GMP_water_system[1].ppt ISSAKA

WaterSystemsISSAKACOLLISON-COFIE(FDB)2TopicWatersystem-ObjectivesandPrinciples目的和原则-Storage,Treatment存储，处理-Contaminants,Sampling污染物，取样Watersysteminspection水系统验证3Objectives-Introductiontowaterforpharmaceuticaluse介绍制药用水的使用-Sourcesandtypesofwaterforpharmaceuticaluse制药用水的来源和类型-Storageofbulk,untreatedrawwater存储量，未处理的原水-Pre-treatmentofwater预处理的水4Principles原则Likeanystartingmaterial,watermustconformtoGMPnorms.原料、水必须符合Itmustbe“potableandcomplywithWHOguidelinesfordrinking-waterquality.它必须是符合WHO的饮用水要求5Potentialformicrobialgrowth潜在微生物的繁殖Systemsmustbeproperlyvalidated系统必须进过验证Waterforparenteralusecouldnotbecontaminatedwithpyrogensorendotoxins水必须经过内毒素检查Specificationsandperiodictestingisrequired说明和定期检测是必须的Principles原则6Waterhardness水的硬度Waterhardnessmg/LorppmClassification等级asCaCO3Soft软水0-60Moderate中度水61-120Hard硬水121-180Veryhard超硬水1807Rawwaterstorage原水的储存Mayberequiredpriortopre-treatmentaccordingtolocalcircumstances可以根据当地的情况进行预处理Checkmaterialofconstruction检测结构-Concrete,steelareacceptablebutcheckcorrosion钢筋，混凝土是可以被检查-Plasticsorplasticliningsmayleach塑料或塑料套筒有可能浸出8Checkcover检查盖子-tokeepoutinsects,birdsandanimals保持昆虫，鸟和动物不能进去Checkcontamination检测污染物Rawwaterstorage91.WaterforInjections–PFW&WFI2.SoftenedWater软化水3.WaterforFinalRinse最终淋洗水4.Pure,orCleanSteam纯蒸汽或者清洁蒸汽5.PurifiedWater纯化水6.WaterforCoolingAutoclaves灭菌冷却水Typesofwaterusedinpharmaceuticalprocesses制药过程中所使用的水的种类10Pre-treatmentsteps预处理步骤Primaryfiltrationandmulti-mediafilter基本过滤和多介质过滤气Coagulationofflocculation絮凝剂(PFS/PAC)Desalination脱盐Softening软化Waterpre-treatmentcomplex设施Externalrawwaterstorage外部原水储罐Pretreatmentroom1112Chlorineremoval除氯Activated-carbon(AC)filtrationorbisulphite活性碳过滤或亚硫酸氢盐ACremoveschlorinebutbacteriacanthengrow.活性炭除氯但是细菌可以滋生ACfiltrationcanremoveorganicimpurities.活性炭过滤能去除有机杂质Bisulphiteleavessulphateresiduesbutisanti-microbial.但亚硫酸氢盐的残留液能抗微生物13Whypurifyrawwater?为什么净化原水？1.Althoughreasonablypure,itisalwaysvariable虽然纯化合理，但是它永远都是可变的2.Seasonalvariationsmayoccurinwater水也会因为季节变化而改变3.Someregionshaveverypoorqualitywater有些地区水质很差4.Mustremoveimpuritiestopreventproductcontamination.必须去除杂质防止生产过程污染5.Controlmicrobestoavoidcontaminatingproducts控制微生物避免产品的污染14Contaminantsofwater(1)水的污染物Thereisnopurewaterinnature,asitcancontainupto90possibleunacceptablecontaminants自然界是没有纯净水的，它甚至可能包含90种不可接受的污染物Contaminantgroups:1.Inorganiccompounds无机化合物2.Organiccompounds有机化合物3.Solids微粒4.Gases气体5.Micro-organisms微生物15Contaminantsofwater(2)水的污染Treatmentdependsonwater’schemistryandcontaminants,influencedby:处理水取决于水的化学污染程度，