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:
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.
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
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 混合器可与MVP系统共同使用，在工艺步骤中确保添加流体的快速分散。
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)
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:
Media and buffer preparation (mixing, pH adjust, 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
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.颇尔 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.
颇尔 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:
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
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
Basic system approximately 205 kg Advanced system approximately 220 kg
0 – 4 bar
Feed pump flow
0.06 - 2220 L/hr
4 – 40 °C
230 V 1-phase 120 V 1-phase
Air source at 6 bar (for operation of valves)
HMI software with Siemens or Allen Bradley PLC
Technical and Validation Support
颇尔 can provide a high level of process validation support, through our Scientific and Laboratory Services (SLS) group.颇尔 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.
Basic System Components
20 L Trays
X2 HDPE biocontainer trays
For use with Allegro 2D 20 L biocontainers
For use with ½ in. or ¾ in.ID tubing
To cover unused pinch valves
Basket and drip trays
For miscellaneous items – pH standards, pinch valve caps
To attach filters
Flexible filter clamps for use with capsule diameters 5.0 cm to 10.54 cm
Single-use with pressure sensitive chip - 3 supplied
-0.48 to 5.2 bar
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)