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ALPINE . BEPEX . MICRON . MIKRO . RIETZ . SCHUGI . STOTT . VITALAIR . VRIECO-NAUTA®

Process Technologies For TomorrowSM

FINE-IMPACT MILLSPOWDER AND PARTICLE PROCESSINGFOR THE PHARMACEUTICAL INDUSTRYS 100... 1400 UPZ

MICRON GROUP

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Pharmaceuticals ...A Core Business of the Hosokawa Micron GroupALPINE . BEPEX . MICRON . MIKRO . RIETZ . SCHUGI . STOTT . VITALAIRVRIECO-NAUTA®

Powder Processing TechnologyExpertise in PharmaceuticalsHosokawa is a global operation withsales, manufacturing and test centersthroughout the world.The pharmaceutical industry is animportant business sector for theHosokawa Group and significantinvestment has been made, over theyears, to enhance and streamline ouroperations in this area, enabling us tooffer increasing levels of expertise,

technological development and service.The Hosokawa Group is a recognisedworld leader in powder processingtechnology and is highly innovative withdevelopments coming out of its researchcentres based in Europe, USA andJapan. All products are designed,engineered and manufactured in houseby the individual Hosokawa units whichgives our customers a single sourcesupply for guaranteed plants withvalidation documentation.

We can offer the pharmaceuticalindustry complete systems in thefollowing areas;qMixing / Powder Blendingq Vacuum Dryingq Size Reduction / Size EnlargementqMicronisation / Jet Millingq Classificationq Compaction / Agglomeration /

Low Pressure Extrusionq Process Containmentq Hygienic Filling and Weighing

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Group Company Services

System Design for CIP/SIPAn increasing requirement for powderprocessing systems in the pharma-ceutical industry is the need for them tomeet CIP and SIP as this has severaladvantages:q Reliable calibration, qualification

and validation.q Reproducibility of the cleaning para-

meters.q Cleaning agents do not endanger

personnel.

q Savings through shorter down timesand reduced equipment dismantlingtimes.

Special equipment designs, whichfacilitate CIP/SIP are offered, such asspecial seal bearings, one piececonstruction of equipment machinedfrom a single piece of stainless steel andelectropolished or finished surfacesdown to Ra = 0,4 microns.

Hosokawa: We complete the picture forevery pharmaceutical powder processingapplication.

Our philosophy is not to just offer astandard machine but to work alongsideour customers and provide tailor madesolutions to process problems using ourmaxim "customer and market orien-tation. With our in-house experrtise,supported by major test centersthroughout the world, we are able tosupply solutions to even the mostchallenging processing problems.

Services offered by Group Companies

q Consultation and TrialsSize reduction and micronisationClassificationCollectionMixingDryingCompactingGranulationLow-pressure extrusionSpheronisationFilling, weighing and containmentAnalysis

Many design standards are used:q cGMP directivesq GAMP directivesq FDA requirementsq 3-A Sanitary standardsq US. Dairy standards (USDA)q American Glovebox

Society Standardq A.S.M.E. or BS 5500q DIN/ISOq Alpine pharma factory standardsq Basel Chemical Industry standards

such as BN93, BN94 and others.Services offered by Group Companies

q Basic EngineeringConceptual studiesFlowcharts . System layoutsSafety conceptsProject documentation

q Detail EngineeringP & I diagramsCalculation and designSystem drawingsSpecification of componentsControls consultationPLC and instrumentation upgradesDesign, programming and net-working of visualisation systemsStructural steel engineering withstatic calculationsPiping & ductwork layoutsAcceptance inspections onsubcontractors’ premises

q System EngineeringProject co-ordinationTurnkey projectsConstruction site managementAssembly . CommissioningCE certification

q Rental Machines

q Pharma-Tech CenterContract Processing

q Technical ServicesSystem optimisationSystem upgradesMechanical start-up andcommissioningOn site repairsMaintenance ContractsServicing . Spare Parts

q AnalysisParticle size analysisAir jet sievingSympatec (Helos/Rodos)In-situ particle size analysisMalvern Master SizerCoulter Counter . SedigraphFischer Sieve Sizer analysesScanning electron microscopyBETVibrating screen . Wet screeningThermal Analysis TG/DTA andDSC

q DocumentationPreparation of documentation(operating manuals, as-builtdocumentation, qualificationdocumentation, DQ, IQ, OQ)Implementation of IQ and OQ

q Quality Control(machines/systems)Surface roughness measurementsWelding seam inspection(X-radiology + ultrasound)Fluorescent penetration processes

