THEADVANTAGESOF TANTALUMANDNICKELBASEDALLOY SHELLANDTUBEHEATEXCHANGERS vs.

CARBONBLOCKHEATEXCHANGERS IN PHARMACEUTICALAPI APPLICATIONS

By:LawrenceJ.HaubnerTITANMETALFABRICATORS/2011
AboutTheAuthor: LarryHaubnerisa20yearindustryveteranintheengineering,design,manufacturingandprojectmanagementofreactivemetal equipmentfortheprocessindustries.HejoinedTITANMetalFabricatorsin2000,andhasbeenresponsiblefordesign,salesandproject managementofreactivemetalheatexchangers,pipingsystems,columnsandpressurevessels.Mr.HaubnermajoredinMechanical EngineeringTechnologyatUniversityofCincinnati.

Formoreinformationontheapplication,specification,designandfabricationofcondensersforpharmaceuticalapplicationsplease contacttheauthoratlhaubner@titanmf.comorviaphoneat15137553394;TITANMetalFabricatorsInternationalHeadquarters, 835FlynnRoadCamarillo,CA93012Phone:18054875050;TITANMetalFabricatorsIndia,Noida,UttarPradesh,India Phone:91.120.4248100www.titanmf.com.

Thepharmaceuticalindustryhastraditionallyusedresinimpregnatedgraphiteblockheatexchangersfor handlingcorrosivefluidsintheiractivepharmaceuticalingredient(API)manufacturingfacilities.Duringthepast threedecades,tantalumandhighnickelalloyshellandtubecondensershaveemergedasaversatilealternative offeringsuperiorcorrosionresistancethatarecommonlyusedbytheworldsleadingpharmaceutical manufacturersandpharmaceuticalengineeringcompaniesincluding: TantalumandHastelloyeliminatemostproblemsassociatedwiththeuseof graphiteforpharmaceuticalprocessing;theiradvantagesinclude: Noproductiondowntimeforrepairsandreplacements Purityofthepharmaceuticalendproduct Faster,validatedcleanoutbetweenbatches Superiorcorrosionresistance Theabilitytoprocessanypharmaceuticalproductwhilemeetingthe strictestregulatorystandards Eliminationofcrosscontaminationofheattransferfluidintotheprocess duetogasketleaksorbrokengraphiteblocks AbbottLaboratories AkerSolutions AstellasPharma AstraZeneca Avecia AventisPharmaceuticals Baxter BayerCorporation BoehringerIngelheim BristolMeyersSquibb Clariant CHM2Hill Covidien EliLilly&Co GlaxoSmithKline HoffmanLaRoche JacobsEngineering JanssenPharma Merck&Co. Noramco Novartis Pfizer Pharmacore ScheringPlough

CorrosionResistance Anaturallyoccurringoxidefilmontantalumssurfacemakesitresistantto TANTALUMPHARMACEUTICAL CONDENSERSINSTALLEDWITH corrosionineventhemostsevereacidenvironmentsandcompletelyresistantto GLASSLINED STEEL REACTORS organiccompounds.Thissuperiorcorrosionresistancemakesitsuitableforany applicationwithinthepharmaceuticalindustry,particularlywhencorrosivechlorinatedorganicsareinvolvedat elevatedtemperaturesandundervacuumconditions.Tantalumisinerttomostorganicandinorganic compoundsattemperaturesupto450F.Itisinerttosulfuricacidbelow300Fandtheattackbelow400Fis notsignificant.Tantalumisalsoinerttohydrochloricacidinallconcentrationsandatalltemperaturesupto 350F.Thecorrosionresistanceoftantalumisvirtuallyidenticaltothatofglassmakingittheperfect complementtoglasslinedreactorsystems. Thecorrosionresistanceofnickelbasedalloysresultsfromahighnickelandmolybdenumcontent.Thesealloys areknowntocorrodeslowlyandpredictably.Whilethecorrosionresistanceofnickelbasedalloysisnotashigh 1

