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NIR Solutions for Solid Dosage Form Analysis
Thermo ScientificAntaris Analyzers
m o l e c u l a r s p e c t r o s c o p y
Part of Thermo Fisher Scientific
Revolutionize Your ProcessThe Thermo Scientific Antaris family of near-infrared (NIR) analyzers offers completely integratedsolutions for virtually every step of the solid-dosage manufacturing process. All Antaris™ analyzershave been developed from the ground up for specific tasks, but with common platform elementsto match how those tasks fit into your process. All models share software, qualification protocolsand tools, design and manufacturing standards, and support team allowing unprecedented efficiency in deployment and the best possible ROI in implementation.
• Easy calibration transfer due torepeatable instrument manufacture andthrough the use of a wide range of software tools that can adjust for environmental differences without changing the original calibration.
• Fast and controlled method deploymentusing Thermo Scientific RESULT softwareworkflows. Thermo Scientific Protocoldeployment with totally controlled instrument parameter assignment, eventsequencing, data collection, reporting andarchival is as simple as a file transferoperation, without any programming.
• Simplified validation with the use of thecommon Thermo Scientific ValPro platformacross analyzers for both lab and plantrequirements. Quality-system compliantdevelopment and documentation traceuser requirements back to design require-ments. Traceable standards, USP testmethodologies and qualification servicesfollow a common path across products so that some of the qualification effortstypically done on multiple analyzersbecomes redundant.
• Dramatically lower costs for trainingand quality management. A common software platform across analyzers, without specialization or orphaned software, is possible because the RESULT™
software platform was designed for end-plant use, regardless of application.
Advantages of Platform Continuity Include:
Antaris MX
Antaris II
Antaris MX
Antaris II
Antaris Target
Antaris EX
Antaris EX
Contents
Method Development 4
API Reaction Monitoringand Control 5
Raw Material Analysis 6
Granulation and Drying 7
Blend Analytics 8
Tablet Testing 9
Software 10
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Antaris MX FT-NIR Process AnalyzersFiber optic sampling is one of thestrengths of FT-NIR for processapplications. The Antaris MX isadaptable for handheld triggerprobe sampling or multi-channel process monitoring. Multiple trigger probes can be attached forfast sample type switching. Moreimportantly, the patent-pendingParaLux™ illumination system eliminates the need to collect backgroundsand provides up to four simultaneous measurement points.
Antaris II Method Developmentand At-line AnalyzersThe Antaris analyzers takenear-infrared technology to the next level. Thepatented multi-techniqueoptical design provides the optimal solution for the development of NIRmethodology and forstatistical knowledgebase building that accompanies today’s PAT projects. Materialscharacterization, tablet analysis, and qualitycontrol methods can be developed andtransferred to dedicated Antaris systems.The Antaris II is the only NIR analyzer available that samples tablets by reflectionand transmission simultaneously, allowingcoordinated, complete NIR assay data inless than half the time.
Antaris EX FT-NIR Process AnalyzersWhen process applications demand proximityof the analyzer, the Antaris EX process ana-lyzer is the best solution. Available certifiedfor Class I Zones 1 and 2 environments, theAntaris EX offers integrated computing andPLC-based analog and digital I/O, OPC communications, and industrial networkcompatibility. The ParaLux illumination systemallows the world’s first true simultaneousmultipoint monitoring with continuous internalreferencing. No mechanical multiplexing ormeasurement lagtime is required, and thesystem can be qualified against traceablereference standards without taking it offline.
NIR and Process Analytical Technology (PAT)
The cost of poor quality can put tremendous strainon the bottom line when a product’s manufacturingprocess is not well controlled. Control strategiesmaking use of real-time analytics hold great promisefor both continuous and batch processes. But controlbegins with understanding, whether a process is newor existing. Whether investigative work gets done inprocess engineering or in product development, ifthe ultimate goal is to apply control to full-scale production, the choice of analytical technology must be carefully investigated.
Process Analytical Technology is not about analyzers. It is about understanding and control, and ultimately, it is about yields, quality, reputation,and competitive advantage. We understand the business issues underlying the PAT initiative. Weunderstand that an analyzer is only a component to a possible solution, and that an analyzer must be more that just an analytical instrument. It must be carefully designed for its intended task.
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Antaris Target Blend AnalyzerThe Antaris Target blend analyzeris the result of a collaborativeeffort between Thermo FisherScientific and pharmaceuticalindustry leaders to use the besttechnologies for pharmaceuticalblending and design them into atotal monitoring package. Theresult is the most complete, reliable, and suitable blending analyticspackage available for tablet manufacturingprocesses. The Antaris Target is designedfor use on large scale blenders, benchtop labscale blenders, and everything in betweenon a single platform. For the first time, formulation project blends can be monitoredin real-time, with eventual migration of thesame technology into production. This commonplatform approach helps to assure that formulation and development analytics arematched to those in full scale processes.
