SB200-X (Climo Shaker)

Product

Product

Orbital shaken bioreactor for disposable bags.

 

Description

The SB200-X is an orbital shaken bioreactor for the cultivation of human, mammalian and plant cells in a disposable bag. Orbitally shaken SUB's preserve kLa and mixing time performance within a very low shear environment. A working volume from 50 liters up to 200 liters for the SB200-X ensures easy scale-up from microtiter plates to shaking  asks and all the way up to 200 liters. 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).

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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

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Disposable bag for a fast and simple set up

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

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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 accurate control of the orbital speed

 

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Trouble free scale-up

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

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Control unit and online measurement

The bespoke control unit, designed by Kuhner, uses the latest touch-screen technology and ISIS-X 8.0 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

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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

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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.

 

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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 ISIS-X 8.0 software.

Filter heater

 

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Technical Data

Technical data

Orbital shaken bioreactor for disposable 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 < 1300Wadjustable
Interface CAN-Bus, RS232
Temperature up to 50oC
Cooling cooling coils are incorporated for connection to an external cooling system (pressure < 0.2bar)

 

Dimensions (in mm)

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Mains connection

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

 

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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 50oC
   
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 precalibration

Drift <0.005 pH per day
Temperature range

up to 50oC

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Filter heater

 

SMX7120

Capacity 2 exhaust filters
Temperature range Ambient temperature up to 70oC, monitored and controlled by ISIS-Software

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Control unit

Order number

SMX7110

Weight 120 kg
Monitor 15" touchscreen monitor

 

Dimensions (in mm)

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ISIS-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/Win8
GMP 21 CFR Part 11 compliance (audit trail)

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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

 

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Gas mixing

 

Number of mass flow controllers up to 4
Ambient conditions 5-40 oC, 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

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Options

Options

Orbital shaken bioreactor for disposable bagss.

 

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 ISIS-Software, regulates the set point temperature.

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IQ-OQ documentation

IQ-OQ (Installation Qualification and Operation Qualification) is an equipment qualification according to GMP procedure. Kuhner offers this service which can also be carried out at the customer’s premises.

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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.

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Accessories

Accessories

Orbital shaken bioreactor for disposable bags

 

Disposable 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 sterilizing procedures. The single-use bag has a working volume from 15 liters up to 50 liters. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling. The bag has built in optical sensors for pH and DO.

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Interfaces

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


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FAQ

FAQ

Orbital shaken bioreactor for disposable bags.

 

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

Yes, no other equipment is required.

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? Is anything else required to fit the disposable bag?
!

No, the disposable bag is simply placed into the SB200-X vessel, positioned and then inflated and filled with media.

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?

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 does not occur, as is the case with STBR's.

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?

Is IQ-OQ documentation available for the shakers?

!

Yes.

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?

Can the machine be used in the GMP sector?

!

Yes

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