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Mixing / Powder BlendingMICRON . RIETZ . SCHUGI . VRIECO-NAUTA®

Fig. 1 Rietz Extrudomix EM6for continuous mixing

Fig. 2 Vrieco-Nauta® MixerFig. 3 Schugi Flexomix Mixer FX 100Fig. 4 Centromix Truncated Cone Mixer

CM 15 Pharma Design, effectivevolume 1500 l

For pharmaceutical applicationsHosokawa Micron B.V. supplies a uniqueupgrade of original Nauta ® mixertechnology.Established features of the Nauta conicalmixer, including gentle mixing to protectproduct integrity, complete discharge toeliminate potential cross contaminationand maximum homogeneity, make it idealfor pharmaceutical applications. Specialpharma design enhancements of themixer incorporate dry, lubricant freeoperation of the orbital arm, integralsampling devices and full CIP/SIPcapabilities.

The Centromix CM series of TruncatedCone Mixers offers space savingadvantages and highly efficient mixingwhile the innovative Schugi Flexomixrange of compact continuous mixer/agglomerators completes our pro-gramme and the Rietz Extrudomix offeralternative mixing/powder blendingtechnology.

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VACUUM DRYING SYSTEM

1. Vacuum Dryer2. Vacuum Filter3. Expansion Tank4. Condenser5. Receptacle6. Heat Exchanger7. Circulation Pump8. Waterring Pump9. Rotating Vacuum Pump

10. Final Condenser11. Receptacle12. Filter Cleaning13. Timer Controlled Valve14. Aerating valve15. Wet Product16. Temperature Indicator17. Dry Product18. Temperature control19. Control Valve20. Condensate21. Service Liquid

DryingMICRON . SCHUGI . VRIECO-NAUTA®

A l t e r n a t i v ewithfinal condenser

Actively involved in the developmentsin pharmaceutical process equipmentrequirements, Hosokawa's state-of-the-art conical vacuum dryer has evolvedinto a total solution for practically anydrying problem known in the hygienicprocessing industry.

Originally used for mainly temperaturesensitive fine chemical dryingapplications, the combination of theunique conical shape and gentle agitatorwithout direct contact between productand shaft seals means the Vrieco-Nauta®

conical Vacuum Dryer is ideal for a widerange of fine bulk pharma chemicals andexcipients.

As the conical shaped vessel togetherwith the cantilevered agitator designensures maximum discharge andminimum heal the basis of an efficientcleaning procedure is there. Followingtypical cGMP design recommendations,the design of this Vrieco-Nauta® contactdryer made it possible to enter pharmaprocessing with the higher requirementsin terms of CIP/SIP cleaning and fullcontainment issues. Vrieco-Nauta ®

dryers are frequently used in processingintermediate and final pharmaceuticaldrug formulations for aerosols, pills,tablets and capsules.

Apart from cleaning and containmentissues, special attention is given to theexclusion of cross contamination risksor any other potential contamination byforeign material. For that reason, theorbital arm, being presented inside thedrying chamber, has no gears inside buta dry timing belt transmission for theauger rotation. This belt of course, unlikegears, needs no lubrication, thereforetotally excluding contamination risks.Another result of Hosokawa's hygienicdesign efforts is the application of uniquedry running nitrogen vented mechanicalvacuum seals. Again no foreign material,in this case seal lubricant, can drop intothe batch.

Vrieco-Nauta®

Vacuum Dryer Model 20 VDC-53

Timing belt drive

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Nearly every stage of drug manufactureinvolves some comminution with rawmaterials, additives and active in-gredients processed to the requiredparticle size. This means that a wholerange of requirements needs to befulfilled, from pure disagglomeration andcoarse grinding right through to ultrafinecomminution.Hosokawa has the systems which meetthe latest requirements as stipulated inthe cGMP and FDA standards.

Fine impact mills are suitable for the finenessrange between approx. 30 µm and 1 mm. Arange of different equipment variants formsthe basis for the universal application ofthis mill type. Modern classifier mills makeit possible to generate steep particle sizedistributions with exact top size limitationFineness of d 97 = 10 µm can be achieved.Machine size range and special designspermit a wide range of applications, fromlab to production-scale applications ofseveral 100 kg/h.

