片劑生產設備

Tabletproductionequipment制藥設備使用與維護

OperationandMaintenanceofCommonPharmaceuticalEquipment知識目標KnowledgeObjectives（1）掌握片劑生產設備的原理、結構和使用方法。(1)Understandingtheprinciples,structures,andusageoftabletproductionequipment.（2）熟悉片劑生產設備的種類和特點。(2)Familiaritywiththetypesandcharacteristicsoftabletproductionequipment.（3）了解片劑生產設備的維護與保養及故障排除。(3)Knowledgeofmaintenance,upkeep,andtroubleshootingoftabletproductionequipment.能力目標AbilityObjectives學會片劑生產設備的基本結構和工作原理。Learningaboutthebasicstructureandworkingprinciplesoftabletproductionequipment.素質目標

Qualitygoal（1）認真執行GMP，嚴格按照SOP的要求進行生產。(1)StrictlyfollowGMPandadheretotherequirementsofSOPintheproductionprocess.（2）使學生具備片劑生產崗位必備的基本知識、基本技能和職業素質。(2)Studentsshouldpossessessentialfundamentalknowledge,basicskills,andprofessionalqualitiesrequiredforthetabletproductionposition.（3）通過片劑生產案例培養踏實工作、安全第一的意識。(3)Cultivateasenseofdiligentworkandprioritizesafetythroughtabletproductioncasestudies.重點KeyPoints片劑生產設備的結構與工作原理Structureandworkingprinciplesoftabletproductionequipment難點Difficulties片劑生產設備的正確操作Properoperationoftabletproductionequipment學習目標

LearningObjectives片劑是由一種或多種藥物與適宜的輔料均勻混合后經制粒或直接壓制而成的圓片狀或異形片狀的固體制劑，可供內服和外用。Tabletsaresoliddosageformsmadebymixingoneormoredrugswithsuitableexcipients,followedbygranulationordirectcompression,resultingincircularorirregular-shapedsolidpreparationsthatcanbetakenorallyorusedexternally.制劑簡介

FormulationIntroduction生產工藝

ProductionProcess

片劑制備方法

Methodsoftabletpreparation干法制粒壓片法

Drygranulationandtabletcompressionmethod將干法制粒的顆粒進行壓片的方法

Methodsforcompressingdrygranulationparticlesintotablets濕法制粒壓片法

Wetgranulationandtabletcompressionmethod將濕法制粒的顆粒經干燥后壓片的方法。

Methodsforcompressingwetgranulationparticlesafterdrying（粉末或結晶）直接壓片法

Directcompressionmethod(powderorcrystal)不經過制粒過程直接把藥物和輔料的混合物進行壓片的方法

Directlycompressingthemixtureofdrugsandexcipientswithoutgranulation

當粉末非常松軟且細粉較多時，將造成壓片困難，在總混壓片前，必須先制粒。

Whenthepowderisverylooseandcontainsalotoffineparticles,itwillbedifficulttocompressthetablets,andgranulationmustbeperformedbeforetabletcompression.生產流程

Productionprocess

目前片劑生產以濕法制粒壓片法為主，但粉末直接壓片法與其他片劑生產工藝相比，具有工藝操作簡單、生產周期短、生產成本低、工藝適應性強等明顯的優勢。Currently,wetgranulationandtabletcompressionarethemainmethodsintabletproduction.However,comparedtoothertabletproductionprocesses,thedirectcompressionmethodofferssignificantadvantagessuchassimpleprocessoperation,shortproductioncycles,lowproductioncosts,andstrongprocessadaptability.原輔料Rawexcipients玻璃瓶GlassbottleD級潔凈區ClassDcleanzone精洗Finecleaning粗洗Grossrinse干燥Drying冷卻Cooling崩解劑Disintegratingagent潤滑劑Lubricatingagent包衣液Coatingliquid配置Configuration包衣Coating分裝Subpackage外包Outsourcing檢驗Inspection入庫Enterwarehouse粉碎Crushing過篩Sieving配料Batching制粒Granulation濕法Wetmethod干燥Drying整粒Sizing總混Mixing壓片Tabletcompression冷卻Cooling直接法Directmethod干法Drymethod沖模Punchanddie消毒Disinfect其他包裝材料Otherpackagingmaterials工序質量控制點

