GPCG DESIGN FEAT U R E S& CUSTOMER SERV I C E

C U S T O M E R S E R V I C E S

PROCESS ASSISTANCEGlatt’s FDA registered feasibility lab offers several GPCG’s from lab scale through full production size units. Our highly trained staffworks with processes from initial feasibility studies through clinical trials and scale-up.

PROCESS AUTOMATIONA full range of data acquisition and control systems is available fromGlatt’s Dataplus series of automated control products. Systems rangefrom simple batch controls through sophisticated menu managementand integrated systems encompassing several pieces of process equipment.

VALIDATIONBased on FDA guidelines and prevailing pharmaceutical industrypractices, Glatt’s support package includes documentation, procedures,protocols and test plans. In addition, Glatt personnel are availablefor on-site implementation of the validation plan.

FIELD SERVICEFactory trained technicians are available at customer sites for calibra-tion, preventive maintenance, repairs and refurbishing. All instrumentsare N.I.S.T. traceable and work is performed under Standard OperatingProcedures.

TURNKEY ENGINEERINGA full range of design and engineering services are available along withsite supervision and construction management. Glatt can provide plantlayout, facilities design, ancillary equipment specification/procurement,detailed construction drawings and contractor specifications.

CONTRACT MANUFACTURINGFor those companies not ready to purchase equipment or interested intesting the market for new products, Glattt provides contract process-ing. This service is available in our FDA registered facilities in Ramsey,NJ and Winchester, KY.

DATAPLUS Family of automated process control sys -tems offers varying levels of automation including:batch control, data acquisition, supervisory control, andcomputer integrated manufacturing. All systems ar ecompletely validatable and can be custom designed andconfigured for specific requirements.

DUAL CHAMBER FILTER HOUSING providescontinuous fluidization. Trapped fines are reincorporatedinto the process without disturbing the fluidization pat-tern. Glatt provides bag or cartridge filters and the abili-ty to switch from one to the other.

CLEAN-IN-PLACE systems enable fully containedprocessing by providing a validatable means to washdown all product contact surfaces within the processingsystem.

BOTTOM DISCHARGE SYSTEMS for verticalintegration and totally enclosed processing applications.Product is discharged through the plenum to a hopper,mill or other post processing unit below.

PRODUCT CHARGING PORTS enable quick andcontained loading of material and can be easily auto-mated for use with integrated processing systems.

T H E P R O C E S S I N G C H A M B E RThe top spray processing insert consists of a conically shapedproduct bowl and expansion chamber. The angled walls of theproduct container allow for a more vigorous fluidization pattern inthe product bowl area. As particles travel from the product bowlinto the extended height expansion chamber, the increased diame-ter reduces the air velocity, resulting in a less dense fluidizationpattern. As gravity overcomes the upward force of the air veloci-t y, particles fall back into the product bowl. Throughout the batch,particles are recirculated through this random and unrestricted flu-idization pattern.

The fluid bed is inherently a highly effective and efficient method ofdrying. Fluidization suspends each particle exposing the entire sur-face area to the air stream for optimal convective heat transfer. Thisassures uniform heating and uniform evaporation of excess moisture,preventing local overheating and allowing the use of higher inlet airtemperatures while maintaining the product slightly above room tem-p e r a t u r e .

For granulation or coating processes, a liquid is introduced to the sys-tem via a pneumatically atomized nozzle. Nozzle entrance ports on theexterior of the expansion chamber allow the height of the nozzle above

the product bowl to be adjusted. In granulationprocesses, the liquid is introduced high in the expan-sion chamber where the bed surface area is at its max-imum, resulting in a narrow particle size distribution ofthe final product. In coating processes, the liquid isintroduced just above the product bowl where particledensity and velocity is at its highest, thus minimizingthe distance the droplets travel before contracting thesubstrate where they spread to form a continuous film.

