片劑生產(chǎn)設(shè)備Tabletproductionequipment制藥設(shè)備使用與維護(hù)Operation

片劑生產(chǎn)設(shè)備

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

OperationandMaintenanceofCommonPharmaceuticalEquipment知識目標(biāo)KnowledgeObjectives（1）掌握片劑生產(chǎn)設(shè)備的原理、結(jié)構(gòu)和使用方法。(1)Understandingtheprinciples,structures,andusageoftabletproductionequipment.（2）熟悉片劑生產(chǎn)設(shè)備的種類和特點(diǎn)。(2)Familiaritywiththetypesandcharacteristicsoftabletproductionequipment.（3）了解片劑生產(chǎn)設(shè)備的維護(hù)與保養(yǎng)及故障排除。(3)Knowledgeofmaintenance,upkeep,andtroubleshootingoftabletproductionequipment.能力目標(biāo)AbilityObjectives學(xué)會片劑生產(chǎn)設(shè)備的基本結(jié)構(gòu)和工作原理。Learningaboutthebasicstructureandworkingprinciplesoftabletproductionequipment.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)生具備片劑生產(chǎn)崗位必備的基本知識、基本技能和職業(yè)素質(zhì)。(2)Studentsshouldpossessessentialfundamentalknowledge,basicskills,andprofessionalqualitiesrequiredforthetabletproductionposition.（3）通過片劑生產(chǎn)案例培養(yǎng)踏實(shí)工作、安全第一的意識。(3)Cultivateasenseofdiligentworkandprioritizesafetythroughtabletproductioncasestudies.重點(diǎn)KeyPoints片劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理Structureandworkingprinciplesoftabletproductionequipment難點(diǎn)Difficulties片劑生產(chǎn)設(shè)備的正確操作Properoperationoftabletproductionequipment學(xué)習(xí)目標(biāo)

LearningObjectives生產(chǎn)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(jìn)行壓片的方法

Methodsforcompressingdrygranulationparticlesintotablets濕法制粒壓片法

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

Methodsforcompressingwetgranulationparticlesafterdrying（粉末或結(jié)晶）直接壓片法

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

Directlycompressingthemixtureofdrugsandexcipientswithoutgranulation

當(dāng)粉末非常松軟且細(xì)粉較多時(shí)，將造成壓片困難，在總混壓片前，必須先制粒。

Whenthepowderisverylooseandcontainsalotoffineparticles,itwillbedifficulttocompressthetablets,andgranulationmustbeperformedbeforetabletcompression.生產(chǎn)流程

Productionprocess

目前片劑生產(chǎn)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(chǎn)工藝相比，具有工藝操作簡單、生產(chǎn)周期短、生產(chǎn)成本低、工藝適應(yīng)性強(qiáng)等明顯的優(yōu)勢。Currently,wetgranulationandtabletcompressionarethemainmethodsintabletproduction.However,comparedtoothertabletproductionprocesses,thedirectcompressionmethodofferssignificantadvantagessuchassimpleprocessoperation,shortproductioncycles,lowproductioncosts,andstrongprocessadaptability.原輔料Rawexcipients玻璃瓶GlassbottleD級潔凈區(qū)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(yàn)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(zhì)量控制點(diǎn)

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.荸薺式包衣機(jī)又稱為普通包衣機(jī)、糖衣鍋，可用于包糖衣、薄膜衣和腸溶衣，是最基本的滾轉(zhuǎn)式包衣設(shè)備。Waterchestnuttypesugarcoatingmachine,alsoknownasaregularcoatingmachineorasugar-coatingpan,canbeusedforsugarcoating,filmcoating,andentericcoating.Itisthemostbasictypeofrollingcoatingequipment.荸薺式包衣機(jī)

Waterchestnuttypesugarcoatingmachine包糖衣

Sugarcoating薄膜衣

Filmcoating腸溶衣

Entericcoating包衣設(shè)備-荸薺式包衣機(jī)

Coatingequipment-waterchestnuttypesugarcoatingmachine荸薺式包衣機(jī)主要由包衣鍋、動力系統(tǒng)、加熱系統(tǒng)、排風(fēng)或吸塵系統(tǒng)組成。常見形狀有荸薺形和蓮蓬形。Thewaterchestnuttypesugarcoatingmachinemainlyconsistsofacoatingpan,powersystem,heatingsystem,andexhaustordustcollectionsystem.Commonshapesincludewaterchestnuttypeandlotusseedtype.加熱器