QualityControlPointsintheProcess以濕法制粒壓片法為例包括：粉碎、過篩、配料、制粒、干燥、整粒、總混、壓片、包衣和包裝等。Thewetgranulationandtabletcompressionmethodtypicallyincludethefollowingsteps:crushing,sieving,ingredientformulation,granulation,drying,sizing,blending,tabletcompression,coating,andpackaging.主要設備

MainEquipment

旋轉壓片設備

Rotarytabletpressequipment.單沖壓片機

Single-punchtabletpress.沖和模

Punchanddie.單沖式壓片機是由一副沖模組成，沖頭作垂直往復運動將顆粒狀的物料壓制成片狀的機器。Thesingle-punchtabletpressconsistsofonesetofpunchanddie.Thepunchheadmovesverticallyinareciprocatingmotiontocompressthegranularmaterialintotabletform.單沖壓片機

Single-punchtabletpress.一副沖模

Asetofcompressionmolds沖頭垂直往復運動壓片

Thepunchmovesverticallyinareciprocatingmotiontocompressthetablet.壓片設備按照工作原理的不同，可分為單沖壓片機、旋轉式多沖壓片機、高速旋轉式壓片機等。Tabletpressequipmentcanbedividedintosingle-punchtabletpress,rotarymulti-punchtabletpress,high-speedrotarytabletpress,etc.,basedondifferentworkingprinciples.壓片設備-單沖壓片機

Tabletpressequipment-Single-punchtabletpress.單沖式壓片機由沖模、加料機構、填充調節機構、壓力調節機構和出片控制機構等組成。Thesingle-punchtabletpressconsistsofcomponentssuchasthepunchanddie,feedingmechanism,fillingadjustmentmechanism,pressureadjustmentmechanism,andtabletejectioncontrolmechanism.②①③壓力調節器

Pressureregulator.④⑤②

①③⑤④①沖模；①Punchanddie.②施料器（加料機構）②Feeder(feedingmechanism).③片重調節器（填充調節機構）；③Tabletweightregulator(fillingadjustmentmechanism).④壓力調節機構；④Pressureadjustmentmechanism.⑤出片調節機構。⑤Tabletejectioncontrolmechanism.壓片設備-單沖壓片機

Tabletpressequipment-Single-punchtabletpress.FeederUpperpunchMiddledieLowerpunchEjectionregulatorTabletweightregulator單沖壓片機的壓片過程是由加料、加壓、出片、自動連續進行的。

Thetabletcompressionprocessofasingle-punchtabletpressiscarriedoutautomaticallyandcontinuously,includingfeeding,pressing,tabletejection.工作過程：

Workingprocess:①上沖上升，下沖下降封住中模，飼料靴轉移到模圈上，將靴內藥料填滿模孔；

①Theupperpunchrisesandthelowerpunchdescendstoclosethemiddledie,andthefeedingbootmovestothemoldring,fillingthebootwiththematerialfortabletformation;②飼料靴移開，同時上沖下降將顆粒壓成片劑；

②Thefeedingbootmovesaway,andsimultaneously,theupperpunchdescendstocompressthegranulesintotablets;③上、下沖相繼上升，下沖上升到與模圈平齊將片劑從模孔中頂出；

③Theupperandlowerpunchesriseoneaftertheother.Thelowerpunchrisestothesamelevelasthemoldringandejectsthetabletfromthediehole;④飼料靴轉移到模圈上把片劑從模圈上推入接受器，同時下沖下降，模內加料；如此反復完成壓片出片動作。

④Thefeedingbootmovestothemoldring,pushingthetabletintothereceptacle,whilethelowerpunchdescendstoaddmaterialtothedie.Thisprocessisrepeatedtocompletethetabletcompressionandejectionactions.①

