制药工程 毕业设计 奥硝唑英文文献2.docx

制药工程 毕业设计 奥硝唑英文文献2.docx

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制药工程毕业设计奥硝唑英文文献2

英文文献2

pessureandfilmproductionequipmentcertificationGMPrequirement

Withthein-depthtransformationofpharmaceuticalGMP,somebackward,anddonotmeetthequalityrequirementsofpharmaceuticalproductionpressurefilmproductionequipmentwillfaceelimination,anditisconsistentwithdrugproductionqualityrequirements,amoreadvancedcontrolsystem,safeandreliableoperationofthepressurefilmproductionequipment.

CurrentdomesticpharmaceuticalenterprisespressurefilmsmadeinChinausedfouraircrafttypesinthesingle-chong-pressurefilmmachine,pressedflowers-piecemachines,rotarymachinesandhigh-speedfilm-pressurerotarykilnpressurefilmplane.Theserotarykilnpressuretablets-pressuremachinesandhigh-speedrotarymachinesinafilmproductionofhigh-qualitystable,suitableforthecharacteristicsoftheproductionscale,asaresultproductionhasbeenthemainequipment,pressureGMPrequrementandfilmproductionequipmentcertificationisthetwotypesofequipmentaroundlaunch.

SectionIpressedfilmproductionequipmentGMPrequrement

First,thedesignofpressureequipmentforfilmproduction

1,andequipmentmodels

1）closetotheadvancedinternationallevelandover,orincomparisonwithdomesticproductsofthesametypeisacleartechnologicaladvantage.

2）haveadustcollectionandcleansingfunctionspurificationfunctions.

3）operationalconvenience,reliability,theneedforregulatorydevices.Mechanicaldevicessuchasregulation,fillingconditioningdevices,andpressureregulatingdevices,speedconditioningdevices,thick-filmdevices.

4）areliablesecurityprotectionfunctions.IfpressureGuozaibaohufunctionscurrentsGuozaibaohufunctions.Somehigherdegreeofautomationcontrolequipmenthascutintoprotectivefunction,orfilmsfromthefunctions,functionalfailureswarning,automaticdetectionfunctionalcomponents.

5）pressedthefilmroomshouldbedesignedtomeettheenclosed（andisolated）,non-polluting,non-dead,easytoobserve,Yiqingxian,erectiondieconveniencerequirements.

6）Havetopreventhumaninjuryprotectiondevices.Ifearthingdevicesincurrentopencircuitprotectiondevices,automaticprotectiondevicevalveopened.

7）designs,stylish,simpleandeasyoperation,observationandmaintenance.

2,thedeterminationofperformanceparameters

1）conformtonationalorindustrystandards.Yandevelopedcountriesintheenterpriseproductstandardsorindustrystandards,andactivelypromotetheapplicationofinternationalstandardssuchastheEUstandardsandtabletsdiesIPTstandards.

2）goodsealedisolationmeasures.Ifmechanicalcomponentsandpressuretabletsroombetweensealedisolation,jumpingpolebody（oncampaign-orientedrole）andChongding（materialsandcontactoccurs）betweensealedisolation,transferplatform,large（forsaltpolebodyorientation）andintermediateworktable（materialflows,balanceformingregion）betweensealedisolation,pressurefilmroomwiththeoutsideworldbetweensealedisolation.

3）goodmechanicalperformance.Transmissionsmooth,precisionfit,lownoise,vibrationandnoapparentunusuallyhotdeformation.

4）tochoosesuitablerawmaterials,componentpartsandstandardpieces.Accordingtothedifferentrolesandusesbodyparts,economicalandrationalchoiceofrawmaterials,componentpartsandstandardpieces.Contactwiththematerialsofrawmaterials,componentpartsandstandardofchoiceshouldbeconsistentwiththewrongdrugnature,purityandqualityofimpact,suchasausteniticstainlesssteelmaterialsselection;Choosedrug-freenon-metallicmaterials;Forsome-carbonsteelorcastironpartssurfacecoatingtreatment（paintingmaterialstomeetGMP要求noteasilyspalling）.

3,themanagementoftechnicaldocuments

1）amorecomplete,consistentwithnationalstandards,inlightoftheactualsituationofenterprises,meettheequipmentmanufacturing,installation,operationandthequalityofthetechnicalpapersrecords.

A）equipmentinthemodelsphase:

informationgathering,marketresearch,technicalinvestigations,feasibilityanalysis,developmentofdecision-makingdocumentsandrecords.

B）equipmentinthedesignstage:

productdesignprogramme,thetechnicalanalysisoftheeconomiccosts,designcalculations,designcertification,structuresandcomponentsdesignedcraftdesigndocumentsandrecords.

2）Establishdocumentcontrolfiles,andstandardizemanagement,andensurequalityandoperatingsystemdesignretroactivity.

Second,thepressurefilmproductionequipmentforthemanufacture

1,procurement

1）Toestablishprocurementqualitycontrolfiles,theselectionofqualifiedandreputablesupplierstoensurethattheprocurementofquality.

