Precise preparation Secure process Flexible solution · Precise preparation Secure process Flexible...
Transcript of Precise preparation Secure process Flexible solution · Precise preparation Secure process Flexible...
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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
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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