①②

②③

③壓片設備-單沖壓片機

Tabletpressequipment-Single-punchtabletpress.旋轉式多沖壓片機是由均勻分布于旋轉轉臺的多副沖模按一定軌跡作垂直往復運動的壓片設備。Therotarymulti-punchtabletpressisatabletpressingequipmentwheremultiplesetsofpunchesareuniformlydistributedonarotatingturntable,andtheymoveinaverticalreciprocatingmotionfollowingacertaintrajectory.旋轉式多沖壓片機

Rotarymulti-punchtabletpress旋轉轉臺

Rotatingturntable多幅沖模

Multiplesetsofpunches壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpress.旋轉式壓片機主要由動力部分、減速傳動部分、工作部分（轉盤、壓輪、片重調節器、壓力調節器、加料斗、月形柵式加料器、吸塵器、保護裝置）等組成，如圖所示。Therotarytabletpressmainlyconsistsofthepowersection,reductiontransmissionsection,workingsection(turntable,pressurerollers,tabletweightregulator,pressureregulator,feedinghopper,moon-shapedgridfeeder,vacuumcleaner,protectivedevices,etc.),asshowninthediagram.旋轉式壓片機結構示意圖

Schematicdiagramoftherotarytabletpressstructure壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpress.轉臺

Turntable軌道

Track月形柵式加料器

Moon-shapedgridfeeder壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpress.加料斗

Feedinghopper吸塵器

Vacuumcleaner壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpress.轉臺順時針方向旋轉

Theturntablerotatesclockwise.1.旋轉式壓片機通過轉臺的旋轉，帶動多組沖模作順時針旋轉。1.Therotarytabletpressdrivesmultiplesetsofpunchestorotateclockwisethroughtherotationoftheturntable.壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpress.壓輪

Pressurerollers2. 物料由加料斗通過月形柵式加料器流入位于其下方旋轉平臺的模圈的中模孔中。2.Materialflowsfromthefeedinghopperthroughthemoon-shapedgridfeederintothemiddledieholelocatedbelowtherotatingplatform.3. 在轉盤回轉到壓片部分時，上沖與下沖在兩個壓輪的作用下將物料壓制成片。3.Whentheturntablerotatestothecompressionsection,theupperandlowerpunches,undertheactionoftwopressurerollers,compressthematerialintotablets.4. 壓片后，下沖上升將藥片從中模孔內頂出，在轉盤運轉到加料器處靠加料器的圓弧形側邊推出轉盤。4.Aftercompression,thelowerpunchrisestoejectthetabletsfromthemiddledieholeandpushesthemoutoftheturntablenearthearcsideofthefeeder.壓片設備-旋轉式多沖壓片機

Tabletpressequipment-Rotarymulti-punchtabletpressUpperpunchUpperpressurerollerFillingbracketPowderscraperMoldringLowerpunchTabletweightregulatorLowerpressurerollerEjectionregulator片劑生產案例——壓片車間事故

Tabletproductioncase-Accidentinthetabletcompressionworkshop.2016年4月21日，下午1點過。壓片生產4車間操作工吳迎，準備對“血塞通”藥品試樣。使用55沖壓片機試樣，下沖裝了55沖，上沖裝了6沖，其余沒有裝上沖的中模塊全部用膠帶貼上封住。由于手搖輪壓出的藥片硬度和分散性不達標。所以吳迎采用了點動（注：點動速度比手動快）。OnApril21,2016,ataround1:00PM,WuYing,anoperatorinthetabletcompressionproductionworkshop4,waspreparingatrialsampleofthedrug"SanqiPanaxNotoginseng".A55-stationtabletpresswasusedforthetrialsample.Thelowerpunchwasequippedwith55stations,andtheupperpunchwasequippedwith6stations,whiletheremainingmiddlemoduleswithoutupperpuncheswerecoveredandsealedwithtape.Duetothehardnessanddispersionofthetabletsnotmeetingthestandardwhencompressedusingthehandwheel,WuYingdecidedtousetheintermittentmode(note:intermittentmodeisfasterthanmanualoperation).2點30分左右，當吳迎用手去取藥片時，手套被旁邊中模的膠帶粘住，導致手指未能及時躲避后面一個下壓的上沖，右手中指骨折。Ataround2:30,whenWuYingreachedforthetabletsbyhand,hisglovegotstucktothetapeofanadjacentmiddlemodule,causinghisfingerstobeunabletoavoidtheupperpunchpressingdownfrombehind,resultinginafracturedmiddlefingeronhisrighthand.踏實工作，安全第一

