GEA Pharma Systems Small Scale Solid Dosage R&D A complete ...

Partner in R&DSpecifically Designed R&D equipmentOur R&D range spans all aspects of oral solid dosage production from highshear mixers, fluid beds and single pot systems to extruders andspheronizers, blenders and containment solutions, right through to R&Dtablet compression.GEA Pharma Systems has a complete range of equipment especially for usein R&D facilities. The equipment is designed for specific applicationstaking into account, right from the start, the often limited space availablefor their installation.Innovation is as important for you as it is for any other businessInnovation is the key to GEA Pharma Systems’ success and to thecontinued prosperity of its customers. In fact it’s much more than that. Weknow that by continually stretching the boundaries of what is possible inpharmaceutical processing we have the ability to support our customers inenhancing the opportunities available to millions of people all over theworld. This is what drives our business. Our innovation takes many formsand affects all parts of the process. We innovate to increase production andreduce costs, to improve containment and safeguard the workforce, toachieve better clinical effectiveness and to enhance quality control.At GEA Pharma Systems innovation never stops – it’s just part of what we do.3

PharmaConnect ProcessingThe centre of the GEA Pharma Systems’ smallscale and R&D approach is PharmaConnect .This innovative system provides a uniquebenefit to the Pharmaceutical Developmentindustry, integrating a single Control Unitwith a diverse range of Process Modules.Based upon GEA Pharma Systems’ class-leadingPMA and Gral granulation technologies, thePharmaConnect provides the user with the abilityto process batches from as little as 100g, right up to25kg or more, all from a single control system.However the PharmaConnect is not limited to justgranulation; the unique design of the Control Unitallows any number of process technologies to beoperated from the single Operator Interface.The key technologies offered include:• PMA - Bottom Driven High Shear Granulation.• Gral - Top-Driven High Shear Granulation.• Nica - Extrusion and Spheronization.• Buck – IBC Blending Systems and Containment.• TRV – High Shear Blending.Each of these technologies is class-leading.PharmaConnect provides the opportunityto try them all.PMA working volumes / batch sizeControl UnitAt the centre of the PharmaConnect technology isthe Control Unit. Available in Through-the-Wall(TTW) or Mobile format. The unit features GEA’sModule Recognition System (MRS), TouchscreenUser Interface and one of the module drive systems.The MRS senses the type and capacity of theconnected module, seamlessly displaying an imageof the process on-screen, enabling the correctoperational set points and defining the parametersfor the electric motors. A true Plug and Play systemfor the busy Formulation Scientist!Equipment Equipment Typical TypicalType Size Minimum MaximumBatch@0.6sg Batch@0.6sgDevelopmentIntermediatePilot1 240g 450g3 720g 1.35kg5 1.2kg 2.25kg10 2.4kg 4.5kg15 3.6kg 6.75kg20 4.8kg 9kg30 7.2kg 13.5kg60 14.4kg 27kg4