The Antaris II MDS contains all thetools you need to analyze solids, liquids, powders, pastes, andtablets. Originally developed for the pharmaceutical industry, itsreflection and transmission samplinghave been designed for optimal performance with loose and com-pressed fine powders and to offertrue simultaneous transmission andreflection assays of tablets. Mostimportantly, the MDS system allowsyou to select the best technique foryour environment. It offers every-thing you need to run any sample:• Integrating sphere module for
diffuse reflectance sampling• Automated transmission sampling• Fiber optic sampling with
the SabIR™ probe• Tablet Analyzer
transmission module (optional)
Easy Method TransferAfter choosing a sampling technique,it is simple to transfer the method toany Antaris instrument, regardless oflocation. Additional Antaris systemsare configured with only the specificsampling techniques required forthe method developed. Becauseevery module uses the same beampath, each Antaris has identicalalignment and performance resultsmaking method and calibrationtransferability achievable. This notonly saves you time and money, butprovides you with dedicated systemsfor your operations.
Method Development System –Features and Options:
• Precision-matched design andmanufacture for calibration transfer
• Alignment-free, user-replaceable components
• Permanent, integrated samplingmodules
• Automatic, internal backgrounds• Easy-to-use push button and
trigger-based operation• Powerful RESULT software suite
for calibration and workflow development
• RESULT Operation software forcontrolled operation
• ValPro™ system qualification package with complete tools forregulatory compliance
• Optional Thermo Scientific OMNIC spectroscopy software for spectroscopic and method-development work
• Rugged design and construction• Extensive applications, service
and support offerings
Method Development for All Points of the Process:Antaris II FT-NIR AnalyzerWhen you have to solve an analytical problem for a product development or productionapplication, selecting the correct sampling tool is crucial. The Antaris II MethodDevelopment Sampling (MDS) system provides a simple solution.
Liquids and Transmission Analysis Tablet Analysis Liquids and Solids
Dedicated Antaris II Configurations
Reflectance Sampling4
Near-infrared is an excellent analyticaltool for monitoring and control ofprimary manufacturing processessuch as reactive synthesis.Consistency, yield, and safety canbe improved in these processesthrough real-time monitoring. Multi-component, near-infraredanalysis can be conducted withoutstopping or altering reactions, andattributes such as chemical stateand crystallinity can be measuredautomatically. Measured informationcan be used to accelerate, slow,stop, or otherwise adjust processesthrough communication to the reactor control system.
Antaris EX Process AnalyzerThe Antaris EX is a fully integrated,near-infrared process analyzer for usein demanding process applicationswhen hazard ratings are required.Explosive environments and integratedprocess control communicationdemands are no problem for this all-in-one analytics package. Thepatent-pending ParaLux illuminationsystem allows simultaneous multi-point measurements and internalreferencing. Optional integratedcomputing allows local control,diagnostics, and communicationready for installation and operation.
Antaris MX Process AnalyzerFor less demanding environments,the Antaris MX offers the samecapabilities with optional PLC communications, without the hazardous environment rating.
Fiber Optic ProbesWe offer a full line of standard andcustomizable fiber optic probes, builtwith superior sealing and opticalquality, for transflectance, simulta-neous transmission and reflectancesampling. Interfacing can be donedirectly on-vessel or on-line with aflow cell.
Reaction Monitoring System –Features and Options:
• Up to four channels of true simultaneous monitoring (patent-pending)
• FT-NIR repeatability, ruggedness,and sensitivity
• Non-mechanical multiplexingwith dedicated detection on each channel
• Automatic internal referencing(backgrounds)
• Hazardous environment certified • Integrated computing• Integrated PLC with multi-channel
analog and digital I/O• RESULT software-based process
monitoring and communications• ValPro system qualification
package• Extensive applications, service
and support offerings
API Reaction Monitoring and Control: Antaris EX and MX Process AnalyzersThe Antaris process analyzers provide a series of solutions for interfacing with a widerange of environmental demands while using the same robust Antaris platform, commoncontrol software, and regulatory and qualification tools.
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Better understanding of raw materialtraits and their influence on tabletquality for a given fixed process isessential. Raw material characteri-zation focuses on understandingand leveraging these relationshipsto improve production yield andquality. This requires understandingmaterials and their traits morebroadly and being able to screen forthem at point-of-use as part of acontrol strategy. These traits includenot only chemical identification andpurity but also physical characteristicssuch as particle size. Collectivelythese traits can be verified by near-
infrared, as a “fingerprint”that verifies manufacturability.
