Additional features
-Easy to wash-in-place (WIP)
-Built to GMP-standards
-Total containment of the product
-Variable speed chopper and impeller
-Operator control panel on the machine
-Automation/PC/PLC controls
-Controlled product discharge
-Automatic end point detection with PROCOLL-software
-Explosion proof design
-Heating and cooling units
-Fill-O-Matic (vacuum) or gravity loading system.
-EC type approved for pressure shock resistant integrated systems and 16-bar pressure shock resistant high shear granulators

Concealed services
The design of the UltimaGral ensures that lines and hoses for the utilities on the machine (water, electricity, hydraulics, etc.) are concealed in the machine encasement. This creates an uncluttered working space and avoids hoses being run to the machine within the process area.

Processing Modules
Dryer: warm air is blown through a perforated distributor to rapidly and gently dry materials until the required residual moisture content is reached. Moisture evaporated from the product is exhausted with the drying air, providing very short processing times.

Precision Granulator: a novel granulation process, a rotating high velocity air stream is established in the central agglomeration tube. Particles are picked up at the base of the tube and accelerated by the air stream. The particles come into contact with liquid droplets produced from the spray nozzle at the base of the tube. The relative velocity of the air, liquid droplets and particles are high, so wetting is efficient and drying begins almost immediately. Most of the feed material is in the outer “holding area,” where the gas velocity is very low. Attrition is greatly reduced. The gas humidity is also low in the holding area so the material is dry not sticky. Individual particles may make repeated cycles (typically from 10 to 1000) through the tube, allowing very large agglomerates to be built up.

Top Spray Granulator: offering granulation and drying in a single-pot process, the top spray granulator agglomerates finer particles into larger, free flowing granulates. Ingredients are mixed and pre-heated by an upward flow of heated air. Granulation occurs by spraying liquid into the fluidized powder. The granules are subsequently dried with heated air. The top spray granulator can also be used for top spray coating, layering from liquid, and instantizing.

Spray Dryer Granulator: with batch or continuous discharge available in continuous mode, the spray dryer granulator transforms suspensions or solutions into dry, free-flowing, dustless granules. A suspension or solution of the substance to be dried is sprayed onto warm air, simultaneously drying and agglomerating the product. The product is discharged at a controlled rate to maintain an optimum bed height. Special features include easy scale-up and a small footprint.

PRECISION-COATER: this multi-functional fluid bed processor can be used to make pellets by layering the active material onto an inert core. Offering high spray rates for short processes, non-pareil starter pellets are sprayed with a solution or suspension of the active material and dried simultaneously.

Controlling Your Process
Advanced PLC-based automation provides seamless integration of process and CIP control functions. Options include a graphical MMI operator interface, online monitoring and trending, recipe handling, batch management, barcoding and full CIM integration. Industry standard communication networks ensure full compatibility with existing control strategies and plant-wide supervisory systems.

Process Analytical Technology
The FDA’s PAT (Process Analytical Technology) initiative has enabled GEA to combine its equipment design skills and process engineering know-how to integrate online (PAT) analyzers into its systems in a way that can provide real insight into the operation of the process and help customers to achieve key product quality targets.
The goal of the PAT initiative is to ensure that pharmaceutical products are manufactured using processes that are understood and monitored so that the key quality characteristics of the products can be actively controlled.

Containment
Our distinctive specialization lies in the integration of the BUCK® containment technology into complete solutions for pharmaceutical solid dosage form facilities. With an emphasis on quality and GMP standards, we are committed to working together with our customers to deliver custom-built, first class solutions for projects of all sizes and complexity.

Safety and the Environment
For full compliance with national, local and in-house regulations, GEA offers a range of emission control options including solvent recovery systems, outlet filters and full containment plants. Equipment can be supplied to meet explosion-proof and pressure shock standards as required.

Cleaning and Maintenance
CIP Skid for Solid Dosage
Process optimisation depends on efficient, effective cleaning. Automation of the cleaning process ensures repeatability, allows validation and minimizes downtime. In recognition of the fundamental role played in today’s advanced powder processing industry by automated clean-in-place procedures, GEA has developed a unique approach to CIP.
Concealed services: The integrated design ensures that all lines and hoses for the utilities of the plant (water, electricity, hydraulics, etc.) are concealed. This creates a safe and uncluttered working space.
CIP and WIP systems: More efficient cleaning is one of the key advantages of system integration. We provide validated cleaning with minimal downtime. GEA offers CIP-by-design (patented) features into all of its process. Every aspect of the integrated plant, from inlet to discharge, has been value-engineered for optimum cleanability. Spray system, tanks cleaners, nozzles and seals are an integral part of our equipment design. Every plant delivered by GEA has a tailor made WIP or CIP system that suits your process.