Granulation, Blending & PelletizingTRV - High Shear BlendingTurbo Rapid machines have a history of over40 years providing a high intensity blending regime fordry powders. Homogeneity and stability are key factorsin the production of inhalable drugs and due to theunique TRV impeller blade and high operating speed,the TRV delivers in both areas. Available with workingcapacities from as little as 150g, and up to 30kg, theTRV can be specified in standalone or inPharmaConnect Formats.PMA - Bottom-Driven High Shear GranulationGranulation is at the heart of the PharmaConnectsystem and the range of capacities that can beprocessed is truly unique. Standard module capacitiesfor the bottom-driven PMA are set at 1, 3, 5, 10, 15, 20,30 and 60 litres with each unit being geometricallyscaleable. Critically, each of these modules features itsown impeller drive motor, maintaining a consistentenergy input per unit volume. By providing this level offlexibility, the development scientist operating at the 1-litre level can provide true scale-up data for commercialexpansion.Gral - Top-Driven High Shear GranulationAs the state-of-the-art, top driven granulation system,the Gral is renowned worldwide for its high quality androbust design. Scaleability is the key to the system’ssuccess.The UltimaGralTM starts from a 10 litre bowl,with further scale-up provided with 25 and 75 litrecapacities. From these sizes, scale-up to productionequipment is easy. Furthermore the system may beintegrated to the PharmaConnect Control Unit,providing complete process flexibility.Nica IPS-5 Extrusion and SpheronizationAs the only pelletization system developed solely forthe Pharmaceutical Industry the Nica IPS-5 extruderand spheronizer represent perfect partners for thePharmaConnect. Offering the capability to pelletizebatches of as little as 50g, but still maintaining theoperating principals of the larger pilot and productionmachines, the PharmaConnect Nica IPS-5 is theperfect development tools.Buck ® – IBC Blending SystemsDesigned to handle a complete range of laboratorysizedIBCs from 3 litres to 715 litres, utilising a singleprocess module. All IBC sizes feature the removableBlending Prism technology unique to GEA PharmaSystems. Furthermore, NIR technology can be appliedto provide online detection of the blend homogeneity.The Prismadds low shear mixing to the rotating IBC,adding to the turbulence of the tumbling product andimproving the time to homogeneously blend products.5

Totally Contained, Completely FlexibleHigh Shear GranulatorsThe Aeromatic-Fielder & Collette High Shear Mixer andGranulator are multi-purpose processors equally suitable forhigh speed dispersion of dry powders, aqueous or solventgranulations, effervescent production and melt pelletization.PharmaConnect which enables diverse GEA developmentequipment to be docked into a single ‘plug and play’ modulewith full cGMP compliance.Process OverviewAt the heart of the production plant are PharmaConnect ® andFlexstream. PharmaConnect ® is GEA’s innovative, modulargranulation and blending system offering an unbeatable rangeof process types and capacities; FlexStream is the worldleading process technology for spray granulation and pelletcoating, delivering unbeatable benefits in terms of greaterproductivity, lower running costs and a robust and scaleableprocess.Containment Valves & DisposableContainment InterfacesThe system includes examples of both rigid and disposableproduct transfer technology offering containment down to lownanogram levels. These options include: the disposableHicoflex ® system with significantly lower capital and runningcosts compared with rigid IBC technology and rapid productchangeover for improved plant utilization; the unique, modularBuck ® MC valve with its simple design that enables completecontainer-to-container transfer flexibility; and the Buck ® TCValve, the highest performing split valve available in the marketplace. By introducing a wash step prior to valve separation, theBuck ® TC Valve is capable of performance to the low nanogramlevel.Integrated ApproachAll of these technologies are brought together for an integratedprocess system that mimics the hundreds of large-scale plantsprovided by GEA Pharma Systems globally. It epitomises theapproach of ensuring customers receive the same technologyfrom the laboratory through to production, using the samecontainment and process technologies to ensure seamless scaleupand the most flexible blend of process capabilities.7

Fluid Bed ProcessingFor fifty years, GEA Pharma Systems has supplied advanced solidsprocessing plants for blending, granulating, drying, pelletizing and coatingto the pharmaceutical industry. This includes small capacity systemsdesigned for R&D as well as industrial size plants for batch production ofpharmaceutical compounds under cGMP conditions.Our plant and process expertise is based on experience and R&D. With plantsinstalled around the world and literally thousands of tests performed, we haveestablished a solid base of expertise related to the needs of the pharmaceuticalmanufacturing industry. Emphasizing the importance of R&D, GPS offers 3complementary dedicated units that fit perfectly into the laboratory environment,offering batch sizes from as little as 50g, up to over 6kg.MP-Micro Optimize the formulation and identify the processparameters to establish the desired productcharacteristics. Test small quantities of rare andexpensive materials before decisions are taken onwhether it’s viable to proceed with the next stage ofproduct development.Purpose-designed for R&D projects, the MP-MICRO Fluid Bed brings all the flexibility of afull-size production fluid bed to the laboratorybench-top.Main features• Variable process control of airflow, temperatureand liquid addition.• Interchangeable product containers.• Filter blow-back system.• Easy strip down for cleaning.STREA-1 Combining versatility with table-top practicality, theStrea-1 is one of the most recognisable processmachines in the pharmaceutical industry. Purposedesigned for processing of fine powders, pellets,granules, crystals and tablets, the STREA-1 is theflexible choice when taking the first steps towardsprocess optimisation.Product drying, top spray granulating and coating –in volumes ranging from 200ml to two litres – canall be handled by the STREA-1, thanks to itsinterchangeable components and containers.Continuing GPS’s strong commitment to researchand development and high quality standards, theSTREA-1 is a vital addition to the laboratorybench-top.8