Workdiligently,prioritizesafety高速旋轉式壓片機是轉臺中模孔中心點的最高線速度不低于60m/min的旋轉式壓片機。它是更為先進的旋轉式壓片設備。通常每臺壓片機有兩套壓輪和兩套給料器。Thehigh-speedrotarytabletpressisarotarytabletpresswithamaximumlinearspeedatthecenterpointofthemiddledieholenotlessthan60m/min.Itisamoreadvancedtypeofrotarytabletpressequipment.Usually,eachtabletpresshastwosetsofpressurerollersandtwosetsoffeeders.高速旋轉式壓片機

High-speedrotarytabletpress兩套給料器

Twosetsoffeeders有兩套壓輪

Ithastwosetsofpressurerollers壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpress高速壓片機系統

High-speedtabletpresssystem高速壓片機系統由壓片機主機、上料器、篩片機、吸塵器等組成，如圖。Thehigh-speedtabletpresssystemconsistsofthetabletpressmainframe,feeder,screeningmachine,vacuumcleaner,etc.,asshowninthediagram.壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpressVacuumcleanerProductbucketsFeederTabletpressmainframeScreeningmachine機座

Machinebase高速壓片機的主體結構示意圖

Schematicdiagramofthemainbodystructureofthehigh-speedtabletpress高速壓片機的主體結構主要有底板、前后立架、前后框架、蝸輪箱、沖盤組合、上支撐塊、控制柜、機座等部分。其中沖壓組合、給料系統（強迫加料裝置）、液壓系統是高速壓片機的重要組成部分。Themainbodystructureofthehigh-speedtabletpressmainlyincludesthebaseplate,frontandrearcolumns,frontandrearframes,wormgearbox,punchassembly,uppersupportblock,controlcabinet,machinebase,etc.Amongthem,thepunchassembly,feedingsystem(forcedfeedingdevice),andhydraulicsystemareessentialcomponentsofthehigh-speedtabletpress.壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpress沖壓組合

Punchassembly沖壓組合包括沖盤（或轉盤）組合（如圖）、上下沖、沖模、上下預壓輪、上下主壓輪、填充裝置、上導軌盤和下導軌凸輪等。Thepunchassemblyincludesthepunchplate(orturntable)assembly(asshowninthediagram),upperandlowerpunches,dieset,upperandlowerpre-pressurewheels,upperandlowermainpressurewheels,fillingdevice,upperguideraildisc,andlowerguiderailcam,etc.壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpress給料系統（強迫加料裝置）

Feedingsystem(forcedfeedingdevice)強迫加料裝置外形圖

Diagramoftheforcedfeedingdevice'sappearance強迫加料裝置主要由料桶、加料電機、加料蝸輪減速器、萬向聯軸器、強迫加料器（如圖）、連接管、加料平臺和調平支腳機構（平臺調整機構）等組成。Theforcedfeedingdevicemainlyconsistsofahopper,feedingmotor,feedingwormgearbox,universalcoupling,forcedfeeder(asshowninthediagram),connectingpipes,feedingplatform,andlevelingsupportmechanism(platformadjustmentmechanism),etc.壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpressFeedingmotorFeedingHopperForcedfeederCenteraxisTurntableMiddledieForcedfeederTabletejectionBlockingplateImpeller給料系統（強迫加料裝置）

Feedingsystem(forcedfeedingdevice)物料

Materials出口

Outlet強迫加料器

Forcedfeeder壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpress液壓系統

HydraulicSystem液壓系統的功能是提供預壓力、主壓力以及進行安全保護。其由液壓泵站、蓄能器、液壓油缸、壓力傳感器、單向節流閥、限壓閥、電磁換向閥、單向閥、預壓油缸、主壓油缸和液壓管路及接頭等組成。Thefunctionofthehydraulicsystemistoprovidepre-pressure,mainpressure,andperformsafetyprotection.Itconsistsofahydraulicpumpstation,accumulator,hydrauliccylinder,pressuresensor,one-waythrottlevalve,pressurereliefvalve,solenoidreversingvalve,checkvalve,pre-pressingcylinder,mainpressingcylinder,hydraulicpipelines,andconnectors,etc.液壓系統

