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SB10-X single-use bioreactor

SB10-X single-use bioreactor
Overview
Overview
Technical Data
Options
Accessories
Science
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Orbital shaken benchtop bioreactor for single-use bags

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 4 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 types of single-use bags available

5 year warranty

5 year warranty

Single-Use

Single-Use

Scale-Up

Scale-Up

GMP

GMP


Bag

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

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.


Scale-Up

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. The SB10-X can also be used as a pilot scale bioreactor.


Online measurement

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-Messung

Vessel module

Vessel module

Kesselmodul

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.


Filter heater

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

Online-Messung

Control unit

Control unit and software

Kesselmodul

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.


Pumping system

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

Gas mixing (FlowCon)

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.

Online-Messung

Machine

SB10-X

SMX7600

Includes 6 module

- Shaker module ES-X
- Control unit

Bioreactor:

- Tray module
- Vessel module
- Cable and tube management module
- Filter heater

Shaken bioreactor

Working volume

4 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) shaken bioreactor

Standarddatei

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

± 0.5 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 aluminum plate provides homogenous temperature distribution of resistance heater

pH and DO control

pH measurement

principle: optical chemosensor,
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

< pH 0.005 per day

Temperature range

up to 50 °C


DO measurement

principle: optical chemosensor,
integrated in tray module

Range

0 % – 100 % DO

Accuracy (chemosensor)

± 0.1 % O2 at 20.9 % O

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)

Massbild Steuermodul

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

Win 7 & 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


C2: 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

Technical data subject to change

Overview options

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.

GMP

Overview Accessories

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 4 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


Light protection jacket

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.

Order number

Description

SMX76005

Light protection jacket

Lichtschutzmante

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


MagFix

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.

Order number

Description

SMX76006

MagFix

MagFix

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.

Publications


Kuhner Notes


Poster

Characterisation of SB10-X single-use bioreactor

Distribution and mixing times of microcarriers

New Orbital Single Use Bioreactor

Orbital Mixing as an Alternative to Stirred-Tank Bioreactors

Characterization of orbitally shaken single-use bioreactors

Baculovirus-based r-protein production in orbitally SUB

Cultivation of entomopathogenic fungi in orbitally shaken bioreactors

Orbital Shaken Bioreactors
The Scale Up Fast Track


In our Science Room, we offer general information and data of cultivation processes in shaken bioreactors.

SB10-X – Our orbital shaken bioreactor for single-use bags

Der SB10-X ist ein orbital geschüttelter Bioreaktor zur Kultivierung von humanen, tierischen und pflanzlichen Zellen in Einwegbeuteln. Das Bioreaktorsystem (SB10-X) besitzt ein Arbeitsvolumen von 4L bis 12L und besteht aus sechs Modulen (exkl. Einwegbeutel).

Der SB10-X kann in der Forschung, Prozessentwicklung oder als Pilotscale-Bioreaktor eingesetzt werden.

The following flyers provide information about the machines and function-specific solutions.

Contact

Adolf Kühner AG (Headquarters)

Dinkelbergstrasse 1

CH-4127 Birsfelden (Basel)

Switzerland

Services

We support our customers in implementation, maintenance and repair of all Kuhner products – efficiently and competently. 

GMP compliant production of shakers and bioreactors

For Kuhner, the quality and durability of their shakers and bioreactors have always been the topics with the highest priority. On this account, Kuhner products have also proven their worth worldwide under GMP requirements. Documentation, development and production along the full life cycle of our products are continuously enhanced to match the requirements of 21 CFR and GAMP 5.

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The world's most reliable shaking machines built in-house in Switzerland.

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