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Capsule Fillingfor Preclinical and Early Clinical Studies

Drug DevelopmentPrecise preparation

Secure process

Flexible solution

QUANTOS Perfect Dosing

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In preclinical and early clinical studies, the filling of capsules ranks among the most critical applications. Since the target quantities of the substances often vary from capsule to capsule, manual dosing is generally performed. However, this involves risks, which Quantos eliminates through automation.

Automatic and PreciseIndividual Capsule Filling

Safety •Automaticmeans

process reliability•Traceableforaudit•Sealeddosingheadsystem

Dosingtoxicsubstancesbyhandis dangerous, takes a long time, and represents a potential source oferrorsthatisnottobeunder-estimated. A single error can cause theresultsoftheentirestudytobecalledintoquestion.Althoughfillingmachinesareclearlyfasterandsaferthandosingbyhand,atlowthroughputtheyaresimplynot

Speed •Nochangeovertime•Nomanualdocumentation•Self-learning

Savings•Efficientsubstanceuse•Smallfootprint•Standardizedvalidation

efficient and are also not capable offillingcapsuleswithdifferenttargetvolumes.Quantosisthesolutionforsmallbatchdispens-ing. Because Quantos is secure. Automated dosing prevents errors andprotectstheuser.Quantosisfast. Despite different target vol-umes per capsule, it requires no changeovertime.Theintelligent

dosingheaddetectsthepowderproperties and independently finds theoptimumparametersforthepowder in question. Quantos is economical. Substances are used efficientlyandonlyintheminimumquantityrequired.Morethanhalfoftheleadingpharmaceuticalcompa-nieshavealreadymadetheswitchto Quantos.

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Whether filling individual capsules or entire series – the modular concept of Quantos offers an effective solution for every application. You decide whether we should expand your Quantos into a fully automatic dosing system or whether you would prefer a 1-to-1 system for individual filling. Whether 1-to-1, 1-to-12 or 1-to-30: with Quantos you can work more quickly, safely and economically than with a spatula.

Evolution in the LabBalancesHaveLearnedtheSkillofDosing

1-to-1Idealforusewithcytostaticdrugs

1-to-12 Manual sample changerIdealforverysmallbatches

1-to-30 Automatic sample changerIdeal for use in preclinical studies

Weighinginhighlyconcentratedandtoxicpowderisoneofthemost common applications in sample preparation. A routine task whichispotentiallydangerous.Aroutinetaskthatcoststimeandmoney.

Themodularstructureofthe Quantos system is like a revolu-tion for your lab. Depending on its intended use, Quantos can be con-verted from a manual to a fully au-tomatic system. However, it always includestheintelligentdosingheadwiththesealed,impact-resistanttransportcontainer,whichprotects

thevaluablematerialfromjoltsand moisture. Quantos positions thedosingheaddirectlyabovethecapsuleandthedosingheadcloses automatically once dosing iscomplete.Theriskofcontamina-tionistherebyreducedvirtuallytozero.

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Aliquoting small volumes of poisonous substances into small containers is a repetitive, monotonous job. This makes the filling of small batches an ideal candidate for automation. The Quantos dosing system is as adaptable and flexible as a chameleon. It fills different capsule sizes, as well as vials and containers of any kind, both quickly and automatically.

Small Batch FillingFullyAutomaticandHighlyEfficient

TheQuantosdosingsystempro-tects employees from poisonous substancesandtakescareoftherepetitive,lesschallengingjobsyouwouldrathernotdobyhand.Quantos is flexible and adaptable. Different target containers are no problem.Itfillscapsulesfromsize

7 down to 9, as well as vials and containerswithdiameterupto28mm.

Quantosisintelligent.TheQuantosConnect application software al-lows an individual fill quantity to bedefinedforeachcapsuleand

thesedatarecordstobecheckedagainstthestudyprotocol.Quantosreliably doses powder quantities ofjust1mg.Withsuchsmallfillquantities, it is also possible to usethematerialwithoutacarriersubstance.Thisallowsyoutosavetheformulationandalsosimplifiesstability tests.

"Catalent" case study CatalentPharmaSolutionsisadevelopmentandmanufacturingservicepartnerforpharmaceutical,bio-logicsandconsumerproductcompanies. Catalent’sfacilityatResearchTriangleParkinNorthCarolina,USAisthecenterofexcellenceforinhaleddrugdevelopmentservicesfrompre-formulation,formulation,analyticaltestingandregulatoryconsultingtoclinicalandcommercialmanufacturing,Catalenthasthebreadthofcapabilitiesandproventrackrecordforadvancinginhaleddrugproductstomarket.“OurpastprojectshavedemonstratedthatimplementingtheQuantosPerfectDosingSystemhasarmedtheCatalentinhalationdevelopmentteamswithextraflexibility,capabilityandcapacityforacceleratingtheresearchanddevelopmentandclinicalmanufacturingofdrypowderinhalersforourclients”commentsDrLeiMao,GroupLeaderofInhalationR&DatCatalent.

YoucanreadthecompletecasestudyandalsoseeQuantosinactionat www.mt.com/quantos

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Technology Quantos and ToxData®

anAlliancetoSecureYourProcessReliability

Maximum process reliabilitySeamless data transfer, automation and plausibility checkspreventerrorsinthestudy.

