Numera®
Advanced Bioprocess Sampling Solution
Numera® is a fully automated sampling system that never sleeps, integrating and improving every process analytical technology with reliable real-time results 24/7. Combined with Lucullus® software, Numera® is a seamless all-in-one sampling solution.
About Numera®
Numera® is a modular PAT system. Each installation includes a Control Module, a Routing Module, and at least one Multiplexer Module, while the Dilution and Filtration Modules for sample preparation are optional.
The Autosampler/Sample Collector stores retained samples at 4°C for further processing.
Numera® can be used in many applications – from single-use, bench-top reactors, up to production.
The modular design of Numera® allows configurations for single reactor sampling and storage up to multiple reactor sampling including dilution, filtration, and integration of various on-line analyzers.
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Setup and Configuration
Autosampler / Sample Collector
Storage of retained samples or intermediate storage of samples for further processing is achieved with the Autosampler. In addition, manually taken samples can be stored for processing with the Numera® and/or for transfer to analyzers. Cooling is guaranteed in a range of 4 to 20 °C. There are two different sizes of Autosampler available. Both are equipped with a syringe pump and a rinse station.
The Autosampler can be equipped with 2 well plates per Peltier rack module. Securecell offers well plates for 1.5 ml and 4.0 ml glass vials. Standard deep-well plates with 2, 5, or 10 ml can also be used.
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 20 μl
Product Configuration
The modular design of Numera® allows configurations for single reactor sampling and storage up to multiple reactor sampling including dilution, filtration, and integration of various on-line analyzers.
A maximum length of 10 m between the Numera® and the reactors is recommended.
Up to 4 Multiplexer Modules can be stacked on a central system. This allows up to 16 bioreactors to be connected.
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 Connection and Sterility
Reactor Connections
Numera® can be used in many applications – from single use, benchtop reactors, up to production. The appropriate connection options are available for all purposes. The modular concept includes:
• Autoclavable sampling sets
• Sample lines 1 – 10m
• Autoclavable 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 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 benchtop (glass) bioreactors.
Adapters
Adapters from 10 – 19 mm and PG13.5 are available to mount the dip tubes to any common headplate 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
Sample lines and sampling sets are autoclaved in bags before use and protected with sterile air filters and clamps to maintain sterility during installation.
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 establish the connection between the sampling set, the sample line, and the 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 the complete removal of ethanol.
Proof of sterility in a technical run
Figure: values for pH (red line), pO2 (blue line), and O2 inflow (black line) over process time. The steady values indicate a sterile process over 15 days. Samples were drawn every 2 h.
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Analytics and Sample Management
Analyzer Integration
Numera® can be used in combination with various analyzers to perform on-line analytics:
1. Cell counters (e.g., ViCELL XR®, Cedex® HiRes)2. Biochemistry Analyzers (e.g., Cedex® Bio HT, Bioprofile® FLEX2)
3. HPLC Sytems (e.g., Agilent 1200 Series, Thermo Fisher Vanquish)
Securecell provides the specific accessories and instructions required for the integration of each analyzer.
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 Lucullus® Process Information Management System, enables the orchestration of the whole workflow comprising 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 execution
- Sample preparation and sample storage
- Automated on-line measurements
- Centralized data management and process monitoring
- Advanced process control and feedback loops
