USD3120
Allegro™ Fully Automated, Single-Use Tangential
Flow Filtration Systems
For control, flexibility and ease of use in manufacturing
The Allegro CS1000 and CS4500 single-use tangential flow (SUTFF) systems offer all the control
and instrumentation for running fully automated UF/DF processes from 500 to 2000 L batches.
The approach to design offers systems that are compact, ensure low feed/retentate volumes,
and have the flexibility to run cassette surface areas from 0.5 to 10 m2.
u Intuitive control system employing step editor software
u Easy set up and installation of manifolds
u Good selection of single-use sensors
System Concept
Allegro SUTFF systems offer a combination of hardware, control
systems and SU assemblies designed to work perfectly together.
Clever system design ensures ease of use in running fully
automated TFF process sequences, with complex single-use
assemblies, incorporating all of the critical sensor and
instrumentation technologies.
Flexibility is a key requirement for single-use system design.
These systems offer the end user a choice of single-use sensors
for feed, retentate and permeate manifolds. A range of 2D and
3D bio-containers are available for retentate, product recovery
and buffer / WFI. Weigh scales and mixer technologies can
also be offered with these systems, to suit individual process
requirements.
The system design gives full consideration to ease of use in
system set up and processing, while ensuring use of components
and instruments that can achieve the performance requirements
for TFF processes.
Adopting SUTFF technologies can have many potential benefits
in a process. Cost of Goods studies have shown significant
savings in capital, materials, labor and facility operating costs
when comparing SUTFF to regular processing with stainless
steel TFF systems. A more flexible approach in manufacturing
can lead to increased productivity and better resource allocation.
Control System
The automation concept is based on the Pall Process Step
Editor (PPSE), which allows the user to configure automated
process sequences (phases) in a very simple and user friendly
way. This is a very intuitive control system ideal for use in the
Allegro SUTFF systems, with a phase editor that allows easy
generation and configuration of end user specific processes.
The software complies with CFR21Part11.
A review of specific process needs with our engineering team
will ensure a solution is offered to meet exactly all of the process
requirements. This might be achieved with one of our standard
platform designs for SUTFF, along with standard totes and
mixers. Or it might lead to the creation of a custom design.
The custom designs will still retain the core components that
we have validated for use in SUTFF processes. But we have the
flexibility to integrate our systems with other plant equipment,
plant control systems and offer systems designed for running
other TFF formats such as hollow fibers.
The use of validated components for running SUTFF processes
is extremely important for success in design and ultimate system
performance of our systems. Continuity of these components is
maintained throughout our offering in SUTFF processing.
The Allegro SUTFF systems facilitate the automated processing
of 500 L to 2000 L batch volumes of monoclonal antibodies,
recombinant proteins, vaccines and antibody-conjugate
processes. The single- use sensors provide the means to
monitor and control the process fully.
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Main screen with indication of all process signals as well as
system/ component status
The user can select the transition points which move the process
from one step to the next. This can be done by selection of one
or several process parameters (with an “AND” or “OR” logic)
such as conductivity, retentate volume, permeate volume,
biocontainer weight.
Further flexibility is added as the system allows the configuration
and use of loop and jump functions thus making selective step
repetitions feasible.
Upon operator’s selection batch reports will be generated
automatically at the end of a batch for each single step. The
content of the batch report is predefined.
