制药用水系统介绍ppt课件.ppt

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1、PharmaceuticalWaterSystems制药用水系统©AlfaLavalSlide2Waterstorageanddistributionsystem水的贮存和分配系统Themostcommonandwellknownsysteminthepharmaceuticalindustry.是最常规的Still,manyconfusionsonhowtoselectthemostsuitable,hygienicandcosteffectivesolution然而，在怎么选择最合适、卫生和成本、效能方面最困惑Thekeyistounderstandth

2、ebasicprinciple关键是要懂得基本的原理©AlfaLavalSlide3FeedwaterReverseosmosisElectro-deionisationTankDistillationsystemTankWaterpurification&distributionloop纯化和分配PurificationprocessDistributionloop©AlfaLavalSlide4Definitions定义ISPEdifferentiatebetweenthreetypesofwater:ISPE区分三种水：USPPurifiedWat

3、er(PW)美国药典的纯化水（PW）USPWaterforInjection(WFI)注射水Non-compendialwater(RO,DI,etc.)饮用水©AlfaLavalSlide5SterilebulkAPIorBPCWFI&PW,inpracticeWFI和PW的使用InjectabledosageformWFINon-injectabledosageformPWBulkAPIorBPCSuitablenon-compendialAPI=ActivePharmaceuticalIngredient活性药用成分（原料药）BPC=BulkPhar

4、maceuticalChemical（医药中间体）MinimumwatertypeEquipmentcleaningandrinsingISPErecommendationISPE推荐©AlfaLavalSlide6USPSpecifications定义:PWvs.WFI*In-linemeasurement,fromequivalentvaluesfromUSPtableCFU=ColonyFormingUnitsAllPharmaceuticalwatermustalsomeettheEPAstandardformicrobiologicalqualit

5、yofpotablewater©AlfaLavalSlide7Bacteriabasicsforwatersystems水系统中的微生物基本知识AerobicBacteria好氧菌GramNegative葛兰氏阴性菌GramPositive葛兰氏阳性菌Endotoxin内毒素Biofilm生物膜©AlfaLavalSlide8Bacteriabasicsforwatersystems水系统中的微生物基本知识MostcommonbacteriainpharmaceuticalwatersystemsareGramnegativebacteria.Gramneg

6、ativebacteriadonotgrowabove60ºC,however,cautionsforGrampositivebacteria,whicharemoreheatresistant,shouldbetakenandperiodicsanitizationandtestproceduresarerecommended.通常在水系统中的微生物多为葛兰氏阴性菌，在高于60ºC情况下不生长，然而，对于耐热菌，建议要定期清洁处理Bacteriainpharmaceuticalwatersystemsgenerallyrangefrom0,3m–5m.

7、水系统中的微生物大小通常在0,3m–5m©AlfaLavalSlide9Bacteriabasicsforwatersystems水系统中的微生物基本知识KilledGramnegativebacteriareleasesendotoxins,whichisalipopolysaccharidemoleculethatcausefeverwheninjectedintothebloodstream.(Thesesubstancesaretermed”pyrogens”meaninggeneratingheat,fever).Pyrogenshaveals

8、obeenlinkedtomoreseriousre