Cogent^™ M Tangential Flow Filtration System

Cogent™ M Tangential Flow Filtration System

Description
- Extremely low hold-up volume for maximum product recovery
- Accurate scale down of production TFF systems
- Easy to use
- Easy to clean
The Cogent M system is a compact, semi-automated tangential flow filtration (TFF) system ideally suited for process development optimization and scaling studies of recombinant protein products, vaccines, gene therapy constructs, and clotting factors. Benefiting from Millipore’s industry leading bioprocess knowledge and expertise, the unit incorporates innovative and intelligent design features that enhance performance and enable a very low hold-up volume for maximum product recovery.

Equipped with a 10-liter tank, the Cogent M system can also be run in fed-batch mode using an optional transfer pump, which enables the system to process up to 100 liters or more based on sample and membrane characteristics.

The unique tank design incorporates maximum mixing capabilities and contributes to a low minimum working volume, and a proprietary membrane holder design with integrated sensors and sanitary connections greatly reduces hold up volume. The system uses from one to five Pellicon^® 2 or Pellicon 3 Mini cassettes and supports a membrane area from 0.1 m² to 0.5 m².


Models Full-Scale Production
Instead of using the standard peristaltic pump, the Cogent M system utilizes a diaphragm pump and 316L stainless steel fluid path components, which are used in most full-scale production systems. By emulating the design of production equipment at the bench scale, customers are able to conduct scale down studies that will reproduce shear characteristics and contact materials typically found in full-scale production systems.


Easy-to-Use System
With a state-of-the-art PLC control unit and touch screen buttons, the Cogent M system is easy to operate —no special training is required. In addition, the ability to establish set-points for automated control (such as target concentration) along with comprehensive safety features, allows unattended operation.


Cleanability
The system is completely drainable and designed for clean-in-place (CIP). The smooth stainless steel surfaces and zero dead space provide enhanced cleanability using standard cleaning agents such as NaOH and NaOCl.


Precise Retentate Flow Measurement
For critical applications that require assurance beyond the pressure flow curves included with the system, the Cogent M system can be fitted with an optional electromagnetic retentate flow meter that directly measures retentate flow with a high degree of accuracy, provided minimum conductivity requirements are met.

Easy to install and commission, the flow meter provides a high degree of measurement accuracy across a wide flow range. The stainless steel housing offers high sanitary safety andthe PFA lining is fully compatible with high process temperatures, and with CIP and SIP cleaning processes.

Cogent M system fitted with the optional flow meter

Typical Applications
- Concentration and diafiltration
- Depyrogenation
- Desalting and buffer exchange
- Small molecule processing
- Cell harvesting/clarification
- Virus harvesting/clarification

Specifications Cassette One to five Pellicon 2 or Pellicon 3 Mini cassettes (not included) Cassette Holder Pellicon Mini holder Vent Filter Opticap® XL 2 disposable capsule with hydrophobic Aervent® membrane Filtration Area 0.1 m2 – 0.5 m2 Tank Volume 10 L Tank Mixer Volume 1.5 – 10 L Hold-up Volume < 10 mL (excluding cassette) Pumps Feed: 0.2 – 4.5 L/min at 5 barg Transfer (option): 0.16 – 2300 mL/min (tubing dependent) Heat Exchanger (option) 0.2 kW Retentate Flow Meter (option) Minimum conductivity: ≥ 5 µS/cm Accuracy: ± 0.5% Maximum System Pressure 6 barg prior to pump shut off Minimum Recirculation Volume at Maximum Flow Rate 300 mL Process Temperature 2 – 50 °C Connection Hoses 1.0 bar maximum Operator Interface PLC via a touch screen Operational Requirements Electrical: Voltage/Current — Single Phase 100 VAC 50 Hz, 100 VAC 60 Hz, 120 VAC 60 Hz, 230 VAC 50 Hz Amperage (maximum): Europe: 2.5 amps North America and Japan: 5 amps Over voltage category: Category II Compressed air: Maximum 60 psi/413 kPa –20 °C dew point, oil-free Environmental Operating Conditions Humidity: 10 – 85% non-condensing environment Temperature range: Ambient operational: 2 °C to 30 °C Process: 2 °C to 50 °C Storage: –10 °C to 55 °C Maximum altitude: 2000 m Dimensions Height: 104 cm (41 in.) Width: 70 cm (28 in.) Depth: 44.5 cm (18 in.) Weight: 59 kg (130 lbs) Wetted Materials of Construction EPDM, 316L stainless steel, Santoprene® elastomer, medical grade epoxy, and silicone Surfaces Stainless steel – internal: < 25 micro-inch (0.67 µm), Ra External: < 50 micro-inch (1.34 µm), Ra Wetted Materials All polymer wetted materials of construction are USP Class VI tested. System Setup Unit shipped requires minimal setup. Pellicon 2 or 3 Mini cassettes (not included) are installed by the user. Regulatory Information The Cogent M system meets the requirements of the Low Voltage Directive 73/23/EEC and the EMC Directive 89/336/EEC, and is CE marked.

State-of-the-Art Design