Control Module
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• Touch screen
• Configurations settings for system preparation, cleaning, and settings
• Various communication ports
• Compressed air distribution
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Multiplexer Module
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• Multiplexing of up to 4 bioreactors per module
• Up to 4 modules per Numera® system
• Pinch valve sterility barrier with ethanol rinsing
• Sterile air blow back mechanism to prevent cross-contamination and preserve low volume sampling
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Routing Module
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• Individual sample distribution within one process
• Direct transfer to maximum 4 analyzers (biochemistry analyzers or cell counters)
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Dilution Module
| • Dilution from 1:2 to 1:20 • Reagent addition, mixing, and incubation • Precise and reproducible sample processing |
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Filtration Module
| • Unique cross-flow filtration technology • Low protein binding PES membrane coil • Up to 700 filtrations per coil • Membrane pore sizes: 0.22 μm, 0.45μm, and 1.2 μm • Fresh membrane section for every filtration cycle avoiding cross-contamination |
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Autosampler / Sample Collector
ASX7200
- 2 Peltier Rack Modules (storage at 4 to 20 °C)
- 4 well plate positions
- Optional: 1 HPLC injection valve
ASX7400
- 4 Peltier Rack Modules (storage at 4 to 20 °C)
- 8 well plate positions
- Optional: 1 or 2 HPLC injection valve(s)
ACCESSORIES
Well plates
- 40 x 1.5 ml vials
- 24 x 4.0 ml vials
- Standard deep-well plates with 2, 5, or 10 ml
HPLC/UHPLC Injection Valves
- Variants from 5,000 to 20,000 psi
- Vertical port injector
- Sample loop (ID 0.14 mm) from 5 to 50 μl
Product Configuration
Up to 4 Multiplexer Modules can be stacked on a central system. This allows to connect up to 16 bioreactors.
Multiplexer Modules can be decentralized, depending on the available space and laboratory organization.
The Autosampler should be put close to the system. The distance to connected analyzers is limited to 10 m.
Reactor Connections
• Single-use sampling sets
• Sample lines 1 – 10m
Single-Use Bioreactors
+ Sample lines
Benchtop Reactors
+ Sample lines+ Dip tube
+ Adapters
Stainless Steel Reactors
+ Sample lines+ Sampling port
Single-Use Sampling Sets
At the Multiplexer, autoclavable single-use sampling sets including all tubings for sterile sampling, ethanol cleaning and flush back with sterile air, are installed for each sample vessel.
Sample Lines
From 1 to 10 meters are used to attach the sampling set at the Multiplexer to the corresponding bioreactor interface with Luer-Lock screw connections.
Dip Tubes
Stainless steel dip tubes with a Luer-Lock connector are used in combination with a suitable reactor adapter to sample from bench-top (glass) bioreactors.
Adapters
Adapters from 10 – 19 mm and PG13.5 are available to mount the dip tubes to any common head-plate port.
Aseptic Sampling Port
The Aseptic Sampling Port enables sampling from stainless steel bioreactors using the 25 mm side port. The connection to the Numera® System is made with a Septum Piercing Needle with side entry. The needle comes with a holder that fits to the Aseptic Sampling Port and with a Luer-Lock connector.
Sampling & Sterility Concept
- Minimal sample loss
- No sample dilution
- Guaranteed sterility
- No cross contamination
The clamps are removed after mounting the tubes on the pinch valves. The tubes are subsequently connected to the Multiplexer Module input and to the bioreactor/vessel interface. Luer-Lock screws ensure the connection between sampling set, sample line and bioreactor interface.
After completion of the sampling procedure, the remaining sample in the sampling line is pushed back into the bioreactor with sterile air. An ethanol rinsing procedure cleans the sampling sets at the Multiplexer Module to remove sample residues and prevent contamination. A rinsing procedure guarantees complete removal of ethanol.
Analyzer Integration
Numera® can be used in combination with various analyzers to perform on-line analytics:
- Cell counters (e.g., ViCELL XR®, Cedex HiRes)
- Biochemistry Analyzers (e.g., Cedex® Bio HT)
- HPLC Sytems (e.g., Agilent 1200 Series, Thermo Fisher Vanquish)
For each analyzer integration, specific accessories and information are needed that are provided by Securecell.
HPLC Integration
The Autosampler setup can include an injection valve for HPLC (up to 20,000 psi). Direct injection provides loss-free and fast analytics with HPLC system of various vendors.
Sample Management with Lucullus Software
The combination of the automated sampling system, Numera®, and the Process Information Management System, Lucullus®, enables the orchestration of the whole workflow covering sampling, measurement, process monitoring and control.
- Sample planning (time- and event-based)
- Analytical methods for all analyzers
- Barcode and label printing
- Automated event-based sample triggering during process
- Sample preparation and sample storage
- Automated on-line measurements
- Centralized data management and process monitoring
- Advanced process control and feedback loops
ADVANCED REAL-TIME MONITORING IN A CONTINUOUS BIOPROCESS
March 21, 2023Automated sampling with Numera® as a central hub along a continuous bioprocess, enabling advanced real-time monitoring and process wide-control.
FACILITATED AND RELIABLE PROCESS MONITORING DURING VACCINE PROCESS DEVELOPMENT AND PRODUCTION USING THE AUTOMATED SAMPLING SYSTEM NUMERA®
October 26, 2022Vaccines are one of the most effective, cost-efficient, and sustainable ways of controlling infectious diseases and have had a significant impact on public health and longevity as well as intensive livestock production.
AUTOMATED ON-LINE CELL CULTURE MONITORING USING NUMERA® AND THE CEDEX® HIRES ANALYZER
May 4, 2022Every biopharmaceutical process aims for real-time monitoring and control of critical process parameters to minimize process variability and at the same time ensure predefined product quality.