Heater包衣設(shè)備-荸薺式包衣機(jī)

Coatingequipment-waterchestnuttypesugarcoatingmachineCoatingpanHeatingwireBlowerExhaustairoutletPowerhoopSupport包衣時(shí)，將片芯放入不斷翻滾的包衣鍋內(nèi)，多次噴灑包衣液，經(jīng)預(yù)熱的熱空氣連續(xù)吹入包衣鍋，這樣邊包層邊加熱使之干燥，必要時(shí)，可打開輔助加熱器，以保持鍋內(nèi)溫度，提高干燥速度，這樣就使衣料在片劑表面不斷沉積成膜層，當(dāng)包衣達(dá)到規(guī)定的質(zhì)量要求，即可停機(jī)后出料。Duringthecoatingprocess,thetabletcoreisplacedinsideacontinuouslytumblingcoatingpan,andthecoatingliquidissprayedmultipletimes.Preheatedhotairisblownintothecoatingpancontinuously,heatinganddryingthecoatinglayerintheprocess.Ifnecessary,theauxiliaryheatercanbeturnedontomaintainthetemperatureinsidethepanandincreasethedryingspeed.Thiscontinuousprocessallowsthecoatingtodepositasafilmlayeronthesurfaceofthetablet.Whenthecoatingreachesthespecifiedqualityrequirement,themachinecanbestopped,andthecoatedtabletscanbedischarged.包衣設(shè)備-荸薺式包衣機(jī)

Coatingequipment-waterchestnuttypesugarcoatingmachine高效包衣機(jī)是對中西藥片芯外表面進(jìn)行薄膜衣和糖衣的包衣設(shè)備。

可分為：網(wǎng)孔式、間隔網(wǎng)孔式、無孔式三類，其中網(wǎng)孔式和間隔網(wǎng)孔式高效包衣機(jī)統(tǒng)稱為有孔高效包衣機(jī)。Thehigh-efficiencycoaterisacoatingequipmentusedforfilmcoatingandsugarcoatingtheoutersurfaceofChineseandWesternmedicinetablets.Itcanbedividedintothreetypes:meshtype,intermittentmeshtype,andnon-meshtype.Themeshtypeandintermittentmeshtypehigh-efficiencycoatersarecollectivelyreferredtoasperforatedhigh-efficiencycoaters.高效包衣機(jī)

High-efficiencycoater網(wǎng)孔式高效包衣機(jī)

Meshtypehigh-efficiencycoater:間隔網(wǎng)孔式高效包衣機(jī)

Intermittentmeshtypehigh-efficiencycoater無孔式高效包衣機(jī)

Non-meshtypehigh-efficiencycoater包衣鍋整個(gè)圓周都有圓孔

Theentirecircumferenceofthecoatingpanhascircularholes.包衣鍋開孔部分不是整個(gè)圓周，而是沿圓周的幾個(gè)等分的區(qū)域

Theopeningofthecoatingpanisnotalongtheentirecircumferencebutdividedintoseveralequalsectionsalongthecircumference.鍋體無圓孔

Thecoatingpanhasnocircularholes分類特點(diǎn)

ClassificationFeatures包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoater網(wǎng)孔式高效包衣機(jī)立體示意圖

Three-dimensionalschematicdiagramofthemeshtypehigh-efficiencycoater網(wǎng)孔式高效包衣機(jī)平面示意圖

Schematicdiagramofthemeshtypehigh-efficiencycoater網(wǎng)孔式高效包衣機(jī)

