小容量注射劑生產(chǎn)設(shè)備Small capacity injection p roduction equipment

小容量注射劑生產(chǎn)設(shè)備

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

OperationandMaintenanceofCommonPharmaceuticalEquipment知識(shí)目標(biāo)KnowledgeObjectives（1）掌握小容量注射劑生產(chǎn)設(shè)備的原理、結(jié)構(gòu)和使用方法。(1)Mastertheprinciples,structure,andusageofsmallcapacityinjectionproductionequipment.（2）熟悉小容量注射劑生產(chǎn)設(shè)備的種類和特點(diǎn)。(2)Familiarizewiththetypesandcharacteristicsofsmallcapacityinjectionproductionequipment.（3）了解小容量注射劑生產(chǎn)設(shè)備的維護(hù)與保養(yǎng)及故障排除。(3)Understandthemaintenance,upkeep,andtroubleshootingofsmallcapacityinjectionproductionequipment.能力目標(biāo)AbilityObjectives學(xué)會(huì)小容量注射劑生產(chǎn)設(shè)備的基本結(jié)構(gòu)和工作原理。Learnaboutthebasicstructureandworkingprinciplesofsmallcapacityinjectionproductionequipment.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)生具備小容量注射劑生產(chǎn)崗位必備的基本知識(shí)、基本技能和職業(yè)素質(zhì)。(2)Studentsshouldpossessessentialknowledge,basicskills,andprofessionalqualitiesrequiredforpositionsinsmallcapacityinjectionproduction.（3）“欣弗注射劑”事件引入達(dá)到強(qiáng)化職業(yè)素養(yǎng)的思政目標(biāo)。(3)The"XinFuInjectionIncident"introducesthegoalofstrengtheningprofessionalethicsandqualitiesinideologicalandpoliticaleducation.重點(diǎn)KeyPoints小容量注射劑生產(chǎn)設(shè)備的結(jié)構(gòu)與工作原理Thestructureandworkingprinciplesofsmallcapacityinjectionproductionequipment難點(diǎn)Difficulties小容量注射劑生產(chǎn)設(shè)備的正確操作Thecorrectoperationofsmallcapacityinjectionproductionequipment學(xué)習(xí)目標(biāo)

LearningObjectives生產(chǎn)工藝

ProductionProcess最終滅菌小容量注射劑生產(chǎn)工藝流程包括原輔料的準(zhǔn)備、配制、過濾、灌封、滅菌、質(zhì)檢、印字、包裝等步驟。Thefinalsterilizationprocessforsmallcapacityinjectionproductionincludesthepreparation,compounding,filtering,filling,sterilization,qualityinspection,printing,andpackagingofrawmaterials.按工藝設(shè)備的不同形式可分為單機(jī)生產(chǎn)工藝和聯(lián)動(dòng)機(jī)組生產(chǎn)工藝兩種。Basedondifferentprocessequipment,itcanbedividedintosingle-machineproductionprocessandlinkedunitproductionprocess.原輔料RawexcipientsC級(jí)潔凈區(qū)ClassCcleanzone配液Fluidpreparation外包Outsourcing入庫EnterwarehouseA級(jí)潔凈區(qū)ClassAcleanzone小容量注射劑制備工藝流程圖Processflowdiagramforpreparationofsmallcapacityinjections燈檢Lightinginspection印字Lettering滅菌檢漏Sterilizationandleakdetection精濾Refinedfiltration粗濾Roughfiltration稱量WeighingWashbottle→Drying→Sterilization→Airinflation→Infusion→Airinflation→Weldedseal洗灌封聯(lián)動(dòng)機(jī)組Washing,fillingandsealinglinkageunit理瓶Bottlesorting安瓿瓶Ampoule過濾Filtration注射用水Waterforinjection多效蒸餾Multipleeffectdistillation純化水Purifiedwater二級(jí)反滲透Secondaryreverseosmosis飲用水Drinkingwater工序質(zhì)量控制點(diǎn)

QualityControlPointsintheProcess主要設(shè)備

MainEquipment1．制水設(shè)備

有純化水生產(chǎn)設(shè)備和注射用水生產(chǎn)設(shè)備。1.Waterproductionequipment

includespurifiedwaterproductionequipmentandinjectionwaterproductionequipment.2．洗瓶設(shè)備