Granulation, Drying, Pelletizing & CoatingMulti-Processor MP-1For true process flexibility and as anintroduction to production scale processing,the MP-1 is the machine of choice.Capable of performing any Fluid Bed Process, theMP-1 features a diverse range of options includinghigh efficiency drying, top spray granulation,bottom spray pellet coating (Precision Coater) andside spray granulation / coating (FlexStream).With a batch range from as little as 500g, up to over6.0kg, the MP-1 complements the GPS granulationand pelletization equipment, but still maintains theflexibility offered by a mobile design.To provide more scale-up capability, GPS can alsooffer the MP-1-size product container as an optionon its pilot size 2 equipment. This expands the rangeof the MP-2 to allow drying of batches from 1kg upto 25kg in a Through-the-Wall, GMP design.FlexStream the ultimate in fluid bedflexibility that offers granulation, drying andcoating in a single processor with built inlinear scale-up. The FlexStream conceptrequires no mechanical adjustment whenswitching between the drying, granulating andcoating modes.MP-Micro Strea-1 MP-1 MP-2Typical Capacity 50-200g 100g—1kg 500g - 5kg 1kg—25kgDrying • • • •Top Spray Granulation • • • •Top Spray Pellet Coating • • • •Precision Coating • • • •Bottom Spray Pellet CoatingFlexStream Granulation • •Side Spray GranulationFlexStream Coating • •Side Spray Pellet/Tablet Coating9

Single-Pot ProcessingSingle-Pot Technology offers a choice of mixing, granulationand drying options integrated into one processing vessel.For development purposes, the Collette UltimaPro 10 and 25has the processing batches capacities of 1 to 9kg. All keycharacteristics, granulation and drying options of the Single-PotProcessor are available for these R&D machines. Both are compact,mobile machines which are easyto install because of a Plug & Play concept.Compact and Cost-Effective ProcessingSingle-Pot technology is a very compact technology achieved byincorporating several processing steps into one machine. Thisreduces the capital cost of the equipment as well as the cGMP &technical space required for granule production andtherefore the overall project cost.Flexible ProcessingWhether for standard wet granulation, melt granulation,pelletizing or effervescent production, combined with vacuum ormicrowave drying, a single-pot processor can achieve the requiredresult. The swinging bowl option enhances this flexibility evenfurther by its capability to process older formulations to a highquality standard. With easy and efficient cleaning, using a CIPsystem, quick product changeover is achievable.UltimaPro combines high-sheargranulation with highly efficient vacuumand microwave drying technologies.The result: the ultimate flexibility for bothpharmaceutical R&D and production.Single Pot Processing - ideal for:- Ecological, organic solvent-based soliddosage processing: UltimaPro-Eco- Efficient processing of effervescentformulations (especially water-basedreaction method): UltimaPro-FZ- High containment solid dosage processingfor oncology, hormone and other highlypotent products: UltimaPro-HCContained ProcessingBecause of its very nature, a single-pot process is a containedprocess. No transfers are required between process steps, exceptfor loading the raw materials and unloading the dry granules. Thisis not only beneficial for protecting the operators from potentproducts, but also for protecting the products from externalinfluences such as heat, light or moisture. Specific solutions areavailable for product loading and discharging to achieve thedesired level of containment for the whole process10

