人福认证文件gdac03sp10ukch

Doc.CustomerWBS/ProjectCopy/ProductionFileMACHINEMODEL机型 PERFIMASERIALN°序列号 Writtenby:作者Checkedby:检查

NAMEDATE日 ApprovedbytheCustomer: ApprovedbytheCustomer ©ZIBOIMAXINHUAPHARMATECHCO., .:Reproductionofthisbyanymeans,inwholeorinpart,isprohibitedwithouttheauthorizationofZIBOIMAXINHUAPHARMATECHCO., NAME01(中英文)MAINCOPY主版本TABLEOFMODIFICATIONSRequestNModifiedDescriptionof ProcessableProductVolume可处理产品 ProcessAirflow进气处 Temperature温 AirProcessTemperature进气处理温 CoreTemperature片剂温 OutletAirTemperature排气温 WorkDepressioninsidePan工作锅负 AtomizationPressure雾化压 PanSpeed锅 REFERENCES参考文 ThisrepresentstheFunctionalTestSpecificationsofZIBOIMAXINHUAPHARMATECHCO.,.forthePERFIMALABsystem,serialnumberGDAC03,developedforYICHANGRENFUPUKEPharm.Co.,.(WBSTechnicalSpecificationsreferenceNA54-00084-MAC-M).TheaimofthisistodescribetheperformanceofthePERFIMALAB本篇文件是淄博伊马制药设备为宜昌人福普克药业生产的PERFIMAM），PERFIMALAB型包衣机的性能。 wasissuedinconformitywiththefollowingWorkInstructions(W_I)ofIMAS.p.A.:文件按照以下操作指令W_I7(5).5“PerformanceSpecifications” “StandardsApplicabletoQualitySystemImplementation “ManagementApplicabletoQualitySystemImplementation Inadditiontotheperformanceoftheequipmentdefinedbelow,theessentialtechnicalspecificationsoftheequipmentareindicatedin[1].ProcessableProductVolumeThevolumeoftheprocessableproductmayvaryfromaminimumof3literstoaumof70litersdependingonthecharacteristicsoftheproduct.370ProcessAirflowTheprocessairflowdependsonthedepressionlevel,onthecharacteristicsandamountoftheprocessedproduct.Theumprocessairflowwillbe11001100TemperatureAirProcessTemperatureThesystemthatregulatestheprocessairtemperatureguaranteesthatthetemperatureiscontrolledinanintervalincludedbetweenroomtemperatureand100°Cwithaprecisionof2°C.100度之间的一个间隔中，精确度为2°C.CoreTemperatureThesystemforthecoretemperaturecontrolgrantsanaccuracyof系统控制片剂温度的精确度为OutletAirTemperatureHavinganoutletaittemperaturebetween20°Cand60°C,withaprecisionofWorkDepressioninsidePanThesystemthatregulatesthedepressioninsidethechamberguaranteesthecheckinanintervalincludedbetween–10Paand–50Pawithaprecisionof10Pa.系统可控制锅内工作负压，以保证其在–10Pa–50Pa之间，精确度为10AtomizationPressureThesystemthatregulatestheatomizationpressureguaranteesthecheckinanintervalincludedbetween0.5and4barwithaprecisionof0.2bar.0