Key Characteristics
-Flexible technology for standard wet granulation, melt granulation, pelletizing or effervescent production, combined with vacuum or microwave drying
-Swinging bowl options during vacuum drying results in an improvement of the granule characteristics and a reduction in drying time
-Easy and efficient cleaning (CIP)
-Compact technology – reduce space requirement by incorporating several processing steps into one machine

Definition
A single pot processor is a high-shear mixer-granulator that is also equipped with drying technologies. Thus, single pot processing is the production of pharmaceutical granules using a wet granulation process in which dry mixing, liquid addition, wet granulation, drying and sizing of the granules is done in one machine.

Main Benefits
-By integrating granulating and drying capabilities into a single unit, capital investment in equipment and good manufacturing practice (GMP) floor space is lower than other alternatives.
-The number of material handling steps is decreased: consequently, the total processing time is shorter while maintaining a high yield and keeping production support to a minimum. At the same time also the number of required operators is reduced.
-Environmental variables, such as humidity, are eliminated from the manufacturing process, which may offer advantages for processing moisture-sensitive formulations.
-Requirements for solvent recovery systems are lower for single-pot processors compared with fluid bed dryers.
-Reaching a high level of containment is easy by application of the correct measures at in- and outlet valves.
-A single pot can be changed over in less than 2 hours, which makes it a very attractive technology if a large number of different products- demanding a high number of product changeovers- has to be produced.

Applications
-Contained production of highly active of toxic products
-Effervescent production
-Wet granulation using organic solvents
-Multiple product facilities requiring fast change-over
-‘special’ applications (e.g. melt granulation, crystallization onto substrates)

Safety First
Safety is a critical aspect of any lifting equipment; the GEA Post Hoist has been designed with absolute operator safety in mind. The hoists use a robust rack and pinion lifting mechanism rated at four times the working load of the hoist, thus eliminating the risk associated with chain breakages.
The lifting drive is an electric ‘braked’ motor. Should utilities be lost, the load will remain in the same position; any risk of carriage slipping is prevented. The operator interface panel is mounted on the rear of the column and operates on a ‘hold-to-run’ principle, ensuring operator safety.

GMP Design
The electric motor lift drive removes the need for hydraulic lifts (and the non-GMP issues associated with hydraulic devices). The lift motor is mounted on the carriage, not at the top of the column, making routine maintenance much easier.

Controls
The control system is simple and user friendly. Simple push buttons control the raising and lowering operations and, for more sophisticated requirements, a Siemens or Allen Bradley PLC/HMI control system is available. For high lift or slow speed docking operations, an inverter can be added to provide a variable speed drive. This allows for fast lifting operations and allows the carriage to stop at controlled speeds.

Modular Design
A ranges of Lifting Carriages is available for the GEA’s Post Hoist. For IBC lifting operations, standard Forks allow the IBC to be securely lifted and accurately aligned.
If the IBC needs to be inverted to be filled through its outlet valve, the IBC Inverting Carriage can be fitted.
And, by fitting the IBC Blending Carriage, the Post Hoist can be used as a blender, offering the same blending efficiency as the Pedestal range of blenders.
Further, the IBC Weighing Carriage allows the IBC to be lifted to a filling point and aligned with a BUCK® Valve to facilitate dynamic weighing of the IBC as it is filled. The column can either be static mounted or positioned on a slewing base to allow the carriage to be swiveled over the inlet of a downstream process container. Slewing can be either manual or electrically driven.

Features and Benefits
-Allows gravity discharge from an IBC to a downstream pharmaceutical process, eliminating the need for vacuum conveying
-Lifts and holds IBC directly above the process machine: no need for a discharge station
-Electrical braked motor
-No hydraulics
-Fully enclosed column and drive motors
-Robust mechanical construction
-IBC forks for secure and accurate lifting and docking
-IBC inverting option
-Validation documentation
-Two speed lifting drive
-User friendly control system.

The ConsiGma® GD 25/80 offers standalone continuous twin-screw granulation and drying for small-scale R&D operations. It allows users to develop the process and achieve high granule quality on a compact unit.
The system comprises the same twin-screw granulator as the smallest unit of the ConsiGma® GD or GS lines and a small dryer that’s similar to one of the drying segments. This allows you to develop your products on the same scale with product quantities starting from just a few 100 grams up to a few kilograms. The results are directly transferrable to the smallest ConsiGma® GD or GC line.
The ConsiGma® GD 25/80 is ideal for pharmaceutical companies who wish to develop a continuous granulation process before the fully integrated production line is installed.

Standard Configuration
-One powder feeder
-One liquid addition system
-Twin-screw granulator
-One dryer segment

Available Options
-Brabender or Ktron Feeder
-Standalone GD 25 w/out dryer segment
-Solvent compatible
-Second liquid addition
-Lighthouse Probe® for LOD measurement
-Melt granulation set-up

Main Benefits
-Controlled granulation
-Less API use during R&D
-Fast R&D
-Reduced time-to-market
-No scale-up from GD 25/80 to GD or GC 25/500