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1、Section1AnoverviewofthegranulationprocessSection2PreparingthegranulationprocessSection3Cleaning&maintainingequipmentSection4Pre-startoperationsSection5GranulationoperationsAttheendofthissection,youwillbeabletodescribeoruse:benefitsofgranulationhowgranulation
2、fitsintopharmaceuticalmanufacturingthebasicingredientsusedingranulationthedifferentgranulationmethodsidentifythemainpiecesofequipmentusedingranulationprocesscontrolsusedduringgranulationuseoccupationalhealthandsafetycontrols(PPE,useofguards,etc.)tomaintainsa
3、fetyintheworkplaceWhatarethebenefits(h?ochù)好處ofgranulation?Granulationisaprocessthatpreparespowderedrawmaterialstobeusedinotherpharmaceuticalprocessesfortablet(yípia?nya?o)一片藥orcapsule(jiaonang)膠囊manufacture.Granulationisusedtomakepowderseasiertohandle,proc
4、essandtransport.Powdersthataregranulatedusuallycontain:activeingredient（zhuyao)主藥ordrug(ya?o)藥(thepartthatwillmedicatethepatient)excipients(theytypicallymakeupmostofthevolumeandbindtheactiveingredientandcanincludebinders,fillers,lubricantsanddisintegrants)Se
5、ction1-AnoverviewofthegranulationprocessBlending(hu?nhe?)混合theingredientsisnotenoughtoensureeven(yiyangde)一樣的distributionoftheactiveingredient(che?ngfe?n).Thisisbecausetheactiveingredientmaysegregate(fēnkāi)分開orstayapartfromtheotheringredientsduringtheblendi
6、ngprocess.BackgroundtoGranulationTheingredientsmaybeincompatiblebecauseof:particlesize(chicun)尺寸particledensity(mìdu)密度flowcharacteristics(liúdongxing)流動性Compressibility(keyaxing?)可壓性moisturecontent(hanshuiliang)含水量ProcessofGranulationGranulationisamixingtec
7、hniquestartingwithahomogeneousmix(uniformthroughout)ofingredientsorrawmaterials.Thentheoverallparticlesizeoftheformulationisincreasedandtheseparticlesadheretogethertoformlarger,multi-particleportionsoftheproduct.Theselargerparticlesarecalledgranules.Granules
8、Granulesconsistofparticlesformedbytheprogressiveenlargementofprimaryparticlesuntiltheiroriginalidentityisnolongervisible.PictureofaGranulatedProductHowdoesgranulationwork?Theparticlesadhereorsti
