Fluid Bed R&D Processing of Pharmaceuticals

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

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

Technical Data

STREA-1 Pro

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

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

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

*  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

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