包括噴淋式洗瓶機(jī)組、氣水噴射式洗滌機(jī)組和超聲波洗瓶機(jī)組等。2.Bottlewashingequipmentincludesspray-typebottlewashers,air-waterinjectionwashers,andultrasonicbottlewashers,amongothers.3．干燥滅菌設(shè)備

包括連續(xù)電熱隧道式滅菌烘箱、熱層流式干熱滅菌機(jī)。3.Dryingandsterilizationequipmentincludecontinuouselectrictunnel-typesterilizationovensandhot-airlaminarflowsterilizers.4．配液設(shè)備

配液罐組包括：濃配罐、粗濾裝置、稀配罐和精濾裝置。4.LiquidpreparationequipmentLiquidpreparationunitconsistsof:Concentratedpreparationtanks,coarsefiltrationdevices,dilutiontanks,andfinefiltrationdevices.5．灌裝熔封設(shè)備

主要是安瓿拉絲灌封機(jī)。5.Fillingandsealingequipmentmainlyinvolvesampouledrawingandsealingmachines.6．滅菌檢漏設(shè)備

包括安瓿檢漏滅菌器、安瓿回轉(zhuǎn)式滅菌器、安瓿水浴式滅菌器。6.Sterilizationleakdetectionequipment

includesampouleleakdetectionsterilizers,rotaryampoulesterilizers,andwaterbathampoulesterilizers.7．印字設(shè)備

主要是安瓿印字機(jī)。7.Printingequipmentmainlyconsistsofampouleprintingmachines.8．包裝設(shè)備

包括安瓿開盒機(jī)、安瓿帖簽機(jī)等。8.PackagingEquipmentTheequipmentincludesampoulebox-openingmachines,ampoulelabelingmachines,etc.配液：系指將原料、溶劑、附加劑等按操作規(guī)程制成體積、濃度等符合質(zhì)量標(biāo)準(zhǔn)要求的藥液的操作過程。Liquidpreparation:referstotheprocessofpreparingpharmaceuticalliquidswiththerequiredvolumeandconcentrationaccordingtotheoperatingprocedurestomeetqualitystandards.工藝流程：Processflow:1.濃配罐

1.Concentratedpreparationtank2.粗濾裝置

2.Coarsefiltrationdevice3.稀配罐

3.Dilutiontank.4.精濾裝置

4.Finefiltrationdevice.配液設(shè)備

Liquidpreparationequipment小容量注射劑配液罐

Smallcapacityinjectionliquidpreparationtank濃配罐Concentratedpreparationtank設(shè)備結(jié)構(gòu)

EquipmentStructure濃配罐是將一種或幾種物料按工藝配比進(jìn)行混配的混合攪拌設(shè)備。

Theconcentratedpreparationtankisamixingandstirringequipmentusedtomixoneorseveralmaterialsaccordingtotheprocessratio.結(jié)構(gòu)主要包括罐體、罐附件和攪拌槳。

Itmainlyconsistsofatankbody,tankaccessories,andstirringblades.工作原理：在適宜溫度條件下，通過攪拌器的攪拌使原輔料溶解。

Workingprinciple:Undersuitabletemperatureconditions,therawmaterialsdissolvethroughthestirringactionoftheagitator.ReflectorampAdditionportforinjectionwaterRefluxinletInletportSightglassStirringBreathingportThermometerRinsingportInletholeRinsingportSteaminletorcondensateoutletInletholeInterlayerStirringbladeOutletportCoolingwaterinletCondensateoutlet設(shè)備結(jié)構(gòu)

EquipmentStructure粗濾裝置Coarsefiltrationdevice鈦棒過濾器

Titaniumrodfilter鈦濾棒：精度高、耐高溫、耐腐蝕、機(jī)械強(qiáng)度高、使用方便、濾芯可反復(fù)再生使用等特點(diǎn)。常用過濾精度為0.2μm。工作原理主要為深層截留過濾方式。

Titaniumfilterrod:Featureshighprecision,hightemperatureresistance,corrosionresistance,highmechanicalstrength,easytouse,andthefilterelementcanberepeatedlyregeneratedandreused.Commonfiltrationaccuracyis0.2μm.Itmainlyworksthroughdeeplayerinterceptionfiltration.適用范圍