Meshtypehigh-efficiencycoater:如立體圖，包衣鍋整個(gè)圓周都帶有圓孔，經(jīng)過濾并加熱的空氣從包衣鍋的右上部通過網(wǎng)孔進(jìn)入鍋內(nèi)，熱空氣穿過運(yùn)動狀態(tài)的片芯間隙，穿過鍋底下部的網(wǎng)孔后經(jīng)排風(fēng)管排出。Inthethree-dimensionaldiagram,theentirecircumferenceofthecoatingpanhascircularholes.Filteredandheatedairentersthepanfromtheupperrightsidethroughthemesh,passesthroughthegapsbetweenthemovingtabletcores,andthenexitsthroughthemeshatthebottomofthepanviatheexhaustduct.平面圖中熱空氣的流向?yàn)橛疑辖沁M(jìn)入左下角排出，這種稱為直流式；熱空氣的流向逆向，即從左下角進(jìn)入右上角排出，稱為反流式。這兩種方式使片芯分別處于“緊密”和“疏松”的狀態(tài)，可根據(jù)品種不同進(jìn)行選擇。Intheplanview,theflowdirectionofhotairisfromtheupperrightcorner,entering,andthenexitingfromthelowerleftcorner.Thisisknownasdirectflow.Iftheflowdirectionofhotairisreversed,meaningitentersfromthelowerleftcornerandexitsfromtheupperrightcorner,itiscalledreverseflow.Thesetwomethodsplacethechipin"tight"and"loose"statesrespectively,andthechoicecanbemadebasedondifferentvarieties.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoaterExhaustairExhaustductShellCleanhotairIntake-tubeCoatingdrumThecoreofthetablet間隔網(wǎng)孔式高效包衣機(jī)

Intermittentmeshtypehigh-efficiencycoater網(wǎng)孔式高效包衣機(jī)平面示意圖

Schematicdiagramofthemeshtypehigh-efficiencycoater如圖，間隔網(wǎng)孔式高效包衣機(jī)的開孔部分不是整個(gè)圓周，而是沿圓周的幾個(gè)等分的區(qū)域。圖中是4個(gè)等分，即每隔90°開一個(gè)網(wǎng)孔區(qū)域，并與四個(gè)風(fēng)管連接。Asshowninthediagram,theperforatedsectionoftheintervalmeshtypehigh-efficiencycoatingmachineisnottheentirecircumference,butratherseveralequallydividedareasalongthecircumference.Thefigureshowsfourequalsections,witheachsectionseparatedby90degrees,formingdistinctairventregionsconnectedtofourairducts.工作時(shí)風(fēng)管與鍋體一起轉(zhuǎn)動，由于4個(gè)風(fēng)管分別與4個(gè)風(fēng)門連通，風(fēng)門旋轉(zhuǎn)時(shí)分別間隔地被出風(fēng)口接通每一管道而達(dá)到排濕的效果。Duringoperation,theairductsrotatealongwiththecoatingdrum.Sincethefourairductsareconnectedtofourairdoors,theairdoorsrotateintermittentlyandalignwiththecorrespondingairventoutlets,achievingtheeffectofdehumidificationbyintermittentlyconnectingeachduct.這種間歇的排濕結(jié)構(gòu)使鍋體減少了打孔的范圍，減輕了工作量。同時(shí)熱量也得到充分的利用，節(jié)約能量，不足之處是風(fēng)機(jī)負(fù)載不均勻，對風(fēng)機(jī)有一定的影響。Thisintermittentdehumidificationstructurereducesthepunchingrangeonthecoatingdrumandreducestheworkload.Additionally,itefficientlyutilizesheatandsavesenergy.However,adrawbackisthattheunevenloadonthefanaffectsitsperformancetosomeextent.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoaterInletairductCoatingdrumThecoreofthetabletOutletairductDamperAxisofrotationAirductAirductAirventregion無孔式高效包衣機(jī)

Non-meshtypehigh-efficiencycoater無孔式高效包衣機(jī)平面示意圖（第一種形式）

SchematicdiagramoftheNon-meshtypehigh-efficiencycoater(firstform)無孔式高效包衣機(jī)的鍋體沒有圓孔，其熱交換主要通過以下兩種形式實(shí)現(xiàn)：ThepotbodyoftheNon-meshtypehigh-efficiencycoaterdoesnothavecircularholes.Itsheatexchangeismainlyachievedthroughthefollowingtwoforms:①將布滿小孔的2－3個(gè)吸氣槳葉浸沒在片芯內(nèi)，使熱空氣穿過片芯間隙后再穿過槳葉小孔進(jìn)入吸氣管道內(nèi)被排出。①2-3suctionbladescoveredwithsmallholesareimmersedinthecoreofthetablet,allowinghotairtopassthroughthegapsbetweenthetabletsandthenthroughthesmallholesinthebladestoenterthesuctionpipelineandbedischarged.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoaterSpraygunPerforatedbladeInletairExhaustairThecoreofthetabletlayerCoatingdrum無孔式高效包衣機(jī)