Raw material ID librariesand qualification models canbe built on Antaris II MDSsystems and transferred to adedicated system for use in goods-in areas.
Raw Material Analytics:Antaris MX ProcessAnalyzers and Antaris II The Antaris MX process analyzercan be configured for dedicatedportable raw material testing using fiber optic trigger sampling.Integrated computing improvesportability and usability runningRESULT workflows dedicated to rawmaterial testing at point-of-use. The system can also be configuredto liquids testing in solvent areas,or for both solids and liquids.
RESULT software with Antarisanalyzers allows integration of barcode identification data (such asID and lot number) to be used toconfirm identity and to integratequality results with LIMS or ERPsystems, using RESULT’s input/out-put events in a production workflow.
For demanding raw materialcharacterization applications, anAntaris II configured for reflectionsampling can be used to samplematerials placed in vials for retention.For example, methods characterizingnon-chemical characteristics maymake use of light scattering proper-ties, in which case the repeatabilityof the integrating sphere helpsensure that sample and samplingproperties are isolated.
Raw Materials Testing System –Features and Options:
• User-replaceable source – no needto open the analyzer housing
• Solid, liquid, or dual mode configurations
• Automatic, internal backgrounds• Easy-to-use push button and
trigger-based operation• RESULT Operation software
for controlled operation• ValPro system qualification
package• Extensive applications, service
and support offerings
Raw Material Confirmation and Control Strategies:Antaris II and Antaris MX FT-NIR AnalyzersRaw Material ID is a critical quality screening operation where near-infrared analysisoffers many advantages over traditional lab-based testing. Raw material analysis by near-infrared also has its place in process understanding and control strategies.
Antaris MX
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Antaris II
Antaris EX Process AnalyzersThe Antaris EX process analyzer fordrying applications is ready for Class IDivision/Zone 1 or 2 installation andincludes integrated computing andOPC and PLC I/O for process control.The ParaLux illumination collectsbackgrounds internally and allowsUSP-based analyzer qualificationeven while the analyzer is online.
ProbesOur retractable probe for dryingapplications features pneumaticprobe insertion and retraction, automatic purge or wipe cleaning of the sampling window, and awash chamber to clean hazardousmaterials without human exposure.
Moisture and Solvent Monitoring of Granulation and Drying Processes: Antaris EX FT-NIR Process AnalyzerDetermination of residual water or organic solvents can be done in-line with near-infrared, given anappropriate sampling system and analyzer suitability. With analyzer connectivity to a control system,these measurements can be used to adapt processes or determine endpoints, improving yields, consistency, and cycle times through the elimination of lab testing.
Moisture Monitoring System – Features and Options:
• Up to four channels of true simultaneous monitoring (patent-pending)
• FT-NIR repeatability, ruggedness, and sensitivity• Non-mechanical multiplexing with dedicated
detection on each channel• Automatic Internal Referencing (backgrounds)• Probe automation and integration options
specific to dryer model and process• Hazardous environment certified • Integrated computing• Integrated PLC with multi-channel analog and digital I/O• RESULT software based process monitoring and communications• ValPro system qualification package• Extensive applications, service and support offerings
Antaris EX 7
Blend Analytics: Antaris Target Blend AnalyzerThermo Fisher Scientific, in collaboration with pharmaceutical industry leaders, offers a dedicated pharmaceutical blend analyzer that provides continuity and scalability between product development and operations facilitating the implementation of control strategies.
Near-infrared is an excellent technol-ogy for pharmaceutical blend analysisbecause it is non-destructive and canmeasure materials in process. Withthe elimination of moving parts andreduction in size, NIR spectroscopymay be done in real-time. With theappropriate data treatment, criticalblending process signatures can bedetected and used in closed-loopcontrol systems. Direct assay of components is also achieved withnear-infrared. Through the use ofstandard deviation and multivariatedata handling, you can achieve athorough control strategy thatensures blend uniformity and confirmscomponents and their concentrationswhile still in the blender.
The Antaris Target blend analyzerfeatures MEMS-based, near-infraredmonitoring built specifically for blendanalysis, and solves many problemsencountered with previously availabletechnologies.
