膠囊劑生產(chǎn)設(shè)備CapsuleProductionEquipment61課件

膠囊劑生產(chǎn)設(shè)備

CapsuleProductionEquipment制藥設(shè)備使用與維護(hù)

OperationandMaintenanceofCommonPharmaceuticalEquipment知識目標(biāo)KnowledgeObjectives（1）掌握膠囊劑生產(chǎn)流程（軟膠囊、硬膠囊）。(1)Mastertheproductionprocessofcapsuleformulations(softcapsules,hardcapsules).（2）熟悉常用膠囊劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理。(2)Familiarizewiththestructureandworkingprinciplesofcommonlyusedcapsuleproductionequipment.（3）了解常用膠囊劑設(shè)備的維護(hù)與保養(yǎng)及故障排除。(3)Understandthemaintenance,upkeep,andtroubleshootingofcommonlyusedcapsuleequipment.能力目標(biāo)AbilityObjectives學(xué)會正確操作常用膠囊劑生產(chǎn)設(shè)備。Learntheproperoperationofcommonlyusedcapsuleproductionequipment.素質(zhì)目標(biāo)

Qualitygoal（1）認(rèn)真執(zhí)行GMP，嚴(yán)格按照SOP的要求進(jìn)行生產(chǎn)。(1)StrictlyfollowGMPandadheretotherequirementsofSOPintheproductionprocess.（2）使學(xué)生具備膠囊劑生產(chǎn)崗位必備的基本知識、基本技能和職業(yè)素質(zhì)。(2)Equipstudentswithessentialknowledge,basicskills,andprofessionalqualitiesrequiredforcapsuleproductionpositions.（3）通過“毒膠囊”案例強(qiáng)調(diào)職業(yè)道德、誠實(shí)守信品德的培養(yǎng)。(3)Emphasizethecultivationofprofessionalethics,honesty,andintegritythroughthecaseof"poisoncapsule".重點(diǎn)KeyPoints膠囊劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理StructureandWorkingPrinciplesofCapsuleProductionEquipment難點(diǎn)Difficulties膠囊劑生產(chǎn)設(shè)備的正確操作ProperOperationofCapsuleProductionEquipment學(xué)習(xí)目標(biāo)

LearningObjectives硬膠囊劑是指將一定量的藥物或藥物加輔料制成均勻的粉末或顆粒充填于空心膠囊中制成的固體制劑。Hardcapsulesrefertosoliddosageformsmadebyfillingacertainamountofuniformpowderorgranules,consistingofdrugsandexcipients,intohollowcapsules.制劑簡介

FormulationIntroduction硬膠囊劑生產(chǎn)流程

HardCapsuleFormulationProcess空心膠囊是由明膠或其它適宜的藥用材料制成的具有彈性的兩節(jié)圓筒，分別稱為囊體和囊帽，兩者能互相緊密套合。Hollowcapsulesarecomposedofelastictwo-partcylindricalbodiesmadeofgelatinorothersuitablepharmaceuticalmaterials.Thesepartsareknownasthecapsulebodyandthecapsulecap,whichfittightlytogether.制劑簡介

FormulationIntroduction我國藥用空膠囊標(biāo)準(zhǔn)共分8個型號，常用的為4、3、2、1、0、00號，其號數(shù)越大，容積越小。InChina,pharmaceuticalcapsulesarecategorizedinto8sizes,withcommonlyusedsizesbeing4,3,2,1,0,and00.Largernumberscorrespondtosmallervolumes.硬膠囊劑生產(chǎn)流程

HardCapsuleFormulationProcess硬膠囊劑是目前應(yīng)用最廣泛的劑型之一

Hardcapsulesareoneofthemostwidelyuseddosageforms.原輔料Rawexcipients內(nèi)包材Innerpackagematerial外包材OuterpackagematerialD級潔凈區(qū)ClassDcleanzone粉碎Crushing過篩Sieving混合Mixing內(nèi)容物制備“粉末、顆粒、小丸等”Preparationofcontents"powder,granule,pellets,etc."空膠囊Emptycapsule消毒Disinfect消毒Disinfect膠囊填充Capsulefilling內(nèi)包Insourcing外包Outsourcing入庫Enterwarehouse工序質(zhì)量控制點(diǎn)

