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NewAPIFacilityDesignRussRyanDanhillConsultantsApril2010Introduction•Ensky&SWNo2areundertakingasignificantcapitalspend,primarilytoachieveInternationalGMPcompliance.•Thereisalsoanopportunitytoachieveworldclassmanufacturingfacilitiesbyconsideringthedesigncarefullyandoperationcarefully.WorkshopNo6asexampleCurrentKeyIssues•Openplantarearesultingin:–Corrosion[lossofassets]duetomaterialsandhighambientRH–Difficulttoclean&maintain–Noseparationofunitoperations–Potentiallyinhibitsflexibleoperation•Lackofprocesscontainmentresultingin:–Operatorexposure&manualhandling[EHSissues]•Lackofprocessautomationresultingin:–Manualoperation&intervention•(e.g.Sampling/Glassthermometers)–Perceived/actualQuality&EHSissues•Buildingfinishes:•Difficulttoclean&maintainDesignConcept•Plantarea:–Enclose&minimiseRoomareaforeachseparateunitoperation–ProvideHVAC–SeparateDispensing/Process&Service/Supply/WasteAreas•ConsidertheabilitytoperformmaintenanceinServiceareas•Considercontainedclean-in-placeinProcessarea•Containwashwatersothattheplantiskeptdry(tominimisecorrosion)–Useappropriatematerialsofconstruction&performDQ•Design-inprocesscontainment:–EliminateOperatorexposure&manualhandling–Containprocessinputsandwaste[includingwashingwater]•Eliminatecrosscontaminationandcleaningissues•Design-inprocessautomation:–Eliminateoperatorintervention–DesigninQualitymonitors&EHScontrols•Buildingfinishes:–HighGMPstandardDispensing&AdditionCentrifuge/DrierControlServices&SupplyServices&WastePackingReactionHVACHVACDesignConceptSomeExamples:•Thefollowingexamplesoffacilities&Servicesuppliersmayhelpto“visualisethevision”.(foremergencyorcleaning)LEVRoomisenclosedwithaGMPhighstandardofroomfinishFixedfireextinguishersystemSafetyShowerFlush&effectivelightingThedesignprincipleistokeepALLsurfacesflushandminimisehorizontalsurfacesProcesscontainmentenablesReactorareatobemaintainedinacleanconditionGoodoperatingpracticeProcessisfullycontained,sooperatorsdonotneedfurtherprotectionOnlycombinereactorswherenecessaryMinimisepipe-workinreactorareaContainPowderaddition(fromadispensingarea)LEVprovidedasbackuponlyProcessControlAutomation[Couldbelocatedinacentralroom]TypicalPowderdispensingareawithairextractionandelectronicrecordofweightings'NoteGMPdeviation!!µg/m³.ContainedpowderhandlingvalvesanddockingsystemsChargePointTechnology’ssplitbutterflyvalvesanddockingsystemsofferavarietyofadvantagesoverothersystemsforcontainedpowderhandling,including:Metal-to-metaldiscseal-reliablecontainmentperformancePrecision-machinedseats-optimumoperationalperformanceandinterchangeabilityRobustfabrication-nofragilepinsorconnectionsfortrouble-freeperformanceSimplemanualorpneumaticoperationEfficientcleaningandmaintenanceSecurepressure-ratedsystemUniqueDiscLock™technologyBulkpowdertransferdockingsystemTheChargePointDLfacilitatesthebulkhandlingofpotentformulationmaterials,settingnewstandardsfortherobustnessandoperabilityrequiredforpowderhandlinginlarge-scaleproduction.IdealforIBCandbigbagfillinganddispensing,theDLisavailableinsizesof200mm,250mmand300mm.TheDLutilisesuniqueDiscLocktechnology(patentpending),whichisdesignedtomaximisecontainmentperformance.Thelowestprofilevalvehasaminimumspacerequirementanddemandslessmovementtodock/undock.TheadditionofthePowerDock™systemensuresaccurateautomateddockingofthevalve,correctinganymisalignmentbetweenthetwounitsastheydock.Potentcompoundhandling–high-containmentpowderprocessingThestandardChargePointwillofferacontainmentperformanceof10µg/m³;however,forapplicationswherehighercontainmentisnecessarytheextractionringsystemortheEXCELChargePointareusedtomeetOELsof1µg/m³.Theextractionringsystemcomprisesofacircularplenumarrangement,whichconnectstotheactivehalfofavalveandiscoupledtoanextractionsource.Duringoperationtheextractionisactivatedtoensureanypotentialairborneparticlesaretakenintotheextractedairstream.Thissystemisabletoretro-fitdirectlyontoanexistingChargePointvalveforacost-effectivesolutiontoincreasingcontainmentdemands.TheEXCELChargePointincorporatespurgeand