Blend Analytics System – Features and Options:
• High spectral resolution improvessensitivity and method robustness
• Integrated battery, optics, and spectrometer engine integratedinto a single NEMA 4 enclosure
• Wireless communications• High stability and repeatability• Spot sizes configurable to correlate
with dosage size• 25-year MTBF semiconductor source• Consistent light output regardless
of battery charge level• Interchangeable rechargeable
batteries while analyzer is stillmounted to blender
• Lab, pilot, and production scaleinstallation on a single system
• Quick on-off installation andremoval, can be moved from oneblender to another
• Switch-free, automatic data trigger (patent pending)
• Calibration-free end-point monitoring• RESULT software based process
monitoring and communications• PLC I/O option • ValPro system qualification package• Extensive applications, service and
support offerings• 3-year warranty
Antaris Target Blend Analyzer
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The Antaris II Tablet Analyzer com-bines the Antaris Integrating Spherewith a highly sensitive transmissionsystem. This patented arrangementallows tablets of all shapes andsizes to be analyzed by bothreflectance and transmission at thesame time. In one simple samplemeasurement, both tablet coatingand ingredient information areobtained in a true simultaneousmeasurement*. The at-sampledetector position allows increasedsensitivity compared to lens or fiber-optic-based transmission detectorsystems. The full intensity of the NIRbeam is used both for reflectanceand transmittance simultaneously.Every system is matched and testedfor instrument sameness to allowmethod transfer.
Tablet methodology can bedeveloped on a dedicated Antaris IIor a Method Development system,in product or process development,and deployed to different parts ofthe organization for operational use.
A dedicated Antaris II tabletanalyzer is optimized for completeNIR assay of tablet surfaces andcontent; identification and concen-trations can be predicted. Methodscan also be developed to predictphysical or functional traits such ashardness or dissolution.
Tablet Testing System –Features and Options:
• True simultaneous reflection and transmission tabletanalysis, using a patented optical arrangement optimizedfor solid dosage forms
• Precision-matched designand manufacture for calibration transfer
• Alignment-free, user-replaceablecomponents
• User-replaceable source – no need to open analyzer housing
• Opaque tablet or softgel sensitivityand spectral range optimization
• Autosampling capabilities, including custom and universalcarousel designs to accommodatedifferent tablet shapes and sizes
• Automatic, internal backgroundhandling
• Easy-to-use push button and trigger-based operation
• RESULT Operation software for controlled operation
• ValPro system qualification package• Extensive applications, service
and support offerings* Patent pending.
Tablet Testing: Antaris II Tablet AnalyzersThe Antaris II Tablet Analyzer systems meet the needs of formulation and quality control groups, and well as specialty functions such as counterfeit identification.
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Only Antaris analyzers offer a familyof compatible packages built for thedistinct utility modes of near-infrared.There is no need to customize oradapt a lab package for the plant or use a routine analysis tool forchemometric development. Ourpartnership with cutting-edgechemometric leader, CAMO, allowsus to easily push practical near-infrared past the boundaries createdby more limited analyzer systems.
RESULT SoftwareSoftware specified, designed and validated from first principles for controlled use in pharmaceuticalcGMP environments, RESULT providesthe first and only environment forthe development of routine or auto-mated analysis workflows and theirdeployment, without programmingor software customization. RESULTallows interactivity with external programs, LIMS and data system connectivity, OPC and PLC outputs,and the broadest chemometric capability in the industry. Calibrationmodels from TQ Analyst (includedwith the RESULT software suite),CAMO’s The Unscrambler, Infometrix’sPirouette®, and GRAMS PLS/IQ canall be used for real-time predictionwithout conversion or modification.
Workflows can be run in auto-mated mode for continuous andsimultaneous monitoring of multiplecomponents and multiple samplingpoints For applications ranging fromnear-infrared reaction monitoring to raw material trend analysis. RESULTprovides all the tools needed for system control, data collection,reporting, control charting and data archival in real-time.
System Suitability and Performance ChecksRESULT includes multi-level diag-nostics and system checks to ensureproper function. RESULT also runsValPro qualification for Antaris analyzers, allowing powerful butroutine assurance for strongly regulated environments.
Trend Analysisand Data ReviewRESULT’s database provides a complete history of measurementsand allows historical trend analysisand reporting.
Comprehensive SoftwareFrom method development or chemometrics to routine operation or automated processoperation, the Antaris software line matches the unique needs of each point in theanalyzer life cycle.