Scopeofapplication:主要用于小容量注射劑濃配方式的脫炭過濾及稀配環(huán)節(jié)中的終端過濾前的保安過濾。

Itisprimarilyusedfordecarbonizationfiltrationinthedilutionprocessofsmallcapacityinjectionandasasecurityfilterbeforeterminalfiltration.設(shè)備結(jié)構(gòu)

EquipmentStructure稀配罐

Dilutiontank.與濃配罐結(jié)構(gòu)基本相同。

Itsstructureissimilartotheconcentratedpreparationtank.設(shè)備結(jié)構(gòu)

EquipmentStructure精濾裝置Finefiltrationdevice.微孔濾膜板式過濾器

Microporousmembraneplatefilter微孔濾膜：精濾孔徑0.45~0.8μm；無菌過濾0.22~0.3μm。

Microporousmembrane:Thefiltrationapertureforfinefiltrationis0.45-0.8μm,andforsterilefiltration,itis0.22-0.3μm.微孔濾膜筒式過濾器

Microporousmembranecartridgefilter1．檢查確認(rèn)設(shè)備已清潔消毒待用。1.Checkandconfirmthattheequipmenthasbeencleanedanddisinfectedforuse.2．檢查確認(rèn)各連接管密封完好，確保各管道無跑冒漏等現(xiàn)象。2.Checkandconfirmthatallconnectionpipesareproperlysealedandensuretherearenoleaksorotheranomaliesinthepipelines.3．檢查確認(rèn)各閥門開啟正常。3.Checkandconfirmthatallvalvesarefunctioningproperly.4．檢查各泵的電路連接，確保各泵的電機(jī)電路連接正常，防止反轉(zhuǎn)、缺相等故障發(fā)生。4.Checktheelectricalconnectionsofallpumpstoensurethatthemotorcircuitsareproperlyconnected,andpreventissuessuchasreverserotationorphaseloss.5．檢查各儀表的安裝狀態(tài)，確保各儀表按照規(guī)范進(jìn)行安裝，量程符合生產(chǎn)要求，且各儀表均在校定有效期內(nèi)使用。5.Checktheinstallationstatusofallinstrumentstoensuretheyareinstalledaccordingtospecifications,havetheappropriatemeasuringrangeforproductionrequirements,andarewithinthevalidcalibrationperiod.6．檢查確認(rèn)各控制部分正常。6.Verifythatallcontrolcomponentsarefunctioningnormally.7．檢查呼吸器閥門已處于開啟狀態(tài)。7.Confirmthatthebreathervalveisintheopenposition.設(shè)備的正確使用

ProperUseoftheEquipment操作前準(zhǔn)備Preparationbeforeoperation1．打開進(jìn)料閥進(jìn)料，至適量后關(guān)閉進(jìn)料閥。1.Openthefeedvalvetointroducethematerialandcloseitafteraddingtheappropriateamount.2．如需加熱或冷卻，開啟夾套蒸氣或冷凍水進(jìn)口和出口，通過夾套對(duì)料液進(jìn)行加熱或冷卻處理，觀察溫度表，達(dá)到工藝要求的溫度后，關(guān)閉換熱系統(tǒng)進(jìn)出口閥門。2.Ifheatingorcoolingisrequired,openthejacketsteamorchilledwaterinletandoutlettoheatorcoolthematerialthroughthejacket.Observethetemperaturegaugeandclosetheinletandoutletvalvesoftheheatexchangesystemafterreachingtherequiredprocesstemperature.3．運(yùn)行中時(shí)刻注意換熱系統(tǒng)的溫度表、壓力表的變化，避免超壓超溫現(xiàn)象。3.Duringoperation,alwaysmonitorthetemperatureandpressurechangesintheheatexchangesystemtoavoidoverpressureoroverheating.4．?dāng)嚢柽m時(shí)后關(guān)停攪拌器。4.Stopthestirrerattheappropriatetime.5．開啟出料閥和輸料泵經(jīng)管道過濾，排料送出。5.Openthedischargevalveandpumpthematerialthroughthepipelineforfiltrationanddischarge.6．出料完畢，關(guān)閉出料閥和輸料泵。6.Afterdischargingiscomplete,closethedischargevalveandpump.7．關(guān)閉配電箱總電源，按設(shè)備清潔消毒規(guī)程進(jìn)行清洗、消毒。7.Turnoffthemainpowersupplyinthedistributionboxandcleananddisinfecttheequipmentaccordingtothecleaninganddisinfectionprocedures.設(shè)備的正確使用

