USD3083
Allegro™ CM150 Single-Use Tangential Flow
Filtration System
Optimized small scale SUTFF processing
The Allegro CM150 single-use tangential flow filtration (SUTFF) system is easy to use and offers all the
critical sensors for running ultrafiltration (UF) and diafiltration (DF) processes at 2-20 L batch volumes.
The system layout is optimized for a low minimum recirculation loop, to ensure final target volumes can
be achieved and provide excellent product recovery.
The programmable logic controller (PLC) based control system ensures easy operation and monitoring of
UF applications, constant volume diafiltration, and provides real-time trending and data logging capabilities.
Designed for ease of use
Single-use sensors
– Pressure, flow, conductivity, temperature, ultraviolet (UV)
Low feed / retentate volume ~100 mL
Excellent product recovery
0.1 – 0.4 m2 cassette area
System Functionality
The Allegro CM150 system is part of a broader range of
SUTFF systems offered by Pall for processing 2 L to 2000 L
batches. The system has the flexibility to run Cadence™ SUTFF
modules or T-series Centramate™ cassettes with Omega™ or
Delta membrane.
Scalability of performance is critical in developing tangential flow
filtration (TFF) processes. The Allegro CM150 system is designed
for use in small scale good manufacturing practice (GMP)
manufacture and for process development activities, to generate
scalable data. Continuity of single-use component choice and
design approach across our system range provides reliable
scale up from Allegro CM150 system to the larger scale Allegro
SUTFF systems.
Allegro manifolds and biocontainer assembly: the well-considered design
and layout ensures easy installation whilst minimizing recirculation volumes.
The system offers the flexibility needed for single-use processing.
The base system can run with just pressure and flow sensors or
utilize the additional optional sensors for conductivity, temperature
and UV, depending on the process requirements. The base
system accommodates this flexibility, and base systems can be
upgraded later if additional features are needed for new projects.
Cadence CM holder. This can accommodate either Cadence 0.1 m2
SUTFF modules or T-series Centramate cassettes, with an appropriate
Allegro manifold from the standard sets available.
Control System
All connections and key controls are easily accessible from the front of
the system.
All process values are shown in the piping and installation diagram
(P&ID) based operator interface. The main screen indicates all
process signals as well as system/ component status.
Flexibility
Single-use sensors
– Pressure: Feed and retentate
– Flow: Retentate
– Temperature: Retentate (optional)
– Conductivity: Retentate (optional)
– UV: Permeate (optional)
The header bar clearly indicates the current user logged into the
system, and provides the operator with navigation buttons to
other areas of the control system.
2
Centramate cassettes (T-series 0.1 to 0.4 m )
Cadence SUTFF modules 0.1 m2
Transmembrane pressure (TMP) control
– Manual pinch valve
Tray for retentate biocontainer assemblies: 5 L and 10 L
– Adjustable tray comes to lower position for easy installation
of the biocontainer assembly, and is then moved to the
upper position for processing
Accessory biocontainers and bespoke trolley
2
The Allegro CM150 system offers essentially manual control of
TFF processes, but has the capability to run constant volume
diafiltration. The diafiltration pump can be set to automatically
control the pump speed to maintain a constant mass in the
retentate biocontainer according to the defined input weight.
A wireless link to a tablet, smartphone or PC enables remote
viewing of the system screen and wireless transfer of data files.
The control software is designed
for flexible and user friendly
control of tangential flow filtration
processes, providing the following
key features:
P&ID based user interface with
dynamic flow path
Retentate biocontainer weight
controller (standard)
System Performance
Full security access to configuration settings screens
Real-time trending
The Allegro CM150 SUTFF system can process at typical crossflows of 5 to 7 L/min/m2, with 0.1 to 0.4 m2 cassette area. The
system is supplied with retentate biocontainers to run 5-10 L
batch volumes. Starting with larger volumes can be managed
by running the system in a fed batch mode.