Nica Pellet ProcessingModular conceptThe unique modular concept of the Nica PelletizingSystem facilitates optimized solutions to meet processneeds exactly.Mixer / granulator, extruder and spheronizer modules arecombined to create a complete integrated pellet productionplant, or selected individually to suit specific requirements.Modules can be operated in either batch or continuous mode,for maximum flexibility of operation, and can be used standalone,or integrated with other up- or down-stream equipmentsuch as fluid bed processing systems.Ideal for both product development and full-scale productionapplications, process scale-up of the Nica Pelletizing Systemis easy – it’s simply a factor of processing time.Nica ExtruderThe Nica Extruder is based on unique low-shear technologydesigned to minimise work input and temperature rise. It isideal for sensitive products which could be damaged by moreintensive systems. A wide range of extrusion screen sizes andconfigurations are offered for optimisation of pellet diameter,surface quality and size distribution.Used for both batch and continuous production, the NicaExtruder has no stagnant areas, and no significant producthold-up. A compact design eases installation and cleaning.With a simple reconfigurationof the extruder, formulationsthat require a highdegree of work inputcan beprocessed.Nica SpheronizerThe Nica Spheronizer features a smooth-edged, close-fittingfriction wheel for good sphericity of pellets and a tight pelletsize distribution. This patented design eliminates problems ofedge-milling and undesirable fines common with traditionaltechnology. Optimisation of the process is achieved by choice ofcycle time, wheel speed, product loading, friction pattern andregulation of air-flow past the wheel periphery.The Nica Spheronizer is fed directly by the Nica Extruder.For high volume applications, two batch spheronizers may befed by a single continuous extruder.• Good pellet sphericity• Produces no fines• Versatile system• Easy to operate• Easy to clean• Efficient low-sheartechnology• Wide choice ofextrusion screens• Gentle on product• Small foot-print• Easy to cleanExtrusion E-Connect E-140Typical Production Rate 0.1—0.5 kg/min 0.5-2.0 kg/minMinimum Batch Size 50g 200gSpheronizing S-Connect S-320 S-450Typical Batch Range 50g—250g 200g –1.0kg 400g—2.0kg12

Integrated EaseBuilding upon GEA’s renowned integrated granulationsystems, Nica is now available in three fully equippedpelletization systems.Based on the ground-breaking PharmaConnect technology, theIPS5 provides the user with a true mini-production machine forthe development environment. Providing batch capacities fromless than 50g, the user is now able to test expensive, raremolecules with formulations and equipment that mimic thosefound in the production environment.For small pilot batches of 250g to continuous production at over25kg/hr, the IPS25 links the E140 and S450 technologies in anintegrated system. Operating in manual mode, the user controlsthe dosing of the extrudate into the spheronizer and the overallspheronization time. With a developed recipe, these timings areautomated to ensure product consistency from the first to thefinal pellet.Further complementing the IPS range, the IPS100 integrates theE220 and S700 technologies scaling 100kg/hr production ratesfrom the first principles developed on the IPS5.13

Tablet ProductionPERFORMA PFeaturing the innovative Exchangeable Die Disc (EDD), is aflexible tablet press for small to medium scale production.On the PERFORMA P, the entire turret, including punches and dies, can be easilyremoved from the machine and replaced with a duplicate turret in less than 30 minutes.Alternatively, the turret removal arm can be used to lift and swing out the upper punchguide part of the turret only, clearing the way for the light-weight EDD holding the diesto be taken out manually. The EDD can then be replaced by a duplicate Die Disc, withthe entire exchange procedure taking less than 30 minutes.The EDD offers additional benefits compared to theexchangeable turret:• Fast and easy format change over: duplicate EDD allows off-line fittingand locking of the dies in the Die Disc.• More economical alternative to the exchangeable turret: only the Die Discneeds to be duplicated, instead of the entire turret.In addition to the exchangeable turret and the EDD, the PERFORMA Pfeatures a swivelling tablet chute enabling fast turret removal and ejectionset-up.An optional easy-to-install kit enables effortless conversion of thePERFORMA P from single-layer to bi-layer machine.The PERFORMA P is now available with a bilayerkit, which quickly transforms the standardmachine making it capable of both single- andbi-layer production. The bi-layer kit consists ofonly a few components, which are very quickand easy to install.By adding this new asset to the many benefits ofits advanced compression technology, GEAPharma Systems - Courtoy has furtherenhanced the flexibility of its machine range.The PERFORMA P is available with the latest Courtoy developmentsin process control:• 6 different compression modes, including equal porosity tableting (EPT).EPT is the ideal compression method for novel solid dosage forms, suchas ODT and MUPS.• Adjustable dwell time at pre-compression, for improved de-aeration ofthe powder bed and optimal particle rearrangement prior to the maincompression effort.14