Non-meshtypehigh-efficiencycoater新穎無孔式高效包衣機(jī)平面示意圖（第二種形式）

SchematicdiagramoftheinnovativeNon-meshtypehigh-efficiencycoater(secondform)②熱風(fēng)由旋轉(zhuǎn)軸的部位進(jìn)入鍋體內(nèi)，然后穿過運(yùn)動的片芯層，通過鍋體下部兩側(cè)而被排出。②Hotairentersthepotbodyfromthepartoftherotatingaxis,thenpassesthroughthemovingcorelayer,andisdischargedthroughthesidesofthelowerpartofthepotbody.無孔包衣機(jī)與有孔包衣機(jī)的包衣效果相同，且無孔包衣機(jī)的鍋體表面平整、光潔，對物料無損傷，鍋體無孔加工更容易，其不僅適用于片劑包衣，還可用于微丸包衣。Thecoatingeffectoftheperforatedandnon-perforatedcoatingmachinesisthesame.Thesurfaceofthenon-perforatedcoatingmachine'spotissmoothandpolished,causingnodamagetothematerials.Thenon-perforatedpotiseasiertoprocesssinceitdoesn'thaveholes.Itissuitablenotonlyforcoatingtabletsbutalsoforcoatingmicrogranules.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoaterRearcoverSpraysystemInletairExhaustairFrontcoverCoatingdrumThecoreofthetablet高效包衣機(jī)成套設(shè)備

High-efficiencycoatercompleteset高效包衣機(jī)成套設(shè)備

High-efficiencycoatercompleteset高效包衣機(jī)轉(zhuǎn)鍋

High-efficiencycoaterrevolvingpan高效包衣機(jī)成套設(shè)備主要由主機(jī)（包衣鍋）、送風(fēng)系統(tǒng)、排風(fēng)系統(tǒng)、噴霧輸液系統(tǒng)及程序控制系統(tǒng)等部件組成。主機(jī)由外殼、轉(zhuǎn)鍋和傳動裝置組成。如圖所示。Thehigh-efficiencycoatercompletesetincludesthemainunit(coatingpot),airsupplysystem,exhaustsystem,sprayfluidsystem,andprogramcontrolsystem,amongothercomponents.Themainunitconsistsofashell,rotatingpot,andtransmissiondevice,asshowninthediagram.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoaterExhaustairsystemProcesscontrolsystemMainunitSprayfluidsystemAirsupplysystem高效包衣機(jī)工作時(shí)，被包衣的片芯在包衣主機(jī)的包衣滾筒內(nèi)作連續(xù)復(fù)雜的軌跡運(yùn)動。Duringtheoperationofthehigh-efficiencycoater,thecorestobecoatedmoveinacontinuousandcomplextrajectorywithinthecoatingdrumofthecoatingmainunit.包衣介質(zhì)經(jīng)過蠕動泵和有氣噴槍（或滴管）自動地噴灑（或滴流）在片芯表面，熱風(fēng)柜按設(shè)定的程序和溫度向片床供給潔凈的熱風(fēng)對藥片進(jìn)行干燥，熱風(fēng)穿過片芯間隙及底部篩孔，由排風(fēng)柜把廢氣排出，使片芯表面快速形成堅(jiān)固、細(xì)密、光滑圓整的表面薄膜。Thecoatingmediumisautomaticallysprayed(ordripped)ontothesurfaceofthecoresthroughaperistalticpumpandanair-assistedspraygun(ordropper).Thecleanhotairsuppliedbythehotaircabinetisusedtodrythetabletsaccordingtothesetprogramandtemperature.Thehotairpassesthroughthegapsandbottomsieveholesofthecoresandisexhaustedbytheexhaustcabinet,rapidlyformingasolid,smooth,anduniformsurfacefilmonthesurfaceofthecores.包衣設(shè)備-高效包衣機(jī)