Undesirable in Manufacturing Environments Desirable Traits in Operation Mode Software Control Package
Macros languages, custom programming Simple for routine shop floor operatorsHigh levels of procedural control customization Automated operationHigh operator skill level requirements Access and workflow (SOP) controlScientific data software Predefined data acquisition, sample prediction, decision-making,
reporting, and archival transportable from one system to anotherModifications or add-ons to software Automatic error checkingnot built for process from inception
Dedicated platform ready-for-process from specification and design
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Communication Format Typical Use
Text List Input Sample lists for automation; LIMS ID number inputText and Spreadsheet Output Report export for LIMS parser; customize reporting and spreadsheet
based tracking; ERP integrationHTML Output Universally viewable report archive formatBarcode ID input from labels on containers of materials; automatic verification
of ID without operator inputRFID ID and inventory information coordinated with data for integration
with LIMS, QMS, and ERP systemsOPC Server for I/O Direct real-time output of analyzer measurement data to control or
other data systems via EthernetCommunications controller for complete setup Direct real-time output of analyzer measurement data to control orof analog and digital outputs other data systems via our Antaris I/O systemSpectral data in OMNIC.spa, JCAMP, Data available for review or use using a wide range of statistical, and CSV ASCII Formats spectroscopic, chemometric, or data management software and
database packages
I/O and Data IntegrationRESULT comes complete with the following tools for moving data to and from the analyzer system:
Method and Model ValidationRESULT’s TQ Analyst™ predictiveengine features a validation toolunique to the industry: completelytraceable and externally verifiablechemometric algorithms. The ValProTQ Algorithms package includescomplete mathematical documentationand equation reproduction in anExcel® spreadsheet, including atraceable data set to confirm softwarepredictive performance. This essentialtool can save months of work ondemonstrating method validity.
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OMNIC SoftwareOMNIC™ software has been theindustry benchmark for molecularspectroscopy work for over ten years.It provides a work environment foreven the most demanding raw dataanalysis and provides seamless data portability to any of the fourchemometric packages available for sample prediction.
The Unscrambler SoftwareWe offer The Unscrambler, by CAMO, for users performing extensive investigation and modeling. The Unscrambler is the standard in chemometric software for near-infrared spectroscopyand can be used to discover, understand, and capitalize on complex sample relationships. In today’s race forprocess understanding, this software tool provides apowerful component to applying analytics to operationalproblems in industry.
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Solving industrial analytical challenges requires bringingthe right tools to the job. The cumulative years of reliablespectroscopic technology from Thermo Fisher Scientifichave been combined with the know-how of experts andeveryday users in industry to produce a range of analyzersthat set a new standard in task suitability. We are pleasedto offer a full line of analyzers with common platform elements in software, validation tools, methodology,support, and implementation. The Antaris product linerepresents an industry-driven migration of spectroscopyfrom science to industry, in a solution that connects thelab and the plant for the first time.
Our Pledge of Support: A Fundamental Analyzer Requirement
The Antaris analyzer product family is backed by theThermo Scientific worldwide applications and processsupport team. With dedicated support for most countriesand regions around the world, our customer supportorganization is the best in the industry. We provide: • Applications Assistance• Qualification Support• Preventive Maintenance• 24/7 Services
We offer a full suite of product and customer services tailored to near-infrared and process analysis.Let us recommend a support configuration, or ask ushow we can customize these services specifically toyour requirements:
1 Feasibility and Site SurveyWe will work with you to evaluate the feasibility ofnear-infrared as a solution to your process analyticalchallenge. One of our NIR specialists will visit yourintended use site to gather key information related toprocess analyzer integration and the necessary compo-nents, services, and preparations. We will provide athorough proposal to ensure a smooth implementation.
2 InstallationOur certified field service engineers ensure proper instal-lation and operation of the analyzer. Prior to installation,we provide a site-readiness form to synchronize installa-tion preparedness between your site and our engineers.
3 Qualification ServicesWe offer a full line of installation and operation qualification services and annual requalification serviceswhich can be used in conjunction with the ValPro system,to demonstrate proper performance and suitability.
4 TrainingOur team of Antaris support specialists can provide:• On-site or factory-based training on the use of
the system • Customized training to ready your staff or plant• Service training and certification to your plant personnel
5 Method Development ServicesIf you do not have the time or resources to model yourprocess parameters using near-infrared, let us providecalibration services for you:• Method Development• Maintenance• Transfer Services
6 Repair and Technical Support ServicesFrom depot repair to critical support, we offer repair andtechnical support services that include 24/7 options tohelp meet the uptime requirements of your application.
About the Antaris Line of Analyzers and Sensors
BR51054_E 09/09M
Thermo Electron Scientific Instruments LLC, Madison, WI USA is ISO Certified.
©2009 Thermo Fisher Scientific Inc. All rights reserved.Excel is a registered trademark of Microsoft Corp. The Unscrambler is a registered trademark of CAMO.Pirouette is a registered trademark of InfoMetrix. Allother trademarks are the property of Thermo FisherScientific Inc. and its subsidiaries.
Specifications, terms and pricing are subject to change.Not all products are available in all countries. Pleaseconsult your local sales representative for details.
