张劲松SystemCriteria系统要求标准ExistingSystems现有系统−OperationsinexistingfacilitiesimposeoperationsSystemCriteriafacilitiesimposeoperationsandphysicalconfigurationboundaries现有系统的影响Mldtihih−Mayleadtousinghighergradewaterthanrequired可能导致更高的水质要求JohnsonZhang/张劲松SystemCriteria系统要求标准FutureCapacityRequirements将来容量要StFutureCapacityRequirements将来容量要求−Flexibilityforfutureexpansion将来是否能灵活扩展？SystemCriteria来是否能灵活扩展？−Distributionpipesizingcapacityrange分配管路的容量范围−Significantreductionsorexpansionsanticipated?容量减少或预期扩展？或预期扩展？JohnsonZhang/张劲松SystemCriteria系统要求标准Generation&DistributionRate产水率Generation&DistributionRate产水率和分配率−Maximumdailyconsumption最大日消耗量SystemCriteria大日消耗量−Peakhourlyorotherperiodsofconsumption峰值消耗时间段？−Momentarypeaks瞬时峰值？−Trade-offversusstorage与储存的