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

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2 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 DATAPLUS Family of automated process control sys - tems offers varying levels of automation including: batch control, data acquisition, supervisory control, and computer integrated manufacturing. All systems ar e completely validatable and can be custom designed and configured for specific requirements. CLEAN-IN-PLACE systems enable fully contained processing by providing a validatable means to wash down all product contact surfaces within the processing system. DUAL CHAMBER FILTER HOUSING provides continuous fluidization. Trapped fines are reincorporated into the process without disturbing the fluidization pattern. Glatt provides bag or cartridge filters and the ability to switch from one to the other. BOTTOM DISCHARGE SYSTEMS for vertical integration and totally enclosed processing applications. Product is discharged through the plenum to a hopper, mill or other post processing unit below. PROCESS ASSISTANCE Glatt s FDA registered feasibility lab offers several GPCG s from lab scale through full production size units. Our highly trained staff works with processes from initial feasibility studies through clinical trials and scale-up. PROCESS AUTOMATION A full range of data acquisition and control systems is available from Glatt s Dataplus series of automated control products. Systems range from simple batch controls through sophisticated menu management and integrated systems encompassing several pieces of process equipment. VALIDATION Based on FDA guidelines and prevailing pharmaceutical industry practices, Glatt s support package includes documentation, procedures, protocols and test plans. In addition, Glatt personnel are available for on-site implementation of the validation plan. FIELD SERVICE Factory trained technicians are available at customer sites for calibration, preventive maintenance, repairs and refurbishing. All instruments are N.I.S.T. traceable and work is performed under Standard Operating Procedures. TURNKEY ENGINEERING A full range of design and engineering services are available along with site supervision and construction management. Glatt can provide plant layout, facilities design, ancillary equipment specification/procurement, detailed construction drawings and contractor specifications. CONTRACT MANUFACTURING For those companies not ready to purchase equipment or interested in testing the market for new products, Glattt provides contract processing. This service is available in our FDA registered facilities in Ramsey, NJ and Winchester, KY. PRODUCT CHARGING PORTS enable quick and contained loading of material and can be easily automated for use with integrated processing systems.

3 TOP SPRAY PROCESSING T H E P R O C E S S I N G C H A M B E R The top spray processing insert consists of a conically shaped product bowl and expansion chamber. The angled walls of the product container allow for a more vigorous fluidization pattern in the product bowl area. As particles travel from the product bowl into the extended height expansion chamber, the increased diameter reduces the air velocity, resulting in a less dense fluidization pattern. As gravity overcomes the upward force of the air velocit y, particles fall back into the product bowl. Throughout the batch, particles are recirculated through this random and unrestricted fluidization pattern. The fluid bed is inherently a highly effective and efficient method of drying. Fluidization suspends each particle exposing the entire surface area to the air stream for optimal convective heat transfer. This assures uniform heating and uniform evaporation of excess moisture, preventing local overheating and allowing the use of higher inlet air temperatures while maintaining the product slightly above room temp e r a t u r e. For granulation or coating processes, a liquid is introduced to the system via a pneumatically atomized nozzle. Nozzle entrance ports on the exterior of the expansion chamber allow the height of the nozzle above the product bowl to be adjusted. In granulation processes, the liquid is introduced high in the expansion chamber where the bed surface area is at its maximum, resulting in a narrow particle size distribution of the final product. In coating processes, the liquid is introduced just above the product bowl where particle density and velocity is at its highest, thus minimizing the distance the droplets travel before contracting the substrate where they spread to form a continuous film. MULTIPLE NOZZLE PORTS in the top spray expansion chamber permit the height of the nozzle above the product bed to be adjusted for granulation or coating processes. APPLICATIONS Drying Short Batch Times Uniform Drying Agglomeration/Granulation Reduce Fine/Dust Enhance Flowability Eliminate Segregation Improve Compressibility Instantizing Improve Dispersibility Increase Porosity Coating Temperature Release Hot Melts Taste Masking Temperature Sensitive Material Alter Bulk Density Improve Disintegration and Dissolution Disperse Surfactants Uniformly Moisture & Oxygen Barrier Coatings Aesthetic Coatings

