ABSTRACT

I.INTRODUCTION Duringthelastfifteenyears,thisauthorhasseenawidevarietyofprocesscontrol systemsimplementedinthebulkpharmaceuticalindustry.*Theprocesscontrol systemsconsistofthefieldmeasurementhardware,thefieldcontrolhardware,the processcontrolcomputerhardware,andtheprocesscontrolcomputersoftware.A typicalautomatedfacilityconsistsofbatchequipmentcontrolledbyavendorsuppliedprocesscontrolsystem.Thisbatchunitoperationequipmentconsistsof materialhandling,pumping,scrubbing,wastetreatment,columns,utilityequipment,filtering,anddrying,aswellasbatchreactorsandstills.Fieldinstruments andvalvescontroleventsinthebatchproductionareathroughtheprocesscontrol system.Processingstepsaremonitoredunderthewatchfuleyeoftheproduction operatorseatedataconsoleintheremotecontrolroom.Theoperatorisresponsibleforthemanybatchunitoperationsintheproductionarea.Theprocesscontrol systemstepsthebatchthroughsequencedoperationsthatallowtheprocessunit toproducethedesiredproduct.Theprocesscontrolsystemgeneratesalarmsto informtheoperatorofabnormalactivity.Processinformationiscollectedina datahistorianforlaterretrievalandanalysisbyproductionandtechnicalpersonnel.