Granulation, Drying & Pelletizing Technology for Pharma Applications
Fluid Bed Processing of Pharmaceuticals
GEA supplies fluid bed processors for blending, granulating, drying, pelletizing and coating applications in the pharmaceutical industry. This includes small capacity systems designed for R&D as well as industrial-size plants for the batch production of pharmaceutical compounds under cGMP conditions.
Fluid Bed Granulation
Fluid Bed Processing
For maximum production flexibility, GEA can supply a single fluid bed unit or the FlexStream fluid bed processor that combines multiple processes in a single piece of equipment.
GEA offers a series of fluid bed processors that are suitable for the formulation, development and production of clinical material through to full-scale manufacture; the philosophy behind the design is that a combination of standardised modules can be combined to meet specific requirements. As such, dryers of equal capacity may be completely different with respect to design, configuration and physical size.
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.
Production Capacities
| PMA Size | 500 | 1000 | 1500 | 3000 | 4500 | 6000 | 9000 | 12000 | |
| Typical Operating Capacity | L | 25-50 | 60-115 | 120-225 | 240-450 | 320-600 | 480-900 | 720-1355 | 960-1800 |
| Typical Batch Weight (@0.5 g/mL) | kg | 25 | 60 | 115 | 225 | 300 | 450 | 680 | 900 |
Flexstream
FlexStream offers multiple processing from a single bowl, providing both flexibility and cost benefits.
The FlexStream Fluid Bed Processor
- A single product container for all unit operations
- Only one design/height for all unit operations
- Reduced building envelope in both height and footprint
- Built in linear scale-up
- Ready for fully contained loading and unloading
- Superior product homogeneity for both LOD and PSD
- In-line particle growth measurement for PAT compliance
- Existing GEA fluid bed processors can be upgraded with FlexStream technology!
FlexStream has spray nozzles mounted in the side walls of the processor. Although this is an optimal nozzle position (from a processing point of view), it still carries the risk of uncontrolled over wetting. Therefore, with the FlexStream, particles are pneumatically driven away from the area of high humidity just in front of the nozzle tips by a protective air stream taken from the normal process air. No compressed air is required for this set-up, which results in higher yields as fewer particles are destroyed.
The system is also very energy efficient compared with those using compressed air as no third air supply is required. The FlexStream concept has the additional advantage that no mechanical adjustment is necessary to switch between using the equipment as a dryer, a granulator or a coater.
Impressive test data prove that, in addition to these commercial benefits, FlexStream gives superior product quality when compared with conventional top-spray granulation or Wurster coating.
Key Advantages of FlexStream
- Reduced investment
- Easy/fast changeover
- Reduced downtime
- Flexible fluid bed concept for drying, granulation and pellet coating
- Linear scale-up
- Compact design
- Cost saving.
Where inspiration meets technology
Inspired processing of effervescents - with FlexStream fluid bed granulation technology.
- Suitable for all effervescent formulations with aqueous and/or organic based solvents.
- Robust processor granulating free flowing products with no lumps.
- Substantial faster process compared to traditional effervescent processing methods.
- Lowest total costs for high quality effervescent processing.
Process Control
Process ControlGEA has integrated its knowledge and experience in pharmaceutical fluid bed processors to help operators monitor and control the process in an easy and self explanatory way.Process Monitoring
The programmable logic controller (PLC) front panel keypad and built-in monitor are used for recipe input and real-time process MIMIC display. For optimum compatibility with existing plant control strategies, fluid bed systems are available with a choice of manual or automated FDA-compliant controls. PLC and PC-based options offer a wide range of recipe handling, data acquisition and network communication functions.
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 process systems in a way that can provide real insight into the operation of the process and help customers 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, and that key product quality characteristics can be actively controlled.
Combining process monitoring using online analyzers, together with solid process engineering principles and advanced modelling techniques, will enable processes to be actively controlled to compensate for minor input variations (raw materials), so that final product specifications will be closer to ideal targets.
Using process models to identify the conditions in which products perform best in subsequent procedures will enable the whole production process to be targeted towards the performance of the final dose, rather than just optimizing each unit operation individually. GEA's wide scope gives it a unique perspective on the entire process.