CoatingEquipment-High-EfficiencyCoater顏色絢麗的包衣片讓患者看了心情愉悅，就不會覺得吃藥很痛苦了。Thecolorfulcoatingonthetabletsbringsjoytopatients,makingthemfeellesspainwhentakingmedication.我們平時(shí)也應(yīng)該多感受生活的五彩斑斕，才能笑對人生，遠(yuǎn)離抑郁。Inourdailylives,weshouldalsoembracethevibrantcolorsoflifetofaceitwithasmileandstayawayfromdepression.（一）開機(jī)前準(zhǔn)備

(I)Preparationbeforestartingthemachine1．檢查機(jī)器各部件是否符合要求，并進(jìn)行消毒。

1.Checkifallmachinecomponentsmeettherequirementsanddisinfectthem.2．開啟總電源，檢查主機(jī)及各系統(tǒng)能否正常運(yùn)轉(zhuǎn)。

2.Turnonthemainpowerandcheckifthehostandallsystemsarefunctioningproperly.3．安裝蠕動泵管道。

3.Installtheperistalticpumppipeline.4．裝噴霧管道部件，連接主管道。

4.Assemblethespraypipelinepartsandconnectthemtothemainpipeline.（1）將噴槍組件安裝在旋轉(zhuǎn)臂上，調(diào)整好組件及管道在滾筒中的合適位置，將各緊固螺釘擰緊。

(1)Installthesprayguncomponentsontherotatingarm,adjusttheirpositionwithinthedrum,andtightenallfasteningscrews.（2）打開蒸氣閥門，在操作面板上點(diǎn)擊“薄膜包衣”。開動高效包衣機(jī)，預(yù)熱包衣鍋。

(2)Openthesteamvalveandselect"FilmCoating"onthecontrolpanel.Startthehigh-efficiencycoaterandpreheatthecoatingpan.5．調(diào)整噴霧模式

5.Adjustingthespraymode（1）包衣鍋預(yù)熱時(shí)，開啟霧化，確認(rèn)噴槍噴液正常，霧化效果良好，三個(gè)噴槍噴出的霧化包衣料均勻?qū)ΨQ。

(1)Whilethecoatingpanispreheating,turnontheatomization,confirmthatthespraygunissprayingliquidcorrectly,andthattheatomizationeffectisgoodwithevenandsymmetricalcoatingfromallthreesprayguns.（2）擰緊噴槍頂端的調(diào)整螺釘。

(2)Tightentheadjustmentscrewsonthetopofthesprayguns.（3）接通蠕動泵電源，打開蠕動泵的開關(guān)，調(diào)整轉(zhuǎn)速至要求的噴霧模式。

(3)Connectthepowersupplyoftheperistalticpump,turnontheswitchoftheperistalticpump,andadjustthespeedtothedesiredspraymode.設(shè)備的正確使用

ProperUseoftheEquipment（二）開機(jī)操作

(II)StartupProcedure1．進(jìn)料：待進(jìn)風(fēng)溫度顯示為45℃～60℃時(shí)，打開鍋門，將需要包衣的基片倒入鍋內(nèi)。

1.Feeding:Whentheincomingairtemperatureshows45°Cto60°C,openthepandoorandpourthetabletsthatneedcoatingintothepan.2．將旋轉(zhuǎn)臂連同噴霧管道及噴槍轉(zhuǎn)入包衣滾筒內(nèi)。

2.Inserttherotatingarmalongwiththespraypipelineandspraygunintothecoatingdrum.3．開啟包衣鍋“轉(zhuǎn)動”按扭，將包衣鍋調(diào)節(jié)至規(guī)定轉(zhuǎn)速，將調(diào)試好的噴槍推入包衣鍋內(nèi)，將其固定在包衣鍋壁上，關(guān)嚴(yán)鍋門，開啟蠕動泵，進(jìn)行包衣。

