Allegro™ MVP Single-Use System product photo Primary L

Allegro™ MVP Single-Use System

A fully automated bioprocessing system, providing flexibility and improved productivity in upstream and downstream single-use processing

Single-use technology continues to be adopted across many areas of bioprocessing. The use of automation provides additional benefits in manufacture such as consistency in product quality, reduced labor costs and reduction of operator errors.

The Allegro MVP system is designed for use across a range of bioprocessing activities such as:
  • Sterile filtration
  • Bioburden reduction
  • Depth filtration
  • Virus filtration
  • Media and buffer preparation
  • Membrane chromatography
  • pH adjustment
  • Virus inactivation
  • Final formulation and filling
The Allegro MVP system uses fully disposable flowpaths, and incorporates single-use sensors for control and monitoring of key parameters. This enables processing to be conducted at optimum conditions, using fully automated process sequences.

Key Attributes

  • Good engineering design provides reliability, robust operation and minimizes risk of operator error
  • High degree of automation enables precise and consistent operation, control of key parameters, and minimizes operator contact
  • High degree of flexibility to run many different processes


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Description

A fully automated bioprocessing system, providing flexibility and improved productivity in upstream and downstream single-use processing

Single-use technology continues to be adopted across many areas of bioprocessing. The use of automation provides additional benefits in manufacture such as consistency in product quality, reduced labor costs and reduction of operator errors.

The Allegro MVP system is designed for use across a range of bioprocessing activities such as:
  • Sterile filtration
  • Bioburden reduction
  • Depth filtration
  • Virus filtration
  • Media and buffer preparation
  • Membrane chromatography
  • pH adjustment
  • Virus inactivation
  • Final formulation and filling
The Allegro MVP system uses fully disposable flowpaths, and incorporates single-use sensors for control and monitoring of key parameters. This enables processing to be conducted at optimum conditions, using fully automated process sequences.

Key Attributes

  • Good engineering design provides reliability, robust operation and minimizes risk of operator error
  • High degree of automation enables precise and consistent operation, control of key parameters, and minimizes operator contact
  • High degree of flexibility to run many different processes
Applications

Application Areas for Allegro MVP System


Specifications

Optimized Design

The system was designed to perform the pH adjustment steps needed in media preparation and virus inactivation, with fully automated addition of acid & base stock solutions. Allegro mixers can be used with the MVP system, to ensure rapid dispersal of the added fluids during these process steps.

A large selection of pre-designed manifolds is available, with a specially designed manifold selection tool to help identify the most suitable manifold for your application.

A choice of sensors, connectors, tubing type, filters and pre-filters when selecting a flowpath ensures the manifold is completely suited to your process application.

No other system offers such a wide range of preconfigured standard manifold options.

The system is designed to automatically monitor multiple parameters and the following sensors can be selected:
  • Pressure (inlet, between filters, outlet single-use sensors)
  • pH (reusable probe in mixer)
  • Flow (inlet single-use sensors)
  • Conductivity (reusable probe in mixer or single-use sensor on outlet)
  • UV (outlet single-use sensors)
  • Mass (via load cell connection)

Easy Configuration

The sensors being used in any given process can be easily selected or deselected on the configuration screen. Sensors not being used are not shown on the main operating screen.

The phase editor in the control system allows the generation and configuration of customer specific processes in a simple and user-friendly way. This facilitates reliable, automated control of processing at optimum conditions.

Allegro MVP System capabilities:

 
Final formulation and filling Membrane chromatography
Sterile filtration pH adjustment
Bioburden reduction Media and buffer preparation (mixing, pH adjust, filtration)
Depth filtration
Virus filtration and inactivation  
 




A universal clamp can be used to support capsules with diameter 5 cm to 10.5 cm
  • Different capsule types
  • Filter combination
  • Filters in series / parallel
Vertical brackets can be moved horizontally to give flexibility with any manifold design

Depending on the process application and the flow range required, either a diaphragm or a peristaltic feed pump can be used with the Allegro MVP system.

Capsules with a diameter 5 cm to 10.5 cm (up to 30 in. Pall Kleenpak™ Nova filter or equivalent) are supported on the Allegro MVP system with universal clamps fixed to vertical brackets. This allows for different filter combinations and running filters in series or parallel.

Stax™ depth modules (up to 20 m2) can be positioned next to the Allegro MVP system, with connections running between the units.

Automated pH Adjustment

The Allegro MVP system has two small pumps which add acid/base as programmed by the software.

The acid and base stock solutions are located in the two 20 L trays.

Mixing is required for virus inactivation and media preparation. An Allegro mixer bag with acid/base ports and pH probe access point can be used with this system. The mixer can be controlled from the HMI on the MVP system.

A reusable, autoclavable, pH probe in the mixing bag will continually monitor the pH, so that the end point can be accurately determined.

Intuitive Flowpath Installation

Unique, intuitive, labelling on the Allegro MVP manifolds ensures quick and easy installation of flowpaths and filters in the correct location.





