Cellicon™ Perfusion Solution
A Superior Cell Retention Solution for N-1 Seed Train intensified with Optimized Process Control
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产品族
Mobius® 3L Single-use BioreactorEliminate the need to clean, autoclave and assemble your traditional glass bioreactors and save days of downtime with the Mobius® 3L Single-use Bioreactor.详细了解 >> |
The benchtop Cellicon™ Perfusion Solution is designed to meet your perfused seed train challenges. It consists of a controller and a flat sheet cell retention filter running in tangential flow filtration mode part of a single-use assembly. This easy-to-use solution increases perfusion process efficiency and provides real-time monitoring and control for reliable and consistent performance.
Perfusion operations deliver high-density cell cultures that alleviate the burden of processing large production bioreactor volumes while increasing manufacturing flexibility. Introducing perfusion to your seed train makes it possible to inoculate a higher quantity of cells for one or more production bioreactors, thus increasing process efficiency.
The filter assembly is supplied gamma-irradiated and dry (preservative-free), eliminating the need for flushing. The controller’s touchscreen interface is easy to use. The P&ID screen monitors all active parameters and the data display provides real-time process monitoring at a glance.
Benefits
- High throughput and low fouling
- Predictable linear scale up from lab to manufacturing scale
- Reliable and reproducible performance
- Low crossflow and cell shear
- Comprehensive monitoring and precise control
- Ready to process in minutes
Membrane
A trusted name in the industry, our Durapore® hydrophilic PVDF 5.0 µm microfiltration membrane is ideally suited for achieving maximum cell retention while minimizing fouling. Durapore® membrane is low protein binding and has low extractables, low shedding, and broad chemical compatibility. It is tough and proven.
Applications
- Monoclonal antibodies
- Recombinant proteins
The Emprove® Program- your fast track through regulatory challenges
Complementing our product portfolio, the Emprove® Program provides three types of dossiers to support different stages of development and manufacturing operations such as qualification, risk assessment and process optimization. The dossiers combine comprehensive product-specific testing data, quality statements and regulatory information in a readily available format to simplify your compliance needs.
Cellicon™ Filter Assembly
| Materials of Construction | |
| Filter | |
| Membrane | Polyvinylidene fluoride (Durapore® membrane, 5 µm) cast on non-woven support |
| Feed Screen | Polyethylene terephthalate (PET); Polyester |
| Housing/Housing Overmold | Polypropylene/Polypropylene (colored blue) |
| Assembly Components | |
| Tubing | AdvantaFlex® thermoplastic elastomer |
| Fittings | Polypropylene |
| Pressure Sensors | Polysulfone |
| Single-Use Pump Head | Polypropylene; magnet encapsulated in polypropylene (non-fluid contact) |
| Tubing Tie Wraps | Nylon (non-fluid contact) |
| Gamma Irradiation | |
| Each assembly is gamma irradiated | |
| Storage Conditions | |
| Temperature | 15 – 30 °C |
| Storage Solution | None; filtration device assembly is supplied dry |
| Maximum Operating Conditions | |
| Recommended Feed Crossflow Rate | 10 L/min/m2 |
| Maximum Recommended Flux | 23 L/m2/hr |
| Maximum Feed (Inlet) Pressure | 5 psi (345 mbar) |
| Maximum Reverse Pressure | 1 psi (69 mbar) |
| Maximum Transmembrane Pressure (TMP) before ending run | 5 psi (345 mbar) |
| Operating pH Range | 4-8 |
| Nominal Dimensions and Hold-up Volume | |
| Membrane Area | 100 cm2 |
| Length | 26 cm (10 in.) |
| Width | 7 cm (2.8 in.) |
| Feed to Retentate Fitting Distance | 22.5 cm (8.8 in.) |
| Feed Hold-up Volume (with tubing) | 3 ml (37 ml) |
| Perfusate Hold-up Volume (with tubing) | 11 ml (42 ml) |
| Tubing Dimensions | |||||
| Location | Material | Diameter | Length In. (cm) | Quantity | |
| Inner in. | Outer in. | ||||
| Feed | AdvantaFlex® | 1/8" | 1/4" | 5 in. (12.7) pre-cut, 2 in. (5) nominal | 1 |
| AdvantaFlex® | 1/8" | 1/4" | 5 in. (12.7) nominal | 1 | |
| Silicone | 1/4" | 7/16" | 6 in. (15.2) | 2 | |
| AdvantaFlex® | 1/8" | 1/4" | 24 in. (60.9) | 1 | |
| Retentate | AdvantaFlex® | 1/8" | 1/4" | 2 in. (5) | 1 |