CS1000 cassette holder, with manual torque, 0.5 to 2.5 m2
T-series cassettes or Cadence™ single-use TFF modules
Key System Features
u Interactive P&ID based user interface with dynamic flow path
u Flow, TMP and bag weight controller
u Phase based automation (one phase comprising up to
30 freely definable steps)
u Easy to use phase editor
Systems Technical Specification CS1000
Membrane area0.5 – 2.5 m2 (dictated by specific process
crossflow versus recirculation pump capacity)
Feed and retentate tubing ID ½ in. (12.7 mm)
Permeate and product ½ in. (12.7 mm)
inlet/diafiltration buffer
Tube ID
Recirculation pump
Quattroflowu 1200SU,
4-Piston Diaphragm Pump
20 to 1000 L/hr
Fed batch/ Buffer pumpIsmatec Flowmasteru FMT300 Peristaltic
pump, ISM Drive
6 – 600 L/hr with 12.7 mm element
Recirculation biocontainer
20 L, 50 L, 100 L tote or 50 L, 200 L mixer
Filter type
Pall Centrasette™ cassettes or equivalent
Over pressure protection
Yes
Maximum pressure
4 barg for reinforced manifold sections
1 barg for permeate and medium pressure
manifold sections
0 barg for biocontainers
Volume in feed and 650 mL
retentate lines
Non recoverable volume
<100 mL
Operating temperature range 4 – 40 ºC
System frame and cabinet 304 stainless steel
materials of construction
Dimensions system with 1800 x 800 x 1600 mm (nominal)
retentate 20 L tray
(length x depth x height)
Dimensions system with 1800 x 800 x 1955 mm (nominal)
retentate 100 L tote
(length x depth x height)
Weight of empty system
350 Kg
Power
230 V, 1-phase 50 Hz; 120 V,
1-phase 60 Hz
u Full security access to configuration
u Real-time trending
u Graphic data analysis using the Pall Analytic Tool (PAT)
u Data and event logging
u Batch report generator (one page per step)
u User administration
u Audit Trail
www.pall.com
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Systems Technical Specification CS4500
¾ in. manifold assembly
1 in.
manifold assembly
Membrane area3.0 – 10 m2 (dictated by specific process crossflow
versus recirculation pump capacity)
Feed and retentate ¾ in. (19.05 mm)
1 in. (25.4 mm)
tubing ID
Permeate and ½ in. (12.7 mm)
½ in. (12.7 mm)
product inlet/
diafiltration buffer
tube ID
Recirculation pump Quattroflow-5050SU 4-Piston Sanitary Diaphragm Pump
480 - 2000 L/h with 600 - 4500 L/h with
3-degree shaft
6-degree Pump Model
480 – 2940 L/h with
6-degree shaft
Fed batch/ Quattroflow-1200SU, 4-Piston Diaphragm Pump 20 to
Buffer pump
1000 L/hr
Recirculation
200 L tote or mixer
500 L tote or mixer
biocontainer
Filter type
Pall Centrasette cassettes or equivalent
Over pressure Yes
protection
Maximum
4 barg for manifold sections 4 barg for manifold sections
pressure
0 barg for biocontainers
0 barg for biocontainers
Volume in feed 1.9 L
2.5 L
and retentate lines
Non recoverable <100 mL
<100 mL
volume
Operating 4 – 40 ºC
temperature range
The CS4500 has been designed to run both ¾ in. and 1 in.
manifolds, using the same base hardware. The clamps on the
pinch valves are specific to one size of tubing and these are
easily changed out.
System frame and cabinet materials of construction
Dimensions process skid (length x depth x height)
Dimensions retentate trolley with 200 L tote
(length x depth x height)
Dimensions retentate trolley with 500 L tote (length x depth x height)
Weight of empty system
Power
304 stainless steel
1920 x 1000 x 1718 mm (nominal)
747 x 975 x 1545 mm (nominal)
955 x 1300 x 1600 mm (nominal)
420 Kg
400 V, 3-phase 50 Hz
CS4500 cassette holder: central distribution plate, with or
without auto torque. 3.0 to 10 m2: regular T-series cassettes
Component Specifications
CS1000
CS4500
¾ in. manifold assembly
1 in. manifold assembly
Recirculation pump
Flow range 20 to 1000 L/hour
480 - 2000 L/hr with 3-degree shaft
480 – 2940 L/h with 6-degree shaft 600 - 4500 L/hr with 6-degree shaft
Fed batch/ Buffer pump
6 – 600 L/hr with 12.7 mm element
20 to 700 L/hr
Pneumatic pinch valves
For use with ½ in. tubing
For use with 1 in. ID or ¾ in. ID tubing (feed and retentate)
For use with ½ in. ID tubing (permeate and product inlet/diafiltration buffer)
Control valve
Single-Use diaphragm valve body with positioner
Single-use diaphragm valve body with positioner
Recovery valve
Single-use diaphragm valve body
Single-use diaphragm valve body
Retentate flow measurement 20 – 1200 L/hr +/-5%
Configurable for a defined flow range (5% accuracy full scale)
Permeate flow measurement 20 – 1200 L/hr +/-5%
Pressure measurement
-0.48 – 5.2 bar; ± 2% from 0 – 0.41 bar; ± 3% from 0.41 – 2.07 bar; ± 5% from 2.07 – 4.14 bar
Temperature measurement 0 – 70 ºC
2 – 50 ºC
Conductivity
High range 10 – 200 mS/cm
Retentate: 0.0 to 150.0 mS/cm
Low range 0 – 100 µS/cm)Permeate: 0.0 to 100.0 µS/cm and 0.1 to 150.0 mS/cm (reading switches
between the two ranges)
± 2% of measured value ± 0.4 µS/cm (dependent of process and ambient
temperature being equal).