astantalumtherearemanyapplicationswhereitcanbeusedwithsatisfactorycorrosionresistanceandallof theadvantagesofthatoftantalumwithareducedcosttotheenduser. THEADVANTAGESOFTANTALUMANDNICKELBASEDALLOYCONDENSERS NoProductionDowntime Metaltubecondensersareexceptionallydurableandwillperformformanyyearswithoutanylostproduction timeforrepairsorreplacements.Thelongservicelifeofametaltubecondenserprovidesthehighest productivityratewhileeliminatingmaintenancecostsandreplacementexpenditures. Incontrast,graphiteissusceptibletomechanicaldamage,withbreakdownscommonlyoccurringduring handling,installation,operationandcleaning.Thegreater failurerateofgraphitesystemsnecessitatesfrequent repairsandreplacements,resultinginlowerproductivity andhighermaintenancecosts. Metaltubecondensersrequirealargerinitialinvestment thangraphitecondensers.However,becauseproduction downtimetranslatesintoassetdepreciation,higher operatingcosts,andlostsalesduetolongertimetomarket, thebreakeventimefortantalumversusgraphiteisonly18 months.(SeeFigure1) Moreover,longtermcostcomparisonsdemonstratethat despitehighercapitalcosts,metaltubecondensersaremoreeconomicalthangraphite,duetoitsgreater durabilityandlongevity. ProductPurity Pharmaceuticalproductpurityismandatedbystringent regulationsatthefederal,state,andlocallevels.Butresin impregnatedgraphiteoftenfailstomeettheindustrysquality controlrequirements.Astheimpregnatedgraphitesurface heatsupandcoolsdown,thedifferencebetweenthethermal expansionratesofgraphiteandthephenolic(orTeflon) impregnatecreatesstress.Thisstresscauseserosionatthe graphitesurfaceinthesamewaythatwatersfreezethaw cycleerodesaconcretesurface.Asaresult,minutegraphite particlesandresinsflakeintotheprocessbatch,contaminating theendproduct. Faster,ValidatedCleanOut
TANTALUMPHARMACEUTICALCONDENSERWITH316L STAINLESSSTEELSHELL

AllcondensersmustbethoroughlyflushedbetweenprocessbatchestosatisfygoodManufacturingPractice (GMP)proceduresaswellasregulatorystandards.Cleanoutisextremelydifficultandtimeconsumingwith impregnatedgraphite,becausegraphitesrough,poroussurfaceabsorbsboththeprocessfluidandtheend product.

Withitssmoothersurface,metaltubecondenserscanbeflushedmuchmorequickly,resultingindramaticcost savingsandincreasedproductivity.Thecleanoutprocedurecanalsobevalidatedeasilybyopeningthe tantalumcondenserforinspection,whichisnotpossiblewiththedesignofagraphitecondenser. NoLeakage/CrossContamination WhenlowsurfacetensionheattransferfluidssuchasSylthermandDowthermJareusedinplaceofcooling water,tantalumpreventsleakage,whilegraphitecreatesproblems.Thegraphiteblockdesignofmultiple gasketsandafloatingheaddynamicsealcannotprovideaneffectiveclosure.Insomecasesshellsidefluidhas beenknowntopermeatethegraphiteblockitself. HighThermalEfficiency Therelativelythinwallsofmetaltubecondenserstransferheatmoreeffectivelythanthethickerwallsofcross boredgraphiteblocks.Inmanycases,tantalumcondensershavebeenshowntorequire40percentlessheat transfersurfaceareathanimpregnatedgraphiteexchangersforthesameapplication.Tantalumcondenserscan bethermallysizedtoprecisespecificationsforanyapplicationtoreducethesurfaceareaandminimizethe requiredspacing. UniversalVersatility Becauseitisversatileenoughtoprocessanypharmaceuticalproduct,tantalumandHastelloycanbefabricated intouniversalsystemstomeetanyproductionrequirement,aswellasthemostexactingregulatorystandards. Thereforecapitalequipmentdecisionscanbemademoreefficientlyandnewpharmaceuticalproductscan reachthemarketwithoutdelaytomaximizeprofits. FABRICATIONFEATURES TITANMetalFabricators,Inc.hasdevelopedhighquality processesanddesignstoservethespecializedneedsofthe pharmaceuticalindustry. Thesedesignfeaturesinclude: LeakDetectionTantalumtubesheetandbonnetdesigns canincludeportsthatallowleakagepastatubesheetweld tobedivertedtoacollectionsystemoutsidethe condenser.Inadditiontoearlyleakdetection,thisdesign minimizescontaminationoftheprocessmediabythecoolantor TANTALUM,HASTELLOYCAND316LSTAINLESSSTEEL PHARMACEUTICALCONDENSERWITH CIPSPRAYBALLS coolantbytheprocessmedia. CompleteDrainabilityTubesheetandbonnetdesignsandwelding processescanminimizetheabilityofthetubesheetareatoretain fluidsduringdrainingandcleaning.