2）basedontherequirementsofprocurementdocuments,procurementmeetqualityrequirements,andqualityassuranceandcertificationofalltypesofrawmaterialsandsupplies.

3）GMPrequirementofkeycomponentsandrawmaterialsnecessarymaterialchemicalanalysis.

4）andmatchingpiecesofimportantstandards,testingandqualitytrackingimplementationintoplants.

2,manufacturing

1）basedonthedesigndrawings,documentsandprocessesrelatedstandardspartsmanufacturing,assemblyanddebugging.

2）manufactureofkeycomponentsforprocessingqualitycontrolpoint,standardizeconstruction.

3）enhancingthequalityofmanufacturedpartsandcomponentswithGMP要求checkstopreventmixingpreventsoundedhairPengshang.

4）GMPrequirementtosomepartsofthesurfacecoatingprocessesnecessaryqualitycontrolcoatingspreventspalling,critical.

3,testing

1）basedonthedesigndrawings,documentsandprocessesrelatedstandardspartsmanufacturing,assemblyandtestingofthetest.

2）Establishmentofpurchaseinspection,processinspection,finalinspectionsystem.

3）developproductsandkeycomponentsforaperformance.

4）Establishingproductqualitycontrolfiles,records,inspections,tracking,productqualityfeedback.

Third,thepressurefilmproductionequipmentinstallationrequirements

1,manufacturersofequipmentusedtodevelopthespecification,covering:

thecompositionanduseofmachinery;Technicalparameters;Transportation,installation,storage;Operationandadjustment;Maintenance;Vulnerablepartscatalogues,andanobligationtoassistandguideuserstoinstalltheproperuseofequipment.

2,userswiththeuseofthespecificationandrequirementsfortheinstallationofequipmentinstallationmethods.

3,equipmentinstallationenvironmenttomeetthe"pharmaceuticalqualitycontrolstandards（1998revision）"therelevantprovisions.

4,theallocationofthenecessaryancillaryfacilities,suchaselectricity,compressedairsources,enricheddevices,removaldevices.

5,theairoperationortestequipmenttoconfirmthestabilityandfunctionoftheagenciesequipmentmayadjustcapacityinstrumentationworkreliability,safety.

6,manufacturersandusersofpharmaceuticalproductionprocessesthatenableequipmentpharmaceuticalproductionprocessestomeettheconditionsandachieveoptimal.

4,thepressurefilmproductionequipmentperformancerequirements

1,chooseoneorseveralphysicaltestingparameters,suchasthesuppressionofopiateshape,size,thickness,determinedcorrespondingrotationalspeedphysicalproduction,therawqualityofthefinishedsuppressionrequirementsandnationalstandards.

2,simulatedproductionequipmentinoperationorproductionoperationinaccordancewiththedesignparameterspressuretabletsworkroomisnotunusualleakpowder,Louyeormetalscrap,Reapspallingphenomenon.

3,operationmaintenancesimple,safe,reasonable,dies,enrichedvehiclessparepartsmeantconvenience.

4,equipmentYiqingxiwithoutend,withoutleakage.

IIpressurefilmsproductionequipmentGMPcertification

First,thedesigncertification

Designcertificationinclude:

equipmentmodels,andsetperformanceparameters,technicaldocumentmanagement.Designcertificationrequirements,certificationmethodsandevaluation.

Second,manufacturingcertification

Manufacturingcertificationinclude:

procurementofmaterials,partsandcomponentsmanufacture,assembly,debuggingandtesting.Manufacturingcertificationrequirements,certificationmethodsandevaluation.

3,installationcertification

Thepurposeofcertificationistheinspectionmachinesinstalledintheinstallationenvironmentadaptability,andancillaryfacilitiescompletethedegree:

checkfunctioningofthemachinesintheair,thestabilityandfunctioningoftheagenciesworkinginstrumentreliability,performancecertificationformachineryprotection.

Installationcertificationinclude:

measurementandrecognitionofcertainperformanceparametersofthepharmaceuticalproductionprocessconfirmed.Installationcertificationrequirements,certificationmethodsandevaluation.

4,performancecertification

PerformancecertificationisrecognizeduseristheuserDepartmentofficialmachineryinactualproductionsimulationtestingmachinestouseperformance.

Certificationbythegeneralperformancegapsidentifiedparticlesimulationmachinesuseperformancebasedontheactualsituationcanbeusedsimilartoparticlesintoproductionnumberstoconfirm.Certificationofthefinishedbatchesandspecificationsmaybebasedonthedevicecharacteristicsortodeterminetheactualproduction.Generalperformancecertificationtestingtimeforonehour,samplingevery15minutestoonceeveryfivefilmseachexporttoLiu.Equipmentmanufacturingunitsmayalsobemadebyconsultationwithusersandcertificationcontentsamplingrequirements.

Performancecertificationcovers:

rawqualitythatrecog