Size ReductionALPINE . BEPEX . MICRON . MIKRO . RIETZ

Alpine Fine Impact Mill 100 UPZ,Pharma Design. Can be equipped withexchangeable milling internals.

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Fig. 1 Alpine Fine Impact Mill250 UPZ Pharma Design,equipped with one rotating andone stationary grinding disc.

Fig. 2 Bepex BexmillFig. 3 Bepex Flake CrusherFig. 4 Alpine Circoplex Classifier Mill

200 ZPS with integratedTurboplex classifier, productcontact parts polished toRa = 0.4 µm.

Fig. 5 Mikro ACM Air Classifier MillFig. 6 Rietz Angle Disintegrator RA 3 (12)

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Micronising / Jet MillingALPINE

Various types of jet mills are employedfor micronising active ingredients. Thistype of impact comminution in a gas jetgenerates end fineness of between 1 and30 µm. The classic exponent of this typeof mill is the spiral jet mill which ischaracterised by its ease of operation,excellent cleaning possibilities and thelack of rotating parts.

The new product line developed byHosokawa Alpine retains all the time-proven elements but integrates a wholebattery of new features to meet therequirements of the pharmaceuticalindustry, i.e. ease of dismantling,cleaning and sterilising, right up to CIPand SIP capability.

With the fluidised bed opposed jet mills,even micronisation of extremely"difficult" products down to the µmrange is possible. The integration of adynamic air classifier in this jet millguarantees reproducible ultra-steepparticle size distributions with exact topsize limitation. The wide range of machinesizes permits laboratory and pilotapplications equally as well as production-scale applications of several 100 kg/h.

Monoblock manufactured Millbody used forAlpine Fluidised Bed Opposed Jet Mill 100AFG.

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Alpine Spiral Jet MillingSystem 200 AS

Fig. 1 Alpine Spiral Jet Mill 100 AS.Grinding Chamber manufacturedas monoblock component.

Fig. 2 Alpine 100 AFG Jet Mill.Millbody designed for CIP/SIPapplications.

Fig. 3 Alpine Fluidised BedOpposed Jet Mill 200 AFGPharma Monoblock Design

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Size Enlargement / CompactionBEPEX . SCHUGI

Agglomeration The Schugi processfor production of free flowing, closelysized granules with very good disper-sing properties is well known and theFLEXOMIX continous process can alsobe used for bulk pharmaceutical manu-facture. A liquid binder(s) is sprayedinto the flexing mixing chamber whereadjustable blades or knives create ahighly turbulent powder flow regime.Evenly sized granules mainly rangingbetween 0.5 to 1.5 mm are produced.

Dry CompactionMost problems in processing tabletmasses are caused by poor flowcharacteristics of the product, asevidenced by the dosing difficultiesencountered in feeding tablet presses.These unfavourable characteristics offinely powdered solid materials can bedecisively improved through agglo-meration.The most economical way for thisparticle size enlargement to be done is

by using dry press agglomeration.Finely dispersed bulk materials arecompacted and pressed into flakes,without using a fluid binding agent.Either smooth or profiled rolls are used.These flakes are crushed and screenedto dust-free, easy-flowing granules.The criteria for the machine design iseasy cleaning and quick roll andpredensifier screw replacement. Avariety of screw and roll configurationsare available to optimise the process.

For the production of cylindrical pelletswith diameters between 0.7 and 3 mm theBEXTRUDER will be used.

The basis of these systems is the lowpressure extrusion of products withsufficient gliding characteristics.

For the production of spherical granulesthe BEXROLLER should be used. Thebatch sizes of this equipment are in therange from 0.2 ltr. to 50 ltr.

Bepex BEXTRUDER

Bepex Compactor Model K 200/100Side view of system showing separation of processing area from cleanprocess/non-hazardous area.

Schugi Flexomix model FXshowing blade knives.

Bepex BEXROLLER

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Size Enlargement /AgglomerationMICRON . RIETZ . SCHUGI

Batch Fluidbed ProcessingThe Agglomaster is our innovativemodular multi-purpose batch fluidbedprocessor developed for drying,agglomeration, coating, layering, microgranulation and spray-agglomeration.Its unique fluid bed bottom design, withrotating slit disk and agitation bladestogether with its opposed pulse jetmechanism and the facility for liquidinjection in different positions, createsa wide range of control of not only theparticle size, but also the shape anddensity of the particles.

