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ID:58602513
大小:1.82 MB
页数:52页
时间:2020-10-20
《制药用水系统介绍ppt课件.ppt》由会员上传分享,免费在线阅读,更多相关内容在教育资源-天天文库。
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Bacteriainpharmaceuticalwatersystemsgenerallyrangefrom0,3m–5m.
7、水系统中的微生物大小通常在0,3m–5m©AlfaLavalSlide9Bacteriabasicsforwatersystems水系统中的微生物基本知识KilledGramnegativebacteriareleasesendotoxins,whichisalipopolysaccharidemoleculethatcausefeverwheninjectedintothebloodstream.(Thesesubstancesaretermed”pyrogens”meaninggeneratingheat,fever).Pyrogenshaveals
8、obeenlinkedtomoreseriousre
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