Allegro™ Single-Use Mixers product photo Primary L

Allegro™ Single-Use Mixers

High performance, easy-to-use mixers for manual to fully automated solution preparation


Mixing is a critical operation within biopharmaceutical processes for many applications, ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation, to final formulation. The Allegro single-use mixers are part of Pall’s expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance.
 
 

The Allegro mixers are available in 50 L, 200 L, 500 L and 1000 L sizes, in both standard and jacketed stainless steel tote formats, and can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control. Sensor signals can be handled locally on the mixer, or alternatively, can be fed directly to an existing Distributed Control System (DCS) or to an Automated Pall MVP single-use system. With the added capability of load cell integration, the Allegro mixers from Pall can be fully integrated to the Allegro MVP automated single-use systems, providing complete automated process monitoring and control solutions for all applications that require mixing (e.g pH adjustment for buffers and virus inactivation).
 

Product Features and Benefits

 
Feature Benefit
4 pitch blade impeller Efficient, low shear general purpose mixing over a wide range of applications and shear sensitive soluitons
Impeller rotation in clockwise or counter-clockwise direction Flexibility to perform both up-flow and down-flow for floating (low density) and settling (high density) fluid or solids
 



 
Feature Benefit
Design principles based on existing Allegro 3D tote format for ease-of-use Very easy and quick to install and remove the single-use systems pre and post-use
 



 
Feature Benefit
Inflation of the mixer bag Provides mixing envelope for consistent performance from 50 - 1000 L and the ability to have a gas blanket in operation and mix a range of volumes
 

 
Mixer Size 200 L 500 L 1000 L
 
Minimum Volume (L)* 50 100 155
Maximum Volume (L) 200 500 1000
 
* minimum volume also covers on-line sensors


 
Feature Benefit
Jacketed Totes Temperature control in appropriate applications
 



 
Feature Benefit
Sensor integration Allows in-process monitoring and control through integration with automated Allegro MVP systems
 



 
Feature Benefit
Uses existing Allegro film with high clarity and ultra-low extractables Material/validation consistency across all Allegro biocontainer based systems
 



 
Feature Benefit
Optional baffles available To assist in reducing air entrapment at high rotation speed for sensitive molecules
 





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Description

High performance, easy-to-use mixers for manual to fully automated solution preparation


Mixing is a critical operation within biopharmaceutical processes for many applications, ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation, to final formulation. The Allegro single-use mixers are part of Pall’s expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance.
 
 

The Allegro mixers are available in 50 L, 200 L, 500 L and 1000 L sizes, in both standard and jacketed stainless steel tote formats, and can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control. Sensor signals can be handled locally on the mixer, or alternatively, can be fed directly to an existing Distributed Control System (DCS) or to an Automated Pall MVP single-use system. With the added capability of load cell integration, the Allegro mixers from Pall can be fully integrated to the Allegro MVP automated single-use systems, providing complete automated process monitoring and control solutions for all applications that require mixing (e.g pH adjustment for buffers and virus inactivation).
 

Product Features and Benefits

 
Feature Benefit
4 pitch blade impeller Efficient, low shear general purpose mixing over a wide range of applications and shear sensitive soluitons
Impeller rotation in clockwise or counter-clockwise direction Flexibility to perform both up-flow and down-flow for floating (low density) and settling (high density) fluid or solids
 



 
Feature Benefit
Design principles based on existing Allegro 3D tote format for ease-of-use Very easy and quick to install and remove the single-use systems pre and post-use
 



 
Feature Benefit
Inflation of the mixer bag Provides mixing envelope for consistent performance from 50 - 1000 L and the ability to have a gas blanket in operation and mix a range of volumes
 

 
Mixer Size 200 L 500 L 1000 L
 
Minimum Volume (L)* 50 100 155
Maximum Volume (L) 200 500 1000
 
* minimum volume also covers on-line sensors


 
Feature Benefit
Jacketed Totes Temperature control in appropriate applications
 



 
Feature Benefit
Sensor integration Allows in-process monitoring and control through integration with automated Allegro MVP systems
 



 
Feature Benefit
Uses existing Allegro film with high clarity and ultra-low extractables Material/validation consistency across all Allegro biocontainer based systems
 