The Hosokawa Agglomaster, typeAGM-2PJ&SD batch fluidbedprocessor, is a multi-purpose twin-unit.It is provided with „Opposed Pulse Jet“Technology and also with „SprayDrying“ Technology. This smaller unitis especially designed for research anddevelopment work.

Extrud-O-MixDesigned to continuously mix,agglomerate and extrude, the RietzExtrud-O-Mix operates with a kneadingaction making it suitable for use withmaterials ranging from light pastes toheavy doughs.Dry materials may be mixed and extrudedwith small quantities of liquid foragglomeration with additional liquidsintroduced through injection pointsalong the Extrud-O-Mix barrel.

* Split barrel for easy cleaning and plate changes* Negative pressure dust elimination for clean environments* Secondary discharge for out of specification material

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Filling, Weighing and Product HandlingMICRON . STOTT . VITALAIR

Hosokawa Stott have extensiveexperience providing hygienic filling,weighing and powder and granulehandling systems for the pharmaceuticalindustry. Incorporating a wide range ofinflatable and extraction type sealingheads the filling and weighing systemswhen combined with a Vitalair downflowbooth maintain the highest levels ofdust control, hygiene and productintegrity. Accurate, integrated weighingplatforms ensure critical and repeatablepacking specifications can be met. These facilities are suitable for use witha range of bags, sacks, drums and boxeswith or without liners, both the Stottfilling systems and Vitalair booths areavailable for manual or automatedoperation.

Micron DenspackThe Denspack is a small and simpledensifier, which deaerates powders priorto filling. It is capable of handlingmaterials with a cohesive nature andoffers improvements in powdercharacteristics which reduce flushingand dust emissions.

Dust Free Tipping BoothsSafe, hygienic discharge of drums orbags can be achieved within a purpose

designed, manual action or automatedStott drum tipping booth. Containerdisposal and cleaning can beincorporated into this system forincreased product containment andoperator safety.

Laminar Flow BoothsFor increased levels of environmentalprotection, operator safety and productintegrity the range of Stott laminar flowbooths with their single pass, non tur-bulent air flow and entrance protectingair curtain can be utilised in conjunctionwith the Stott filling and weighingsystems. They are also suitable forinspection, product transfer or liquidpumping applications.

Stott Filling and Weighing System within a Vitalair Downflow Recirculation Booth

Stott Laminar Flow Booth with SolidDownward Sealing Head

Quad cell, solids discharge Drum Tipping Booth.

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Containment TechnologySTOTT . VITALAIR

Dispensing suite incorporating Vitalair Downflow Booths.

Hosokawa Stott and Vitalair are settingthe standard for innovative, high qualityprocess containment for the pharmaceuticalindustry. As the requirement for greaterlevels of containment increases Hosokawaspecialist barrier/isolation technologyis more widely used to safe guard theenvironment, personnel and maintainproduct integrity.

Hosokawa's extensive experience ofclean air environments and associatedtechnology means we are able to workclosely with our customers from initialspecification to commissioning to ensureindividual requirements.

Downflow BoothsFully self contained areas for the handlingof hazardous powders and liquids,downflow booths use the verticalpassage of clean air from the boothsceiling plenum to push dust or vapoursaway from the operators breathing zone.Achieving a minimum 99.99% filtrationperformance the high levels of operatorprotection and product integrity offeredmakes them ideal for all dispensing,transfer, sampling, mixing and weighingapplications.

Process Equipment IsolatorsWhere pharmaceutical companies wishto retain a shirt sleeve environment

without the need for operators to wearprotective suits, isolators offer anergonomic option. Positive or negativelycharged sealed isolator booths enableproduct and equipment to be handledthrough rubber gloves.

Recent break throughs from Hosokawahave incorporated process equipmentinside isolators to provide the ultimateclean environment for processing,cleaning and maintenance.

Process integration incorporating equipment into Stott Isolator. Integration of Alpine 315 UPZ into Stott Isolator.

Stott Keg Filling Isolator integrated withVitalair Downflow Booth.