TOP SPRAY PROCESSING

APPLICATIONS

Drying• Short Batch Times • Temperature• Uniform Drying Sensitive Material

Agglomeration/Granulation• Reduce Fine/Dust • Alter Bulk Density• Enhance Flowability • Improve Disintegration• Eliminate Segregation and Dissolution• Improve Compressibility

Instantizing• Improve Dispersibility • Disperse Surfactants• Increase Porosity Uniformly

Coating• Temperature Release • Moisture & Oxygen• Hot Melts Barrier Coatings• Taste Masking • Aesthetic Coatings

MULTIPLE NOZZLE PORTSin the top spray expansion chamber permit the heightof the nozzle above the product bed to be adjusted forgranulation or coating processes.

TANGENTIAL SPRAY PROCESSING

APPLICATIONS

Granulation• Enhance Disintegration• Improve Compressibility• Increase Density• Spherical Morphology

Spheronization• Increase Density• Produce Spherical Particles• High Potency Spheres• Smooth Surface Properties

Layering• Solution/Suspension • Narrow Particle

Layering Size Distribution• Powder Layering • Increase Density• High Potency Pellets

Coating• Film Coating • Sustained Release Coatings• Enteric Coatings • Hot Melt Coatings

MULTIPLE ROTOR DISKSwith different surface geometries are available to controlthe surface friction imparted to the product.

THE ROTOR

T H E P R O C E S S I N G C H A M B E RThe rotor processing insert consists of a cylindricallyshaped product bowl and expansion chamber. The rotordisk sits at the base of the product bowl and seats alongthe circumference of the chamber when the rotor is not inmotion. The disk is raised during processing to create aslit between the edge of the rotor disk and the conicallyshaped bottom of the rotor product bowl. The patentedadjustable disk height allows control of air volumethrough the slit independent of velocity. This key featurepermits very low drying rates for direct pelletization andpelletization by powder layering. For granulating or coat-ing applications requiring a medium to be evaporatedq u i c k l y, the air volume can be significantly increasedwhile keeping are velocity constant. This flexibilityresults in a single unit processor capable of granulating,pelletizing, layering and coating.

The fluidization pattern in the rotor processor canbest be described as a spiraling helix. Three fac-tors act on the product to create this flow pattern.The centrifugal force of the rotating disk causes productto flow radically towards the product bowl wall. Airflowthrough the slit creates a vertical force causing the prod-uct to become fluidized. Gravity soon overcomes the forceof the airflow and the fluidized product falls back into thebowl towards the center.

Liquids or powdered solids can be added to the processthrough air atomizing nozzle located on the product bowlside wall. The nozzles spray tangentially into the pro-cessing chamber in the same direction as the fluidizationp a t t e r n .

BOTTOM SPRAY PROCESSING

MULTIPLE WURSTER BOTTOM PLATESprovide the ability to vary air volume in theinner and outer partitions of the Wursterprocessing insert to accommodate a varietyof product sizes and bulk densities fromtablets and pellets to fine powders.

THE WURSTER HS

APPLICATIONS

Coating• Aqueous or Solvent

Based Polymeric Solutions or Dispersions

• Sustained ReleaseCoatings

• Enteric Release Coatings

• Fine Particle Coating(50um and smaller)

• Active Layering

T H E P R O C E S S I N G C H A M B E RThe Wurster HS was introduced in 1992 as the next evolutionin Wurster Te c h n o l o g y. This patented processing techniqueoffers larger batch volumes, higher throughputs and for the firsttime, the ability to coat fine particles under 50um, all withoutthe occurrence of agglomeration.

The Wurster HS processing insert consists of a conically shapedproduct container with an open ended cylindrical inner partition.An air distribution plate is located at the lower end of the productcontainer to distribute the fluidizing air between the inner andouter partitions. The majority of the air is channeled through theinner partition, leaving sufficient airflow to just suspend particlesin the outer partition. Particles are drawn into the inner partitionby the pressure differential created by the differences in air veloci-ties between the two partitions. The particles are carried throughthe inner partition and into the expansion chamber by the fluidizeda i r. As gravity overcomes the force of the fluidized air, the particlesfall back into the outer partition where they are suspended in a slow-ly moving “down bed.”