| AdvantaFlex® | 1/8" | 1/4" | 24 in. (60.9) | 1 | |
| Perfusate | AdvantaFlex® | 1/8" | 1/4" | 2 in. (5) | 1 |
| AdvantaFlex® | 1/8" | 1/4" | 24 in. (60.9) | 1 | |
| * The filter is connected to the bioreactor via tube welding on the feed and retentate lines. The perfusate line is also tube welded to a sterile bag or collection vessel to collect the perfusate. | |||||
| Manufacturing Release Criteria | |
| 100% Filter Integrity Tested | Each filter unit must pass an in-process integrity test using a visual inspection under magnification method. |
| 100% Filter Housing Pressure Test: | Each filter unit must pass a housing pressure decay test at an operating pressure above 5 psi. |
| Flow Rate and Pressure Drop | A statistically representative number of filter units from each lot must meet a pressure drop of less than or equal to 2 psi at 100 mL/min average feed flow of water. |
| 100% Assembly Leak Integrity Testing in Manufacturing | Each assembly unit is tested and must pass a leak integrity test using a pressure decay method. |
| Regulatory Information | |
| Component Material Toxicity | All parts in the fluid path were tested pre-gamma irradiation and met the criteria of the USP <87>. Biological Reactivity Tests for Class VI Plastics and USP <88>, Cytotoxicity Testing, |
| Good Manufacturing Practices | This product is manufactured in a facility that adheres to current GMP. |
| ISO® 9001 Quality Standard | This product was manufactured in a facility with a Quality Management System approved by an accredited registering body to the appropriate ISO® 9001 Quality System Standard. |
| Validated Production Process | This product was fabricated using a validated manufacturing process. Principles of statistical process control and determinations of process capability have been applied to critical variables in the device fabrication process. In-process controls are used to assure stability of the process. |
Cellicon™ Controller
| Pressure measurement | |
| Number of pressure sensors | 3 single-use sensors (feed, retentate, perfusate) |
| Pressure range | -7 to 15 psi |
| Pressure accuracy | +/- 0.25 psi @ 5 psi |
| Calibration required (Y/N) | No |
| Tare required (Y/N) | Yes |
| Flow measurement | |
| Technology | Ultrasonic |
| Flow range | 0.05 to 1 L/min (or 5-100 L/min/m2) |
| Flow accuracy | Characterized at 100 mL/min |
| Tare required (Y/N) | Yes |
| Way of detection | Measurement out of fluid path |
| Pump motor | |
| Pump motor | Levitronix® Puralev i30 |
| Pump flow | capped at 7000 RPM |
| Max. Viscosity | 10 cP |
| Priming required (Y/N) | Yes |
| Console Interfaces | |
| PLC interface | 2X digital inputs, 2X digital outputs, 1 analog input 4-20 mA, 1 analog output 4-20 mA |
| Network interface | Modbus® TCP/IP control and access to setpoints, data registers, alarms, warnings and recipes |
| DC supply connector | 24 VDC with external AC/DC supply, software configurable, auto-resume function, 3-pin connector, global power supply |
| USB interface | USB port for data collection and software updates |
| Touch screen interface | 7 in. color multi touch |
| Controls | |
| Pump control | RPM (priming mode) or flow rate (perfusion mode) control possible, maximum pump RPM and RPM ramp rate both field adjustable |
| Language | English |
| PLC control | PLC control confirmed on touchscreen, disabling controls on console |
| Flow rate PID settings | P and I values are field settable |
| Pressure scaling and calibration | Via HMI |
| Software | |
| Definable user account levels | Yes |
| Alarm systems | Yes |
| Data logging | Yes, via USB |
| Start-up requirements | System has default settings |
| Back-up solution (Y/N) | Yes |
| Material of construction | |
| Pump head socket | Anodized aluminum |
| Integrated pump driver | Epoxy coated aluminum, polypropylene for bottom lid |
| Flow meter clamp on sensor | Anodized aluminum, 304 stainless steel |
| Filter holder | Zinc-aluminum alloy |
| Dimensions and weight | |
| Dimensions | D: 31 cm (12 in.) H: 21 cm (8.2 in.) W: 11 cm (4.4 in.) |
| Weight | 3.6 kg (8 lbs) |
| Regulatory Information | |
| Enclosure rating | IP54 |
| CE Mark | Controller is self-declared to meet the applicable European Directives. Please reference the product's Declaration of Conformity for more information. |
| User guide | Yes, online |