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ID:13550935
大小:432.50 KB
页数:22页
时间:2018-07-23
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1、Section1AnoverviewofthegranulationprocessSection2PreparingthegranulationprocessSection3Cleaning&maintainingequipmentSection4Pre-startoperationsSection5GranulationoperationsAttheendofthissection,youwillbeabletodescribeoruse:benefitsofgranulationhowgranulation
2、fitsintopharmaceuticalmanufacturingthebasicingredientsusedingranulationthedifferentgranulationmethodsidentifythemainpiecesofequipmentusedingranulationprocesscontrolsusedduringgranulationuseoccupationalhealthandsafetycontrols(PPE,useofguards,etc.)tomaintainsa
3、fetyintheworkplaceWhatarethebenefits(hăochù)好处ofgranulation?Granulationisaprocessthatpreparespowderedrawmaterialstobeusedinotherpharmaceuticalprocessesfortablet(yÍpiànyào)一片药orcapsule(jiaonang)胶囊manufacture.Granulationisusedtomakepowderseasiertohandle,proc
4、essandtransport.Powdersthataregranulatedusuallycontain:activeingredient(zhuyao)主药ordrug(yào)药(thepartthatwillmedicatethepatient)excipients(theytypicallymakeupmostofthevolumeandbindtheactiveingredientandcanincludebinders,fillers,lubricantsanddisintegrants)Se
5、ction1-AnoverviewofthegranulationprocessBlending(hùnhé)混合theingredientsisnotenoughtoensureeven(yiyangde)一样的distributionoftheactiveingredient(chéngfèn).Thisisbecausetheactiveingredientmaysegregate(fēnkāi)分开orstayapartfromtheotheringredientsduringtheblendi
6、ngprocess.BackgroundtoGranulationTheingredientsmaybeincompatiblebecauseof:particlesize(chicun)尺寸particledensity(mìdu)密度flowcharacteristics(liúdongxing)流动性Compressibility(keyaxing̀)可压性moisturecontent(hanshuiliang)含水量ProcessofGranulationGranulationisamixingtec
7、hniquestartingwithahomogeneousmix(uniformthroughout)ofingredientsorrawmaterials.Thentheoverallparticlesizeoftheformulationisincreasedandtheseparticlesadheretogethertoformlarger,multi-particleportionsoftheproduct.Theselargerparticlesarecalledgranules.Granules
8、Granulesconsistofparticlesformedbytheprogressiveenlargementofprimaryparticlesuntiltheiroriginalidentityisnolongervisible.PictureofaGranulatedProductHowdoesgranulationwork?Theparticlesadhereorsti
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