Lighthouse Probe® Technology
GEA has created a compact and cleanable in-process optical probe for use in powder processing equipment. The result is the novel Lighthouse Probe®, which can be used with a range of spectroscopic techniques, including NIR and UV/vis, to overcome the traditional problem of product sticking to observation windows.
The probe is compact and easy to install, and makes it possible to take a reliable in-process measurement of quality critical product characteristics, including
- material and active content identification
- active content uniformity during high shear blending operations
- moisture content and end-point during drying processes
- coat growth during coating processes.
Optical methods such as UV/vis or NIR spectroscopy can be very powerful tools to analyze a range of product characteristics. In processes involving wet and sticky powders, however, it is necessary to ensure that the system has a clear view of the product. Conventional windows used in process equipment such as fluid bed systems or high shear granulators have always suffered from the risk of window fouling. The new Lighthouse Probe® has overcome this problem.
Plant Design
Plant DesignUsing proven standard components, GEA can supply both simplicity and flexibility in fluid bed plant design. User-selected process modules, filters, control systems and air preparation units can be combined to meet your process requirements. This modular approach ensures that qualification and validation procedures are kept to a minimum.Through-the-Wall Installation
By positioning the support column at the back of the fluid bed, a through-the-wall installation is achieved that ensures that all the auxiliary equipment is housed outside the process room. This greatly simplifies compliance with GMP guidelines.
Solvent Emission Control
A range of open- and closed-cycle systems to remove or recover organic solvents is available. Options include condensation, adsorption, thermal oxidation and wet scrubbing.Spraying Systems
Nozzles, pumps and liquid preparation units are supplied according to process needs.Product Discharge
For automatic product discharge, pneumatic conveying or gravity-based systems are available for use with the Non-Sifting Gill Plate air distributor technology.
Inlet Air Preparation Unit
Inlet air is treated using a series of filters and conditioning units according to the sensitivity of the process and the ambient climatic conditions. Options range from the basic minimum, consisting of a pre-filter, heater and final filter, to full air-conditioning to provide consistent processing conditions all year round. Condensers are used for dehumidifying in most applications, but for hygroscopic or effervescent products that require a very low dew point, additional adsorption devices can be installed. Humidification is achieved by an injection of steam.
Process Filters
In granulation, drying and most pelletizing applications, a process filter is used to trap small particles, which are subsequently returned to the bed when the filter is cleaned. In coating applications, fine particles usually need to be removed. Fluid beds that are used for more than one type of process can be supplied with interchangeable process filters.
Filter Options
Single shaker bag filter: a simple, basic filter with a single bag, which is cleaned by shaking. Fluidization stops during filter cleaning.
Multi-shaker bag filter: this filter is divided into two or more sections, with a separate filter bag in each one. Bags are cleaned individually by shaking the filter, while fluidization continues in the other sections, for faster and more efficient production.
Blow-back filter: there are multiple filter bag sections in this design. Cleaning takes place one bag at a time, so that a large proportion of the filter is always available for continuous fluidization.
Cartridge filter: stainless steel filter cartridges are cleaned one at a time, so that a large proportion of the filter is always available for continuous fluidization. Unlike bag filters, this system can be cleaned-in-place.
Particle retainer:Containment
Containment
High Equipment Costs vs Operator Friendly Working Environments
- Better containment technology allows operators to work outside of containment suites
- Operators are less restricted, allowing a more efficient working environment
- Low risk of re-contamination
- Development of more potent products/compounds
- More stringent regulations
- Better housekeeping.
Containment Interfaces
The demands made on equipment used in the pharmaceutical industry are continually rising, especially with regard to the protection of the working environment and the product itself from harmful contaminants. Highly specialized solutions are required, including
- the Buck® MC Valve split-valve: this breakthrough concept unifies all the current requirements in high containment equipment: full GMP design, no need for vacuum, robust centering, free orientated docking and tool-free quick release as standard. But, the most innovative step is the idea of using only passive valves that are driven by a modular actuator unit.
- the Hicoflex® disposable containment interface, for fast materials handling, performs a variety of functions simultaneously: it provides a reliable means of secure transportation, an ergonomic docking system, a contamination-free way of transferring media and a reliable sealing system for transport containers. It’s simple, effective and inexpensive.
- containment experts: GEA not only offers the largest variety of hardware solutions for contained materials handling, but also unrivalled experience in identifying the most appropriate solution based on a containment risk analysis.
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