 
Feature Benefit
Optional baffles available To assist in reducing air entrapment at high rotation speed for sensitive molecules
 



Applications
The Allegro mixers are designed to provide exceptional mixing performance for a wide range of applications from upstream through the downstream process to formulation and filling. With jacketed and standard totes that can integrate on-line sensor technologies and load cells, potential applications include:
  • Upstream media preparation for cell culture
  • Downstream pH adjustment, virus inactivation and buffer preparation
  • Final formulation mixing
In addition to the mixers, Pall also offers a wide range of complimentary technologies within the Allegro single-use platform (such as filters incorporating state-of-the-art membranes and sterile connection and disconnection devices) providing fully validated, integrated processing solutions from upstream to final formulation and filling. The Allegro mixers can be combined with the Pall MVP system to fully automate mixing and filtration processes, including fluid transfer to and from the mixers. The high performance mixer lends itself especially well to difficult mixing applications (mixing dense powders or high viscosities), applications requiring repeatable, fast mixing performance, or where biologicals sensitive to shear are being mixed.

Application Summary

 
Type of Mixing Solution 200 L 500 L (150 rpm) 1000 L (150rpm)
Solid – Liquid Allura Red Dye (.05 g/L) 5 seconds (75 rpm) 2 min 5 min
DMEM Media (5.36 g/L) < 7 min (150 rpm) 6 min 11 min
PBS Buffer (9.6 g/L) < 5 min (150 rpm) 4 min 7 min
NaCl (1 M) (58.44 g/L) < 1 min (150 rpm) 7 min 12 min
Liquid – Liquid NaCl (200 g/L - 10 g/L) < 1 min 4 min 6 min
 
Specifications

Technical Specifications

 
  Standard Mixer Jacketed Mixer
Mixer Tote Part Number LGRMXTTE200L230B
LGRMXTTE200L120B
LGRMXJTTE200L230B
LGRMXJTTE200L120B
Mixing volume – Max (L) 200 200
Voltage (Vac) 230
120
Current (A) 5.1
9.2
Frequency (Hz) 50
60
Motor power (kW) 0.37
Impeller range (rpm) 50 - 150
Mixing volume - Covering impeller (L) 40 40
Mixing volume - Covering sensors/sample port (L) 46 46
Gas supply (barg/psig) 4 - 6 / 60 - 90
Gas connections SUPPLY & CABINET VENT: 10 mm Pneumatic tubing outside diameter
BAG VENT: 12 mm Pneumatic tubing outside diameter
Weight - empty (kg) 120 195
Weight - full (kg) 340 421
Footprint* (L x W) (mm) 785 x 615 785 x 615
Height (mm) 1401 1401
 


 
Materials of Construction Standard Mixer Jacketed Mixer
Mixer Tote Part Number LGRMXTTE200L230B
LGRMXTTE200L120B
LGRMXJTTE200L230B
LGRMXJTTE200L120B
Mixer tote 304 SS
Mixer biocontainer (original) Biocontainer film; outlet port; inlet manifold & top hat: Low Density Polyethylene (LDPE);
Impeller: Polysulfone (PS); Flush outlet port valve (12 in.): Polysulfone (PS); Shaft: Stainless Steel SS;
O-rings: Silicone; Mechanical seals: Low Density Polyethylene (LDPE)
Mixer biocontainer (sensor biocontainer) Biocontainer film; inlet ports; top hat; hose barb outlet port: Low Density Polyethylene (LDPE);
Impeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone;
Mechanical seals: Low Density Polyethylene (LDPE)
 
