CELL-tainer single-use bioreactor for microbial fermentation and cell

CELL-tainer single-use bioreactor for
microbial fermentation and
cell cultures – CM200US / CM200EU
The CELL-tainer ® bioreactor system provides accurate, low shear mixing
and high mass transfer rates. Mixing of cell cultures is essential to create
and maintain homogenous conditions in the bioreactor. The single-use
bioreactor bag is positioned in the tray and placed on the rocking platform
creating a two-dimensional movement (including a wave like motion) in
the culture medium. The rocker angle and frequency can be adjusted to
increase or decrease the mixing time and the oxygen transfer rate.
The CELL-tainer ® control system has three password protected access
levels. The access to the local human interface can be blocked by the
supervisory software allowing the system to be used in compliance with
21 CFR part 11. The robust design and heavy-duty motor guarantee years
of trouble-free operation at extreme low noise levels.
Specifications
System specifications - CM200US/CM200EU
Dimensions unit W x H x D = 3500 x 1670 x 1750 mm (approx.) (Height excl. signal light is 1500 mm)
Weight (empty) 1100 kg (approx.)
Floorload < 210 kg/m2 under operation
Dimensions bag or shaker platform W x H x D = 1400 x 1000 x 200 mm (approx.)
Light protection Closed cabinet. The top sections of the cabinet can be shift to side in order to load the bag.
Internal view is possible with camera mounted inside.
Movement profile 20 movement: horizontal displacement combined with vertical displacement. Tilt angle is manually adjustable.
Tilt angle: 7 steps from 5.35 – 14.41°; positioning in steps of 1.28°
Rotational speed 1– 30 rpm; resolution 1 rpm; accuracy 0.3 rpm
Temperature control Sensor on platform, directly under the bag; accuracy ± 0.2º C
Control range: 20 – 40º C (under ambient temperature conditions)
Resolution: 0.5º C
Heating/cooling capacity Temperature control by heat-exchanger (water-filled) underneath the bag, connected to a thermo-circulator (electrical heater / chiller,
integrated in the CELL-tainer-system). Heating capacity: 5 KW. Cooling capacity: 2.4 KW
DO measurement Dissolved Oxygen amplifier with polarographic electrode to be positioned into a separate membrane plug mounted in the bottom of the bag.
5 – 150% air saturation (± 5% air saturation). Air flow control by mass flow controller (HTK) 0 – 200 Ln/min
DO control (PID) Mass flow controllers (HTK), 0 – 50 Ln/min O2, 0 – 50 Ln /min N2
pH measurement pH – amplifier with disposable electrochemical sensor fixed mounted in the bottom of the bag. pH = 2.00 – 10.00 (± 0.03 unit)
pH control (PID) Alkaline: Peristaltic pump Watson-Marlow, 24VDC, 45 rpm
Watson-Marlow Pumphead 313: applicable with 1.6mm wall tube
Complete with adjustable tube clamps for 0.5 mm to 8.0 mm ID tubing
Acid: Peristaltic pump Watson-Marlow, 24VDC, 45 rpm
Watson-Marlow Pumphead 313: applicable with 1.6mm wall tubing
Complete with adjustable tube clamps for 0.5 mm to 8.0 mm ID tubing
or
Mass flow controller (CO2) 0 – 50 Ln/min
Air supply 1 – 6 barg. Additional gasses (O2, N2): 1 – 2 barg. Gasses internally reduced to 0.1 barg max.
Maximum bag pressure (operating) 0.12 barg
Exhaust gas Easy-Load filter heater for exhaust gas filter.
Maximum setpoint 15º C above culture temperature; cut-off at 50º C
170 mm
1750 mm
Bag specifications – CB-260L-CELL
Film materialClear-Pak® film
Ultra Low Density Polyethylene (ULDPE) Outer Layer
EVOH Gas Barrier Layer
1500 mm
Ultra Low Density Polyethylene (ULDPE) Contact Layer
3500 mm
Process monitoring and control Single Board panel PC (B&R) with I/O cards PP5OO
Display 15" XGA display touchscreen
Data storage and operation - Measuring rpm. T, DO, pH (adjustable sampling time)
- Data storage / batch
- Alarm logs: door open, change set-points,
not reaching set-point, sensor failure
- Dose monitoring: show total sec/ml or percent in the
Process View screen
- Manual operation of valves and pumps
- Manual position of tray (jog, sample, drain)
Data export USB interface (csv. file)
Safety Door opening / safety switch (stop) on all functions
Protection
CE/ IP54
Power EU: 400 VAC, 50hz, (3 Phase, 0, ground) 16 A
NA: To be specified by order
Manuals Operation and Installation
The CELL-tainer software consists of:
• Process Parameters:
- PID factors, dead zone for pH, %DO (including rpm cascade with 02)
and temperature control
- PID set points and motor speed
- Constant outputs actuators
• Measurements and control of pH, %DO and temperature
Charter Medical’s Clear-Pak® bio-containers are designed for applications in
processing, handling, storage and transport of sterile fluids. Clear-Pak® is a
single web film in a multilayer, co-extruded format with an Ultra Low Density
Polyethylene (ULDPE) contact layer, EVOH gas barrier layer, and Polyethylene
(PE) outer layer. The film thickness is 13 mil and offers superior clarity,
excellent gas barrier properties and is animal derivative component free.