The coating solution is added to the system via a pneumatically atom-ized nozzle located at the center of the air distribution plate. The noz-zle sprays upward, providing a concurrent application of solution ontothe substrate. As atomized droplets of the coating solution contact theparticles in the inner partition, they spread and coalesce on the particlesurface. As the particles continue traveling upward in the expansionc h a m b e r, excess moisture from the applied liquid is evaporated.

The ordered particle flow pattern lends itself to the production of coatingsof extremely uniform thickness and consistency, an important factor incontrolled release applications.

I N T R O D U C T I O NThe GPCG is a line of multi-purpose fluid bed processorsdesigned to accommodate drying, granulation, coating,spheronization and layering operations all in one piece ofequipment. In addition, a variety of options are available formaterial handling, control systems, solvent abatement,clean-in-place and exhaust filtration. Thus the GPCG pro-vides the ultimate in terms of both processing performanceand flexibility.

T H E G P C G S Y S T E MA GPCG processing system is composed of several majorcomponents: an air handling unit, a machine tower and anexhaust fan. Air is drawn in through the air handling unitwhere it is preconditioned before it enters the machinet o w e r. Components within the air handling unit may includefilters, heaters, humidifiers and dehumidifiers.

The machine tower is a multi-component unit consisting of anair inlet plenum, a process insert and a filter housing all heldin place by the side support columns. Process air enters thetower through the inlet plenum which evenly distributes

airflow across the bottom of the process insert. The process-ing air exits the machine tower through the filter housingwhich contains two identical filters, each in its own airtightpartition. Airflow is regulated by an exhaust damper locatedupstream of the exhaust fan.

This “twin filter system” allows continuous fluidization sinceeither filter is capable of handling the total air volume pass-ing through the fluid bed processor while its twin undergoesa purging cycle. An airtight outlet flap prevents airflow dur-ing the purging cycle thus allowing material to fall back intothe product bed where it is reclaimed by the process. Glattoffers filter housings designed for use with bag filters, car-tridge filters, as well as a “convertible” housing capable ofusing bags or cartridges.

The heart of any fluid bed processor is the processing insert;the GPCG can accommodate three processing insert designs,each differing in particle flow dynamics and liquid additionmethods. Thus, each offers distinct processing capabilities.

GPCG PROCESSINGBOTTOMSPRAY INSERTExclusively used for highperformance coating andlayering applications.

TOPSPRAY INSERTMost commonly used for dryingand granulating and certaincoating applications.

TANGENTIALSPRAY INSERT

The most versatile of the threeinserts, this provides the ability to

spheronize, granulate, coat andlayer in a single insert.

PROCESSED PRODUCTSGPCG flexibility provides a variety of processing techniques from a single fluid bed system.This versatility is demonstrated by the broad range of products manufactured in Glatt fluid bed processors.

Pictured below are scanning electron microscope (SEM) images of some typical GPCG applications.

Fluid Bed Spray Dried AgriChemical

Top Spray Granulated Pharmaceutical Top Spray Granulated Pharmaceutical(cross-section)

Top Spray Enteric CoatedPharmaceutical

Top Spray Hot Melt Coated Flavor Wurster HSLatex CoatedPharmaceutical

Wurster HSLatex CoatedPharmaceutical

Wurster HSLatex CoatedPharmaceutical (cross-section)

Rotor Pelletized Pharmaceutical

Rotor Spheronized Pharmaceutical(population)

Rotor Solution Layered Pharmaceutical Rotor Solution Layered Pharmaceutical(cross-section)