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Particle Separation and Product CollectionALPINE . MICRON . STOTT

Particle Separation and ProductCollectionFrequently, powdered pharmaceuticalproducts need to be separated fromprocess air or gas streams and the MicroPulreverse jet filter units are available inspecial pharma design to meetrequirements such as CIP/SIP/explodibledusts. The filter unit was the originaldesign using reverse pulse jet cleaningand as such, Hosokawa experience spansdecades and many application areas.

Cyclone CollectorsA range of pre-filtration high efficiencyeasy clean cyclones are also availablefor collection of pharmaceutical productsand they are sometimes used prior to thefinal product filtration unit to collect themajority of product.

Crevice free "easy-clean" flange design.360° spray balls for cleaning

s Special bag plate for MikroPul pharma filter

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HEPA FiltersResponding to customer needs we offera safe change push-push technologyHEPA/ULPA filter unit, designed for all

toxic or sterile systems. Elementsspecially designed for fitting to the unitscan be supplied up to grade EU14. Filterhousings manufactured in a variety ofmaterials, from stainless steel to specialchomically inert polymers, tailered tosuit individual customer processes.Spcial design for inline filtration up to 10bar g PSR with CIP options

Inline HEPA filter

MikroPul Pharma-Design reverse jetfilter delivered to ZENECA/UK

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Advanced Control SystemsALPINE . BEPEX . MICRON B.V. . MICRON Ltd. . MICRON GmbHMICRON POWDER SYSTEMS

Because state-of-the-art GMP-compatible process solutions demandsophisticated and integratedautomation, Hosokawa has extended itsrange of products and services beyondthe supply of mere hardware.

The connection of field measurementtechnology to the control unit is beingrealised increasingly via communicationsystems such as Profibus DP, FMS, and

PA or via the industrial Ethernet.Intelligent network components whichcan also be used in potentially explosiveareas minimise the amount of wiringnecessary, thus contributing to a reliableand moreover visually aestheticsolution.The lifecycle model as described in theGAMP directives is our model inelaborating this solution. The scope ofactivities ranges from preparing the

CUSTOMERANDHOSOKAWA

HOSOKAWA

PRIMARYRESPONSIBILITYFORTESTING

Basis for AutomationPRIMARYRESPONSIBILITYFORSPECIFICATION

CUSTOMER

USERREQUIREMENTSSPECIFICATION

FUNCTIONALSPECIFICATION

HARDWAREDESIGN

SPECIFICATION

SOFTWAREDESIGN

SPECIFICATION

SOFTWAREMODULE

SPECIFICATION

CODE MODULES

SOFTWAREMODULETESTING

SOFTWAREINTEGRATION

TESTING

HARDWAREACCEPTANCE

TESTING

SYSTEMACCEPTANCE

TESTING

CUSTOMERANDHOSOKAWA

HOSOKAWA REVIEW ANDTEST MODULES

Testing of theHardwareSpecification

Testing of theFunctionalSpecification

hardware and software specifications towriting programs based on PLC systemsor also highly integrated visualisationsystems. Great store is set by dataintegrity and data archiving as well aserror message protocols and batchrecords. The integration of electronicsignatures is being realised accordingto the requirements stipulated in 21 CFRPart 11.

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Turnkey Process SystemsAvailable from HOSOKAWAALPINE . MICRON GMBH . MICRON B.V. . MICRON LTDMICRON POWDER SYSTEMS

We provide a complete service and givedocumentation and assistance with thefour basic stages of our customer'svalidation namely DQ, IQ, OQ, and PQ.

Materials of constructionHigh quality stainless steel such asAISI 304, 304L, 316, 316L, or evenHastalloy ® or Titanium are used. Onepiece construction of individualmachines using CNC machining to createHosokawa's unique "mono-block"designs is used wherever appropriate.

Hosokawa offer a total engineeredsolution from initial process conceptionto final validated plant.We are your sin-gle source supply for integrated powderand particulate processing systems andcomponent machinery. We offer arange of services to ensure yourpharmaceutical processing needs aremet:

q Laboratory testingq Full scale trials or site trialsq Process designq Procurementq Engineering and

project managementq Installationq Commissioning

Operational Trial EquipmentHosokawa are able to offer a range ofequipment on loan/rental topharmaceutical companies to enableoperational trials to take place. Thisensures that process parameters can befinalised and production flows monitoredprior to equipment and process layoutfinalisation. At this stage the highlyexperienced Hosokawa engineers willwork very closely with your in-houseengineering team to advise and developthe best solution to your processingrequirements.