3.Turnonthe"Rotation"buttonofthecoatingpanandadjustittothespecifiedspeed.Inserttheproperlyadjustedspraygunintothecoatingpanandfixitonthewallofthepan.Closethepandoor,turnontheperistalticpump,andbeginthecoatingprocess.4．包衣大約45～60分鐘，待基片表面有薄薄一層包衣料時(shí)，將包衣鍋轉(zhuǎn)速調(diào)節(jié)至3.8r/min～4.2r/min。當(dāng)包衣料包完一半時(shí)，將包衣鍋轉(zhuǎn)速調(diào)節(jié)至4.8r/min～5.2r/min。

4.Coatingtakesabout45to60minutes.Whenthereisathinlayerofcoatingmaterialonthesurfaceofthetablets,adjustthecoatingpanspeedto3.8r/minto4.2r/min.Whenhalfofthecoatingprocessiscompleted,adjustthecoatingpanspeedto4.8r/minto5.2r/min.5．待包衣料噴完后，先將蠕動泵關(guān)掉，將噴槍從鍋內(nèi)拿出，將鍋速調(diào)至2.5r/min～3.2r/min，保持進(jìn)風(fēng)溫度對片床進(jìn)行干燥。

5.Aftercompletingthecoatingprocess,firstturnofftheperistalticpump,removethespraygunfromthepan,andadjustthepanspeedto2.5r/minto3.2r/minfordryingthetabletbedwithincomingair.6．操作完畢后，關(guān)閉電源，按清潔操作規(guī)程對設(shè)備進(jìn)行清潔。

6.Afterfinishingtheoperation,turnoffthepowerandfollowthecleaningprocedurestocleantheequipment.設(shè)備的正確使用

ProperUseoftheEquipment（三）操作注意事項(xiàng)

(III)OperatingPrecautions1．包衣料為有機(jī)溶劑應(yīng)注意安全防火、防爆。

1.Forcoatingsusingorganicsolvents,payattentiontofireandexplosionsafety.2．啟動前檢查確認(rèn)各部件完整可靠。

2.Beforestarting,carefullycheckandconfirmthatallcomponentsareintactandreliable.3．電器嚴(yán)格按順序操作：啟動時(shí)，開滾筒→開排風(fēng)→開加熱；關(guān)機(jī)時(shí)，關(guān)加熱→關(guān)排風(fēng)→關(guān)滾筒

3.Followtheelectricaloperationsequencestrictly:Startbyturningonthedrum→exhaustfan→heating;Shutdownbyturningofftheheating→exhaustfan→drum.4．注意熱風(fēng)柜的送風(fēng)口附近不得有雜物。

4.Ensurethattherearenomiscellaneousitemsneartheairsupplyportofthehotaircabinet.5．主機(jī)上的所有清洗用軟連接管路在包衣時(shí)應(yīng)拆下。

5.Duringcoating,removeallcleaningflexibleconnectingpipesfromthemainunit.6．裝蠕動泵硅膠管時(shí)應(yīng)特別注意將硅膠管安裝在滾道的中間，壓下泵頭蓋時(shí)應(yīng)注意硅膠管應(yīng)在兩側(cè)的卡子V型槽的中間，避免夾破硅膠管。

6.Wheninstallingthesiliconetubefortheperistalticpump,payspecialattentiontoplacingthesiliconetubeinthemiddleoftheroller,andwhenpressingdownthepumpheadcover,ensurethatthesiliconetubeisinthemiddleoftheV-grooveoftheclampsonbothsidestoavoidsqueezinganddamagingthesiliconetube.7．為了保證藥品和設(shè)備的安全，在清洗時(shí)，必須關(guān)閉排風(fēng)電機(jī)、送風(fēng)電機(jī)，薄膜包衣關(guān)閉，打開清洗開關(guān)。清洗完成后，關(guān)上所有的閥門，使用排風(fēng)/送風(fēng)烘干主機(jī)鍋。

7.Toensurethesafetyofdrugsandequipmentduringcleaning,theexhaustfan,supplyfan,andfilmcoatingmustbeturnedoff,andthecleaningswitchshouldbeturnedon.Aftercleaning,closeallvalvesandusetheexhaust/supplyairdryingmainunit.設(shè)備的正確使用

ProperUseoftheEquipment高效包衣機(jī)清潔操作

Cleaningprocedureforthehigh-efficiencycoater清潔對象

Cleaningtargets高效包衣機(jī)

