Data
The Xpansion Multiplate Bioreactor is part of the
Pall Life Sciences Integrity single-use bioreactor family. The Xpansion system is especially developed for fragile adherent cell culture applications such as stem cell culture.
The Xpansion Multiplate Bioreactor is industrialized for safe, large-scale production of traditional 2-D cell cultures. Its multiplate structure promotes a large cell growth surface area (up to 122,400 cm 2 ). Its compact efficient design enables the elimination of the gas phase between the plates. This gas phase is replaced by an automatically controlled aeration system which provides advanced gas diffusion.
Control is automatic via disposable pH and DO sensors.
Temperature monitoring and agitation control are also included. Xpansion bioreactors offer the possibility of monitoring cell morphology and density by a specific holographic microscope.
Features
• USP class VI certified materials
• Designed for adherent cell culture applications
• Completely single-use closed bioreactor from vessel to sensor for sterility and contamination risk reduction
• Multiplate, 2-D cell-culture design enables easy transfer from traditional multitray stacks
• Cell culture reproducibility and traceability by monitoring culture parameters (pH, DO, temperature) and real-time controls
• Monitoring of cell morphology and density by holographic microscope
• Upstream and downstream processing flexibility: reduction of numbers of operations, complexity and risks related to operations (e.g., seeding, medium exchange, harvest)
• Designed for use in a complete closed system from seeding to harvest
Xpansion System Structure
The Xpansion system includes a single-use bioreactor, a docking station and a controller.
Single-Use Bioreactor with Stacked Multiplate Design
Comprised of stacked hydrophilized polystyrene radial plates, the Xpansion Multiplate Bioreactor is designed to promote cell growth on the top of each plate. Each plate has a hole in the center. The stacking of these plates forms the central column which allows circulation of the medium in the bioreactor and gas exchange.
The plates are covered by an outer tube, a head plate on the top and a base plate on the bottom. On the head plate, there are:
• Two sensor connectors: one for pH, one for DO
(dissolved oxygen) and four optional
• Three windows for easy viewing under a specialized holographic microscope
• Two vent filters
• Two gas filters (in and out) for aeration system
• One thermowell port
• One sampling port
In the bottom side of the bioreactor, there are:
• Two fluid operation ports (e.g., inoculation, harvest, etc.)
• One magnetic impeller
13
2
1
Illustration of an Xpansion plate
3
2
1
4
5
6
7
8
13
10
9
11
12
Cut-away illustration of Xpansion Multiplate Bioreactor
Materials
1. Gas in & out
2. Vent 1 and 2
Silicone tubing ID 1/4”, Midisart BV 0.20 µm hydrophobic filters (PTFE, Polyester, Polypropylene)
Silicone tubing ID 1/4”, Midisart BV 0.20 µm hydrophobic filters (PTFE, Polyester, Polypropylene)
3. Sampling port
4. Headplate
Silicone tubing ID 1/4”, luer female connector
Clear Polystyrene
5. Cell surface plates
Cell culture plasma treated clear Polystyrene
6. Aeration support Polypropylene and Polycarbonate
7. Aeration tubing Silicone ID 0.58”, OD 0.77”
8. Outer tube Polyvinyl chloride
9. Stirrer cover
10. Impeller
Clear Polystyrene
UHMWPE
11. Bearing
12. Base
13. Liquid in/ out tubing
Sealing material
PEEK
Clear Polystyrene
C-Flex Clear 374 Tubing ID 3/8”, CPC MPC male on which connects Silicone tubing ID 1/4”, luer female connector or Silicone tubing ID 1/4”, 0.20 µm hydrophobic filters
Resin
Docking Station
The bioreactor is based on a docking station that includes a magnetic drive stirring unit. The magnetic agitation system is a quiet operation which is compatible with the magnetic impeller.
Control of agitation speed is integrated in the controller.
The setpoint is defined via the screen on the front side of the controller.
Controller
The controller is on a separate skid with measurement/control hardware and a gassing system with a digital control.
Features of the Xpansion controller include:
• Graphical user interface with color display and touch screen operation with two security levels:
Administrator and
Operator
• Integrated amplifiers for temperature, disposable DO and pH sensors
• Integrated control loops for DO and pH
• Agitation control (speed range from 5 up to 250 rpm)
• Temperature monitoring
• Calibration of pre-calibrated DO and pH sensors: Sensor patches come precalibrated. Calibration data are transferred via a USB key to the controller
• In-process DO and pH recalibration is possible
• Trend display for up to four process values (pH, DO, T, Q: flow rate)
Controller Gas Module
The controller is connected to the user’s gas supply line.
Its “gas outlet” is connected to the “gas in” filter of the bioreactor. Gas composition to be injected in the bioreactor is regulated by controller solenoid gas valves. The flow rate of the mixed gas is adjusted by a massflow controller
(0-200 mL/min).The controller gas module contains:
• One gas diffuser outlet
• Four solenoid valves of Air (1x), N and CO
2
(1x)
2
(1x), O
2
(1x),
• One Mass Flow Controller for gas mixing flow control
• Control via pH/DO controller
Data Management
Xpansion Multiplate Bioreactor systems have one Ethernet port for data communication/acquisition. It could be linked to Egraph (optional software provided by Pall Life Sciences).
Egraph is installed on a host PC and provides data acquisition for all process values.
Xpansion Controller and Docking Station
Controller
Height
Depth
Width
Weight
Power Supply
Interface
Stirrer speed
Integrated Measurement
Module
One Point
Recalibration Function
Gas Options
Temperature Monitoring
50 cm (19.7”)
40 cm (15.7”)
25 cm (9.8”)
15 kg (33 lbs.)