Small-Scale and VersatileMODUL PThe small-scale tablet press is the most versatile and powerfultablet compression machine for development work and clinicaltrial production.Various methods of tablet compression and process control:• 6 different compression modes are available on the MODUL P.• The ‘equal porosity compression’ method is ideal for novel solid dosageforms, such as ODT, MUPS, etc.• The force versus time compression profile is fully controllable and, onceset up, is kept constant irrespective of machine speed.Full flexibility for tooling types:• The turret can be equipped with a customised and mixed number of D, Band BB punch positions.• The most common configuration for formulation development andresearch purposes is a turret with 10 B and 10 D punch positions. Blankdies are supplied to blank off unused positions.Special features for small powder quantities (down to 1kg)• Special ‘low-volume’ powder feeder with slide-in wear plate tominimise powder losses.• The machine can work with just one punch.• The dust extraction can be switched off.Different ECMs (Exchangeable Compression Module) can be usedin the same basic machine with one and the same control system:• C-ECM (contained ECM) for non-potent products.• WOL-ECM (wash-off-line ECM) for potent/toxic products.• BL-ECM (bi-layer ECM) for bi-layer tablet production(up to 100.000 tab/hour).All ECMs offer unmatched operator protection andextremely fast product change-over.The highly sophisticated CDAAS (Courtoy Data Acquisition and Analysis System)measures and samples the following signals at high frequency:• Pre-compression force • Main compression force • Ejection force (optional)• Pre-compression displacement • Main compression displacement • Punch stroke (optional)A large number of advanced signal analysis functionalities are included, such as automaticcalculation of the compression energy exerted on and absorbed by the tablets and Heckel plots.15

Contained Product TransferMC Valve for rigid transport containersFor over 10 years, Buck ® has supplied dust- and contaminationfreecontainment interfaces for the safe transfer of powders,particulates and tablets in the pharmaceutical industry.These interfaces ensure the protection of both people andproducts when charging and discharging high-potent APIs.The Buck ® MC Valve concept unifies all the currentrequirements in high containment equipment: full GMP design,no need for vacuum, robust centering,free orientated docking, quick release without any tools asstandard.But the most innovative step is the idea of using only passivevalves driven by a modular actuator unit.1. undocked, unlocked & closed 2. docked, locked & closed 3. docked, locked & openedSpecificationsSuitabilitypowders, granules, pellets, tabletsFeatures100% FDA conformityanti-static seal material availableproduct contacting materials: AISI 316Lspecialities available on demandBuck ® Valve TCBuck ® Valve UMCBuck ® Valve UHC

