Pharmaceutical R&D Technology
Fluid Bed R&D Processing of Pharmaceuticals
Offering a complete range of application-specific technologies for R&D, our small-scale equipment solutions cover every aspect of pharmaceutical oral solid dosage production: from high shear mixers, fluid bed dryers and single pot systems to extruders and spheronizers, from blenders and containment solutions to tablet presses and coaters.
Unrivaled Expertise
Based on a long history of experience, thousands of completed tests and with plants installed around the world, we have established a solid base of manufacturing plant and pharmaceutical process expertise. Highlighting the importance of R&D, GEA offers three complementary laboratory scale units, capable of processing batch sizes from 50 g to more than 6 kg.
Contained and Flexible Granulation
Based on a long history of experience, thousands of completed tests and with plants installed around the world, we have established a solid base of manufacturing plant and pharmaceutical process expertise. Highlighting the importance of R&D, GEA offers three complementary laboratory scale units, capable of processing batch sizes from 50 g to more than 6 kg.
GEA's completely contained granulation line for R&D takes the process from dispensed raw materials to finished tablet. The system offers unsurpassed process flexibility - during high shear granulation, pelletization and/or blending, etc. – in a totally contained environment. It illustrates how GEA's inspired technology can be used to provide a total solution that's tailored to suit each user’s specific requirements, whether through integration or split valve technology.
The system is aimed at producers of small quantities of highly potent compounds. The intelligent contained handling systems inherent in the GEA pilot plant allow it to be flexible, efficient, clean and safe without the need for expensive, bulky and difficult to clean isolator systems. Furthermore the level of containment avoids the need for costly and uncomfortable air-suits, allowing the users to focus on the product, creating faster and more secure results.
Process Overview
At the heart of the production plant is PharmaConnect® and the MP1 Flexstream fluid bed processor. PharmaConnect® is GEA’s innovative, modular granulation and blending system, offering an unbeatable range of process types and capacities. FlexStream is the world-leading process technology for spray granulation and pellet coating, delivering unbeatable benefits in terms of productivity, reduced running costs and a robust and scalable process.
Contained Product Transfer
The system includes examples of both rigid and disposable product transfer technologies, offering containment down to low nanogram levels. These options include
- the disposable Hicoflex® system, providing significantly lower capital and running costs compared with rigid IBC technology and rapid product changeover for improved plant utilization
- the unique, modular Buck® MC Valve with its simple design that enables complete container-to-container transfer flexibility
- the Buck® TC Valve, the highest performing split valve available in the marketplace; by introducing a wash step prior to valve separation, the Buck® TC Valve is capable of low nanogram level performance.
Integrated Approach
All of these technologies are brought together in an integrated process system that mimics the hundreds of large-scale plants provided by GEA globally. It epitomizes the approach of ensuring that customers receive the same technology from the laboratory through to production, using the same containment and process technologies to guarantee seamless scale-up and the most flexible blend of process capabilities.
STREA-1 Classic
Lab Scale Fluid Bed Processor 0.8-4 litresThe STREA-1 Classic is the flexible choice when taking the first steps towards process optimisation. The STREA-1 is ATEX certified and suitable for use with organic solvents (explosion group IIA). It is designed for processing of fine powders, pellets, granules, crystals, and mini tablets.Product drying, spray granulating and coating – in volumes ranging from 0.8 to 4L – can all be handled by the manually operated STREA-1 Classic, thanks to its interchangeable components and containers. The STREA-1 Classic has been supplied to research centres and companies for use in the production of pharmaceuticals, food stuffs, dairy products, fine ceramics, and chemicals. Continuing GEA’s strong commitment to research and development and high-quality standards, the STREA-1 Classic is an essential addition to the laboratory benchtop. It is tested to the European Standard, EC Type Examination, by a Notified Body. All parts of the unit are assembled in our own workshop to guarantee the highest level of workmanship. The units are also tested at maximum capacity prior to delivery. Below are some of the key functions and features of the Strea-1 Classic.
Granulation & Drying
Air is filtered and heated prior to passing through the distributor plate fluidizing the product and absorbing moisture. The product is completely contained within the unit due to the highly efficient product filters. A binding agent is sprayed onto the fluidized product for controlled agglomeration. The formed agglomerates are subsequently dried.
Coating
Liquid is sprayed onto the product from below to ensure uniform coating. An attachment for top spray coating is also available.