ServiceHosokawa is committed to providingcontinual customer support, long afterthe plant has been installed andcommissioned.We have highly skilledService engineers to cover machinerybreakdowns, routine inspections andservicing on site. Whilst our experiencedtechnical engineers can provide bothprocess and maintenance advice.

Milling System withMikro ACM 10 Classifier Mill

Multi-processing milling system incorporating Alpine 70 ZPS and 140 AFG.

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System DesignExplosion Protection

The integration of several powderprocessing operations into one turnkeysystem calls for carefully managed andexecuted engineering and it is in thisfield that Hosokawa units have exten-sive experience.Process Guarantees can be given aftertestwork in our Group Test Centreshence, a one source totally engineeredpackage is offered.CAD systems are used to create flow-sheets, P and ID drawings, layouts,detailed designs to whatever code isbeing employed and units operate to theQuality System ISO 9001.

The design of a safe system is ofparamount importance and dustexplosions with organic pharmaceuticalpowders are nearly always a real risk.This risk can be minimised by avoidinga source of ignition but this is frequentlynot possible in high speed rotatingequipment and then the system has to bedesigned to contain any explosion.

Normally explosion relief by venting isnot usual in the pharmaceutical field butif this is acceptable then this method toocan be designed in.

A pressure shock resistant (PSR) designis more usual and here the system isdesigned to withstand the maximumexplosion pressure, usually under 10bars, without rupture. A typical designcode is the German VDI 2263 and thiscalls for all vessels to be speciallystrengthened and in some cases fullpressure vessel design codes may bespecified.

Explosion Activated closure valves orbarrier valves are manufactured andtested to high standards and these areused in process ductwork to stop thepropagation of any flame front followinga dust explosion therefore isolating thedanger.Running systems under an inert gassuch as nitrogen is also frequently used

to stop any explosion from occuring andHosokawa has supplied many suchsystems for size reduction, blending anddrying.

Explosion Barrier Valve

Alpine Milling System with Fluidised BedOpposed Jet Mill 100 AFG, 10 bar g PSRdesign.

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Lab and Pilot Plant EquipmentALPINE . BEPEX . MICRON . RIETZSCHUGI . STOTT . VRIECO-NAUTA®

Complete Product RangeLaboratory and small scale equipment isreadily available covering the mainHosokawa product range. This meansthat when a process is scaled up to fullproduction from laboratory trials, thesame equipment type can be used whichfrequently makes validation somewhateasier. Small scale mixers, impact mills,classifier mills, micronisers, rollercompactors, fluidbed processors andvacuum dryers can be supplied or insome cases rented out for site trials if theproducts are particularly hazardous.

Particle Size Analysis and PowderPropertiesThe Alpine Air Jet Sieve 200 LS-N is wellknown for accurate particle size sieveanalysis in the particle size range fromapprox. 10 micron up to 4 mm.It is complete with an integral calculatorand processor which converts sieveresidue in grams from an external balanceinto percentage and can be suppliedwith Alpine's software LS-PROto transmit information to remote datalogging devices.

Powder CharacteristicsMeasurementThe Hosokawa Powder CharacteristicsTester PT-R is also becoming widelyused in the pharmaceutical industry tomeasure certain powder characteristicswhich helps in quality control ofpowdered products.One compact unit can measure;

q Angle of reposeq Compressibilityq Angle of spatulaq Cohesivenessq Angle of fallq Dispersibilityq Angle of difference

Bulk density and some particle sizeanalysis can also be carried out.

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Fig. 2 Alpine Jet Milling System100 AFG-M 4

Fig. 3 Alpine Spiral Jet Mill 50 ASFig. 4 Alpine Milling System with

Fine Impact Mill 100 UPZFig. 5 Mikro ACM 2 Air Classifier MillFig. 6 Alpine Particle Size Analyser

200 LS-N, operating range from10 µm up to 4 mm.

Fig. 7 Bepex Pharmapactor L200/50 PFig. 8 Hosokawa Powder Characteristics

Tester PT-R

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Fig. 1 New 5 litre Vrieco-Nauta®

Lab. Mixer with timing belt design.10 l and 20 l versions also available.