Data logging with data transfer in comma separated value
(CSV) or line-delimited format
3 level user login, user administration and password control
The data in figures 1 to 4 show the results from a x20 IgG
concentration (starting concentration 10 g/L) and x5 diafiltration
volumes with phosphate-buffered saline (PBS). The efficiency of
the diafiltration was monitored by following the removal of 7%
glucose added to the protein solution
The system showed good mixing, negligible foaming in the
retentate biocontainer, and efficient diafiltration of the solution.
The system is fully drainable via the low point recovery valve.
Figures 1 and 2
Data for 5 L starting volume IgG processed on 0.1 m2 cassette area
Concentration of IgG During Concentration
Diafiltration with Glucose: % T
Transfer
ransfer
% Glucose T
Transfer
ransfer
Concentration (g/L)
140
120
Concentration at Bottom (g/L)
Concentration at T
Top
op (g/L)
100
80
60
40
20
0
0
1
2
3
4
Volume
V
olume
ol
in the Biocontainer (L)
5
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0
6
1
2
3
Diavolumes
% Glucose Transfer
Transfer (Glucose)
4
5
Theoretical
Figures 3 and 4
Data for 10 L starting volume IgG processed on 0.4 m2 cassette area
Concentration of IgG During Concentration
Diafiltration with Glucose: % Transfer
Transfer
Concentration (g/L)
100
% Glucose Transfer
Transfer
120
Concentration (g/L) Top
Top
Concentration (g/L) Bottom
80
60
40
20
0
0
2
4
6
8
Volume
V
olu
olume
in the Biocontainer (L)
10
12
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0
1
2
Diavolumes
3
% Glucose T
Transfer
ransfer (Glucose)
4
5
Theoretical
%
www.pall.com
3
System Technical Specification
Membrane area
Tubing internal diameter (ID)
Retentate vessel
Operating temperature
Operating pressure
Over pressure protection
Minimum working volume
Non recoverable volume
0.1- 0.4 m2, operating in typical crossflow
range of 5 to 7 L/min/m2
Pall Centramate T-series cassettes or
equivalent; Pall Cadence SUTFF modules.
For other suppliers cassettes please check
recommended running conditions and
torque settings
Feed and retentate tube: 3⁄8 in. (9.6 mm)
Permeate tube: ¼ in. (6.4 mm)
5 L or 10 L Allegro biocontainers, for larger
process volumes system may be operated
in fed batch mode.
4 – 40 ºC
4 barg for high pressure reinforced section
on feed and retentate manifolds
1 barg permeate and medium pressure
manifolds; 0 barg for biocontainers
Yes (on recirculation pump)
Minimum recirculation volume approximately: 105 mL (Estimated with 0.1 m2
Pall membrane surface area installed).
Volume in feed and retentate line: 98 mL
Approximately: 10 mL (Hold-up volume will
increase by ~ 10 mL / 0.1 m2 of installed
Pall membrane)
Process Wetted Components
Materials of Construction
Tubing
Recirculation pump
Platinum cured silicone tube, reinforced
Head: Polypropylene; Diaphragm: ethylene
propylene diene monomer (EPDM)/
Polypropylene compound, Valves: EPDM
Polysulfone, silicone
Polypropylene
Polysulfone
Polysulfone with stainless steel sensor and
silicone ring
PVDF with ruby bearing
Polysulfone with gold electrode
Connector: Polypropylene
Gaskets: Silicone
Connectors
Fittings, distribution plates
Pressure sensor, UV sensor
Temperature sensor
Flow sensor
Conductivity sensor
Sanitary fittings (tri-clamp)
Instrument
Type
Measuring Range/Accuracy
Flow measurement
Single-use flow
cell with turbine
30 - 1200 L/hour
Pressure
measurement
Single-use sensor
with pressure