UV
0 – 2 AU +/- 0.1 AU
0 – 3 AU +/- 0.5%
pH
n/a
0 – 12 pH units
Level sensor
n/a
Presence/Absence liquid on the product inlet line
Air flow
n/a
0-12500 sccm +/-1%
Mass measurement
0 – 150 kg
Appropriate size load cell will be defined for each process
+/- 20 g readability
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Quality Standards
Pall maintains a stringent approach to quality of purchased and
manufactured components. The system hardware is designed
and built to well recognized industry standards, including but not
limited to:
uG
ood automated manufacturing practice (GAMP)
current version
uC
ode of Federal Regulations 21 – Good manufacturing
practice for finished pharmaceuticals.
u 2004/108/EC
uS
oftware complies with CFR21Part11 for electronic records,
signature and audit trail
uC
ode of Federal Regulations 21 – Good manufacturing
practice for finished pharmaceuticals.
uT
he rules governing medicinal products in the European
Community, Volume IV, and Good Manufacturing practice
for medicinal products, Annex 11, computerized systems.
Pall has implemented a quality management system according
to DIN EN ISO9001: 2008, EN 729. The Pall quality management
system is certified by an independent third party
Product contact materials for Allegro CS1000 and CS4500
SUTFF Systems
Process wetted components Materials of construction
TubingPlatinum cured silicone, reinforced in high
pressure sections
Product recirculation pump Machined polypropylene head, EPDM valves
CS1000 and CS4500
and O-rings, Santopreneu diaphragm
Diafiltration / fed batch pump Molded polyethylene head, polypropylene
CS4500ports, EPDM valves and O-rings, Santoprene
diaphragm
Connectors and fittings
Polypropylene
Single sensors:
• Pressure, UV • Polysulfone
• Temperature
• Polysulfone with stainless sensor
and silicon ring
• Flow
• PVDF with ruby bearing
• Conductivity
• Polysulfone with gold electrode
Multi sensor cell:
temperature/ conductivity/pH/UVPPSU (electrodes: SS 316 L, gaskets:
EPDM, UV window: quartz)
Sanitary fittings
Polypropylene, gaskets silicone
TC gaskets
Silicone
Diaphragm valves
Body polypropylene, diaphragm TPE
BiocontainersLDPE
Distribution plate
Polypropylene
Single-Use Manifolds
uA
re assembled in a class 10000 clean room to ISO standards
9001:2008 and using validated assembly methods
Summary
uH
ave components that are tested for biocompatibility and
certified to USP<88>
The combination of single use technologies and automation
provides many benefits in bioprocessing. Fully automated SUTFF
systems make UF/DF a straightforward process with full control
over the key parameters.
u Have components that are certified TSE/BSA free
u Are manufactures according to a validated assembly process
uA
re supplied double bagged and irradiated at a minimum
dose of 25 KGy
u Extractables data reports are available on request
The Allegro SUTFF systems provide control, flexibility and enable
processing to be carried out under optimum conditions using
fully automated process sequences
Full automationEnables precise and consistent operation and
control of key parameters
Minimizes operator contact
Fully disposable flowpaths
Easy system set up
Reduces cleaning time, improves productivity
and provides cost savings in manufacturing
Single-use sensorsMonitoring and control of key TFF process
parameters
Enables automated control of processing to
optimum conditions
Process step editor softwareFlexibility to create recipes to suit individual
processes
Monitors all process variables and provides
data logging and batch reports
www.pall.com
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Visit us on the Web at www.pall.com/allegro
E-mail us at allegro@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.
© 2016, Pall Corporation. Pall,
, Allegro, Cadence and Centrasette are trademarks of Pall Corporation.
® indicates a trademark registered in the USA. TM indicates a common law trademark. Filtration.Separation.
Solution. is a service mark of Pall Corporation. uSantoprene is a trademark of Exxon Mobil, Quattroflow is
a trademark of Almatec, and Flowmaster is a trademark of Ismatec.
www.pall.com
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USD3120