ProperUseoftheEquipment開機(jī)操作StartupProcedure1．本機(jī)組須在電源安全情況下進(jìn)行開機(jī)。1.Thisunitmustbestartedundersafepowerconditions.2．安全閥的壓力設(shè)定不得超過規(guī)定的工作壓力。2.Thepressuresettingofthesafetyvalvemustnotexceedthespecifiedworkingpressure.3．設(shè)備使用期間，嚴(yán)禁打開手孔及各連接管。3.Duringequipmentusage,openingthehandholeandvariousconnectingpipesisstrictlyprohibited.4．本機(jī)組各管道連接為卡盤式結(jié)構(gòu)，如使用過程中有漏液跑氣現(xiàn)象，應(yīng)及時(shí)更換其密封圈。4.Theconnectionsofallpipelinesinthisunitareofclamp-typestructure.Ifthereisanyleakageorairrunningduringuse,thesealingringshouldbereplacedpromptly.5．清洗時(shí)，忌用水沖洗儀表、減速機(jī)部位。5.Avoidusingwatertocleaninstrumentsandreducerpartsduringcleaning.設(shè)備的正確使用

ProperUseoftheEquipment注意事項(xiàng)Precautions1．每個(gè)生產(chǎn)周期結(jié)束后，應(yīng)對(duì)設(shè)備進(jìn)行徹底清潔。1.Aftereachproductioncycle,theequipmentshouldbethoroughlycleaned.2．根據(jù)生產(chǎn)頻率，定期檢查設(shè)備，是否有密封墊損壞、泄漏、螺絲松動(dòng)及其他潛在可能影響產(chǎn)品質(zhì)量的因素，及時(shí)做好檢查記錄。2.Accordingtotheproductionfrequency,regularlychecktheequipmentfordamagedgaskets,leaks,loosescrews,andotherfactorsthatmayaffectproductquality,andmakeinspectionrecordspromptly.3．定期檢查攪拌器運(yùn)轉(zhuǎn)情況及機(jī)械密封情況，發(fā)現(xiàn)有異常噪音，磨損等情況應(yīng)及時(shí)進(jìn)行修理。3.Regularlychecktheoperationoftheagitatorandtheconditionofthemechanicalseal.Ifabnormalnoiseorwearisfound,timelyrepairsshouldbecarriedout.4．定期對(duì)攪拌器減速機(jī)運(yùn)轉(zhuǎn)情況進(jìn)行檢查，減速機(jī)潤滑油不足時(shí)應(yīng)立即補(bǔ)充，半年換油一次。4.Regularlychecktheoperationoftheagitatorreducer.Ifthereducerlackslubricatingoil,itshouldbereplenishedimmediately,andtheoilshouldbechangedeverysixmonths.5．每半年對(duì)設(shè)備筒體進(jìn)行一次試漏試驗(yàn)。5.Conductaleaktestontheequipmentcylindereverysixmonths.6．長(zhǎng)期不用應(yīng)對(duì)設(shè)備進(jìn)行清潔，并干燥保存，再次啟用前，需對(duì)設(shè)備進(jìn)行全面檢查，方可投入生產(chǎn)使用。6.Iftheequipmentisnotusedforanextendedperiod,itshouldbecleaned,dried,andstored.Beforereusing,acomprehensiveinspectionoftheequipmentisrequiredbeforeputtingitintoproduction.7．嚴(yán)禁用于對(duì)設(shè)備有腐蝕的介質(zhì)環(huán)境。7.Itisstrictlyprohibitedtousetheequipmentinenvironmentswithcorrosivemedia.8．日常要做好設(shè)備使用記錄，應(yīng)包括運(yùn)行、維修等情況。8.Dailyequipmentusagerecordsshouldbekept,includingoperationalandmaintenancesituations.設(shè)備的維護(hù)與保養(yǎng)

Maintenanceofequipment常見故障及排除方法

Commonmalfunction