High-efficiencycoater清潔頻次

Cleaningfrequency每日生產(chǎn)結(jié)束

Attheendofdailyproduction更換品種前或清潔合格證已過有效期，重新開工前

Beforechangingtheproductvarietyorwhenthecleaningcertificatehasexpiredbeforeresumingwork.設(shè)備維修后

Afterequipmentmaintenance每星期生產(chǎn)結(jié)束

Attheendofeachweek'sproduction清潔時(shí)間

Cleaningtime應(yīng)在生產(chǎn)結(jié)束2小時(shí)內(nèi)進(jìn)行清潔。

Cleaningshouldbedonewithin2hoursafterproductionends.清潔地點(diǎn)

Cleaninglocation就地清潔

On-sitecleaning清潔工具

Cleaningtools刷子、絲光毛巾、紗布、水桶

Brushes,lint-freetowels,gauze,waterbucket

清潔劑

Cleaningagents飲用水、純化水、洗滌劑、75%乙醇、0.2%新潔爾滅溶液

drinkingwater,purifiedwater,detergent,75%ethanol,0.2%benzalkoniumbromidesolution清潔方法

Cleaningmethod啟動振打電機(jī)除塵；將蠕動泵輸液管插入盛有飲用水的桶中，啟動蠕動泵，清洗輸液管道和噴槍內(nèi)部，直至噴槍流出澄清的液體；用刷子和熱的飲用水擦洗噴槍、支架、配液桶、攪拌槳、包衣機(jī)內(nèi)表面，直至可見殘留物消失；用潔凈的紗布蘸取清潔劑擦拭噴槍、支架、配液桶、攪拌槳、包衣機(jī)內(nèi)、外表面；將蠕動泵輸液管插入盛有純化水的桶中，啟動蠕動泵，開啟包衣機(jī)，通過噴槍沖洗包衣機(jī)內(nèi)部10分鐘；用絲光毛巾蘸取純化水擦拭將噴槍、支架及包衣機(jī)內(nèi)、外表面殘留的清潔劑擦洗干凈；開啟熱風(fēng)、排風(fēng)，對設(shè)備內(nèi)表面進(jìn)行干燥。Startthevibrationmotorfordustremoval.Inserttheperistalticpumptubingintoabucketfilledwithdrinkingwater,starttheperistalticpump,andcleanthetubingandinternalpartsofthespraygununtilclearliquidcomesoutfromthegun.Useabrushandhotdrinkingwatertoscrubthespraygun,supportbracket,liquidcontainer,stirringpaddle,andtheinternalsurfacesofthecoatingmachineuntilvisibleresiduesareremoved.Useacleangauzesoakedindetergenttowipethespraygun,supportbracket,liquidcontainer,stirringpaddle,andboththeinternalandexternalsurfacesofthecoatingmachine.Inserttheperistalticpumptubingintoabucketfilledwithpurifiedwater,starttheperistalticpump,andturnonthecoatingmachinetoflushtheinternalpartsofthemachinefor10minutesusingthespraygun.Uselint-freetowelssoakedinpurifiedwatertowipeoffanyremainingdetergentfromthespraygun,supportbracket,andboththeinternalandexternalsurfacesofthecoatingmachine.Turnonthehotairandexhaustfantodrytheinternalsurfacesoftheequipment.清潔效果

Cleaningeffectiveness目檢設(shè)備內(nèi)、外表面無可見污跡。用潔凈絲光毛巾擦拭滾筒內(nèi)部，無殘留藥物。

Visualinspectionshowsnovisiblestainsontheinternalandexternalsurfacesoftheinspectionequipment.Usecleanlint-freetowelstowipetheinsideofthedrum,andtherearenoresidualdrugs.設(shè)備的清潔

EquipmentCleaning設(shè)備的維護(hù)與保養(yǎng)