HydraulicSystem1.液壓泵站；

1.Hydraulicpumpstation;2.單向節流閥；

2.One-waythrottlevalve;3.2#蓄能池；

3.Accumulator#2;4.1#蓄能池；

4.1#Accumulator;5.壓力傳感器；

5.Pressuresensor;6.主壓油缸；

6.Mainpressingcylinder;7.預壓油缸

7.Pre-pressingcylinder;壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpress1. 高速旋轉式壓片機的主電機通過無級調速，并經蝸輪減速后帶動沖盤逆時針旋轉。1. Themainmotorofthehigh-speedrotarytabletpressrotatescounterclockwisethroughsteplessspeedregulationandisdrivenbyawormgearboxtorotatetheturntable.2. 沖盤的轉動帶動沖模一起旋轉，并使上、下沖頭沿固定的上下導軌做上、下相對運動（上沖頭端只有在預壓和主壓時才進入中模孔內，而下沖頭端始終在中模孔內）。2. Therotationoftheturntabledrivesthepunchtorotatetogetherandmakestheupperandlowerpunchesmoveupanddownrelativelyalongfixedguiderails(theupperpunchendonlyentersthemiddledieholeduringpre-pressingandmainpressing,whilethelowerpunchendremainsinthemiddledieholethroughout).3. 顆粒經過加料裝置、填充裝置、預壓裝置、壓片裝置等機構完成加料、定量、預壓、主壓成型、出片等連續的工藝過程。3.Thegranulesgothroughstructuressuchasthefeedingdevice,fillingdevice,pre-pressingdevice,tabletpressingdevice,etc.,tocompletethecontinuousprocessoffeeding,quantification,pre-pressing,mainpressing,andtabletejection.壓片設備-高速旋轉式壓片機

Tabletpressequipment-High-speedrotarytabletpressTabletejectionrodTabletejectionsegmentFeederScraperFeedingsegmentPre-pressurewheelMainpressurewheelPre-pressuresegmentTabletpresssegmentTabletejectionguiderailTabletFillingguiderailMeasuringguiderailLowerpunchprotectiveguiderailPre-pressurewheelPre-pressingcylinderMainpressurewheel1.做好開機前準備檢查：包括設備清潔、狀態等情況檢查，安裝沖模、刮粉器、加料器；安裝完畢，轉動手輪，旋轉轉臺1～2圈，檢查機器手動運轉情況，并開機運行，檢查設備開機運轉是否正常，有無異響。1.Performpre-startchecks:Thisincludesinspectingthecleanlinessandconditionoftheequipment,installingthepunches,powderscraper,andfeeder.Afterinstallation,rotatethehandwheel,rotatetheturntable1to2rounds,checkthemanualoperationofthemachine,andstartthemachinetocheckifitrunsnormallywithoutanyabnormalnoises.2.壓片前調節藥片重量或者藥片厚度。2.Beforetabletpressing,adjustthetabletweightorthickness.3.開機打開電源，壓力/轉速顯示儀顯示壓片支承力，轉速顯示“0”，其余元件無指示。3.Turnonthepower,thepressure/rotationspeedindicatorshowsthetabletcompressionforce,therotationspeeddisplays"0",andothercomponentshavenoindications.4.將物料用真空上料機裝入壓片機的料斗內。4.Loadthematerialintothetabletpresshopperusingavacuumloadingmachine.5.按動增壓按鈕，觀察并調整液壓泵電機轉向，然后將顯示壓力調整至所需壓力。5.Presstheboostbuttonandobserveandadjustthedirectionofthehydraulicpumpmotor.Thenadjustthedisplayedpressuretothedesiredlevel.6.將緊停開關置于“按下”狀態，指示燈亮，此時主電動機電磁搶閘機構位于“脫開”位置，操作者可手動操作，完成裝拆沖模工作。6.Placetheemergencystopswitchinthe"pressed"position,theindicatorlightwillbeon,andthemainmotorelectromagneticinterlockmechanismwillbeinthe"disengaged"position,allowingmanualoperationtocompletetheinstallationanddisassemblyofthepunches.7.當壓片機準備就緒，即可進行正常運行。首先將緊急停車開關置于正常位置，按下電機開關鍵，電機運轉，轉動電位器，壓力/轉速顯示儀顯示轉臺轉速。在轉臺運行過程中，調節電位器，可對機器進行無級調整。7.Oncethetabletpressisready,itcanbeoperatednormally.First,returntheemergencystopswitchtoitsnormalposition,pressthemotorswitchkey,andstartthemotor.Turnthepotentiometer,andthepressure/rotationspeedindicatorwilldisplaytheturntablespeed.Duringtheoperationoftheturntable,adjustthepotentiometertomakecontinuousandsmoothadjustmentstothemachine.8.開車后要經常核對片重，觀察電腦的壓力值和偏差值及計量自動調節的行程，與片劑硬度、重量的關系，以及自動潤滑、自動剔廢功能是否正常。