sensitive chip
Temperature
measurement
Single-use
temperature
sensitive transistor
Single-use sensor
Conductivity
measurement
UV
Mass measurement
Single-use sensor
Load cell
Typically +/- 5% of range
-0.48 to 5.2 bar
± 2% in the range
0 to 0.4 bar
± 3% in the range
0.41 to 2.0 bar
± 5% in the range
2.07 to 4.1 bar
0 to 70 °C ± 0.2 °C
Range: 0.1 to 100 mS/cm
0.1 to 2 mS/cm ±
0.1 mS/cm
2 to 50 mS/cm ± 5% of
reading;
50 to 100 mS/cm typically
± 5% of reading
0 – 2 AU ± 0.1 AU
0 to 30 kg (in situ readability
0.01 g)
Quality Standards
Pall maintains a stringent approach to quality of purchase and
manufactured components. The system hardware is designed
and built to well recognized industry standard, including but not
limited to:
Good automated manufacturing practice (GAMP)
EMC 89/336/EEC
Software complies with CFR21 Part11 for electronic records
Single-Use Manifolds
Are assembled in dedicated class 10000 clean room
to ISO standards 9001:2008 and using validated assembly
methods
Have components tested for biocompatibility and certified
to USP<88>
Components are certified TSE/BSA free
System Hardware
Type
Specifications
Feed pump
Flow range 5 to 150 L/hour
Buffer pump
4-Piston diaphragm
pump, single-use
Peristaltic pump
Valves
Control valve
Manual pinch valves
Manual pinch valves
Recovery valve
Manual pinch valves
4
Are supplied double bagged and irradiated at a minimum dose
of 25 KGy
Extractables data reports available on request
Flow range 0 to 54 L/hour (with
4.8 mm bore tubing)
For use with 3⁄8 in. ID tubing
Manual valve (allows control
to ±0.1 bar TMP at 0.8 bar
TMP at 0.52 L/min with
0.1 m² membrane area)
For use with ¼ in. ID tubing
System Information
Base System
Part numbers
Dimensions W x D x H
System weight
System components
SUTFF09-ZZ (Europe & Asia)
SUTFF10-ZZ (US)
1015 x 764 x 1225 mm
110 kg
QF150 recirculation pump; WM313 peristaltic DF
pump; Cadence CM Holder; 2 x 3⁄4 in. pinch valves;
1 x 3⁄4 in. manual TMP control valve
Software
Weigh scale
Pressure and flow transmitter
Additional Hardware
LGRTFFCMTRL
LGRTFFCMCONDKIT
LGRTTFFCMUVKIT
Bespoke trolley, supplied with 1x 20 L tray and
1 x 50 L 3D tote
Add conductivity transmitter to base system
Add UV transmitter to base system
Biocontainer Sets
744-69L
744-69M
7442-03030P
7442-0303G
7442-0318X
7442-0318Z
5 L retentate biocontainer assembly
10 L retentate biocontainer assembly
1 L product recovery biocontainer assembly
5 L product recovery biocontainer assembly
20 L Feed / collection biocontainer (for trolley)
50 L Feed / collection biocontainer (for trolley)
Feed/Retentate/
Permeate Sets
Cassette Type
Single-use
Sensors in Manifold
744-69N
744-69P
Cadence SUTFF modules
Cadence SUTFF modules
744-70H
744-70J
Centramate cassettes
Centramate cassettes
7440-70W
744-70T
FAT test set
Pressure, flow
Pressure, flow, temperature,
conductivity
Pressure, flow
Pressure, flow, temperature,
conductivity
UV assembly for permeate
Contains all sensor
options and 5 L retentate
biocontainers
Visit us on the Web at www.pall.com/biopharm
E-mail us at biopharm@pall.com
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
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.
© 2015, Pall Corporation. Pall,
, Allegro, Cadence, and Centramate are trademarks of Pall Corporation.
® indicates a trademark registered in the USA. Filtration.Separation.Solution.SM is a service mark of
Pall Corporation.
9/15, PDF, GN15.6345
USD3083