Main Features
- Easily transportable due to table-top size
- Ready to plug into standard laboratory utilities
- Easy operation
- Simple to clean and maintain
- Special air distributor plate for controlled product movement
- Continuously operating blow-back filter cleaning system
- Instrumentation for measuring air flow, product and filter pressure drop
- Device for product sampling
- A Filter Blow-back system for consistent air flow by blowing down dust adhering to the filter bags.
- An air handling system
- Predisposition for top or bottom spray
Available Options
- Two-fluid nozzle for atomizing liquids
- Heated atomizing air to the nozzle for hot melt granulation liquids
- Acrylic, Glass or Stainless-Steel Bowls
- Top spray and coating capability
- Peristaltic pump for liquid addition
- ATEX compliant
Typical Operating Capacities
| Vivak® PMMA | Borosilicate Glass | Stainless Steel 316L | ||
|---|---|---|---|---|
| Operating Volume | Min | 0.8 litres | 0.8 litres | 0.8 litres |
| Max | 4 litres | 4 litres | 4 litres | |
| Bottom Spray Coating | Max | 6.5 litres | 6.5 litres | 6.5 litres |
| Allowable Temperature | Max | 65°C | 80°C | 100°C |
Technical Data
| Technical Data | Strea-1 Classic | |
|---|---|---|
| Single Phase motor fan | Air Flow range @ 20°C | 10-120 m³/hr |
| Max. Static pressure @ 20°C | 5 kPa | |
| Motor power | 1 kW | |
| Voltage | 230 VAC | |
| Frequency50/60 Hz | ||
| Heater | Heating capacity | 2.5 kW |
| Voltage | 230 VAC | |
| Frequency | 50/60 Hz | |
STREA-1 Pro
The GEA STREA-1 Pro fluid bed combines 'process ability' and table-top practicality of the well established STREA-1 Classic with the advantages of OP / PLC Control.OP / PLC Control
This control system unites functionality and process visualisation with data recording via a separate paperless recorder. It provides a level of process automation with recipe control.
Product drying, top spray granulating and coating – in volumes ranging from 200g to 2kg – can all be handled by the STREA-1, thanks to its interchangeable components and containers.The STREA-1 has been supplied to research centres and companies for use in the production of pharmaceuticals, food stuffs, dairy products, fine ceramics and chemicals. Continuing GEA’s strong commitment to research and development and high quality standards, the STREA-1 Pro is a vital addition to the development benchtop.
Dryer
Air is filtered and heated prior to passing through the distributor plate fluidizing the product and absorbing moisture. The product is completely contained within the unit due to the highly efficient product filters.
Granulator
A binding agent is sprayed onto the fluidized product for controlled agglomeration. The formed agglomerates are subsequently dried.
Coater
Liquid is sprayed onto the product from below to ensure uniform coating. An attachment for top spray coating is also available.
Main Features
- Easy manoeuvrability due to table-top size
- Ready to plug into standard laboratory utilities
- Easy operation
- Simple to clean and maintain
- Special air distributor plate for controlled product movement
- HEPA filter for process air
- Continuously operating blow-back filter cleaning system
- Instrumentation for measuring air flow, product and filter pressure drop
- Allen Bradley color PLC Controls
- Data and trend recording
Available Options
- Two-fluid nozzle for atomizing liquids
- Heatable nozzle for atomizing melts
- Selection of material for product filter
- Air volume control system
- Atomising air control system
- Device for product sampling
- DQ, IQ, OQ qualification on-site and documentation
- PLC-PC communication
Technical Data
| Product volume | 0.2 - 2 kg |
| Air Flow | 2m3 / min |
| Stat. pressure | 5000N / m2 |
| Motor power | 1.00 kW |
| Type of current | single or 3 phase |
| Heating capacity
delta t = 60° C delta t = 90° C | -
1.5 kW (110 volt) 2.2 kW (220 volt) |
| Container volume | 16.5 liter |
| Weight | 75 kg |
All parts of the STREA-1 unit are assembled in our own workshop to guarantee the highest level of workmanship. The units are tested at maximum capacity prior to delivery.
MP-1
MP-1 Pharma Fluid Bed Processor - with FlexStream TechnologyThe MP-1 Multi-Processor is a compact, mobile system designed for laboratory scale drying, coating and spray granulation. Fully self-contained, with all controls and ancillary air handling devices built into the machine base, the MP1 capacity ranges from 0.2 up to 6 kg.The MP-1 Model
Developed by GEA to meet the industry's requirements for flexible unit operations, the MP1 is based upon the principle that one basic unit can be used for numerous processes simply by interchanging a module.
