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1、AppendixTheverificationofKGL400high-speedcappingmachineOverviewNanjingthesolidextensionPharmaceuticalEquipmentCo.,Ltd.toprovideKGL400high-speedcappingmachineissuitableforavarietyofspecificationsvials,versatility,specificationsfewerpartsreplacement,easytoreplace.ItadoptsPLCcontrol,frequencycon
2、trolorHMItouchscreencontroltechnology,stableandreliableoperation,CompliancewithGMPrequirements.Howitworks:Afterpacking,Stoppardvialsbyflatbeltfedsmoothlyintothescrew,screwevenlyfeedingbottledial;Oscillatorisfedthroughthehopperandtrackthecompositelidoraluminumcovertotheweartocoverstation,Diali
3、ntothebottlewearingthebottlecapintothecappingstation;Centerrevolvesaroundthestationrollinghirablecampressure,Coverispressed,theclutchisclosed,proppingseatwithaglassbottletostarthigh-speedrotation,thediscrollingcutterfixedinthecenterofthestationeasy-to-digestgraduallyextrudedaluminumcover,alum
4、inumcovertightlywrapthebottlemouth;Whentherollingthehirablerotationtothepositionofthehighestpointofthecam,andglassbottlesmovingawayfromdialoutofthebottle,thebottleaside,intothebottlestrack,soastocompletethecappingprocess.TheverifyofimplementationThepurposeoftheverificationisconfirmedbypre-ins
5、tallationcheck,OQandperformanceconfirmationfromtheinstallationandoperationofthecappingmachineperformancetomeetthedesignrequirementsandGMPrequirements,andperformancetomeetthetechnologicalrequirements.1.Designvalidation/pre-confirmation(DQ)Content:thetechnicalindicatorsandtheirdesignrequirement
6、s,includingproductioncapacityofequipment,materials,pressurecontrolsystems,ancillaryfacilities,sizerequirements;equipmentmanuals,operatinginstructions,andmaintenance.Accordingtothedesignandtechnicalparametersoftheequipment,designdrawings,purchaseorders,vendor-suppliedtechnicalinformationequipm
7、entwithpre-determinedevaluationconfirmedinclude:equipmentperformance,quality,andapplicability.Theaimistoconfirmthespecificationsoftheequipmentsuppliedshallconformtotherequirements,thedevicetechnicalinformationshouldbecomplete(operationguide,m