Disposable Materials HandlingHicoflex ® , the first time in the industry the benefits of bags have beencombined with split valve containment performance! Its simple yeteffective design provides levels of containment normally associated withexpensive and complicated split butterfly valves.Clear and flexible bags allow users to physically agitate product flow andvisually confirm full product transfer. Providing 100% yield on materialtransfers without putting operators safety at risk with poor levels ofcontainment. Equipment no longer needs to sit unused while you wait forthe process areas to be cleaned.Hicoflex ® productsHicoflex ® Charge BagFully-contained powder transferbag for contamination-freecharge/discharge of hazardousmaterials.Hicoflex ® AdaptorProcess equipment adaptor thatfits all Hicoflex ® bags.Tri-clamp size: 2”, 4”, 6”Throw Away Your Cleaning Concerns• Zero risk of cross contamination.• No expensive wash media & detergent needed.• No effluent treatment required.• No expensive swab testing.• Keep your operators free to do the jobs you pay them to do.Disposable Containment enables your operators to perform thejobs they should be doing, not changing in & out of air suits,not washing small fiddly containers and not waiting for cleaningvalidation.Hicoflex ® gives you the power to work more effectively andefficiently. Reducing over-heads and running costs while improvingyield and output, means you get your product faster to the market.Hicoflex ® Spray BagUnit to rinse the internalsurfaces of the adaptor beforeremoval to ensure full operatorprotection.Hicoflex ® Sample BagFully-contained samplingdevice for sampling the processthrough an adaptor or bulkmaterial out of a Hicoflex ®charge bag.Sampling volume: 1/5/10 mlHicoflex ® Charge Bag plusHicoflex ® charge bag equippedwith an internal rinsing deviceto ensure a full yield discharge.Safer, Flexible and more Cost Effective!17

GEA Pharma Systems Technology CentresWith the GPS Technology Centres, GEA Pharma Systems takescustomer partnership and R&D to new levels. Our centresoffer a complete range of R&D and product testing services,where customers can test and optimise existing processes,develop new procedures, and perform pilot scale productionsof any aqueous or solvent based pharmaceutical product. Ourcustomers can perform comparative process studies with ourskilled operators by testing complete process trains. Allprocessing is optimized by utilising advanced CIP technology.Furthermore, our centres have full demonstration and trainingfacilities making GEA Pharma Systems your obvious choicefor a pharmaceutical process partner.The GPS Technology Centre (GPS TC) in Bubendorf,Switzerland supports pharmaceutical companies to bring newproducts to market quickly, effectively and with easy scale-upto full production. The Centre is equipped with a full range ofGPS batch solid dosage processes including: containedmaterials handling, dispensing, blending and powder mixing,granulation and drying, extrusion, spheronization,pelletization, tablet production and coating.Batch ProcessesGEA Pharma Systems is in the unique position to havein-house experience with all commonly used wetgranulation methods. Therefore, at the GPS TechnologyCentre you can test your material in a fluid bed spraygranulator, top or bottom drive high shear granulatorwith fluid bed drying, with all tests being made indevelopment, pilot scale plant or small scaleproduction, depending on your needs.At the GPS Technology Centre we can handle productvolume from 20g to 100kg.Test and developmentGEA Pharma Systems has many years ofexperience in adapting a wide range oftechnologies and processes into viable solutions forcustomers whom are looking to maximise potentialopportunities. An on-going developmentprogramme is constantly examining emergingtechnologies and their development within theglobal environment. The staff work closely withGEA Pharma Systems (and other GEA Groupcompanies) sales divisions, providing an in-depthunderstanding of current market demands acrossthe entire process equipment portfolio.The staff of our technology centres consists ofvery experienced and dedicated people with abackground in engineering, chemistry andpharmacy. They will assist customers with allquestions concerning processes in GPSequipment.18