4 TANGENTIAL SPRAY PROCESSING THE ROTOR T H E P R O C E S S I N G C H A M B E R The rotor processing insert consists of a cylindrically shaped product bowl and expansion chamber. The rotor disk sits at the base of the product bowl and seats along the circumference of the chamber when the rotor is not in motion. The disk is raised during processing to create a slit between the edge of the rotor disk and the conically shaped bottom of the rotor product bowl. The patented adjustable disk height allows control of air volume through the slit independent of velocity. This key feature permits very low drying rates for direct pelletization and pelletization by powder layering. For granulating or coating applications requiring a medium to be evaporated q u i c k l y, the air volume can be significantly increased while keeping are velocity constant. This flexibility results in a single unit processor capable of granulating, pelletizing, layering and coating. The fluidization pattern in the rotor processor can best be described as a spiraling helix. Three factors act on the product to create this flow pattern. The centrifugal force of the rotating disk causes product to flow radically towards the product bowl wall. Airflow through the slit creates a vertical force causing the product to become fluidized. Gravity soon overcomes the force of the airflow and the fluidized product falls back into the bowl towards the center. Liquids or powdered solids can be added to the process through air atomizing nozzle located on the product bowl side wall. The nozzles spray tangentially into the processing chamber in the same direction as the fluidization p a t t e r n. APPLICATIONS Granulation Enhance Disintegration Improve Compressibility Increase Density Spherical Morphology Spheronization Increase Density Produce Spherical Particles High Potency Spheres Smooth Surface Properties MULTIPLE ROTOR DISKS with different surface geometries are available to control the surface friction imparted to the product. Layering Solution/Suspension Layering Powder Layering High Potency Pellets Coating Film Coating Enteric Coatings Narrow Particle Size Distribution Increase Density Sustained Release Coatings Hot Melt Coatings

5 BOTTOM SPRAY PROCESSING THE WURSTER HS T H E P R O C E S S I N G C H A M B E R The Wurster HS was introduced in 12 as the next evolution in Wurster Te c h n o l o g y. This patented processing technique offers larger batch volumes, higher throughputs and for the first time, the ability to coat fine particles under 50um, all without the occurrence of agglomeration. The Wurster HS processing insert consists of a conically shaped product container with an open ended cylindrical inner partition. An air distribution plate is located at the lower end of the product container to distribute the fluidizing air between the inner and outer partitions. The majority of the air is channeled through the inner partition, leaving sufficient airflow to just suspend particles in the outer partition. Particles are drawn into the inner partition by the pressure differential created by the differences in air velocities between the two partitions. The particles are carried through the inner partition and into the expansion chamber by the fluidized a i r. As gravity overcomes the force of the fluidized air, the particles fall back into the outer partition where they are suspended in a slowly moving down bed. The coating solution is added to the system via a pneumatically atomized nozzle located at the center of the air distribution plate. The nozzle sprays upward, providing a concurrent application of solution onto the substrate. As atomized droplets of the coating solution contact the particles in the inner partition, they spread and coalesce on the particle surface. As the particles continue traveling upward in the expansion c 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 coatings of extremely uniform thickness and consistency, an important factor in controlled release applications. APPLICATIONS Coating Aqueous or Solvent Based Polymeric Solutions or Dispersions Sustained Release Coatings Enteric Release Coatings Fine Particle Coating (50um and smaller) Active Layering MULTIPLE WURSTER BOTTOM PLATES provide the ability to vary air volume in the inner and outer partitions of the Wurster processing insert to accommodate a variety of product sizes and bulk densities from tablets and pellets to fine powders.