ThecollaborationbetweenMETTLERTOLEDOandPDSischaracterizedbyprocessreliabilityanduserfriendli-ness.TheQuantosdosingsystemandtheToxDatasoftwareforpreclinicalstudiesareaperfectmatchforoneanother.ToxDatadisplaystheentirepreclinicalprocessandtherebycreatescomprehensiveprocessreliability.Thesoftwareiseasytouse.Itmanagestherecordedweightsandusesthesetogenerateworklistswithindi-vidualtargetvolumesforcapsulefilling.IttransferstheworklistsautomaticallytotheQuantosdosingsystem.Quantosfillsthecapsulespreciselywiththeirtargetvolumebasedontheinformationintheworklists,eachofwhichcontainsacodetopreventconfusion.

Theentireprocedureissecuredandloggedthroughautomaticcrossvalidations.ToxDatameets21CFRPart11requirementsandautomaticallydraftsacompletereportattheendofeachstudy.Weofferservice& supportforthesolutionfromasinglesource.TheQuantosToxDatasystemisplug-&-play:simplyposition,connect and start your study!

www.pds-preclinical.com

Capsules identified by barcode

Validation TheQuantosToxDatasolution…•isfullyvalidatableasper21CFRPart11•issuppliedwithInstallationQualification(IQ)•hasvalidationscriptsavailable

Automatic capsule filling

DrugBase™ worklist Captureweight Study protocol secures assignment

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Quantos and ToxData®

anAlliancetoSecureYourProcessReliability

Intelligent stirrerFeeds powder continuously andhomogeneously.

Intelligent dosing pinPrecisely doses any and all target volumes.Sealsoffthesubstance completelyforyoursafetywhennotdosing.

Intelligent RFID* chip Savesallsubstance-relevantdataandtherebysecurestraceability.

Dosingwithoutstudying–thedosingheaddosesallfree-flowingpowders. Itsalgorithmlearnsthepowdercharac-teristicsandregistersdeviationsintheparticlesize.

* Radiofrequencyidentification

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Technicaldata

QuantosDosing System

1-to-1

1-to-12

1-to-30

Quantos QB5Maximumload 220g

Max.loadofthefinerange 81g

Readability 0.01mg

Readabilityinthefinerange 0.005mg

Repeatability 0.007mg

Repeatabilityinthefinerange 0.003mg

Typicalminimumweight(1%,2sd) 1mg

Configuration QB5

Numberoftargetcontainers 1

Samplechange n/a

Footprint 489x241cm

Configuration QB5

+ Ergodisk

Numberoftargetcontainers 12

Samplechange manual

Footprint 489x241cm

Configuration QB5

+QS30

+ QuantosConnect

Numberoftargetcontainers 30

Samplechange automatic

Footprint 610x431cm

Targetcontainers

Diameter(max) 28mm

Opening(min) 8mm

Height(max) 115mm

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DosingSubstancesthatcanbedosed Powder

Dosingrepeatabilityoftypicalsamplesizes(50mg) <2%

Speedofdosing(50mg) 20…30s

Containervolumes 120ml

Dosedquantitydeviation(CaCO3) 0.5mg

DosingheadQH120-L:dosingcapacity 1mg-5g

Maximumrecommendednumberofdosingsperdosinghead* 250

Maximumpossiblenumberofdosingsperdosinghead 999

Features

• Secureandsimpleoperationwiththeconvenienceofatouchscreen.• AntiStaticKitimmediatelyeliminatesanyunwantedelectrostaticcharges.• Motorizedfrontdoors,dimensionedforuseintheglovebox.• EthernetandRS232interfacesforfullconnectivity.• SafePosfunctionalityensuresthatnopowderisspilled.

Dosing Heads

TheQuantosdosingheadsallowyoutodispensepowderinaninstant.Eachdosinghead

isfilledwithonesubstance.Thismakestime-consumingcleaningprocessesathingof

thepastandalsoeliminatestheriskofpotentialcross-contamination.Yourvaluableor

sensitivesubstancesarepermanentlyandsecurelyprotectedinthestoragecontainers.

TheQuantosdosingheadsemployahigh-precisionstirrerwhichprovidesahomogeneous

powderflow,andadosingpinwhichsealstheheadcompletelybeforeandaftereach

dosing.

*Therecommendationofnomorethan250dosingsperdosingheadisbasedonexperi-

encewithaverywiderangeofpowders,morethan95%ofwhichreachedthisvalue

withoutdisplayinganymeasurablewear.

94 mm

200mm

For more informationwww.mt.com/quantos

Mettler Toledo AGLaboratory&WeighingTechnologiesCH-8606Greifensee,SwitzerlandTel.+41(0)449442211Fax+41(0)449443060

Subjecttotechnicalchanges©06/2014Mettler-ToledoAGPrintedinSwitzerland 30008325GlobalMarComSwitzerland

AutomationthroughQuantosrevolutionizescapsulefilling in preclinical and early clinical studies.

Quantos is fast, secure and economical.

IncreatingQuantos,theweighingexpertiseof METTLERTOLEDOhasbeencombinedwithintelligentdosingtechnology.ThishasledtoaproductwiththetypicalMETTLERTOLEDOcharacteristics:

•Easeandconvenienceofuse•Innovation•Quality

QuantosAutomation