A fully automated bioprocessing system, providing flexibility and improved productivity in upstream and downstream single-use processingSingle-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:
- Bioburden reduction
- pH adjustment
- 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
Application Areas for Allegro MVP System
Optimized DesignThe 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)
Easy ConfigurationThe 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:
|Bioburden reduction||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
- Filter combination
- Filters in series / parallel
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 AdjustmentThe 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 InstallationUnique, intuitive, labelling on the Allegro MVP manifolds ensures quick and easy installation of flowpaths and filters in the correct location.
Product Validation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:
- 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.
- 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|
Basic system approximately 205 kg
Advanced system approximately 220 kg
|Pressure||0 – 4 bar|
|Feed pump flow||0.06 - 2220 L/hr|
|Temperature||4 – 40 °C|
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|
|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
|管道||Platinum cured silicone, C-Flex®|
|Diaphragm pump head||Head – polypropylene; diaphragm - EPDM; valves - EPDM|
|Manifold connectors||Polysulfone, silicone|
|Flow sensor||PVDF with ruby bearing|
|LGRMVPB230||Basic system 230 V|
|LGRMVPA230||Advanced system 230 V|
|LGRMVPB||Basic system 120 V|
|LGRMVPA||Advanced system 120 V|
Delivery Pump Options
|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)|