QualityControlPointsintheProcess硬膠囊劑的生產(chǎn)工序：空膠囊的制備和充填物料的制備、裝囊（充填）、拋光、質(zhì)檢、包裝等。ProductionStepsofHardCapsules:Preparationofemptycapsulesandfillingmaterials,capsulefilling,polishing,qualityinspection,packaging,etc.主要設(shè)備

MainEquipment

半自動膠囊填充機(jī)結(jié)構(gòu)和工作原理

StructureandWorkingPrinciplesofSemi-AutomaticCapsuleFillingMachine由送囊定向分離機(jī)構(gòu)、藥料充填機(jī)構(gòu)、播囊機(jī)構(gòu)、鎖囊機(jī)構(gòu)、氣動控制和電器控制系統(tǒng)、保護(hù)裝置等部件以及真空泵和氣泵附件組成。Composedofcomponentssuchasthecapsulefeedingandseparatingmechanism,drugfillingmechanism,capsuledispensingmechanism,capsulelockingmechanism,pneumaticcontrolandelectricalcontrolsystems,safetydevices,aswellasvacuumandairpumpattachments.設(shè)備外觀

EquipmentAppearance全自動膠囊填充機(jī)

FullyAutomaticCapsuleFillingMachine填充桿計量盤

FillingRodMeteringDisc膠囊板

CapsuleTray設(shè)備結(jié)構(gòu)

EquipmentStructure空膠囊排序與定向裝置

HollowCapsuleSortingandOrientingDevice拔囊裝置

CapsuleExtractionDevice帽體錯位裝置

CapDisplacementDevice計量充填裝置

MeteringFillingDevice剔除廢囊裝置

RemovingWasteCapsuleDevice閉合膠囊裝置

CapsuleClosureDevice出囊裝置

CapsuleEjectionDevice清潔裝置

CleaningDevice設(shè)備結(jié)構(gòu)

EquipmentStructure工作原理

Workingprinciple1.SupplyandarrangementorientationCleaning2.Separationofbodyandcap3.Capdisplacement4.Materialfilling5.Removalofwastecapsules6.Capclosure7.Capsuledischarge工作原理

Workingprinciple1.供給→排列

Supply→Arrangement空膠囊從供給池下落到排列軌道

Emptycapsulesfallfromthesupplypoolontothearrangementtrack.工作原理

Workingprinciple校準(zhǔn)方向

CalibratingDirection先水平定向，囊體在前，囊帽在后；

Horizontalorientationfirst,withthecapsulebodyinfrontandthecapsulecapintheback;再垂直定向，囊體在下，囊帽在上。

Thenverticalorientation,withthecapsulebodybelowandthecapsulecapabove.定向原理

OrientationPrinciple推爪的推力點(diǎn)在囊體上；滑槽的寬度比囊帽的外徑小，比囊體的外徑大，滑槽只對囊帽有卡緊作用；Thepushingpointoftheclawisonthecapsulebody;thewidthofthechuteissmallerthantheouterdiameterofthecapsulecapbutlargerthantheouterdiameterofthecapsulebody,sothechuteonlyclampsthecapsulecap.工作原理

Workingprinciple2.體帽分離

2.SeparationofBodyandCap負(fù)壓吸入空膠囊整體到上囊板?？字?，限位臺階孔擋住囊帽下行，膠囊體則落入下囊板孔中。Negativepressuresuckstheemptycapsuleasawholeintotheupperplatemoldhole,andthelimitstepholestopsthedownwardmovementofthecapsulecap,allowingthecapsulebodytofallintothelowerplatehole.限位臺階