Maintenanceofequipment1.設(shè)備的潤滑1.EquipmentLubrication（1）包衣機(jī)主機(jī)的減速機(jī)使用150號工業(yè)齒輪油潤滑，一般首次加注潤滑油經(jīng)100～250小時(shí)運(yùn)轉(zhuǎn)后，應(yīng)更換新油，以后每運(yùn)轉(zhuǎn)1000小時(shí)后再更換新油。(1)Thegearboxofthecoatingmachine'smainunitshouldbelubricatedwithindustrialgearoilofNo.150.Generally,afterthefirstoilfilling,thelubricatingoilshouldbereplacedafter100to250hoursofoperation,andthenreplacedevery1,000hoursofoperation.（2）主軸軸承、滾筒的前支撐滾輪每運(yùn)行3個(gè)月更換新的潤滑脂。(2)Replacethelubricatinggreaseforthemainspindlebearingsandthefrontsupportrollersofthedrumeverythreemonths.（3）蠕動泵的硅膠管在滾輪接觸段加硅酮潤滑脂或滑石粉潤滑。(3)Applysiliconelubricantortalcumpowdertothesiliconetubingoftheperistalticpumpatthecontactwiththerollers.2.設(shè)備每運(yùn)行3個(gè)月，由維修人員進(jìn)行一次全面維護(hù)，操作人員參加。2.Everythreemonths,themaintenancepersonnelshouldconductacomprehensivemaintenance,andtheoperatorsshouldparticipate.（1）清掃、檢查電器柜等電控系統(tǒng)，清理電氣線路，檢查接觸器、開關(guān)、繼電器，發(fā)現(xiàn)問題及時(shí)解決。(1)Cleanandchecktheelectricalcontrolsystem,cleanelectricalcircuits,checkcontactors,switches,andrelays,andpromptlyaddressanyissuesfound.（2）清洗或更換熱風(fēng)柜防塵過濾板，清洗排風(fēng)柜的除塵袋，給減速機(jī)加潤滑油。(2)Cleanorreplacethedustfilterboardinthehotaircabinet,cleanthedustbagintheexhaustcabinet,andlubricatethegearbox.（3）檢查各密封件、傳動皮帶、風(fēng)門開關(guān)機(jī)構(gòu)、各彈簧桿等部件是否齊全、有效，檢查調(diào)速油缸頂桿行程、各儀表和安全防護(hù)裝置。發(fā)現(xiàn)問題及時(shí)修復(fù)、調(diào)整或更換。(3)Checkifallseals,transmissionbelts,damperswitches,springrods,andothercomponentsarecompleteandeffective.Also,checkthestrokeofthespeedregulatingoilcylinder,variousinstruments,andsafetyprotectiondevices.Identifyandpromptlyrepair,adjust,orreplaceanyissuesfound.（4）檢查蠕動泵、噴槍是否正常。(4)Checkiftheperistalticpumpandspraygunareworkingproperly.（5）檢查壓縮空氣、蒸汽管道以及電磁閥是否安全、有效。(5)Checkthecompressedair,steampipelines,andelectromagneticvalvesforsafetyandeffectiveness.（6）檢查包衣機(jī)主機(jī)電機(jī)，并調(diào)整包衣機(jī)轉(zhuǎn)動口的徑向和軸向跳動。(6)Checkthecoatingmachine'smainmotorandadjusttheradialandaxialrunoutofthecoatingmachine'srotatingmouth.流化床包衣機(jī)

Fluidizedbedcoatingmachine流化床包衣法目前只限于包薄膜衣，除片劑外，微丸劑、粉末、顆粒劑等也可包衣。

其優(yōu)點(diǎn)表現(xiàn)為：①包衣速度快，不受藥片形狀限制；②噴霧區(qū)域粒子濃度低，速度大，不易粘連，適合于小粒子包衣；③可制成均勻、圓滑的包衣膜。

缺點(diǎn)：包衣層較薄，且藥物做懸浮運(yùn)動時(shí)碰撞較強(qiáng)烈，外衣易碎，顏色欠佳，設(shè)備的容積效率低，大型機(jī)的放大有困難。Thefluidizedbedcoatingmethodiscurrentlylimitedtocoatingthinfilm,butitcanalsobeusedforcoatingmicrogranules,powders,andgranulesinadditiontotablets.Itsadvantagesareasfollows:①Fastcoatingspeed,notlimitedbytheshapeofthetablets.②Theparticleconcentrationinthesprayingareaislow,withhighspeed,makingitlesspronetoadhesionandsuitableforcoatingsmallparticles.③Uniformandsmoothcoatingcanbeachieved.Disadvantages:

However,thecoatinglayer