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1、AppendixTheverificationofKGL400high-speedcappingmachineOverviewNanjingthesolidextensionPharmaceuticalEquipmentCo.,Ltd.toprovideKGL400high-speedcappingmachineissuitableforavarietyofspecificationsvials,versatility,specificationsfewerpartsreplacement,easytoreplace.ItadoptsPLCcontr
2、ol,frequencycontrolorHMItouchscreencontroltechnology,stableandreliableoperation,CompliancewithGMPrequirements.Howitworks:Afterpacking,Stoppardvialsbyflatbeltfedsmoothlyintothescrew,screwevenlyfeedingbottledial;Oscillatorisfedthroughthehopperandtrackthecompositelidoraluminumcove
3、rtotheweartocoverstation,Dialintothebottlewearingthebottlecapintothecappingstation;Centerrevolvesaroundthestationrollinghirablecampressure,Coverispressed,theclutchisclosed,proppingseatwithaglassbottletostarthigh-speedrotation,thediscrollingcutterfixedinthecenterofthestationeasy
4、-to-digestgraduallyextrudedaluminumcover,aluminumcovertightlywrapthebottlemouth;Whentherollingthehirablerotationtothepositionofthehighestpointofthecam,andglassbottlesmovingawayfromdialoutofthebottle,thebottleaside,intothebottlestrack,soastocompletethecappingprocess.Theverifyofi
5、mplementationThepurposeoftheverificationisconfirmedbypre-installationcheck,OQandperformanceconfirmationfromtheinstallationandoperationofthecappingmachineperformancetomeetthedesignrequirementsandGMPrequirements,andperformancetomeetthetechnologicalrequirements.1.Designvalidation/
6、pre-confirmation(DQ)Content:thetechnicalindicatorsandtheirdesignrequirements,includingproductioncapacityofequipment,materials,pressurecontrolsystems,ancillaryfacilities,sizerequirements;equipmentmanuals,operatinginstructions,andmaintenance.Accordingtothedesignandtechnicalparame
7、tersoftheequipment,designdrawings,purchaseorders,vendor-suppliedtechnicalinformationequipmentwithpre-determinedevaluationconfirmedinclude:equipmentperformance,quality,andapplicability.Theaimistoconfirmthespecificationsoftheequipmentsuppliedshallconformtotherequirements,thedevic
8、etechnicalinformationshouldbecomplete(operationguide,m