A Partnership inPharmaceutical R&DThe Process Development Center (PDC) inWommelgem, Belgium plays a major role in thepartnership between the customer and GEA PharmaSystems. This fully equipped laboratory offers theopportunity to benefit from GPS’s years ofexperience in wet granulation, pelletising and dryingprocesses.Single Pot ProcessingA fixed, through-the-wall installation of anUltimaPro 75 High Shear Processor is at thedisposal of GPS’ customers to test the equipmentwith their own products. Also, 2 mobile units, anUltimaPro 10 and 25 High Shear Processors areavailable to rent, for customers who prefer toperform tests in their own facilities. Finally, the PDCalso has one or more MicroGrals available fortesting small-scale batches or for rent. This enablesprocessing batches between 100g and 30kg.From powder to tabletThe PDC has also played a key role in thedevelopment on the new revolutionary concept forproducing tablets, ConsiGma. ConsiGma is aconcept that integrates different techniques forproducing tablets in a continuous manner, such ascontinuous high shear granulation or continuousblending for direct compression. Our customers canbenefit from their experience with this innovativesystem during trials on the ConsiGma unitavailable at the lab. ConsiGma-1 is wet granulationsystems for early process development. ConsiGma-25 is a continuous wet granulation line integratedwith a Courtoy Modul P for compression. TheConsiGma-CDC is a direct compression system,integrating continuous blending and Courtoycompression technology.Analytical toolsNext to the process equipment, a wide range ofanalytical equipment is available for characteristicsof granulate and tablets. PAT tools can be fitted toall process equipment in the PDC for onlinemonitoring of the critical quality attributes.High Shear GranulationHigh Shear Granulation can be single process ORwith integrated fluid bed dryer.Equipment Scale Average Fluid bedBatch Size integrationfor dryingUltimaGral 75 development / 20kg Size 2 fluid bedpilotUltimaGral 300 pilot / 100kg Size 4/5 fluid bedsmall scaleproductionPMA 65 development / 20kg Size 2 fluid bedpilotPMA 300 pilot / 100kg Size 4/5 fluid bedsmall-scaleproductionFluid Bed ProcessingGranulation, Drying Pelletizing and Coating.Equipment Scale Batch SizeMP Micro development 20-200gSTREA-1 development 0.2-2kgMP-1 development 0.2 -6kgFlexStream size 2 development 1-30kgMP-2/3 pilot 1-30kgFlexStream size 4 Small-scale production 30-100kgMP-4/5 Small-scale production 30-100kgNICA PelletizingThough more challenging to produce, pellets offer alot of advantages over normal tablets.Equipment: NICA E140 & S450Extrusion E-140Typical Production RateMinimum Batch Size0.5-2.0 kg/min200gSpheronizing S-450Typical Batch Range400g—2.0kgTablet CompressionFor small-scale tablet production and formulationdevelopment - using such a press for R&D workmeans saving a lot of up-scaling and surprises.Equipment: MODUL P: single and bi-layer tableting.19

Process Analytical TechnologyProcess IntelligenceOptical methods like UV/Vis-, NIR-, IR- or Raman spectroscopy haveearned their spurs in many areas in chemical, pharmaceutical and foodindustry for a long time, mainly in off-line applications. The biggest hurdleto use these optical methods online is the problem of “window fouling”.The observation window is covered with material (bulk solids, sticky, pulpytype products etc.) and needs to be cleaned from time to time.After assisting multiple tests with various customers and suppliers ofoptical measurement techniques in its labs, GEA Pharma Systems hasrecognised this and developed the Lighthouse Probe in cooperation withJ&M Analytik AG. The combination of GPS’s expertise in containment,automation and pharmaceutical processing and J&M’s expertise in opticshas resulted in a robust and reliable probe with in-line calibration andcleaning capabilities.The Lighthouse Probe is the only probe on the market that can clean itsobservation window online.Thanks to the big observation area, the probe also analyses a volume closerto normal sampling volumes than traditional probes. This results in amuch more stable measurement. The Lighthouse Probe has been adaptedto suit the extensive rate of machinery GPS can deliver. It has a manualversion to fit a R&D machine; a mechanical window clean system for apilot plant system and fully automated version suitable for production orhigh containment systems.In processmeasurement positionClean andcalibrate positionThe strength of the Lighthouse Probe is that it is not limited to onesupplier of optical spectroscopy:• For moisture detection, one of the most seen applications, the probe isconfigured with an NDC system resulting in an online LOD apparatus.Thanks to over 30 years of experience, the NDC algorithm for moisturedetection is very robust and precise. This reduces calibration to adjustingtwo parameters instead of model development as us is standard with allspectroscopic system. The development considerably reduces theinvestment, installation and maintenance costCIP position atend of process• GPS recognizes and respects the end user’s choice of spectrometers andcan deliver the probe tuned for various brands now.• As real process understanding comes from combining differentparameters, we also understand that online models can hardly ever bemade using spectra only. The Lighthouse Probe can be delivered andconfigured with the necessary software to make this possible.Please ask our sales force for details.20