6 GPCG PROCESSING BOTTOM SPRAY INSERT Exclusively used for high performance coating and layering applications. TANGENTIAL SPRAY INSERT The most versatile of the three inserts, this provides the ability to spheronize, granulate, coat and layer in a single insert. I N T R O D U C T I O N The GPCG is a line of multi-purpose fluid bed processors designed to accommodate drying, granulation, coating, spheronization and layering operations all in one piece of equipment. In addition, a variety of options are available for material handling, control systems, solvent abatement, clean-in-place and exhaust filtration. Thus the GPCG provides the ultimate in terms of both processing performance and flexibility. TOPSPRAY INSERT Most commonly used for drying and granulating and certain coating applications. T H E G P C G S Y S T E M A GPCG processing system is composed of several major components: an air handling unit, a machine tower and an exhaust fan. Air is drawn in through the air handling unit where it is preconditioned before it enters the machine t o w e r. Components within the air handling unit may include filters, heaters, humidifiers and dehumidifiers. The machine tower is a multi-component unit consisting of an air inlet plenum, a process insert and a filter housing all held in place by the side support columns. Process air enters the tower through the inlet plenum which evenly distributes airflow across the bottom of the process insert. The processing air exits the machine tower through the filter housing which contains two identical filters, each in its own airtight partition. Airflow is regulated by an exhaust damper located upstream of the exhaust fan. This twin filter system allows continuous fluidization since either filter is capable of handling the total air volume passing through the fluid bed processor while its twin undergoes a purging cycle. An airtight outlet flap prevents airflow during the purging cycle thus allowing material to fall back into the product bed where it is reclaimed by the process. Glatt offers filter housings designed for use with bag filters, cartridge filters, as well as a convertible housing capable of using 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 addition methods. Thus, each offers distinct processing capabilities.

7 PROCESSED PRODUCTS GPCG 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 Fluid Bed Dried Pharmaceutical Granulate Fluid Bed Instantized Flavor Top Spray Granulated Pharmaceutical Top Spray Granulated Pharmaceutical Top Spray Granulated Pharmaceutical (cross-section) Top Spray Enteric Coated Pharmaceutical Top Spray Enteric Coated Pharmaceutical (cross-section) Top Spray Hot Melt Coated Flavor Wurster HSLatex Coated Pharmaceutical Wurster HSControlled Release Nutritional Wurster Layered and Coated Pharmaceutical Wurster HSLatex Coated Pharmaceutical Wurster HSLatex Coated Pharmaceutical (cross-section) Rotor Pelletized Pharmaceutical Rotor Spheronized Pharmaceutical Rotor Spheronized Pharmaceutical (population) Rotor Solution Layered Pharmaceutical Rotor Solution Layered Pharmaceutical (cross-section)

8 GPCG DATA TECHNICAL DATA OF GPCG PRODUCT LINE Glatt Powder Coater Granulator GPCG Model No Unit Maximum Working Volume of Standard product Container Top Spray ltr Wurster HS(1) ltr 2.4 (6 ) 5.4 (7 ) 6.3 (7 ) 14 ( ) 38 (12 ) 14 ( ) 38 (12 ) 102 (18 ) 38 (12 ) 102 (18 ) 120 (18 ) 417 (32 ) 417 (32 ) 417 (32 ) 820 (46 ) 820 (46 ) 820 (46 ) 1105 (55 ) Rotor ltr Inlet Air Handling Unit Heating Capacity Temperature Range Steam Consumption Exhaust Air Fan Capacity kw Air Volume (3) m3/wg Differential Pressure (3) mm/wg kw C Kg/hr Maximum Air Top Spray Consumption of Air Handler Atomizing Nozzle Rotor Weight Machine Tower Air Handler Exhaust Fan Control Panel (4) Complete System Notes: (1) Excluding the volume in partition (s) FRONT VIEW 4.5 (0mm)4.5 (0mm) (480mm) (480mm) (620mm) C C < < m3/hr m3/hr m3/hr bar (g) saturated steam pressure SIDE VIEW 20 C and 1,103mbar (620mm) 105 (70mm) 180 (0mm)4 (1400mm) 4 (1400mm) 105 (70mm)180 (0mm) 640 (10mm) C > N/A (4) Pneumatic Control System (5) On production size GPCG s, Wud Rotors ar FRONT VIEW TOP VIEW e typically supplied as stand-alone machines SIDE VIEW All dimensions in millimeters All dimensions and specifications are for reference only and subject to change. TOP VENTED Patent Numbers: 4,588,366 5,236,503 4,772,13 5,1,384 5,284,678 REAR VENTED DIMENSIONS SIZE A1 A2 A3 B C 0D E1 E2 F G Spear Road, Ramsey, New Jersey Phone: Fax: > 56