The Advantages of Tantalum and Nickel Based Alloys in Pharma 2011

7/31/2019 The Advantages of Tantalum and Nickel Based Alloys in Pharma 2011

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THEADVANTAGESOF

TANTALUMANDNICKELBASEDALLOY

SHELLANDTUBEHEATEXCHANGERS

vs.

CARBONBLOCKHEATEXCHANGERS

IN

PHARMACEUTICALAPI

APPLICATIONS

By:LawrenceJ.HaubnerTITANMETALFABRICATORS/2011

AboutThe

Author:

LarryHaubnerisa20yearindustryveteranintheengineering,design,manufacturingandprojectmanagementofreactivemetal

equipmentfortheprocessindustries. HejoinedTITANMetalFabricatorsin2000,andhasbeenresponsiblefordesign,salesandproject

managementofreactivemetalheatexchangers,pipingsystems,columnsandpressurevessels.Mr.HaubnermajoredinMechanical

EngineeringTechnologyatUniversityofCincinnati.

Formoreinformationontheapplication,specification,designandfabricationofcondensersforpharmaceuticalapplicationsplease

[email protected];TITANMetalFabricatorsInternationalHeadquarters,

835FlynnRoadCamarillo,CA 93012Phone:18054875050;TITANMetalFabricatorsIndia,Noida,UttarPradesh,India

Phone:91.120.4248100www.titanmf.com.


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TANTALUMPHARMACEUTICAL

CONDENSERSINSTALLEDWITH

GLASSLINED STEEL REACTORS

Thepharmaceuticalindustryhastraditionallyusedresinimpregnatedgraphiteblockheatexchangersfor

handlingcorrosivefluidsintheiractivepharmaceuticalingredient(API)manufacturingfacilities. Duringthepast

threedecades,tantalumandhighnickelalloyshellandtubecondensershaveemergedasaversatilealternative

offeringsuperiorcorrosionresistancethatarecommonlyusedbytheworldsleadingpharmaceutical

manufacturersandpharmaceuticalengineeringcompaniesincluding:

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

TantalumandHastelloyeliminatemostproblemsassociatedwiththeuseof

graphiteforpharmaceuticalprocessing;theiradvantagesinclude:

Noproductiondowntimeforrepairsandreplacements Purityofthepharmaceuticalendproduct Faster,validatedcleanoutbetweenbatches Superiorcorrosionresistance

The

ability

to

process

any

pharmaceutical

product

while

meeting

the

strictestregulatorystandards

Eliminationofcrosscontaminationofheattransferfluidintotheprocessduetogasketleaksorbrokengraphiteblocks

CorrosionResistanceAnaturallyoccurringoxidefilmontantalumssurfacemakesitresistantto

corrosionineventhemostsevereacidenvironmentsandcompletelyresistantto

organiccompounds. Thissuperiorcorrosionresistancemakesitsuitableforany

applicationwithinthepharmaceuticalindustry,particularlywhencorrosivechlorinatedorganicsareinvolvedat

elevatedtemperatures

and

under

vacuum

conditions.

Tantalum

is

inert

to

most

organic

and

inorganic

compoundsattemperaturesupto450F. Itisinerttosulfuricacidbelow300Fandtheattackbelow400Fis

notsignificant. Tantalumisalsoinerttohydrochloricacidinallconcentrationsandatalltemperaturesupto

350F. Thecorrosionresistanceoftantalumisvirtuallyidenticaltothatofglassmakingittheperfect

complementtoglasslinedreactorsystems.

Thecorrosionresistanceofnickelbasedalloysresultsfromahighnickelandmolybdenumcontent. Thesealloys

areknowntocorrodeslowlyandpredictably. Whilethecorrosionresistanceofnickelbasedalloysisnotashigh


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astantalumtherearemanyapplicationswhereitcanbeusedwithsatisfactorycorrosionresistanceandallof

theadvantagesofthatoftantalumwithareducedcosttotheenduser.