- Drying module
- Top Spray Granulation module
- FlexStream
- PRECISION-GRANULATOR module
- PRECISION-COATER module
These modules are available in sizes ranging from the MP-1 lab unit up to full production scale equipment built in compliance with current GMP and safety standards. Only the highest quality materials are used to build the MULTI-PROCESSOR giving you a long lasting and reliable unit for your process work.
MP-1 Standard Features
- Self-contained control and air handling unit
- PLC control system with touch screen HMI
- ProcessView software
- Automatic recipe control function
- Data- capture equipment
- Peristaltic Pump
- Hinged Expansion Chamber
- Inlet and Exhaust HEPA filtration
| Size | Lab Bowl | Development Bowl | |
| Drying | kg | 0.2 - 3 | 0.4 - 6 * |
| Top Spray Granulation | kg | 0.2 - 2 | 1 - 4 * |
| FlexStream
| kg | N/A | 1 - 5* |
| PRECISION-COATER™ | kg | 0.2 - 3 | 0.4 - 5 ** |
* Products with bulk density of 0.5gms/cm³
** Products with bulk density of 0.8gms/cm³
Options for Special Applications
The standard MP-1 is equipped to carry out the majority of every day processing. However, to meet special customer requirements a range of options is available.
- Dehumidification of inlet air
- Loss-in-weight scales
- Wash Lance
- PAT ports
- Selection of filter materials
- Secondary filtration for coating processes
- GPS Proces Manager
- 21 CFR part 11 compliant data handling and recipe management
All process can be easily scaled-up to larger pilot or production-scale Fluid Bed Processor.
Alternative Containers:
- Lab-Scale Stainless Steel Product Container
- Lab-Scale Polycarbonate Product Container
- Development -Scale Polycarbonate Steel Product Container
- Precision Coating Modules
- Selection of air distributors
- Standard hole plate and mesh
- The GEA overlap gill plate
- Precision Coater Fielder plate
Technical Data
| Standard Development Product Container | Min. batch weight | 400 g |
| Max. batch weight | 6.0 kg | |
| Standard Lab-Scale Product Container | Min. batch weight | 200 g |
| Max. batch weight | 3.0 kg | |
| Peristaltic pump | Throughput rate | 300 ml / min |
| Customer Supply | Europe | 3 x 400 v |
| USA | 3 x 480 v | |
| Electrical data | Europe | 50 Hz |
| USA | 60 Hz | |
| Electrical power (max.) | 18 kW | |
| Compressed air | 6 barg | |
| Weight (approx.) | 850 kg | |
| Dimensions (L x W x H) | 1700 x 1000 x 2800 mm | |
Flexstream 90
FlexStream 90 - Contained Pharma Fluid Bed Processing - development scale.
FlexStream 90
The FlexStream 90 was developed to specifically to meet the expanding requirements of the pharmaceutical industry for highly contained process equipment at the research and development scale.
By mimicking the technologies employed on production equipment FlexStream 90 operates safely at the OEB 5 level when integrated with suitable Buck® containment valve technologies.
The FlexStream 90 offers the following process capabilities:
- Fluid Bed Drying
- Top Spray Granulation
- FlexStream Granulation
- FlexStream Pellet Coating
To meet the highest cGMP standards a FlexStream 90 is built on a Through-the-Wall (TTW) basis. The air handling and ancillary equipment are located in the technical area removing maintenance requirements from the process room.
FlexStream 90 Features
- TTW Design
- GPS ProcessManager PLC/HMI Control System
- Integrated Loading and Discharge Valves
- Sample Port designed for Buck® Contained
- Sampling device
- FlexStream system for Coating and Granulation
- Top Spray system for Granulation Processes
- Integrated Peristaltic Pump
- Fabric Filter System with Compressed Air Blowback
- Wash nozzles allowing WIP operations
- Configurable Inlet and Exhaust Air Handling systems
FlexStream Options
- Replacement Product Container for Precision Coating
- Stainless Steel filtration for CIP Operations
- Vacuum discharge system incorporating GEA’s Lean-Phase technology
- End Product Handling, including dry mill and containment valve
Downloads
Смежные продукты
PharmaConnect® R&D Processing
PharmaConnect® allows a number of diverse process modules to be docked to one control unit, including high shear granulation, pelletization and blending, coating.
Fluid Bed Processing of Pharmaceuticals
GEA supplies fluid bed processors (known as fluid bed Multi-Processor in the USA) for blending, granulating, drying, pelletizing and coating for the pharmaceutical industry.
FlexStream Fluid Bed Processor
FlexStream is a new multi-purpose processor that addresses the current shortfalls of traditional fluid bed processing, including linear scale-up, fully contained loading and unloading for Pharmaceutical applications.
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