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tl_files/kuhner/product/safety/Bilder/pdf.jpg Shaken Bioreactors Provide Culture Alternative (GEN, 11/2009)

 

SB200-X (OrbShake)

Product

Orbital shaken bioreactor for single-use bags

Short description

The SB200-X is an orbital shaken bioreactor for the cultivation of human, mammalian and plant cells in a single-use bag. A working volume from 50 litres up to 200 litres for the SB200-X ensures easy scale-up from microtiter plates to shaking  asks and all the way up to 200 litres. This user friendly system can be easily deployed in research, process development or production.


The SB200-X was developed and tested in collaboration with ExcellGene SA (Monthey, Switzerland) and the Swiss Federal Institutes of Technology EPFL (Lausanne, Switzerland).

Performance characteristics

 
 
+ Large capacity (200L working volume)
single use bioreactor system
+ Cultivation of human, mammalian and plant cells
+ Fast, simple set up
+ Easy scale-up
+ Online measurement of pH and DO

Single-use bag for a fast and simple set up

The vessel accepts a single-use bag. This bag requires no additional mixing device, enables quick set up times and eliminates elaborate cleaning and sterilising procedures. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The bag has built in optical sensors for pH and DO.

 

Single-use bag with pH & DO sensors and various ports

Orbital motion

The orbital motion of the SB200-X ensures efficient liquid mixing. 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. This motion is particularly suitable for microcarrier cultivation. The SB200-X uses the unique Kuhner direct drive which provides acurate control of the orbital speed.

Trouble free scale-up

Another advantage of the SB200-X is easy scale-up from microtiter plates all the way up to 200 litres. The consistent hydro-dynamics of shaken bioreactors provide reproducible cultivation conditions throughout the volume range.

Control unit and online measurement

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

The SB200-X can be heated or cooled. Temperature ramps are easily programmed and processed.
Duplex online measurement of each parameter (dissolved oxygen and pH value) is available ensuring greater process safety.


Reader Box-X: Online measurement of pH and DO

Pumping system

The control unit incorporates two small and one big peristaltic pump. This enables simple regulation of the pH value, feeding and the transfer of the culture media (scale-up or processing).


Pumps

Gas mixing

The SB200-X 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 (1. limit) and shutting off the gas flow in the second step (2. limit). Step limits can be freely programmed by the user. Integrated air filters and back pressure valves 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 vapour condensation in the outlet air which might cause the membranes to block. The temperature is monitored and controlled by Kuhner Insight software.


Filter heater

Technical data

Orbital shaken bioreactor for single-use bags

Shaker

  SMX7100
Shaker speed max. 80 rpm
Shaker diameter 50 mm (orbital motion)
Weight approx. 400 kg without liquid
Accuracy, absolute 0.1 rpm
Setting, digital 1 rpm
Active brake adjustable
Interface CAN-Bus, RS232
Temperature up to 50°C
Cooling cooling coils are incorporated for connection to an external cooling system (pressure < 0.2bar)

Dimensions (in mm)

 

Mains connection

   
SMX1021 220 - 240 V / 50-60 Hz
SMX1023 110 - 120 V / 50-60 Hz
SMX1024 95 - 105 V / 50-60 Hz

Reader Box-X

SMX7130
Oxygen Sensor Optical measuring method
Range 0-100%
Accuracy ± 0.01%O2 at 0.21%O2
± 0.1%O2 at 20.9%O2
Drift < 0.015%O2 per day
Temperature range up to 50°C
   
pH Sensor Optical measuring method
Range 5.5 - 8.5
Accuracy ± 0.05 pH at pH 7 with one point calibration
± 0.10 pH at pH 7 with pre calibration
Drift < 0.005 pH per day
Temperature range up to 50°C

Filter heater 

  SMX7120
Capacity 2 exhaust filters
Temperature range Ambient temperature up to 45°C,
monitored and controlled by Kuhner Insight software

Control unit

 

Order number

SMX7110
Weight 120kg
Monitor 15'' touchscreen monitor

Dimensions (in mm)

