Pharma Biotech Applications
Pharma Bioreactors
Standard and Customized Bioreactors. A Bioreactor is any manufactured or engineered device or system that supports a biologically active environment.
Standard and Customized Bioreactors. A Bioreactor is any manufactured or engineered device or system that supports a biologically active environment.
At one level, a bioreactor is a vessel, often cylindrical and made of stainless steel, in which a chemical process (aerobic or anaerobic) takes place that involves organisms or biochemically active substances derived from such organisms. They can range in size from litres to cubic meters. A bioreactor can also be a device or system to grow cells or tissues in the context of cell culture for tissue or biochemical engineering applications.
Based on their mode of operation, a bioreactor may be classified as batch, fed batch or continuous such as a continuous stirred-tank reactor like a chemostat.
Altricell™ Standard Bioreactors
GEA offers a range of standardised, pilot-scale bioreactors for your cell culture needs. Available with very short delivery times, our bioreactors 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 efficient mixing while keeping shear stress to a minimum.
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.
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 bioreactors 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 certification if required), no indentations or pits and gap-free components and accessories.
Customized Bioreactors
GEA has a solution for all of your cell culture needs, whether grown in suspension or on a microcarrier. These types of processes require a much longer residence time in the reactor; therefore, maintaining complete sterility for long periods of time is critical. We offer a magnetic seal option specifically for this type of application. Our design includes low shear agitation systems (marine impellers) for sensitive cells and/or the use of either porous or ring spargers.
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.
• cGMP/FDA
• Manufactured as per PED (Pressure Equipment Directive)
• ASME U-Stamp
• China Manufacture License (SELO)
• Quality plan and materials tracing
• Own non-destructive testing
• Weld seam documentation
• Qualification (IQ/OQ)
• 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.
• Unit sizes: 10 to 15,000 L working volume
• Systems designed to customer requirements
• H/D 2:1
• Defined surface finish (dry grinding) up to Ra ≤ 0.2 µm; e-polished
• Pressure: –1/+3 bar to –1/+10 bar depending on customer requirements
• Temperature: –20 °C/200 °C (SIP up to 130 °C)
• Cleaning options: CIP, SIP
• Jacket with half pipe or spiral guide, optionally insulated.
Agitator systems as per process requirements (angled blades, Marine impellers)
• Double mechanical seal or magnetic drive
• Aeration system with optional gas mix and sterile filter
• Exhaust 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 or in-situ sterilizable vessels (10–20000 L)
• Sensors and actuators for temperature, pH, pO2, pressure, etc.
• Local control system for operation, visualization, Distributed Control Systems (DCS)
• Optional communication with external SCADA and MES systems (servers)
• Testing, qualification and documentation services
• Materials in regular use: stainless steel types 1.4404, 1.4435, 1.4539, 1.4547 (SMO), 2.4605 (alloy), 2.4610 (alloy)
• Optional: pickled and passivated or electropolished
• Delta ferrite content <3 %
• Local installation and start-up, qualification support and maintenance.
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.
GEA supplies a range of standardised & customized, fermenters for your microbial culture needs - bacterial or yeast.
Preparation and Pressure Vessels set new performance standards and ensure that our customers 'central process components' have competitive advantages.
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.
A GEA é uma fonte única de fornecimento de vasos, fermentadores e biorreatores para atender às necessidades de qualquer processo farmacêutico, microbiano ou de fermentação de células.
Mantenha-se atualizado com as inovações e histórias da GEA, se registrando para receber notícias sobre a GEA.
Registrar-seEstamos aqui para ajudar! Com apenas alguns detalhes poderemos responder à sua pergunta.
Entre em contato