Kühner SB2500-Z single-use bioreactor

Orbital shaken bioreactor for single-use bags with a working volume up to 2500 litres
The next generation of manufacturing-scale orbital shaken bioreactor (OSB) SB2500-Z is now available for the cultivation of human, mammalian, plant, and insect cells in a single-use bag. The bioreactor system has a working volume of 500 to 2500 liters. This user-friendly system has comparatively short set-up times and can be easily deployed in production. The SB2500-Z complies with GMP requirements and regulations.

Single-use bag for a fast and simple set up
The gamma irradiated 3D single-use bag for the Kühner orbital shaken bioreactor requires no additional mixing device and is therefore light and easy to handle. This enables quick set up times and eliminates elaborate cleaning and sterilizing procedures. The single-use bag has a working volume from 500 liters up to 2500 liters. Various ports are incorporated to allow inoculation, feeding, sampling, pH regulation, and harvesting. Two optical sensors each for pH and for DO measurement are built in. Customized bags are easily available on request.

Orbital motion
The orbital motion of the SB2500-Z ensures efficient liquid mixing with low localized power input per unit volume. It allows high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing.

Trouble free scale-up
Another advantage of the SB2500-Z is the easy scale-up from microtiter plates over shake flasks to shaken bioreactors all the way up to 2500 liters. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the scaling process.

Good Manufacturing Practice (GMP) and IQ/OQ Documentation
The SB2500-Z complies with GMP requirements and regulations. Kuhner products have established a global reputation of excellence under GMP requirements. Documentation, development and production along with the full life cycle of our products are continuously enhanced to match the requirements of 21 CFR and GAMP 5.
IQ-OQ (Installation Qualification and Operation Qualification), an equipment qualification required for GMP procedures, is available from Kuhner and qualification services can also be provided at the customer's premises.
We subject all our shaking machines to an elaborate final test before delivery and send the test protocols to our customers.

Reliable and monitored drive system
The shaking unit of the SB2500-Z uses a robust and long-lasting drive system which guarantees accurate control of the orbital speed and low energy consumption. The drive system (agitation) requires zero bag penetrations and runs without belts, meaning no abrasion or particle generation, an important factor for production processes in cleanrooms. Motor-specific parameters are constantly monitored, allowing for predictive maintenance and failure prevention. The entire drive unit may be exchanged with a process in place in less than 2 hours.

Control unit
The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and Siemens SCADA for data recording, calibration, programming and controlling. Technical controls for 21 CFR Part 11 compliance are built into the software.

Temperature regulation
The SB2500-Z can be electrically heated or (optionally) cooled. If cooling is chosen as an option, a cooling ring is embedded in the base plate of the SB2500-Z. Cooling is achieved by connecting an external cooling device. An integrated valve, controlled by the software, regulates the set point temperature. Temperature ramps are easily programmed and processed.

Online measurement and control of pH and DO (dissolved oxygen)
The single use bag has built in pre-calibrated, optical sensors for pH and DO (two of each). The duplex online measurement of both parameters in the medium ensures greater process safety. The pH value can be controlled by the addition of acid/base via peristaltic pumps or stabilized via dosage of CO2. To control the DO, the gas flow of the inlet gas can be increased or decreased, the percentage of oxygen in the inlet gas can be varied (via the gas mixing device), and the shaker speed can be adjusted.

Pumping system
There are three peristaltic pumps, which can be placed external, mobile and can be controlled by the bioreactor software. The control unit incorporates two smaller and one large peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media for downstream processing.

Gas mixing (FlowCon)
The SB2500-Z has an integrated gas mixing device (FlowCon). Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor by reducing the gas flow in the first step and shutting off the gas flow in the second step. Step limits can be freely programmed by the user. There is also another pressure sensor directly connected to the bag via the filter. Integrated gas filters ensure interference free and long operating times for the FlowCon.

Filter heater
A height adjustable filter heater, with up to two exhaust filters, is installed above the vessel. Special emphasis has been placed on developing a user-friendly unit. The filter heater combats any water vapor condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by the Siemens SCADA software of the control unit.

Orbital shaken bioreactor for single-use bags with a working volume up to 2500 litres
The next generation of manufacturing-scale orbital shaken bioreactor (OSB) SB2500-Z is now available for the cultivation of human, mammalian, plant, and insect cells in a single-use bag. The bioreactor system has a working volume of 500 to 2500 liters. This user-friendly system has comparatively short set-up times and can be easily deployed in production. The SB2500-Z complies with GMP requirements and regulations.