Limitstep3.物料填充

3.MaterialFilling工作原理

WorkingprincipleTremiepipeFillingfinetuningknobFillingmissingprobeconductorFillingpushrodpositionscaleFillingscrewfixedplatformFillingpushrodPackingtablesupportshaftPack3.物料填充

3.MaterialFilling工作原理

Workingprinciple裝藥量的大小主要由設(shè)備中計量盤的厚度確定，計量盤厚度要根據(jù)充填物的粒度、流動性等因素來選擇。

Theamountofmedicinefilledismainlydeterminedbythethicknessofthemeasuringdiscintheequipment.Thethicknessofthemeasuringdiscshouldbeselectedbasedonfactorssuchasthegranularityandfluidityofthefillingmaterial.作為一種判定標(biāo)準(zhǔn)，可以用現(xiàn)有充填物直接測量單個計量盤孔的裝填量以確定計量盤的厚度是否合適。

Asacriterion,theamountoffillinginasinglemeasuringdischolecanbedirectlymeasuredusingexistingfillingmaterialtodetermineifthethicknessofthemeasuringdiscissuitable.充填桿由第1到第5工位下降深度一般為50%、30%、20%、10%、1%。

Thedescentdepthsofthefillingrodsforstations1to5aregenerally50%,30%,20%,10%,1%.PackStep6Step5Step4Step3Step2Step11-充填桿2-導(dǎo)向裝置3-計量盤4-成型粉柱5-膠囊體1-Fillingrod2-Guidingdevice3-Measuringdisc4-Moldingpowdercolumn5-CapsulebodyFigure2Fillingmeasuringscheme4.剔除廢囊

4.RemovalofWasteCapsules吸走空膠囊

Suckawayemptycapsules工作原理

Workingprinciple5.膠囊閉合

5.CapsuleClosure軸線對齊

Aligningtheaxes.工作原理

Workingprinciple6.出囊

6.CapsuleEjection工作原理

Workingprinciple7.清潔

7.Cleaning工作原理

WorkingprincipleConnectedtocompressedairsystemConnectedtothesuctionsystem“毒膠囊”事件

"ThePoisonCapsule"Incident河北一些企業(yè)，用生石灰處理皮革廢料，熬制成工業(yè)明膠，賣給紹興新昌一些企業(yè)制成藥用膠囊，最終流入藥品企業(yè)，進(jìn)入患者腹中。由于皮革在工業(yè)加工時，要使用含鉻的鞣制劑，因此這樣制成的膠囊，往往重金屬鉻超標(biāo)。經(jīng)檢測，修正藥業(yè)等9家藥廠13個批次藥品，所用膠囊重金屬鉻含量超標(biāo)。針對此事件，2012年4月21日，衛(wèi)生部要求毒膠囊企業(yè)所有膠囊藥停用，藥用膠囊接受審批檢驗(yàn)。2012年4月22日，公安部通報，經(jīng)調(diào)查，公安機(jī)關(guān)已立案7起，依法逮捕犯罪嫌疑人9名，刑事拘留45人。InHebei,someenterprisesprocessleatherwastewithquicklime,refiningitintoindustrialgelatin,whichisthensoldtocertaincompaniesinShaoxing'sXinchangregion.Thesecompaniesusethegelatintoproducemedicinalcapsules,whichultimatelyfindtheirwayintopharmaceuticalenterprisesandintothebodiesofpatients.Duetotheuseofchromium-containingtanningagentsintheindustrialprocessingofleather,thecapsulesproducedinthismanneroftencontainexcessivelevelsoftheheavymetalchromium.Upontesting,itwasfoundthat13batchesofpharmaceuticalproductsfrom9companies,includingXiudingPharmaceuticals,hadexceededthepermissiblelevelsofchromiumintheircapsules.Inresponsetothisincident,onApril21,2012,theMinistryofHealthissuedadirectivetohalttheuseofcapsulesfromthetoxiccapsule-producingenterprises,anddemandedthatthecapsulesusedformedicinalpurposesundergoinspectiona