*Leg centre distances


 
  Standard Mixer Jacketed Mixer
Mixer Tote Part Number LGRMXTTE500L230B
LGRMXTTE500L120B
LGRMXJTTE500L230B
LGRMXJTTE500L120B
Mixing volume – Max (L) 500 500
Voltage (Vac) 230
120
Current (A) 5.1
9.2
Frequency (Hz) 50
60
Motor power (kW) 0.37
Impeller range (rpm) 50 - 150
Mixing volume - Covering impeller (L) 80 80
Mixing volume - Covering sensors/sample port (L) 100 100
Gas supply (barg/psig) 4 - 6 / 60 - 90
Gas connections SUPPLY & CABINET VENT: 10 mm Pneumatic tubing outside diameter
BAG VENT: 12 mm Pneumatic tubing outside diameter
Weight - empty (kg) 180 313
Weight - full (kg) 730 878
Footprint* (L x W) (mm) 1170 x 815 1170 x 815
Height (mm) 1470 1470
Materials of Construction
Mixer tote 304 SS
Mixer biocontainer (sensor biocontainer) Biocontainer film; inlet ports; top hat; hose barb outlet port: Low Density Polyethylene (LDPE);
Impeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone;
Mechanical seals: Low Density Polyethylene (LDPE)
 
*Leg centre distances


 
  Standard Mixer Jacketed Mixer
Mixer Tote Part Number LGRMXTTE1000L230B
LGRMXTTE1000L120B
LGRMXJTTE1000L230B
LGRMXJTTE1000L120B
Mixing volume – Max (L) 1000 1000
Voltage (Vac) 230
120
Current (A) 5.1
9.2
Frequency (Hz) 50
60
Motor power (kW) 0.37
Impeller range (rpm) 50 - 150
Mixing volume - Covering impeller (L) 125 125
Mixing volume - Covering sensors/sample port (L) 155 155
Gas supply (barg/psig) 4 - 6 / 60 - 90
Gas connections SUPPLY & CABINET VENT: 10 mm Pneumatic tubing outside diameter
BAG VENT: 12 mm Pneumatic tubing outside diameter
Weight - empty (kg) 220 434
Weight - full (kg) 1320 1549
Footprint* (L x W) (mm) 1360 x 1084 1360 x 1084
Height (mm) 1482 1482
Materials of Construction
Mixer tote 304 SS
Mixer biocontainer (sensor biocontainer) Biocontainer film; inlet ports; top hat; hose barb outlet port: Low Density Polyethylene (LDPE);
Impeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone;
Mechanical seals: Low Density Polyethylene (LDPE)
 
*Leg centre distances


Heat Exchange Area Estimation for Jacketed Mixer Totes:

 
Mixer Capacity (L) Assumed Minimum Working Volume (L) Area Available for Heat Exchange @ Min. Working Volume (m2) Calculated Maximum Working Volume (L) Area Available for Heat Exchange @ Max. Working Volume (m2)
200 46 0.49 200 1.0
500 100 0.93 500 1.8
1000 155 1.37 1000 2.9
 
Performance

Single-Use Mixer Design

The Allegro single-use mixer design is based on proven engineering principles used to develop efficient and appropriate mixing in a wide range of biopharmaceutical applications. Aspects of power input, impeller geometry and position, flow characteristics, flow pattern, pumping and shear were all considered as part of the design process.







pH target of 8.40 to an accuracy of ± 0.06 pH units achieved after
36.5 doses in <12 minutes.

High Performance Mixing

The Allegro mixers have been tested on a wide range of applications representing a broad range of biopharmaceutical operations where mixing is required. The Applications Summary Table summarizes the applications tested and the mixing performance achieved.

Allegro single-use mixers have been tested to demonstrate capability to mix a wide variety of liquid-liquid, solid-liquid, and high viscosity solutions. For further details on mixing performance, please refer to the Application note, document reference: USD2744.

Quality Standards and Validation

The Allegro single-use mixer biocontainers are 100% leak tested at manufacture.

All Allegro biocontainers, including the mixer, are manufactured in a controlled environment (Class 10,000) certified to ISO 13485 and ISO9001.

The materials of construction of the Allegro mixer biocontainer meet:

  • USP<88> Biological reactivity test In Vivo for Class VI - 50 °C Plastics
  • USP<87> Biological Reactivity Tests In Vitro, Cytotoxicity
  • ISO 10993 Biological Evaluation of Medical Devices
  • USP<661> Physico-chemical testing for plastics
  • European Pharmacopeia (section 3.1.5)
  • Japanese Pharmacopeia (section 61 Part 1)
The mixer totes are manufactured under a Quality Management System Certified to ISO 9001 and ISO 14001 and is in conformity with the requirements of the European Directive 2004/108/EC (Electromagnetic Compatibility) and European Directive 2006/95/ EC (Low Voltage Safety).

