SST 20-590 l

 

The Pilot system bioreactor range is divided in a microbial range and in a cell culture range of volumes. The microbial Sterilizable-In-Place bioreactor systems come in a total volume of 20 liter, 40 liter, 70 liter and 140 liter. The cell culture Sterilizable-In-Place bioreactor systems come in a total volume of 30 liter, 60 liter and 130 liter. The main difference between these two lines is the aspect ratio of the bioreactors. The microbial system have an aspect ratio of 3.0 at total volume while the cell culture systems have an aspect ratio of 1.5 at total volume. Applications are pilot plant and small scale production for both mammalian cells and micro-organisms. The pilot range is the first step in the scale-up to production level and these systems have the same functionality as the full production scale. This minimizes risks in process transfer to the final production volume.  The small footprint guarantees that the minimal amount of floor space is occupied by the system. All systems are fully documented for cGMP usage and are supplied with an extensive documentation package to support validation.

Modularity

A wide range of standard and extensively tested modules is available to customize the systems to the specific demands of the customer. The modularity extends to the control systems that can be supplied with the systems. A wide range of add-on packs are available. These standard packs include pressure control, weight control, double gas inlet lines, CIP modules, biomass sensors, perfusion systems and many more.

 

Control

Abacus offers a choice of process control systems. The i-Control can be supplied with an Allen Bradley or with a Siemens PLC. Both systems offer automated Sterilization procedures. The i-Control software is just as customizable as the pilot system hardware. The basic software is capable of completely automatic control of the most complex bioreactor system. The i-Control is customized by disabling the un-used features for the specific application. This means that when process demands changes, the controller can easily be adapted to these new demands but enabling the extra functionality. No additional programming is needed so no extra paperwork is required for validation of the control system. The Pilot bioreactors can also be used with control systems that are already in place at the customers site. The BioXpert software is used for data collection, data visualization  and advanced supervisory control actions.

Specifications:

Application Microbial culture Cell culture

Bioreactor type

20 liter

40 liter

70 liter

140 liter

30 liter

60 liter

130 liter

Inner Diameter (mm)

211 mm

265 mm

395 mm

395 mm

320 mm

395 mm

491 mm

Inner Height (mm)

631 mm

795 mm

957 mm

1158 mm

448 mm

566 mm

764 mm

Liquid Height (mm)

440 mm

546 mm

655 mm

850 mm

300 mm

388 mm

604 mm

Ports Head Space section

5 x 27 mm

5 x 27 mm

5 x 27 mm

6 x 27 mm

5 x 27 mm

5 x 27 mm

6 x 27 mm

Ports Bottom section

5 x DN 25

5 x DN 25

5 x DN 25

7 x DN 25

5 x DN 25

5 x DN 25

7 x DN 25

Ports Head Plate

1 x 69 mm

3 x 16 mm

4 x 27 mm

3 x 1.5" TC

1 x 69 mm

3 x 16 mm

4 x 27 mm

3 x 1.5" TC

1 x 69 mm

3 x 16 mm

4 x 27 mm

3 x 1.5" TC

1 x 69 mm

2 x 16 mm

5 x 27 mm

3 x 1.5" TC

2 x 2" TC

1 x 3" TC

1 x 69 mm

3 x 16 mm

4 x 27 mm

3 x 1.5" TC

1 x 69 mm

3 x 16 mm

4 x 27 mm

3 x 1.5" TC

1 x 69 mm

2 x 16 mm

5 x 27 mm

4 x 1.5" TC

2 x 2" TC

Bottom Drain

0.5"TC

1"TC

1.5"TC

1.5"TC

1"TC

1.5"TC

1.5"TC

Floor Space (WxD)

1250 x 800 mm

1250 x 800 mm

1250 x 800 mm

1500 x 1000 mm

1250 x 800 mm

1250 x 800 mm

1500 x 1000 mm

Height

2100 mm

2100 mm

2100 mm

2750 mm

2100 mm

2100 mm

2100 mm

Total Volume

20 liter

40 liter

70 liter

140 liter

30 liter

60 liter

130 liter

Working Volume

15 liter

30 liter

50 liter

100 liter

20 liter

40 liter

100 liter

Min. Working Volume

5 liter

7.5 liter

10 liter

20 liter

7.5 liter

10 liter

28 liter

H/D Total

3.0

3.0

3.0

3.0

1.5

1.5

1.5

H-D Work Vol.