Performance characteristics

• Large range of working volume: 500-2500 L

• Cultivation of human, mammalian, plant, and insect cells

• User-friendly & fast and simple set-up

• 3D single-use bag

• Trouble-free scale-up

• Online measurement and control of pH and DO

• Qualification for GMP production processes

Single-use bag for a fast and simple set up
The gamma irradiated 3D single-use bag for the Kühner orbital shaken bioreactor requires no additional mixing device and is therefore light and easy to handle. This enables quick set up times and eliminates elaborate cleaning and sterilizing procedures. The single-use bag has a working volume from 500 liters up to 2500 liters. Various ports are incorporated to allow inoculation, feeding, sampling, pH regulation, and harvesting. Two optical sensors each for pH and for DO measurement are built in. Customized bags are easily available on request.

Orbital motion
The orbital motion of the SB2500-Z ensures efficient liquid mixing with low localized power input per unit volume. It allows high oxygen transfer rates with low shear forces. Mechanical stress on the cells is reduced thanks to bubble-free surface gassing with almost no frothing.

Trouble free scale-up
Another advantage of the SB2500-Z is the easy scale-up from microtiter plates over shake flasks to shaken bioreactors all the way up to 2500 liters. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the scaling process.

Good Manufacturing Practice (GMP) and IQ/OQ Documentation
The SB2500-Z complies with GMP requirements and regulations. Kuhner products have established a global reputation of excellence under GMP requirements. Documentation, development and production along with the full life cycle of our products are continuously enhanced to match the requirements of 21 CFR and GAMP 5.
IQ-OQ (Installation Qualification and Operation Qualification), an equipment qualification required for GMP procedures, is available from Kuhner and qualification services can also be provided at the customer's premises.
We subject all our shaking machines to an elaborate final test before delivery and send the test protocols to our customers.

Reliable and monitored drive system
The shaking unit of the SB2500-Z uses a robust and long-lasting drive system which guarantees accurate control of the orbital speed and low energy consumption. The drive system (agitation) requires zero bag penetrations and runs without belts, meaning no abrasion or particle generation, an important factor for production processes in cleanrooms. Motor-specific parameters are constantly monitored, allowing for predictive maintenance and failure prevention. The entire drive unit may be exchanged with a process in place in less than 2 hours.

Control unit
The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and Siemens SCADA for data recording, calibration, programming and controlling. Technical controls for 21 CFR Part 11 compliance are built into the software.

Temperature regulation
The SB2500-Z can be electrically heated or (optionally) cooled. If cooling is chosen as an option, a cooling ring is embedded in the base plate of the SB2500-Z. Cooling is achieved by connecting an external cooling device. An integrated valve, controlled by the software, regulates the set point temperature. Temperature ramps are easily programmed and processed.

Online measurement and control of pH and DO (dissolved oxygen)
The single use bag has built in pre-calibrated, optical sensors for pH and DO (two of each). The duplex online measurement of both parameters in the medium ensures greater process safety. The pH value can be controlled by the addition of acid/base via peristaltic pumps or stabilized via dosage of CO2. To control the DO, the gas flow of the inlet gas can be increased or decreased, the percentage of oxygen in the inlet gas can be varied (via the gas mixing device), and the shaker speed can be adjusted.

Pumping system
There are three peristaltic pumps, which can be placed external, mobile and can be controlled by the bioreactor software. The control unit incorporates two smaller and one large peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media for downstream processing.

Gas mixing (FlowCon)
The SB2500-Z has an integrated gas mixing device (FlowCon). Whether stabilizing the pH with CO2, or preventing low dissolved oxygen concentrations, the gas mixer meets all user needs. Four mass flow controllers ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor by reducing the gas flow in the first step and shutting off the gas flow in the second step. Step limits can be freely programmed by the user. There is also another pressure sensor directly connected to the bag via the filter. Integrated gas filters ensure interference free and long operating times for the FlowCon.

Filter heater
A height adjustable filter heater, with up to two exhaust filters, is installed above the vessel. Special emphasis has been placed on developing a user-friendly unit. The filter heater combats any water vapor condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by the Siemens SCADA software of the control unit.