小容量注射劑生產(chǎn)設(shè)備Smallcapacityinjectionproductionequipme

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(lèi)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概述

Overview水針劑使用的玻璃容器稱(chēng)為安瓿，國(guó)家標(biāo)準(zhǔn)(GB2637—1995)規(guī)定水針劑使用的安瓿一律為曲頸易折安瓿。規(guī)格有1ml、2ml、5ml、10ml、20ml五種。在外觀上分為兩種，即色環(huán)易折安瓿和點(diǎn)刻痕易折安瓿，均可平整折斷。Theglasscontainersusedforwaterinjectionsarecalledampoules,andaccordingtothenationalstandard(GB2637—1995),theampoulesusedforwaterinjectionsmustallhaveacurvedneckandbeeasilybreakable.Specificationsinclude1ml,2ml,5ml,10ml,and20ml.Intermsofappearance,theyaredividedintotwotypes:colorringampoulesanddot-etchedampoules,bothofwhichcanbeeasilybrokenevenly.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(guò)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(kù)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(chēng)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(guò)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)。