Pharmaceutical R&D Technology
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.
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.
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.
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.
The system includes examples of both rigid and disposable product transfer technologies, offering containment down to low nanogram levels. These options include
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.
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.
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.
Liquid is sprayed onto the product from below to ensure uniform coating. An attachment for top spray coating is also available.
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 | 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 |
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.
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.
Liquid is sprayed onto the product from below to ensure uniform coating. An attachment for top spray coating is also available.
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.
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.
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.
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
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.
All process can be easily scaled-up to larger pilot or production-scale Fluid Bed Processor.
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 |
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.
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.
PharmaConnect® allows a number of diverse process modules to be docked to one control unit, including high shear granulation, pelletization and blending, coating.
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 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.