料桶內物料不得少于1/3。8.Afterstarting,regularlycheckthetabletweight,observethepressurevaluesanddeviationvaluesdisplayedbythecomputer,andchecktheautomaticadjustmentofthedosingtoensuretherelationshipbetweentablethardnessandweight,aswellastheproperfunctioningofautomaticlubricationandwasterejectionfunctions.Thematerialinthehoppershouldnotbelessthan1/3full.9.經常檢查機器運轉情況，有無雜音，零部件有無松動及溫升情況。機器正常運轉中，不得接觸運轉部位。9.RegularlyCheckthemachineforanyabnormalnoises,loosecomponents,andtemperaturerise.Donottouchtherotatingpartsofthemachinewhileitisinoperation.10.當需停機時，按下停止按鈕，機器做正常停車。當發生緊急情況量，按下急停按鈕，機器即迅速停機，同時操作臺面板緊急停車指示燈點亮。10.Whenstoppingthemachine,pressthestopbuttonforanormalshutdown.Incaseofanemergency,presstheemergencystopbutton,andthemachinewillstopimmediately,whiletheemergencystopindicatorlightonthecontrolpanelwilllightup.11.壓片完成后，關閉電源，按“高速旋轉壓片機清潔規程”清潔、消毒設備。11.Aftertabletpressingiscomplete,turnoffthepowerandcleananddisinfecttheequipmentfollowingthe"High-SpeedRotaryTabletPressCleaningProcedure".12.填寫“設備運行記錄”。12.Filloutthe"EquipmentOperationRecord".設備的正確使用