THEADVANTAGESOFTANTALUMANDNICKELBASEDALLOYCONDENSERS

NoProductionDowntime

Metaltubecondensersareexceptionallydurableandwillperformformanyyearswithoutanylostproduction

timeforrepairsorreplacements. Thelongservicelifeofametaltubecondenserprovidesthehighest

productivityrate

while

eliminating

maintenance

costs

and

replacement

expenditures.

Incontrast,graphiteissusceptibletomechanicaldamage,withbreakdownscommonlyoccurringduring

handling,installation,operationandcleaning. Thegreater

failurerateofgraphitesystemsnecessitatesfrequent

repairsandreplacements,resultinginlowerproductivity

andhighermaintenancecosts.

Metaltubecondensersrequirealargerinitialinvestment

thangraphitecondensers. However,becauseproduction

downtimetranslatesintoassetdepreciation,higher

operatingcosts,

and

lost

sales

due

to

longer

time

to

market,

thebreakeventimefortantalumversusgraphiteisonly18

months. (SeeFigure1)

Moreover,longtermcostcomparisonsdemonstratethat

despitehighercapitalcosts,metaltubecondensersaremoreeconomicalthangraphite,duetoitsgreater

durabilityandlongevity.

ProductPurity

Pharmaceuticalproductpurityismandatedbystringent

regulationsatthefederal,state,andlocallevels. Butresin

impregnatedgraphite

often

fails

to

meet

the

industrys

quality

controlrequirements. Astheimpregnatedgraphitesurface

heatsupandcoolsdown,thedifferencebetweenthethermal

expansionratesofgraphiteandthephenolic(orTeflon)

impregnatecreatesstress. Thisstresscauseserosionatthe

graphitesurfaceinthesamewaythatwatersfreezethaw

cycleerodesaconcretesurface. Asaresult,minutegraphite

particlesandresinsflakeintotheprocessbatch,contaminating

theendproduct.

Faster,

Validated

Clean

Out

AllcondensersmustbethoroughlyflushedbetweenprocessbatchestosatisfygoodManufacturingPractice

(GMP)proceduresaswellasregulatorystandards. Cleanoutisextremelydifficultandtimeconsumingwith

impregnatedgraphite,becausegraphitesrough,poroussurfaceabsorbsboththeprocessfluidandtheend

product.

TANTALUMPHARMACEUTICALCONDENSERWITH316LSTAINLESSSTEELSHELL


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Withitssmoothersurface,metaltubecondenserscanbeflushedmuchmorequickly,resultingindramaticcost

savingsandincreasedproductivity. Thecleanoutprocedurecanalsobevalidatedeasilybyopeningthe

tantalumcondenserforinspection,whichisnotpossiblewiththedesignofagraphitecondenser.

NoLeakage/CrossContamination

WhenlowsurfacetensionheattransferfluidssuchasSylthermand DowthermJareusedinplaceofcooling

water,tantalumpreventsleakage,whilegraphitecreatesproblems. Thegraphiteblockdesignofmultiple

gaskets

and

a

floating

head

dynamic

seal

cannot

provide

an

effective

closure.

In

some

cases

shellside

fluid

has

beenknowntopermeatethegraphiteblockitself.

HighThermalEfficiency

Therelativelythinwallsofmetaltubecondenserstransferheatmoreeffectivelythanthethickerwallsofcross

boredgraphiteblocks. Inmanycases,tantalumcondensershavebeenshowntorequire40percentlessheat

transfersurfaceareathanimpregnatedgraphiteexchangersforthesameapplication. Tantalumcondenserscan

bethermallysizedtoprecisespecificationsforanyapplicationtoreducethesurfaceareaandminimizethe

requiredspacing.

UniversalVersatility

Becauseit

is

versatile

enough

to

process

any

pharmaceutical

product,

tantalum

and

Hastelloy

can

be

fabricated

intouniversalsystemstomeetanyproductionrequirement,aswellasthemostexactingregulatorystandards.

Thereforecapitalequipmentdecisionscanbemademoreefficientlyandnewpharmaceuticalproductscan

reachthemarketwithoutdelaytomaximizeprofits.