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Hosokawa Pharma-Tech CenterSM

MICRON POWDER SYSTEMS

As the requirements of the pharmaceuticalindustry become more complex withincreased needs for ease and rigour ofcleaning and containment, HosokawaMicron Powder Systems have openedits Hosokawa Pharma-Tech CenterSM, tobetter serve this important market.

The Hosokawa Pharma-Tech Center SM

is a cGMP facility designed to meetcurrent pharmaceutical and FDAstandards. This 1,600 square foot facilityis designed for pilot plant productionand testing of a diverse range ofpharmaceutical products. The facilityincludes two processing suites, a cleanequipment storage area, equipmentwashroom, material quarantine andrelease areas, analytical laboratory, andclient conference room.

The Hosokawa Pharma-Tech CenterSM

provides Hosokawa’s pharmaceuticalcustomers the unique opportunity toexplore and develop process solutionsto critical processing problems in acontrolled environment. Designed asclass 100,000 areas, the two processsuites incorporate the most advancedlevels of engineering design.

Facility FeaturesAutomated air handling systems withtemperature and humidity control forthe process areasq Once through air designed for 20

changes per hourq HEPA filtration throughout

processing areasq On-site nitrogen supply for inert

processingq Validated equipment operating

procedures and control systemsq Analytical lab for on site powder

analysis and characterization.

With a commitment to total qualitymanagement, Hosokawa Micron PowderSystems seeks to develop and maintaina true partnership by meeting yourcontinuing requirements for superiorpharmaceutical powder processtechnology. We understand the inherentvalue of testing, and are committed tooperating the Hosokawa Pharma TechCenterSM to the highest industrystandards as an extension to ourcustomers’ production and researchcapabilities.

Micron Air Jet Sieve (MA JS-II)Powder Characteristics Tester (PT-R)

Stott Filling and Weighing system.Contained system with high fill accuracies

Alpine Spiral Jet Mill (100 AS) micronising to d97 < 10 µmparticle size

Alpine fine grinding Pin Mill (160 UPZ). Versatile grindingPSD's from 500 micron to 25 micron

Systems and Technologies Offered by Units

l CIP/SIP-Systems

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Size Reduction

Global FacilitiesHosokawa is a truly global operationwith many operating units offering notonly single machines but completesystems. Research, development,process optimisation, system design/engineering, project execution, projectmanagement, installation and commis-sioning - all can be provided for completecustomer satisfaction.

SystemDesign

ExplosionProtection

Product CollectionProduct Containment

MicronisingJet Milling

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Mixing / PowderBlending

Rental MachinesMany of today's drugs and pharma-ceutical chemicals are toxic and cannotbe handled safely away from theirmanufacturing base.

Frequently placebos or similar low riskcompounds are used to evaluatemachines in supplier test centres.However as a Group we offer a rentalmachine service where specificequipment can be hired and tested on

the customer's own site using Hosokawasupplied installation/instruction teams.

This rental route is a very useful one andprovides customers with temporaryproduction or pilot plant facilities. A furt-her example of Hosokawa's totalcommitment in satisfying customer needs.

Process equipment to pharma standardsincludes a spiral jet mill, a Pharmapaktorwith flake crusher, 160 UPZ impact mill,a vacuum dryer and a Stott fillingmachine.

Testing FacilitiesProcess guarantees are offered whenmaterials are sent to our many TestCentres for machine/process evaluation.

Many units offer this facility and one ofthe largest and most comprehensive iswith Alpine AG in Augsburg, Germany.

The multi million dollar Test Centrecompleted in 1987 is one of the largest ofits kind in the world.

Further evidence of Hosokawa's commit-ment to its pharmaceutical customers isthe opening in Spring of 1998 of acomprehensive 1400 square foot specialcGMP Pharma Laboratory in the USA.Located at Hosokawa Micron PowderSystems in Summit, New Jersey this willinclude two equipment process suites, aclean equipment storage area, anequipment wash room, material storage,analytical testing lab and customermeeting rooms.

Systems and Technologies for Pharmaceutical Applications.

Full manufacturing programme for eachHosokawa unit on request.