ProperUseoftheEquipment設備的正確使用

ProperUseoftheEquipment操作注意事項

OperatingPrecautions1．啟動前檢查確認各部件完整可靠，故障指示燈處于不亮狀態；檢查各潤滑點潤滑油是否充足，壓輪是否運轉自如；觀察沖模是否上下運動靈活，與軌道配合是否良好。1.Beforestarting,Checkandconfirmthatallcomponentsarecompleteandreliable,andthatthefaultindicatorlightsarenotlit.Checkifalllubricationpointshavesufficientlubricatingoilandifthepressurerollersrotatesmoothly.Observeifthepunchesmoveupanddownflexiblyandwhethertheyfitwellwiththetrack.2．拆卸模具時關閉總電源，并且只能一人操作，防止發生危險。2.Whendisassemblingthemolds,turnoffthemainpowerandonlyallowonepersontooperatetopreventaccidents.3．安裝加料斗注意高度，必要時使用塞規，以保證安裝精度。3.Wheninstallingthefeedinghopper,payattentiontotheheightand,ifnecessary,useagaugetoensurepreciseinstallation.4．啟動主機時必須先開吸塵器，并確認調速鈕處于零。4.Whenstartingthemainmachine,thevacuumcleanermustbeturnedonfirst,andthespeedadjustmentknobshouldbesettozero.5．運轉中如遇跳片、疊片或阻片等，切莫用手或工具撥動，以免造成傷害事故，應停車檢查。5.Duringoperation,incaseofissuesliketabletsjumping,overlapping,orblocking,avoidusinghandsortoolstodislodgethemtopreventaccidents,andstopthemachineforinspection.6．機器運轉時操作人員不得擅自離開，應經常檢查設備運轉情況，發現異常及時停車檢查。6.Operatorsshouldnotleavethemachineunattendedwhileitisrunning.Regularlychecktheequipment'soperationandstopforinspectionifanyanomaliesarefound.7．生產將結束時，注意物料余量，接近無料應及時降低車速或停車，不得空車運轉，否則易損壞模具。7.Whenproductionisabouttoend,payattentiontotheremainingmaterial.Whenapproachinganemptystate,reducethespeedorstopthemachinepromptly.Donotrunthemachineempty,asitmaydamagethemolds.8．緊急情況下按下急停按鈕停機，機器故障燈亮時機器自動停下，及時檢查故障并加以排除。8.Incaseofanemergency,presstheemergencystopbuttontostopthemachine.Whenthemachine'sfaultlightison,themachinewillstopautomatically.Checkandtroubleshoottheissuepromptly.9．關玻璃門時要特別小心，由于支撐玻璃門的氣彈簧力量很大，關門時應用力拉住門把，輕輕將門關上，否則易損壞玻璃。9.Beparticularlycarefulwhenclosingtheglassdoor.Thegasspringsupportingtheglassdoorexertssignificantforce.Whenclosingthedoor,holdthedoorhandlefirmlyandgentlyclosethedoortoavoiddamagingtheglass.10．新機器處于磨合期，一般速度控制24r/min以下，運轉3～4個月后再提高速度，最高不超過32r/min。10.Newmachinesareintherunning-inperiod,andthespeedshouldgenerallybecontrolledbelow24r/min.Afterrunningfor3to4months,thespeedcanbeincreased,butitshouldnotexceed32r/min.高速旋轉壓片機清潔操作

Cleaningoperationforhigh-speedrotarytabletpress清潔對象

Cleaningtargets高速旋轉壓片機

High-speedrotarytabletpress清潔頻次

Cleaningfrequency日常清潔：每次生產前后清潔

Routinecleaning:Cleanbeforeandaftereachproduction換品種、換規格、換批號清潔

Cleanwhenchangingtheproducttype,specifications,orbatchnumber連續生產同一品種一周時清潔

Cleanaftercontinuousproductionofthesameproductforoneweek設備維修后清潔；超過清潔有效期（3天）清潔

Cleanifthecleaningvalidityperiod(3days)isexceeded.清潔時間

Cleaningtime應在生產結束2小時內進行清潔。

Cleaningshouldbedonewithin2hoursafterproductionends.清潔地點

Cleaninglocation設備主體就地清潔，加料器、沖模、刮粉器、吸塵機等可拆卸部件移至工器具清洗間清潔。

Foron-sitecleaningoftheequipmentmainbody,removablepartssuchasthefeeder,punches,powderscraper,andvacuumcleanershouldbetakentothecleaningareaforequipmentandtools.清潔工具

Cleaningtools尼龍毛刷、

純化水、無塵抹布、塑料小桶、瓷盤

Nylonbrushes,purifiedwater,lint-freecloths,plasticbuckets,ceramicdishes

清潔劑

Cleaningagents飲用水、純化水、1%NaOH溶液、75%乙醇、0.1%新潔爾滅溶液

Drinkingwater,purifiedwater,1%NaOHsolution,75%ethanol,0.1%benzalkoniumbromidesolution.清潔方法

Cleaningmethod生產前：干凈抹布擦除模具表面和模孔的潤滑油，用飲用水和抹布擦洗干凈，再用純化水擦洗一遍，最后用75%乙醇擦拭消毒。

Pre-productioncleaning:Useacleanclothtowipeoffthelubricatingoilonthemoldsurfaceanddieholes,washitwithdrinkingwaterandcloth,thenrinsewithpurifiedwater,andfinallywipeitwith75%ethanolfordisinfection.生產結束后清潔：先用刷子清理殘留藥粉，純化水、清潔劑擦拭機器內外壁，拆卸加料器、刮粉器、料斗、吸塵機等，飲用水沖洗3次，必要時加入適量清潔劑；潔凈抹布擦干表面，用消毒劑擦拭；擦拭各部件時時始終朝一個方向擦拭，直至擦拭完畢，間隔5分鐘，再用潔凈抹布蘸取純化水擦拭2遍，用熱風烘干。