ContactsGEA Pharma SystemsAeromatic-Fielder Buck ®GEA Pharma Systems AGPO Box 112, Hauptstrasse 145, CH-4416 Bubendorf, SwitzerlandTel. +41 61 936 36 36, Fax: +41 61 936 36 00E-mail: aeromatic-fielder@gea.comCourtoy GEA Process Engineering nvBergensesteenweg 186, B-1500, Halle, BelgiumTel. +32 2 363 8300, Fax +32 2 356 0516E-mail: courtoy@gea.comAeromatic-Fielder GEA Process Engineering Ltd.PO Box 15, Eastleigh, Hampshire SO53 4ZD, United KingdomTel. +44 23 8026 7131, Fax +44 23 8025 3381E-mail: aeromatic-fielderGB@gea.comGEA Pharma Systems USAGEA Process Engineering Inc.9165 Rumsey Road, Columbia,Maryland, 21045, USATel. +1 410 997 7010, Fax +1 410 997 5021E-mail: info@niroinc.comBuck Systems GEA Process Engineering Ltd.Wharfdale House, 257 Wharfdale Road, Tyseley, Birmingham,B11 2DP, United KingdomTel: +44 121 765 5800, Fax: +44 121 765 5801E-mail: buck.systems@gea.comGEA Process Engineering China Limited99 Hexiang Road Minhang District,Shanghai 201109, P.R.ChinaTel +86-21-2408 2288, Fax +86-21-2408 2222info@geape-asia.comCollette GEA Process Engineering nvKeerbaan 70, B-2160, Wommelgem, BelgiumTel. +32 3 350 1211, Fax +32 3 353 2055E-mail: collette@gea.comGEA Pharma Systems (India) Private LimitedBlock No. 8, Phase B, Village Dumad,Savli Road, Vadodara - 391740 Gujarat, IndiaTel. +91 (0) 265 3074 272, Fax +91 265 3074 255,E-mail: pharma-india@gea.compharma@gea.comwww.geapharmasystems.com

Contact usGEA Pharma Systems Goes SocialFacebook, YouTube, LinkedIn or Twitter: GEA Pharma Systems uses thesemedia to provide customers, the press and fans with frequent up-to-dateinformation.Our Newsletter Keeps You in the LoopOnce or twice a month we issue a newsletter to inform you on currentprojects, newly developed products and integration of our products intoprocesses. Subscribe to this newsletter to be permanently up-to-date.Publications from GEA Pharma SystemsHere you can find all brochures of GEA Pharma Systems. Learn moreabout our products, process solutions. www.gea-ps.com/libraryFollow us on LinkedInFollow us on TwitterJoin us on FacebookLearn more on YouTubeGEA Pharma Systems – Know-How on a Global ScaleGEA Pharma Systems is a global specialist in solid and liquid dose technology forthe pharmaceutical industry. As part of the Process Engineering segment of theGEA Group, with manufacturing and technology centres in Belgium, Denmark,Germany, Switzerland, the UK, Singapore, and the USA, and additional manufacturingfacilities worldwide including India and China, we provide the services thepharmaceutical industry needs. Test facilities … technical know-how …process evaluation … product development … market-leading technology …project management … ongoing support.Contracting Profitable ExperienceA world leader in supplying pharmaceutical equipment, GEA Pharma Systems offersmanufacturers all over the world the opportunity to enter into a profitablepartnership for development and contract. GPS combine advanced in-housetechnology with a thorough understanding of the pharmaceutical industry to helpcustomers maximize their development results.© GEA Pharma Systems 2013. Specifications subject to change without notice. All trademarks recognized.All copyrights reserved. Under no circumstances should this document or any part of it be copied without GPS’s written consent.GEA Pharma Systemsgea-ps.com