Pharma Biotech Applications
Pharma Fermenters
GEA supplies a range of standardised & customized, fermenters for your microbial culture needs - bacterial or yeast.
GEA supplies a range of standardised & customized, fermenters for your microbial culture needs - bacterial or yeast.
Quality counts: it drives efficiency and productivity; and with GEA, it’s never a compromise. GEA is the worldwide specialist in the manufacture of vessels for the pharmaceutical and biotech industries. We have a solution for all your bioprocessing/fermentation needs because we understand bioreactors and the processes required to manufacture pharmaceuticals according to strict cGMP guidelines.
GEA is a single-source supplier of modular systems and solutions to meet the needs of any pharmaceutical, microbial or cell fermentation process. The company has the expertise and industry knowledge to help customers test processes and make the right choice of equipment to ensure security of outcome and the fastest time to market. All vessels can be supplied as standalone equipment or as automated process units delivered as fully functional modules, installed on site, including agitators, homogenizers, metering and regulating technology, control units, valves and pipe connections. Options for hazardous environments are also available.
Whatever you want from your fermentation plant, from the production of recombinant genetic products for therapeutic purposes (TPA, interferon, insulin, h-Factor VII) to growth hormones and enzymes, and/or for diagnostic applications (monoclonal antibodies), our wide range of plant concepts will provide the equipment you need to meet any requirements or conditions. We use the latest components and valve technologies to produce high performance fermenters and skids.
In addition to fermentation systems, GEA also supplies apparatus and modules for the production and storage of media, product harvesting, the storage and distribution of highly purified media/clean steam and API formulation.
Our fermenters ensure long-term sterility during medium or nutrient change, aseptic sampling, aeration, venting or transfer, highly accurate temperature control, stirrers adapted to provide optimum oxygen transfer rates and cell densities and dead-leg-free design.
Altriferm™ Standard Fermenter
GEA offers a range of standardised, pilot-scale fermenters for your microbial culture needs — bacterial or yeast — that are available with very short delivery times. Our fermenters ensure long-term sterility during medium or nutrient change, aseptic sampling, aeration, venting or transfer, highly accurate temperature control, and stirrers that are adapted to provide optimum oxygen transfer rates and cell densities.
Our systems features include sterile design (free from dead-leg areas), high quality components complemented by a fully automated control system and a full cGMP documentation package.
Temperature control and agitation are also critical factors. GEA ensures that product temperatures can be controlled — using the latest heat exchanger technology and careful agitation — within narrow limits (±0.5 °C) to achieve the highest growth and product formation rates and avoid product variation during production. Precise instrumentation monitors all key parameters — pH, pO2, temperature, agitator speed and weight — throughout the process.
• cGMP/FDA
• Manufactured as per PED (Pressure Equipment Directive)
• ASME U-Stamp (optional)
• China Manufacture License (SELO) (optional)
• Quality plan and materials tracing (optional)
• Own non-destructive testing
• Weld seam documentation (optional)
• Qualification (IQ/OQ) (optional)
• Quality Management System according to DIN EN ISO 9001
From a manufacturing perspective, an important quality criterion is weld quality. The execution and quality of the welds play a crucial role on the safety and lifecycle of our vessels. We guarantee
• thorough weld penetration
• only experienced and highly qualified welders are assigned to the task
• uncompromising implementation of weld quality requirements.
The cleaning characteristics of pharmaceutical vessels and fermenters are key requirements. Dead-leg areas must be eliminated/minimized and effective clean-in-place (CIP) equipment must be installed. GEA uses computer-aided spray pattern simulations during the design phase to ensure optimum cleaning, minimize the use of cleaning media and reduce running costs. A riboflavin test is done for every vessel to ensure that the theory works in practice.
Exterior cleaning is important too, and all GEA vessels are designed with appearance and practicality in mind. Specific features include round edges and corners, homogenous surface finishes (with certificate if required), no indentations or pits and gap-free components and accessories.
• Unit sizes: 50 to 1000 L working volume
• Systems include options for process adaptation
• H/D 3:1
• Defined surface finish (dry grinding) to Ra ≤ 0.8 µm; e-polishing optional
• Pressure: –1/+3 bar
• Temperature: 0 °C/130 °C)
• Cleaning options: CIP, SIP
• Jacket with spiral guide, optionally insulated
• Contact material: 316 L.
• Agitator systems with Rushton turbines
• Double mechanical seal
• Aeration system with optional O2 addition and sterile filter
• Exchaust system with optional cooler and heater, sterile filter and pressure control
• Valve groups for the addition of media and corrective agents, sampling, harvest
• Additional autoclavable vessels
• Sensors and actuators for temperature, pH, pO2, pressure, etc.
• Local control system for operation, visualisation, PLC
• Optional communication with external SCADA and MES systems (servers)
• Testing, qualification and documentation services optional.
Customized Fermenter
GEA has a solution for all of your microbial culture needs, whether bacterial, yeast or fungal. These types of processes require adapted stirrer systems with high power inputs and specific gassing. Our design includes these agitation systems with Rushton turbines, hollow blades or low speed high diameter axial flow elements for highly viscous media. The aeration elements are also specifically designed. Our systems feature sterile design (free from dead-leg areas), high quality components complemented by a fully automated control system and a full cGMP documentation package. We can also help with process testing and equipment selection to ensure security of outcome and the fastest time to market. Options for hazardous environments are also available.
Temperature control and agitation are also critical factors. GEA ensures that product temperatures can be controlled — using the latest heat exchanger technology and careful agitation — within narrow limits (±0.5 °C) to achieve the highest growth and product formation rates and avoid product variation during production. Precise instrumentation monitors all key parameters — pH, pO2, temperature, agitator speed and weight — throughout the process.
From a manufacturing perspective, an important quality criterion is weld quality. The execution and quality of the welds play a crucial role on the safety and lifecycle of our vessels. We guarantee
The cleaning characteristics of pharmaceutical vessels and fermenters are key requirements. Dead-leg areas must be eliminated/minimized and effective clean-in-place (CIP) equipment must be installed. GEA uses computer-aided spray pattern simulations during the design phase to ensure optimum cleaning, minimize the use of cleaning media and reduce running costs. A riboflavin test is done for every vessel to ensure that the theory works in practice.
Exterior cleaning is important too, and all GEA vessels are designed with appearance and practicality in mind. Specific features include round edges and corners, homogenous surface finishes (with certificate if required), no indentations or pits and gap-free components and accessories.
Standard and Customized Bioreactors. A Bioreactor is any manufactured or engineered device or system that supports a biologically active environment.
Preparation and Pressure Vessels set new performance standards and ensure that our customers 'central process components' have competitive advantages.
GEA is a single source for the supply of vessels, fermenters & bioreactors to meet the needs of any pharmaceutical, microbial or cell fermentation process.
GEA draws upon the comprehensive theoretical knowledge and expertise of its engineers to provide you with modern, bespoke and cost-efficient process technology to manufacture new medicines according to cGMP guidelines and US FDA requirements.
GEA provides high quality storage and transportation vessels made of stainless steel. Each vessel is designed to customer´s requirements.