Product Validation

Pall maintains a very stringent approach to quality of purchased and manufactured components. The system is designed and built to well recognized industry standards, including but not limited to:
  • EMC 89/336/EEC
  • Good Automated Manufacturing Practice (GAMP) current version
  • CFR21 Part 11 for electronic records
  • The rules governing medicinal products in the European Community, Volume IV, and Good Manufacturing practice for medicinal products, Annex 11, computerized systems.
The Single Use Flowpaths:
  • Are assembled in a dedicated Class 10000 (Grade C) Clean Room, to ISO standards 9001:2008 and 14001:2004 using validated assembly methods.
  • Have components which have been tested for biocompatibility and certified to USP <88> Biological Reactivity Tests, in vivo, for Class VI plastics.
  • Include components that are certified TSE/BSE free.
  • Are supplied double bagged and irradiated at a minimum dose of 25 KGy

System Description and Components

 
System Frame 304 stainless steel
230 V system dimensions (LxWxH) 1278 x 957 x 1133 mm
120 V system dimensions (LxWxH) 1321 x 981 x 1185 mm
System weight Basic system approximately 205 kg
Advanced system approximately 220 kg
 

Operating Conditions

 
Pressure 0 – 4 bar
Feed pump flow 0.06 - 2220 L/hr
Temperature 4 – 40 °C
Power supply 230 V 1-phase
120 V 1-phase
Compressed air Air source at 6 bar (for operation of valves)
Software HMI software with Siemens or Allen Bradley PLC
 

Technical and Validation Support

Pall can provide a high level of process validation support, through our Scientific and Laboratory Services (SLS) group. Pall places its extensive technical resources at the disposal of its customers in the form of world-wide technical advice and training. We can provide guidance to select and efficiently size filters that can be run on the Allegro MVP System across the range of applications.





System Options

Basic System Components

 
20 L Trays X2 HDPE biocontainer trays For use with Allegro 2D 20 L biocontainers
Pinch valves Pneumatic actuated For use with ½ in. or ¾ in. ID tubing
Valve caps 6 supplied To cover unused pinch valves
Basket and drip trays HDPE For miscellaneous items –
pH standards, pinch valve caps
Vertical brackets 4 supplied To attach filters
Universal clamps 6 supplied Flexible filter clamps for use with capsule diameters 5.0 cm to 10.54 cm
Pressure measurement Single-use with pressure sensitive chip - 3 supplied -0.48 to 5.2 bar
Flow measurement Single-use turbine with reusable sensor - 3 supplied 30 to 1200 L/hr +/- 5% >180 L/hr
 

Additional Components for Advanced System1

 
Acid and base pumps Peristaltic dosing pumps - 2 supplied 0 – 180 L/hr (9.5 mm tubing)
0.24 - 2.40 L/hr (6.4 mm tubing)
pH/temperature probe Re-usable lnPro3253i 0 - 12 pH +/- 0.1 pH unit
0 - 100 ºC +/- 1 ºC
Conductivity probe Re-usable lnPro7100i 0.02 - 500 mS/cm +/- 7%
0 - 100 ºC +/- 1 ºC
Conductivity in-line Single-use flow cell 10 – 200 mS/cm, +/- 0.25 mS/cm
0 – 100 μS/cm, +/- 0.3 μS/cm
Temperature in-line Single-use flow cell 4 – 50 ºC +/- 0.50 ºC
UV measurement Single-use flow cell 0-2 AU +/- 0.1 AU
 
1Advanced system consists of Basic system components plus Additional components listed above.

Main Delivery Pump Options (pump must be ordered in addition to the base system)

 
Quattroflow 1200 pump For high pressure, low pulsation unit operations 30 – 1080 L/hour
Watson Marlow 720 DuN double headed peristaltic pump For low pressure, high volume unit operations 0.06 – 2220 L/hr
 

Product Contact Components

 
Components Materials
Tubing Platinum cured silicone, C-Flex®
Diaphragm pump head Head – polypropylene; diaphragm - EPDM; valves - EPDM
Manifold connectors Polysulfone, silicone
Fittings Polypropylene
Pressure sensor Polysulfone
Flow sensor PVDF with ruby bearing
UV sensor Polysulfone
Conductivity sensor Polypropylene
Triclamp gaskets Silicone
 
Ordering Information

Hardware

 
Part Numbers Description
LGRMVPB230 Basic system 230 V
LGRMVPA230 Advanced system 230 V
LGRMVPB Basic system 120 V
LGRMVPA Advanced system 120 V
 

Delivery Pump Options

 
Part Numbers Description
LGRMVPP Allegro MVP system peristaltic pump WM720 (dual voltage motor)
LGRMVPD230 Allegro MVP diaphragm pump Q1200 (230 V fan)
LGRMVPD120 Allegro MVP diaphragm pump Q1200 (110 V fan)
 

To discuss your process needs and the full range of manifold options for this system, please contact your local Pall Specialist.
Application
Systems
Segment
Single-Use Solutions