TANTALUMCONDENSERWITHFLUSHFACE TUBESHEETTOENSUREFULLDRAINABILITY

PolishingOfMetalCondensersTantalummillproductsthatareusedintantalumpharmaceuticalcondenseris offeredasastandardasaminimumof20Rasurfacefinish.Thistypicallyexceedstherequiredsurfacefinishofa condenserforthisservice.Hastelloycondenserscanbeofferedinavariety ofsurfacefinishfromstandardmillfinishtoanelectropolishedsurfaceof approximately10Ra. CIPCleaningDevicesCIP(CleanInPlace)spraydevicescanbeinstalledto ensurefastthoroughcleaningoftheprocesssideofthecondenser. RiboflavinTestingAllCIPspraydevicesappliedintothesecondenserscan beriboflavintestedtoensurethattheCIPspraydeviceisadequately cleaningtheprocesssideofthecondenser.
TANTALUMCONDENSERWITHCIPSPRAY BALLSFORCLEANINPLACE

SightGlassesforviewingofcondensation/verification ofcleaningThemechanicaldesignofametalshelland tubeheatexchangerallowsfortheapplicationofsite glassesonthebonnetsforviewingofcondensation performanceaswellasthepositiveverificationofthe cleaninginbetweeneachbatch.

ALLOYCCONDENSERWITHTUBESIDEPOLISHEDTO 20RAANDSIGHTGLASSESONBONNETFOR VIEWINGCONDENSATION

IntegralInsulationPolishedstainlesssteelsheathedinsulation canbeappliedtoourcondenseratourfacilitytosavetimeduring installation. SilverbrazingAlltantalumliningsaresilverbrazedtothe carbonsteelsubstratetopreventcontaminationandgasket leakage. COSTEFFECTIVE

TANTALUMCONDENSERWITHINTERGRALINSULATION, SIGHTGLASS,ANDCIPSPRAYBALLS

Despitehighercapitalinvestmentcosts,tantalumandHastelloycondensershaveconsistentlyproven themselvestobemorecosteffectivethangraphite.TantalumandHastelloycondensersarevirtually maintenancefree,providinglongtermdurabilityandfastervalidatedcleanout.Lifecyclecoststudieshave shownthatthepaybacktimefortantalumcanbelessthantwoyears.

References: TantalumandNiobiumMaterialsforthePharmaceuticalIndustryMikeCoscia/HCStarck MaterialsSelectionIssuesforHeatExchangersinthePharmaceuticalIndustryLJRCohen/RCYoung/AstraZeneca TeflonisaregisteredtrademarkofE.I.DuPontdeNemoursandCompany SylthermandDowthermaretrademarksofDowCorningCorporation AmericanSocietyforMetalsPropertiesandSelectionNonFerrousAlloysandPureMetals,1979 Photos/DiagramscourtesyofTITANMetalFabricators.