100 – 240 VAC, 50 – 60 Hz
Ethernet
USB host
5 – 250 rpm
Disposable DO sensor
Disposable pH sensor
Temperature
Disposable DO sensor
Disposable pH sensor
O
2
N
2
CO
Air
2
0 – 50 ºC (32 – 122 ºF)
Performance
Standard Cell Environment Preservation
As in multitray stacks, cells adhere and grow on hydrophilized polystyrene plates and are harvested using a cell dissociation reagent.
Because of its specific design, the system maintains the same environment as T-flasks or multitray stacks, and enables implementation of a process easily-adapted from these traditional methods.
Cell Culture Parameters (pH, DO) Control and
Temperature Monitoring
Xpansion Multiplate Bioreactor head plate includes patches ports for optical non invasive measurement of pH and dissolved oxygen (DO). The determination of pH and
DO are based upon the principle of fluorescence for contamination risk elimination. Depending on the DO and pH measurement, gas regulation is activated via the controller according to users’ requirements.
Temperature is measured for monitoring via a PT100 reusable sensor installed in a thermowell of the bioreactor.
The heating is done via an incubator or in a warm room.
Each measure (pH, DO and T) is associated with an alarm.
Optical pH Sensor Performance Specifications
Detection range
Accuracy
Precision
Response time (t90 )
Calibration
Materials pH 6.0 – 9.0
±0.1 @ pH 6.5 – 8.5
±0.1 @ pH 7.0
30 seconds
Shipped pre-calibrated, optional one point user recalibration
USP Class VI certified
Optical DO Sensor Performance Specifications
Detection range
Accuracy
Precision
Response time (t90 )
Calibration
Materials
= 0% airsat - 150% airsat
+/- 2% airsat @ DO 15% airsat -
75% airsat
+/- 0.5% @ airsat
15 seconds
Shipped pre-calibrated, optional one point user recalibration
USP Class VI certified
Aeration System
Gas aeration occurs depending on pH and DO control limits set by the users. Gas composition control depends on pH and DO measurement in the bioreactor. The gas coming from the controller enters via the “gas in” filter of the bioreactor and passes through very thin silicone tubing placed in the central column. The gas inlet and outlet include pre- installed hydrophobic aeration filters. Gases diffuse through the tubing.
Homogenization by Medium Circulation
Medium circulation is coupled with the aeration system which depends on pH and DO control. The medium could also circulate in the bioreactor independently of gas aeration according to users’ requirements. Each plate contains 16 radial channels supporting media flow rate.
The liquid goes up through the first plate channel, flows horizontally over the plate, then goes up to reach the second plate, and so on.
Illustration of the Xpansion Bioreactor aeration system
Cell Morphology and Density Monitoring
Cell density and morphology are monitored via a specialized holographic microscope developed by Ovizio and integrated through collaboration with Pall Life Sciences. Ovizio’s technology provides a platform to observe cells on multiple layers with high image quality.
Illustration of media circulation throughout the Xpansion bioreactor plates
Technical Specifications
Bioreactors Xpansion MPB 10 Xpansion MPB 50
Number of plates
Cell culture surface
Ratio of media volume / surface area
Volume of the bioreactor
10
6,120 cm 2 (949 in.
2 )
0.26 mL/cm
1.6 L
Volume of the central column 26 mL
Overall weight
Overall height
2
2.5 kg (5.6 lbs.)
29 cm (11.4 in.)
50
30,600 cm
Minimum space requirement 49 cm x 48 cm x 40 cm for the bioreactor and (19 in. x 19 in. x 16 in.) docking station (HxWxD)
Plate surface 612 cm 2 (94.9 in.
2 )
Plate thickness 0.1 cm (0.04 in.)
Distance between two plates 0.16 cm (0.06 in.)
Volume between two plates 98 mL
Volume of the head space 50 mL
Sterilization Irradiated to dose exceeding 25KGy
2
0.18 mL/cm 2
(4,743 in.
2
5.6L
132 mL
6.9 kg (15.2 lbs.)
47 cm (18.5 in.)
67cm x 48cm x 40cm
(26 in. x 19 in. x 16 in.)
)
Xpansion MPB 100
100
61,200 cm 2 (9,486 in.
2 )
0.18 mL/cm 2
11.2L
263 mL
12.5 kg (27.5 lbs.)
55 cm (21.6 in.)
75cm x 48cm x 40cm
(30 in. x 19 in. x 16 in.)
Xpansion MPB 200
200
122,400 cm 2 (18,972 in.
2 )
0.18 mL/cm 2
21.9L
527 mL
23.4 kg (50.7 lbs.)
81 cm (31.9 in.)
99 cm x 48 cm x 40 cm
(39 in. x 19 in. x 16 in.)
Corporate Headquarters
Port Washington, NY, USA
+1.800.717.7255 toll free (USA)
+1.516.484.5400 phone biopharm@pall.com e-mail
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
LifeSciences.EU@pall.com e-mail
Asia-Pacific Headquarters
Singapore
+65 6389 6500 phone sgcustomerservice@pall.com e-mail
Visit us on the Web at www.pall.com/biopharm
E-mail us at biopharm@pall.com
International Offices
Pall Corporation has offices and plants throughout the world in: Argentina, Australia,
Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy,
Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore,
South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and
Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.
© 2014, Pall Corporation. Pall, , Intergrity and Xpansion are trademarks of Pall Corporation.
® indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration.
Separation. Solution.
is a service mark of Pall Corporation.
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