2.2

2.2

2.2

2.2

1.0

1.0

1.0

Design Pressure Reactor

3.1 barg and full vacuum

3.1 barg and full vacuum

3.1 barg and full vacuum

3.1 barg and full vacuum

3.1 barg and full vacuum

3.1 barg and full vacuum

3.1 barg and full vacuum

Design Pressure Jacket

6.2 barg and full vacuum

6.2 barg and full vacuum

6.2 barg and full vacuum

6.2 barg and full vacuum

6.2 barg and full vacuum

6.2 barg and full vacuum

6.2 barg and full vacuum

Max. Temperature Reactor

150 oC

150 oC

150 oC

150 oC

150 oC

150 oC

150 oC

Pilot Bundles have the following configuration:

Parameter cell culture microbial culture
Temperature Electrical heating and cooling water injection into jacket. Steam injection into jacket for sterilization.
SIP systems have a pneumatically operated wetpart.
Options:
Double heatexchanger (closed loop),
Single heatexchanger for steam,
Superheated water
Empty sterilization,
Full sterilization.
Electrical heating and cooling water injection into jacket. Steam injection into jacket for sterilization.
SIP systems have a pneumatically operated wetpart.
.
Options:
Double heatexchanger (closed loop),
Single heatexchanger for steam,
Superheated water
PH Acid via CO2 gas rotameter with valve, alkali via fixed speed pump
Option:
MFC CO2,
Acid pump
Acid and alkali liquids via fixed speed pump.
DO2 O2 and Air via rotameters, O2 with valve. Air @ 0.1 vvm, O2 @ 0.01 vvm
Optional:
MFC's for both gasses
N2 gas via rotameter or MFC
O2 and Air via rotameters. O2 with valve. Air @ 2 vvm, O2 @ 0.6 vvm
Optional:
MFC's for both gasses
N2 gas via rotameter or MFC
Agitation 1 m/s tipspeed
1 Marine impeller vortex for suspension cells or 1 Marine impeller scoping for anchorage dendant cells.
4 m/s tipspeed
2 or 3 rusthon impellers depending on aspect ratio of the tank. One impeller per 0.7 H/D at working volume.
Gas flow
Air and O2 sparge are present.
CO2 is present for cell culture.
Other gases are optional.
0.1    Vvm
Air sparge 0.1 vvm
Air overlay 0.2 vvm
O2 sparge 0.01 vvm
O2 overlay 0.1 vvm
N2 sparge 0.1 vvm
N2 overlay 0.2 vvm
CO2 sparge 0.05 vvm
CO2 overlay 0.1 vvm
Separate overlay is an option
2-3 vvm
Air sparge 2 vvm
Air overlay 0.5 vvm
O2 sparge 0.6 vvm
O2 overlay 0.3 vvm
N2 sparge 1 vvm
N2 overlay 0.3 vvm
Separate overlay is an option
Gas outlet Non jacketed condenser, gas preheater and exhaust filter. Non jacketed condenser, gas preheater and exhaust filter.
Sterilization setpoint 121 deg C 20 minutes
Sterilization of the tank and gas inlet and outlet line is automatic.  Addition lines are manual.
Full automatic is an option with I-Control.
121 deg C 20 minutes
Sterilization of the tank and gas inlet and outlet line is automatic.  Addition lines are manual.
Full automatic is an option with I-Control.
Pressure Pressure control is an option.
0 - 1 barg
Pressure control is an option.
0 - 1 barg
Culture modes Batch, Fed Batch, Perfusion Batch, Fed Batch, Continuous, Repeated fed batch.
Sparger type Poral. Ring  or L-type.
Headspace aeration Yes, combined filter
(Second filter line optional)
Yes combined with sparger filter.
(Second filter line optional)
Integrity testing of filters No (optional) No (optional)
Liquid inlets 2 push valves as standard.
Alkali, inoculum.
Contained inlets and extra push valves are optional
4 push valves as standard.Acid, Alkali, Antifoaming agent, inoculum.
Contained inlets and extra push valves are optional
Sensors Standard PH, DO2, Temperature, (optional pressure, level, foam, biomass, O2 gas, CO2 gas and others) Standard PH, DO2, Temperature, foam (optional pressure, level, OD, O2 gas, CO2 gas and others)
Draining Tank outlet with large bore diameter to allow CIP Tank outlet with large bore diameter to allow CIP
Tank aspect ration
Pilot systems only
H/D=1 at working volume,
H/D=1.5 at total volume.
H/D=2.2 at working volume,
H/D=3 at total volume.
Agitation mounting Pilot systems Top Bottom (Top is optional)
Spareparts Sparepart/startup kit included Sparepart/startup kit included
Software
ez-Control
ez-Control or i-Control

BioXpert Lite
BioXpert  2, BioXpert W7 are optional

BioXpert Lite
BioXpert  2, BioXpert W7 are optional BioXpert Lite