Rotor Spheronized Pharmaceutical

Wurster HSControlled ReleaseNutritional

Wurster Layered and CoatedPharmaceutical

Top Spray Enteric CoatedPharmaceutical (cross-section)

Fluid Bed Dried PharmaceuticalGranulate

Fluid Bed Instantized Flavor Top Spray Granulated Pharmaceutical

Top Spray ltr 1 5 22 45 100 220 420 670 1100 1560

Wurster HS(1) ltr 2.4 (6”) 5.4 (7”) 6.3 (7”) 14 (9”) 38 (12”) 120 (18”) 417 (32”) 417 (32”) 820 (46”) 820 (46”)14 (9”) 38 (12”) 102 (18”) 417 (32”) 820 (46”) 1105 (55”)

38 (12”) 102 (18”)

Rotor ltr 4.5 (300mm)4.5 (300mm) 30 (480mm) 30 (480mm) 60 (620mm) 60 (620mm) 105 (790mm) 180 (1000mm)430 (1400mm) 430 (1400mm)105 (790mm)180 (1000mm) 640 (1600mm)

Heating Capacity kW 4 10.5 22 44 86 132 174 227 291 348Temperature Range °C 10°--140°C 0°--100°C < -10°-- +60°C >Steam Consumption Kg/hr n/a 18 37 75 147 226 297 389 498 596

Capacity kW 2.2 2.2 5.5 7.5 15 22 30 37 45 55Air Volume (3) m3/WG 255 200 1000 1500 3000 4500 6000 8000 10000 12000Differential Pressure (3) mm/WG 750 800 < 1000 >

Top Spray m3/hr 9 22 25 25 30 30 30 95 95 200Air Handler m3/hr 9 9 25 70 70 210 210 210 360 630Rotor m3/hr 9 9 25 25 30 30 60 60 60 N/A

Machine Tower kg n/a n/a 600 900 1400 2100 2400 3000 3400 4400Air Handler kg n/a n/a 500 580 710 800 890 985 1165 1370Exhaust Fan kg n/a n/a 200 220 300 360 500 510 550 620Control Panel (4) kg n/a n/a 100 100 100 100 100 100 100 100Complete System kg 400 750 1400 1800 2210 3360 3890 4595 5215 6490

GPCG DATA

TECHNICAL DATA OF GPCG PRODUCT LINE

1 3 5 15 30 60 120 2005 3005 5005Glatt Powder Coater Granulator GPCG Model No.

MaximumWorking

Volume ofStandardproduct

Container

Inlet AirHandling

Unit

ExhaustAirFan

Maximum AirConsumption of

Atomizing Nozzle

Weight

Unit

SIZE A1 A2 A3 B C 0D E1 E2 F G5 3240 3587 3260 2155 913 500 2975 2780 750 680

15 3855 3827 3500 2315 965 900 3800 3050 1280 1200

30 4250 3952 3625 2475 1065 1200 4200 3300 1765 1520

60 5070 4590 4260 2955 1175 1500 4720 3900 2060 1865

120 5150 4860 4530 3030 1375 1500 5160 4180 2060 1865

200 5490 5070 4730 3230 1600 1800 5900 4205 2500 1865

300 6100 5250 4910 3410 1770 1800 6500 4400 2540 1865

500 7290 7170 6830 4740 1980 2700 7850 6320 3340 2300

20 Spear Road, Ramsey, New Jersey 07446 • Phone: 201-825-8700 Fax: 201-825-0389 www.glattair.com

DIMENSIONS

Notes: (1) Excluding the volume in partition (s) (2) @ 3 bar (g) saturated steam pressure (3) @ 20°C and 1,103mbar (4) Pneumatic Control System (5) On production size GPCG’s, Wud Rotors ar e typically supplied as stand-alone machines

All dimensions in millimetersAll dimensions and specificationsare for reference only and subjectto change.

Patent Numbers: 4,588,3665,236,5034,772,1935,251,3845,284,678

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