FABRICATIONFEATURES

TITANMetalFabricators,Inc.hasdevelopedhighquality

processesanddesignstoservethespecializedneedsofthe

pharmaceuticalindustry.

Thesedesignfeaturesinclude:

LeakDetectionTantalumtubesheetandbonnetdesignscanincludeportsthatallowleakagepastatubesheetweld

tobedivertedtoacollectionsystemoutsidethe

condenser. Inadditiontoearlyleakdetection,thisdesign

minimizescontaminationoftheprocessmediabythecoolantor

coolantbytheprocessmedia.

CompleteDrainabilityTubesheetandbonnetdesignsandweldingprocessescanminimizetheabilityofthetubesheetareatoretain

fluidsduring

draining

and

cleaning.

TANTALUM,HASTELLOYCAND316LSTAINLESSSTEELPHARMACEUTICALCONDENSERWITH CIPSPRAYBALLS

TANTALUMCONDENSERWITHFLUSHFACETUBESHEETTOENSUREFULLDRAINABILITY


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TANTALUMCONDENSERWITHCIPSPRAYBALLSFORCLEANINPLACE

TANTALUMCONDENSERWITHINTERGRALINSULATIONSIGHTGLASS,ANDCIPSPRAYBALLS

PolishingOfMetalCondensersTantalummillproductsthatareusedintantalumpharmaceuticalcondenserisofferedasastandardasaminimumof20Rasurfacefinish.Thistypicallyexceedstherequiredsurfacefinishofa

condenserforthisservice. Hastelloycondenserscanbeofferedinavariety

ofsurfacefinishfromstandardmillfinishtoanelectropolishedsurfaceof

approximately10Ra.

CIPCleaningDevicesCIP(CleanInPlace)spraydevicescanbeinstalledtoensurefastthoroughcleaningoftheprocesssideofthecondenser.

RiboflavinTestingAllCIPspraydevicesappliedintothesecondenserscanberiboflavintestedtoensurethattheCIPspraydeviceisadequately

cleaningtheprocesssideofthecondenser.

SightGlassesforviewingofcondensation/verificationofcleaningThemechanicaldesignofametalshellandtubeheatexchangerallowsfortheapplicationofsite

glasseson

the

bonnets

for

viewing

of

condensation

performanceaswellasthepositiveverificationofthe

cleaninginbetweeneachbatch.

IntegralInsulationPolishedstainlesssteelsheathedinsulationcanbeappliedtoourcondenseratourfacilitytosavetimeduring

installation.

SilverbrazingAlltantalumliningsaresilverbrazedtothecarbonsteelsubstratetopreventcontaminationandgasket

leakage.

COSTEFFECTIVE

Despitehighercapitalinvestmentcosts,tantalumandHastelloycondensershaveconsistentlyproven

themselvestobemorecosteffectivethangraphite. TantalumandHastelloycondensersarevirtually

maintenancefree,providinglongtermdurabilityandfastervalidatedcleanout. Lifecyclecoststudieshave

shownthat

the

payback

time

for

tantalum

can

be

less

than

two

years.

References:

TantalumandNiobiumMaterialsforthePharmaceuticalIndustryMikeCoscia/HCStarck

MaterialsSelectionIssuesforHeatExchangersinthePharmaceuticalIndustryLJRCohen/RCYoung/AstraZeneca

TeflonisaregisteredtrademarkofE.I.DuPontdeNemoursandCompany

SylthermandDowthermaretrademarksofDowCorningCorporation

AmericanSocietyforMetalsPropertiesandSelectionNonFerrousAlloysandPureMetals,1979

Photos/DiagramscourtesyofTITANMetalFabricators.

ALLOYCCONDENSERWITHTUBESIDEPOLISHEDTO20RAANDSIGHTGLASSESONBONNETFOR

VIEWINGCONDENSATION


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Documents

The Advantages of Tantalum and Nickel Based Alloys in Pharma 2011