 

Kuhner Insight Software

   
Software for monitoring, calibration, controlling
Monitoring O2, pH, shaking speed, temperature
Calibration pre-calibrated sensors in bag
Recalibration one point recalibration is possible
Applicable XP/Vista/Win7&8
GMP 21 CFR Part 11 compliance (audit trail)

Pumps

   
2 small pumps (A+B) Watson-Marlow 313VBM/D
Gear 10
Maximum Speed 100 rpm
Power 70 W
Rollers 3
Tube 1.6 mm wall tubing
Delivery Pressure max. 2bar
   
   
1.6 mm wall tubing
Bore diameter (mm)
Flow rates (ml/min at 100 rpm)
0.5 3.4
0.8 7
1.6 27
3.2 100
4.8 220
6.4 360
8.0 500
1 big pump (C) Watson-Marlow 520VBM/R2
Gear 10
Maximum Speed 400 rpm
Power 70 W
Rollers 2
Tube 2.4 mm wall tubing
Delivery Pressure max. 2bar
   
   
2.4 mm wall tubing
Bore diameter (mm)
Flow rates (ml/min at 100 rpm)
0.5 4.1
0.8 10.5
1.6 42
3.2 170
4.8 380
6.4 680
8.0 1040
9.6 1500

Gas mixing

   
Number of mass flow controllers
up to 4
Ambient conditions 5-40 [°C], max. 85 [%rH]
Input up to 4 gases, push in connector 6 [mm]
(air, oxygen,nitrogen, carbon dioxide)
(gas mixtures can also be connected)
Input pressure 1-2 bar
Output 1, (tube fitting for tube ID 13 [mm])
Flow rate 0 - 20 [sL/min]
Accuracy ±1.5% from the end value
Pressure sensor integrated, 0-400 [mbar], programmable
prevents overpressure in the connected vessel
Air filter integrated, prevents blocking the mass flow controllers
Back pressure valve integrated, prevents reflux into the mass flow controllers
Controlled filter
heating box
for the outlet filters, prevents blocking of the filters caused by condensation
(only air inlet and outlet with silicon tubing)
C-Flex material for the tubing, enables the user to connect additional components via tube welding

Options

Orbital shaken bioreactor for single-use bags

Cooling

The SB200-X has a cooling ring embedded in the base plate. Cooling is achieved by connecting an external cooling device. An integrated valve, controlled by the Software, regulates the set point temperature.

IQ-OQ Documentation

IQ-OQ (Installation Qualification and Operation Qualification) is an equipment qualification required for GMP procedures. Documentation is available from Kuhner and Qualification services can also be provided at the customer`s premises.

Tubing support bar

Order number: SMX714001

 

A tubing support bar is available for attaching the various tubes (feeding, medium, air and pH regulation) and keeping them tidy.

Accessories

Orbital shaken bioreactor for single-use bags

Single-use bag for a fast and simple set up

Order number: SMX710001


The gamma irradiated bag for the Kuhner shaken bioreactor requires no additional mixing device, enables quick set up times and eliminates elaborate cleaning and sterilising procedures. The single-use bag has a working volume from 50 litres up to 200 litres. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The bag has built in optical sensors for pH and DO.

Interfaces

Kuhner shakers are equipped with a CAN-bus. CAN-USB, CAN-Ethernet, EMI-60 and NET-60 are all well established interfaces.

FAQ

Orbital shaken bioreactor for single-use bags

?

Is it possible to move the SB200-X with a manually operated fork lift?

!

Yes, no other equipment is required.

? Is anything else required to fit the single-use bag?
!

No, the single-use bag is simply placed in the SB200-X vessel, positioned and then inflated.

 

?

Is the mechanical stress on the cells greater than with the stirred system?

!

No, shaken systems have a very homogenous and low local power input. This means that high local power inputs which are responsible for mechanical stress, simply don’t occur.

? Is IQ-OQ documentation available for the shakers?
! Yes
?

Can the machine be used in the GMP sector?

!

Yes