Complex validation package available upon request.
Sealing Heat sealing
Sterilization Gamma irradiation
Sensor mounting Mounted through 2 bottom plugs: polycarbonate
• disposable pH sensor, fixed mounted
• disposable DO sensor, fixed mounted
Bag positioning Via 2 bottom plugs: polycarbonate
Connections top • 3x addition, C-Flex® 1/4" x 3/8", + female luerlock and (male) cap
• 1x gas inlet line, Silicone 1/2" x 3/4" including filter, 0.2µm
• 1x gas outlet line, Silicone 1/2" x 3/4" including filter, 0.2µm
• A 1 1/2" Tri-clover port in the gas-outline line prevents liquid
being forced into this line.
• 1x diptube line: sample-septum (luer, swabable valve)
Connections bottom 1x drain line, C-Flex®, 1/2" x 3/4", press-in-plug
Size 1320mm x 1000 mm
Physical Test Data (post gamma irradiation*)
Property
Test Protocol
Tensile Strength
ASTM D882
Yield Strength
ASTM D882
Elongation at Break
ASTM D882
Elastic Modulus
ASTM D882
Tear Resistance
ASTM D1004
Penetration Resistance
ASTM F1306
ASTM D3985
O2 Transmission Rate
ASTM F2476
CO2 Transmission Rate
Moisture Vapor Transmission Rate
ASTM F1249
Clarity
ASTM D1003
Haze
ASTM D1003
Transmittance
ASTM D1003
Operating Range
Average Value
1900 psi
1200 psi
460%
39,000 psi
5.25 lb
4.94 in.lb
<0.003 cc/100in2-day-atm
<0.01 cc/100in2-day-atm
0.021 g/100in2-day
97%
7%
93%
-80ºC to 50ºC
• Activation of valves and pumps: O2, N2, Base and Acid / CO2 and Feed
• Feed control:
a)auto-feed, on timer basis
b)on basis of DO% (feed reduction, to prevent anaerobic conditions in the culture)
• Alarms and Events: Stop, Start, Emergency Stop, Opening Door, Sensor Failure,
Motor Failure, Parameters too Low / High
• Safety: when the motor is running, the covers (sliding left and right) are secured (locked).
When released, covers can be opened and the bag can be positioned.
• System settings: IP address, screensaver, log interval, volume factors
The CELL-tainer life cycle is according to Laboratory equipment Category D/E.
Biocompatibility Test Data (post gam ma irradiation*)
Property
USP Class VI
Cytotoxicity
Bacteria Endotoxin
Heavy Metals
Buffering Capacity
Non-Volatile Residue (NVR)
Residue on Ignition
Appearance
Acidity and Alkalinity
Absorbance
Reducing Substances
Local Effects After Implantation
Irritation and Delayed-type Sensitivity
Systemic Toxicity
Particulates
Test Protocol
USP <88>
USP <87>
USP <85>
USP <661>
USP <661>
USP <661>
USP <661>
EP <3.1.5>
EP <3.1.5>
EP <3.1.5>
EP <3.1.5>
ISO 10993-6
ISO 10993-10
ISO 10993-11
USP <788>
Value
Pass
Pass
Pass
Pass
< 1 mL
< 1 mg
Pass
Pass
Pass
0.01,Pass
0.02 mL, Pass
Pass
Pass
Pass
Pass
*Gamma Irradiation Level; Minimum 25 kGy
3948-A Westpoint Blvd., Winston-Salem, NC 27103, USA
Toll Free: 866.458.3116 | Fax: 336.714.4241 | www.chartermedical.com
is owned by Lydall, Inc. and/or its subsidiaries and is registered at least in the US.
CELL-tainer ® is owned by Cellution Biotech B.V.
Watson-Marlow is owned by Watson-Marlow Pumps Group
®
C-Flex is owned by Saint-Gobain Performance Plastics
®
Clear-Pak is owned by Charter Medical, Ltd. and is registered at least in the US.
All data and statements concerning these products may be considered as being indicative of
representative properties and characteristics obtainable. We make no warranty, express or
implied, concerning actual use or results because of industry specific influences.

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