主要影响有：1.Rainfall降雨量5.Evaporation蒸发2.Erosion腐蚀6.Sedimentation沉淀3.Pollution污染7.Decomposition分解，变质4.Dissolution分解，溶解16Contaminantsofwater(3)水的污染3Problemminerals矿物质问题1.Calciumandmagnesium钙和镁2.Ironandmanganese铁和锰3.Silicates硅酸盐4.Carbondioxide二氧化碳5.Hydrogensulfide硫化氢6.Phosphates磷酸盐17Furtherproblemminerals更进一步的矿物质问题1.Copper铜2.Aluminium铝3.Heavymetals重金属–Arsenic,lead,cadmium砷，铅，镉4.Nitrates硝酸盐Contaminantsofwater(4)水的污染418Micro-organisms–Biofilm微生物菌类1.Algae藻类2.Protozoa原生动物类–Cryptosporidium隐性孢子虫–Giardia鞭毛菌虫类3.Bacteria细菌–Pseudomonas假单胞菌–Gramnegative,non-fermentingbacteria革兰氏阴性菌，酵母菌–Escherichiacoliandcoliforms埃希斯杆菌，大肠杆菌Contaminantsofwater(5)水的污染5rawwaterin«S”traptosewerWateriskeptcirculatingTowatersoftener&DIplantPretreatment–schematicdrawing示意图cartridgefilter5micrometersactivatedcarbonfiltersprayballbreaktankairbreaktodraincentrifugalpumpairfilterfloatoperatedvalvesandfilterexcesswaterrecycledfromdeioniser19PlumbingchlorinationSSSSPre-treatmentDistillationHoldingTake80ocSPumpSSSSourcewater*S:Sampling.1.Filtration-Sandfilter-Charcoalfilter-Cartridgefilter2.Primarywatertreatment-Watersolftener-Deionizer-ReverseOsmosis20brineandsalttankbrinehardwaterinzeolitewatersoftener-exchanges-CaandMgforNadrainsoftwatertodeioniserbypassvalveWaterSoftener–schematicdrawing水的软化原理示意图21Waterpurification水的净化CartridgefiltrationRO/Deionizer22WaterpurificationRemoveparticles,bacteria,pyrogen,organic,inorganicionsandsilicaReverseOsmosis反渗透23WaterpurificationDeionization电离Removeorganic,inorganicions,silicaandcarbondioxide去除有机、无机离子，二氧化硅和二氧化碳24WaterpurificationDistillation蒸馏Removeparticles,bacteria,pyrogen,organic,non-volatile,inorganicionsandsilicaforWFI去除离子，细菌，热原，有机不挥发的，无机离子和二氧化硅25WaterpurificationUltrafiltration超滤KillbacteriaandbreakdownTOC杀死细菌和分解有机碳26AutoDIRO/AutoDI2stagesROPurifiedwater27-Conductivitymeter电导率表-pHmeterPH值表-Temperaturemeter(80oC)温度表-Alarmmeter报警装置2829Sampling取样Theremustbeasamplingprocedure.取样过程Sampleintegritymustbeassured.取样的完整Samplertraining取样培训Samplepoint取样点Samplesize取样量Samplecontainer取样容器30Samplelabel取样签Samplestorageandtransport样品的保存和运输Arrivalatthelaboratory送检化验室Startoftest开始测试Sampling取样31WaterforInjectionsInternationalpharmacopoeiarequirementsforWFIarethoseforpurifiedwaterplusitmustbefreefrompyrogens.除热原的纯化水WFIUsuallypreparedbydistillation.通常是蒸馏Storagetimeshouldbelessthan24hours.保存时间小于24小时Microbiallimitsmustbespecified.必须规定微生物限度32PyrogensandendotoxinsAnycompoundinjectedintomammalswhichgivesrisetofeverisa“Pyrogen”.任何使哺乳动物体温身高的物质，统称为热原33WFItestingMicrobialtest,1CFU/10mlW