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SB10-X (OrbShake)

Product

Orbital shaken benchtop bioreactor for single-use bags

Short description

The SB10-X is an orbital shaken benchtop bioreactor system for the cultivation of human, mammalian and plant cells in a single-use bag. It consists of six modules (excluding the bag) and has a working volume from 3 litres up to 12 litres.
The SB10-X can be used in research, process development or as a pilot scale bioreactor.

Performance characteristics

 
 
+ Cultivation of human, mammalian and plant cells
+ Fast, simple set up
+ Easy scale-up
+ Online measurement and control of pH and DO
+ Three different single-use bags available

Single-use bag for a fast and simple set up

The cylindrical vessel accepts a single-use 3D 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 standard bag has built-in optical sensors for pH/DO allowing online measurement and control of pH and DO in the medium. Two other bag types are available: a basic single-use bag with no optical sensors and a perfusion bag for ATF and TFF perfusion.

Orbital motion

The orbital motion of the SB10-X ensures efficient liquid mixing. It facilitates 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 SB10-X uses the unique Kuhner direct drive which is very robust and provides accurate control of the orbital speed.

Trouble free scale-up

The SB10-X fills a gap in the scale-up chain from commonly used single-use flasks all the way up to 50 L and 200 L bioreactors. The consistent hydrodynamics of shaken bioreactors provide reproducible cultivation conditions throughout the volume range. The culture from the SB10-X can serve as a preculture for the SB50-X and SB200-X OrbShakers. The SB10-X can also be used as a pilot scale bioreactor.

Heating and online pH & DO measurement

The tray module, which is fixed onto the ES-X shaker module, contains integrated heating and the connections for online pH and DO measurement.


Online pH and DO measurement

Vessel module

Special emphasis has been placed on developing a user-friendly vessel module. The vessel together with its bag can be easily detached by the user and carried to the clean bench.

Vessel module

Filter heater

A filter heater for one exhaust filter is placed above the vessel module. The magnetic mounting makes handling the filter heater very simple and allows its location in various places. The filter heater combats water vapour condensation in the outlet air preventing blockages in the membrane.

Filter heater

Control unit and software

The compact and functional design of the control unit provides easy handling and monitoring of the bioprocess parameters. The control unit has an integrated and adjustable 12” touch screen with USB and Ethernet connections. The Kuhner Insight application software for data recording, calibration, programming and controlling is user-friendly and
21 CFR Part 11 compliant. Control of pH/DO, medium temperature, shaking frequency and gas flow rate and mixture is possible.

Control unit with touch screen and pumps

Pumping system

The control unit incorporates three peristaltic pumps which allow aseptic fluid management. This enables simple regulation of the pH-value, feeding and the transfer of the culture media (scale-up or processing).

Gas mixing

The SB10-X control unit 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 (N2, O2, CO2 and air or gas mixture) ensure highly accurate and reproducible gas mixing. An integrated pressure sensor prevents over pressure in the bioreactor. 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.


Technical data

Orbital shaken benchtop bioreactor for single-use bags

SB10-X

  SMX7600
Includes 6 modules - Shaker module ES-X
- Control unit
Bioreactor:
- Tray module
- Vessel module
- Cable and tube management module
- Filter heater

Shaken bioreactor

   
Working volume 3 L - 12 L
Total bag volume approx. 24 L
Weight
(bioreactor incl. shaker)
approx. 75 kg without liquid
Required footprint
(excl. control unit)
669 mm x 646 mm

Dimensions (in mm)

 

Shaker module ES-X

   
Motor modified ES-X benchtop shaker
Shaking diameter 50 mm (orbital motion)
shaking diameter is adjustable
(12.5 mm, 25 mm, 50 mm)
Shaking speed 20 rpm - 140 rpm
(when used with SB10-X)
Loading, maximum 25 kg
Setting, digital 1 rpm
Accuracy, absolute ± 0.1 rpm
Active brake adjustable
Ambient temperature 5°C - 40°C
Casing stainless steel 1.4301

Mains connection

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

Temperature control

   
Heating resistance heater (100 W),
integrated in tray module
Temperature max. 40 °C
Temperature min. approx. ambient temperature (no cooling)
Temperature accuracy ± 0.25 °C
Temperature distribution 8 mm thick aluminium plate provides homogenous temperature distribution of resistance heater

pH and DO control

   
pH measurement principle: optical chemosensor (PreSens),
integrated in tray module
Range pH 5.5 – pH 8.5
Accuracy (chemosensor) ± pH 0.05 at pH 7 with one point calibration
± pH 0.10 at pH 7 with pre-calibration
Drift < 0.005 pH per day
Temperature range up to 50 °C
   
DO measurement principle: optical chemosensor (PreSens),
integrated in tray module
Range 0 % – 100 % DO
Accuracy (chemosensor) ± 0.1 % O2 at 20.9 % O2
Accuracy (system) ± 10 % DO
Drift < 0.015 % O2 per day
Temperature range up to 50 °C

