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1、AppendixTheverificationofKGL400high-speedcappingmachineOverviewNanjingthesolidextensionPharmaceuticalEquipmentCo.,Ltd.toprovideKGL400high-speedcappingmachineissuitableforavarietyofspecificationsvials,versatility,specificationsfewerpartsreplacement,easytoreplace.ItadoptsPLCcon
2、trol,frequencycontrolorHMItouchscreencontroltechnology,stableandreliableoperation,CompliancewithGMPrequirements.Howitworks:Afterpacking,Stoppardvialsbyflatbeltfedsmoothlyintothescrew,screwevenlyfeedingbottledial;Oscillatorisfedthroughthehopperandtrackthecompositelidoraluminum
3、covertotheweartocoverstation,Dialintothebottlewearingthebottlecapintothecappingstation;Centerrevolvesaroundthestationrollinghirablecampressure,Coverispressed,theclutchisclosed,proppingseatwithaglassbottletostarthigh-speedrotation,thediscrollingcutterfixedinthecenterofthestati
4、oneasy-to-digestgraduallyextrudedaluminumcover,aluminumcovertightlywrapthebottlemouth;Whentherollingthehirablerotationtothepositionofthehighestpointofthecam,andglassbottlesmovingawayfromdialoutofthebottle,thebottleaside,intothebottlestrack,soastocompletethecappingprocess.Thev
5、erifyofimplementationThepurposeoftheverificationisconfirmedbypre-installationcheck,OQandperformanceconfirmationfromtheinstallationandoperationofthecappingmachineperformancetomeetthedesignrequirementsandGMPrequirements,andperformancetomeetthetechnologicalrequirements.1.Designv
6、alidation/pre-confirmation(DQ)Content:thetechnicalindicatorsandtheirdesignrequirements,includingproductioncapacityofequipment,materials,pressurecontrolsystems,ancillaryfacilities,sizerequirements;equipmentmanuals,operatinginstructions,andmaintenance.Accordingtothedesignandtec
7、hnicalparametersoftheequipment,designdrawings,purchaseorders,vendor-suppliedtechnicalinformationequipmentwithpre-determinedevaluationconfirmedinclude:equipmentperformance,quality,andapplicability.Theaimistoconfirmthespecificationsoftheequipmentsuppliedshallconformtotherequire
8、ments,thedevicetechnicalinformationshouldbecomplete(operationguide,m