Process TechnologiesFor TomorrowSM

HOSOKAWA ALPINE Germany

HOSOKAWA BEPEX GmbH Germany

HOSOKAWA MICRON GmbH Germany

HOSOKAWA MICRON Ltd. England

HOSOKAWA RIETZ Ltd. England

HOSOKAWA STOTT Ltd. England

HOSOKAWA MICRON B.V. Netherlands

USAHOSOKAWAMICRON POWDER SYSTEMS

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Global Network of Hosokawa Micron Group

HOSOKAWAMICRON POWDER SYSTEMS10 Chatham RoadSummit, NJ 07901 / USA

Tel.: 001 908 277 6360Fax: 001 908 273 7432E-Mail: info@hmps.hosokawa.com

HOSOKAWAMICRON Ltd. (Canada)9275 Highway 48Suite 202Markham, OntarioL3P 3J3 Canada

Tel.: 001 905 471-5854Fax: 001 905 471-0293E-Mail: info@hml.hosokawa.com

AMERICA

2001 HMII. All Rights Reserved. Printed in Germany. Ph/Group 3.01/2e

HOSOKAWA BEPEX GmbHP.O. Box 1152D-74207 Leingarten / Germany

Delivery addressDaimlerstraße 8D-74211 Leingarten / Germany

Tel.: 0049 (0)7131 907-0Fax: 0049 (0)7131 907301E-Mail:compaction@bepex.hosokawa.com

HOSOKAWA MICRON GmbHP.O. Box 92 02 62D-51152 Köln / Germany

Delivery addressWelserstraße 9 - 11D-51149 Köln / Germany

Tel.: 0049 (0)2203 308-0Fax: 0049 (0)2203 308-293E-Mail:info@hmgmbh.hosokawa.com

HOSOKAWA MICRON B.V.P.O. Box 98NL-7000 AB Doetinchem / NL

Delivery addressGildenstraat 26NL-7005 BL Doetinchem / NL

Tel.: 0031 (0)314 37 33 33Fax: 0031 (0)314 37 34 56E-Mail: info@hmbv.hosokawa.com

HOSOKAWA MICRON B.V.Team SchugiP.O. Box 98NL-7000 AB Doetinchem / NL

Tel.: 0031 (0)314 37 33 33Fax: 0031 (0)314 37 33 00E-Mail: schugi@hmbv.hosokawa.com

HOSOKAWA MICRON Ltd.Rivington RoadWhitehouse Industrial EstateRuncorn, Cheshire WA7 3DS / UK

Tel.: 0044 (0)1928 755 100Fax: 0044 (0)1928 714 325E-Mail:powder@hmluk.hosokawa.com

HOSOKAWA RIETZA Division of HOSOKAWA MICRON Ltd.Rivington RoadWhitehouse Industrial EstateRuncorn, Cheshire WA7 3DS / UK

Tel.: 0044 (0)1928 755 100Fax: 0044 (0)1928 714 325E-Mail: rietz@hmluk.hosokawa.com

HOSOKAWA STOTTA Division of HOSOKAWA MICRON Ltd.P.O. Box 11Bacup, Lancashire OL13 9E / UK

Delivery addressBeech Industrial EstateBacup, Lancashire OL13 9E / UK

Tel.: 0044 (0)1706 875 413Fax: 0044 (0)1706 875 468E-Mail: stott@hmluk.hosokawa.com

HOSOKAWA VITALAIRA Division of HOSOKAWA MICRON Ltd.Unit B, Stephenson WayWakefield 41 Industrial EstateWakefieldWest Yorkshire WF2 0XH / UK

Tel.: 0044 (0)1924 876600Fax: 0044 (0)1924 876606E-Mail:vitalair@hmluk.hosokawa.com

The Hosokawa Micron Group will always be the leadingglobal company covering the mountain range of PowderTechnologies. The group will achieve peaks of excellencein the development and commercialisation of advancedmaterials,process equipment and systems engineering.

EUROPE

HOSOKAWAALPINE Aktiengesellschaft&Co. OHGP.O Box 10 11 51D-86001 Augsburg / Germany

Delivery addressPeter-Dörfler-Str. 13 - 25D-86199 Augsburg / Germany

Tel.: 0049 (0)821 5906-0Fax: 0049 (0)821 573578E-Mail: mail@alpine.hosokawa.com

HOSOKAWA MICRON GROUP