Filter heater 

   
Capacity 1 exhaust filter
Casing polycarbonate
Heating resistance heater (6 W)
Max. temperature approx. 40 °C at 23 °C ambient temperature
Control orange LED light indicates that filter heater is active and working

Control unit

(SMX76011)
Weight approx. 30 kg
Required footprint 698 mm x 328 mm
Casing Stainless steel 1.4301
Interface 2 x CAN-Bus
Optional: EMI-60, NET-60

Dimensions (in mm)

 

Touch screen

   
Display 12.1’’ screen (resistive)
front is splash proof and dust protected (IP 64)
Resolution 1024 x 768
Cooling passive with no fan
Main memory 2 GB (1.6 GB usable)
Interfaces 4 x USB, 2 x RS 232,
2 x LAN, 1 x VGA

Software

  Kuhner Insight application software
Monitoring pH & DO, shaking speed, temperature, gas flow and mixture, pressure
Calibration pre-calibrated sensors in bag
Recalibration one point recalibration is possible
Applicable Win7 & 10
GMP 21 CFR Part 11 compliant

Pumps

  3 peristaltic pumps
Type Watson-Marlow 313 VBM/D
Rollers 3
Power 70 W
Maximum Speed 100 rpm
Tube 1.6 mm wall thickness
Delivery Pressure max. 2bar
   
   
Tube ID (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
8 500

Gas mixing device (FlowCon)

   
   
Number of mass flow controllers
4
Ambient conditions 5 °C – 40 °C, max. 85 %rH
Input up to 4 gases (air, oxygen, nitrogen, carbon dioxide)
different gas mixtures
can also be connected
push in connector for tubes OD 6 mm
required input pressure: 1 bar – 2 bar
Output 1 (tube fitting optimal for tubing 9 x 1 mm)
Flow rates:
N2: 0.1 L min-1 – 1.99 L min-1
O2: 0.1 L min-1 – 1.99 L min-1
CO2: 0.1 L min-1 – 1.4 L min-1
air: 0.1 L min-1 – 1.99 L min-1
accuracy: ± 1.3 % of full scale
Pressure measurement gas output: pressure sensor DELOS SI (Jumo),
integrated in FlowCon
Differential pressure 0 mbar – 100 mbar (programmable)
Gas filter integrated, prevents blocking of mass flow controllers

Options

Orbital shaken benchtop bioreactor for single-use bags

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.

Interfaces

Two additional interfaces, EMI-60 and NET-60, are available as options.
  • EMI-60:
    The EMI-60 has several interfaces: two analogue outputs and two individually configurable alarm relays.
  • NET-60:
    NET-60 allows the machine to be connected to almost all conventional Bus-systems and to OPC servers.

Accessories

Orbital shaken benchtop bioreactor for single-use bags

Single-use bag

Kuhner offers three different single-use bag types to meet all user needs. Each pack contains three bags.
These gamma-irradiated bags for the Kuhner shaken bioreactor require no additional mixing device, enable quick set up times and eliminate elaborate cleaning and sterilising procedures. All bags have a working volume from 3 litres up to 12 litres. Various ports are incorporated to allow feeding, inoculation, harvesting and sampling.

The standard bag (SMX760001) has built in optical sensors for pH and DO which allow non-invasive online measurement and control of pH and DO. This standard bag is suitable for ATF perfusion.
The basic single-use bag (SMX760002) is the same as the standard bag, but has no optical sensors.
The perfusion bag (SMX760003) has two exhaust filters and is equipped with additional tubes and ports for TFF perfusion. ATF perfusion is also possible.

Order number

  Description
SMX760001 3 x standard single-use bags for SB10-X with optical chemosensors for pH/DO and tubes
SMX760002 3 x basic single-use bags for SB10-X
with no optical sensors
SMX760003 3 x perfusion single-use bags for SB10-X with
2 exhaust filters, optical chemosensors for pH/DO and additional tubes

Overpressure valve & glass fibers (spare parts)


Order number

  Description
SMX76007 Red overpressure valve, OD 9mm
SMX876001 2 glass fibers for pH/DO probes, length 40cm

Light protection jacket

Order number: SMX76005

This light protection jacket is easily placed over the vessel module. It protects light sensitive media or products from UV and artificial light as well as daylight.

MagFix

Order number: SMX76006

MagFix is a set of 8 magnetic tube holders to help secure and guide all the tubing. It consists of 6 units for tubing OD 6mm/11mm and 2 units for tubing OD 15mm. The tubing fits easily into the slots on each unit. These magnetised holders can be attached to various steel surfaces on the vessel module, cable management module and shaker module of the SB10-X. The magnets on these units are so strong that they are also effective through the light protection jacket.