Post-productioncleaning:First,useabrushtocleantheremainingdrugpowder.Thenwipetheinsideandoutsideofthemachinewithpurifiedwateranddetergent.Removethefeeder,powderscraper,hopper,vacuumcleaner,etc.Rinsethreetimeswithdrinkingwater,andaddanappropriateamountofdetergentifnecessary.Wipethesurfacewithacleanclothandthenwipewithadisinfectant.Wipeeachpartinonedirectionuntilitisclean.Waitfor5minutes,thenuseacleanclothdippedinpurifiedwatertowipetwice,andusehotairfordrying.清潔效果

Cleaningeffectiveness目測設備內、外表面無可見殘留物，無污跡、水漬。

Visualinspectionshowsnovisibleresiduesorstainsontheinsideandoutsidesurfacesoftheequipment.設備的清潔

EquipmentCleaning設備的維護與保養

Maintenanceofequipment機器的維護

Equipmentmaintenance1．渦輪減速器的維護保證渦輪減速器的吸氣和排氣口空氣流通順暢。渦輪減速器的油面應定期檢查。每工作400小時～500小時應更換機油。1.MaintenanceoftheturbinereducerEnsuresmoothaircirculationattheinletandoutletoftheturbinereducer.Checktheoilleveloftheturbinereducerregularly.Replacethemachineoilevery400hoursto500hoursofoperation.2．液壓維護系統要定期檢查油面，油壓最高時，液面不能低于5cm，否則應加液壓油。2.HydraulicmaintenancesystemRegularlychecktheoillevel.Whentheoilpressureisatitshighest,theoillevelshouldnotbelowerthan5cm.Ifitislower,hydraulicoilshouldbeadded.3．潤滑系統3.Lubricationsystem（1）機器的潤滑由中心潤滑系統來完成。潤滑后的廢油通過排油口流到廢油箱里，廢油箱要定期清理。中心潤滑系統可通過PLC控制面板“潤滑控制”頁面調整潤滑油的傳送。(1)Thelubricationofthemachineisdonebythecentrallubricationsystem.Thewasteoilafterlubricationflowsintothewasteoiltankthroughthedrainport,andthewasteoiltankshouldbecleanedregularly.ThecentrallubricationsystemcanadjustthetransmissionoflubricatingoilthroughthePLCcontrolpanelonthe"LubricationControl"page.（2）干油潤滑系統為手動給油系統，每班工作前推手動泵1～2次。潤滑脂的牌號為00號氮化硼潤滑脂。(2)Thedryoillubricationsystemisamanualoilsupplysystem,andthemanualpumpshouldbeoperated1to2timesbeforeeachshift.ThegreaseusedisNo.00boronnitridegrease.（3）主軸軸承的潤滑打開左門，在座體的油池邊有一個注壓式油杯，每工作200小時要注油，潤滑油為鉀基潤滑脂。(3)LubricationofthemainspindlebearingOpentheleftdoor,andthereisapressurizedoilcuponthesideoftheseatbody'soilpool.Theoilshouldbereplenishedevery200hoursofwork,andthelubricantusedispotassium-basedgrease.4．給料裝置的維護4.Maintenanceofthefeedingdevice（1）預先填充和排空按下“給料裝置”按鈕，則可以進行預先填充，再拉出給料裝置下邊的滑板就能把給料裝置內藥粉排空。(1)Pre-fillingandemptyingPressthe"FeedingDevice"buttontopre-fill,andthenpullouttheslideunderthefeedingdevicetoemptythedrugpowderinside.（2）給料裝置平臺的校準在機器運行期間加料器與沖盤的間隙校準到0.05mm。(2)CalibrationofthefeedingdeviceplatformDuringtheoperationofthemachine,calibratethegapbetweenthefeederandthepunc