Product Validation

As part of our rigorous approach to product validation, Pall has conducted a wide range of tests in addition to the general performance tests to prove the robustness of the Allegro mixer. A summary of key validation tests are summarized below:

  • Biological safety (USP<87> and <88>)
  • Physico-chemical tests (USP<661>)
  • Particulate matter in Injections (USP <788>)
  • USP<85> LAL Endotoxin (compared to limit for WFI)
  • Extractables testing (Water and ethanol)
  • Gamma resistance (Maximum 50 kGy)
  • Leak tests
  • Drainage/product recovery
  • Tubing connection robustness

The mixer totes are manufactured under a Quality Management System Certified to ISO 9001 and ISO 14001 and is in conformity with the requirements of the European Directive 2004/108/EC (Electromagnetic Compatibility) and European Directive 2006/95/EC (Low Voltage Safety).

Ordering Information

Allegro Mixer Standard Single-Use Systems Ordering Information

 
Scale Part Number Description
200 L LGRMXTTE200L230B Standard Mixer Tote 230 Volts
200 L LGRMXJTTE200L230B Jacketed Mixer Tote 230 Volts
200 L LGRMXTTE200L120B Standard Mixer Tote 120 Volts
200 L LGRMXJTTE200L120B Jacketed Mixer Tote 120 Volts
200 L LGRMX20023003 Standard Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
200 Lt LGRMXJ20023004 Jacketed Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
200 L LGRMX20012003 Standard Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
200 L LGRMXJ20012004 Jacketed Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
200 L LGRMXJ20023005 Jacketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor
200 L LGRMXJ20012005 Jacketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor
200 L LGRMXTTE200L-FAT FAT for Mixer Tote 120 or 230 Volts
200 L LGRMXW200 Standard tote weighing platform
200 L LGRMXJW200 Jacketed tote weighing platform
200 L LGRMX200LIQOQ IQ/OQ Documentation for 200 L Mixer
500 L LGRMXTTE500L230B Standard Mixer Tote 230 Volts
500 L LGRMXJTTE500L230B Jacketed Mixer Tote 230 Volts
500 L LGRMXTTE500L120B Standard Mixer Tote 120 Volts
500 L LGRMXJTTE500L120B Jacketed Mixer Tote 120 Volts
500 L LGRMX50023003 Standard Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
500 L LGRMXJ50023004 Jacketed Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
500 L LGRMX50012003 Standard Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
500 L LGRMXJ50012004 Jacketed Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
500 L LGRMXJ50023005 Jacketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor
500 L LGRMXJ50012005 Jacketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor
500 L LGRMXTTE500L-FAT FAT for Mixer Tote 120 or 230 Volts
500 L LGRMXW500 Standard tote weighing platform
500 L LGRMXJW500 Jacketed tote weighing platform
500 L LGRMX500LIQOQ IQ/OQ Documentation for 500 L Mixer
1000 L LGRMXTTE1000L230B Standard Mixer Tote 230 Volts
1000 L LGRMXJTTE1000L230B Jacketed Mixer Tote 230 Volts
1000 L LGRMXTTE1000L120B Standard Mixer Tote 120 Volts
1000 L LGRMXJTTE1000L120B Jacketed Mixer Tote 120 Volts
1000 L LGRMX100023003 Standard Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
1000 L LGRMXJ100023004 Jacketed Mixer Tote 230 Volts + Mettler Toledo (pH &/or Cond) Transmitter
1000 L LGRMX100012003 Standard Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
1000 L LGRMXJ100012004 Jacketed Mixer Tote 120 Volts + Mettler Toledo (pH &/or Cond) Transmitter
1000 L LGRMXJ100023005 Jacketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor
1000 L LGRMXJ100012005 Jacketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor
1000 L LGRMXTTE1000L-FAT FAT for Mixer Tote 120 or 230 Volts
1000 L LGRMXW1000 Standard tote weighing platform
1000 L LGRMXJW1000 Jacketed tote weighing platform
1000 L LGRMX1000LIQOQ IQ/OQ Documentation for 1000 L Mixer