TFF perfusion for commercial production
The KrosFlo® KPS Systems automatically control and maintain critical operational parameters defined by the operator during pilot and large-scale cell culture perfusion. While traditional stainless steel systems need to be cleaned in place (CIP) or steamed in place (SIP) prior to use, the KrosFlo® KPS Systems are integrated with sterile ProConnex Flow Paths for easy ready-to-operate tangential flow perfusion.
KrosFlo® KPS TFF SYSTEMS
KrosFlo® KPS Systems are set up on a mobile cart that supports the hollow fiber filter module, an integrated ProConnex® flow path, and an integrated TFF system that automatically controls and maintains critical operational parameters (Recirculation Shear Rate, TMP control, Permeate Flow/VVD and Reactor Volume Maintenance). Robust integrated solutions and associated connections minimize the hold up volume and provides a completely drainable process loop.
Integrated system
Hollow fiber filter, configurable ProConnex® flow path, complete TFF system mounted on a mobile cart
custom flow path
Fully integrated with sterile,custom-engineered ProConnex® flow path
可放大性
Compatible with KrosFlo® TFF perfusion systems from process development to commercial manufacturing
Automatic Back Pressure Control Valve
Unique to Repligen, the KrosFlo® Back Pressure Control Valve is key to integrating and automating the TFF process, reducing operator process management time and TFF processing time.
- Automatically adjusts tubing pinch distance according to user-defined set-points for inlet, retentate, permeate or transmembrane pressures (TMP) when attached to the ProConnex® flow path
- Maintains a uniform TMP throughout the process run, decreasing membrane fouling
- Controls the permeate pressure and flow during microfiltration applications
- Releases and tightens the pinch valve as solution viscosity increases or decreases during a process
- Can be set to start pinching from the open, middle, or closed position
- Compatible with tubing sizes 13, 14, 16, 25, HP15, 17, HP24, 18, HP35, 36, and HP36
CONFIGURABLE Pro-Connex® FLOW PATHS
Enhanced through an engineering design process, ProConnex® Flow Paths are customized, configurable and complete assemblies for tangential flow filtration. Designed for use with hollow fiber and/or flat sheet TFF systems, the assemblies are sterile, fit for upstream or downstream processing and manufactured in compliance with ISO guidelines in an ISO 7 clean room.
Proprietary KF Comm Software
KF Comm Software
- Automatically collects process data
- Provides real-time overviews of the filtration process
Microsoft Surface Pro 4 with Excel
- Automatically graphs data in Excel-based software
- 21CFR Part 11 enabled when used with optional KF Comm Compliant Workbook and interface software package from OFNI Systems (ExcelSafe™)
Real-time operating parameters
- Time
- Feed Pressure
- Retentate Pressure
- Permeate Pressure
- Feed Flow Rate
- Diafiltration Flow Rate
- Permeate Flow Rate
- Feed Scale Weight
- Permeate Scale Weight
- Pump RPM
- Notes (Alarms, Process status, Functions)
- Pump Mode
Processing parameters
- Transmembrane Pressure (TMP)
- Pressure Drop (ΔP)
- Retentate Flow Rate
- Permeate Flux
- Volumetric Throughput (VT)
- Concentration Factor
- Shear
- Diafiltration Volumes
- Process Time
- UV, Conductivity, and Temperature (with KONDUiT)
Compatible Filter Modules
| Primary Application |
Volume | Inlet/ Outlet | Side Port |
Scale Length |
Effective Length (cm) | Total Length (cm) |
Surface area |
|
|---|---|---|---|---|---|---|---|---|
MiniKros Sampler |
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 |
Batch TFF of small volumes | 3 L -15 L | 0.75" TC | 0.75" TC | 1 x FL 2 x FL 3 x FL |
20 41.5 65 |
25 47 70 |
490 – 1000 cm2 1000 - 2200 cm2 1600 - 3400 cm2 |
MiniKros |
||||||||
 |
Pilot-scale TFF | 5 L - 50 L | 1.5" TC | 0.75" TC | 1 x FL 2 x FL 3 x FL |
20 41.5 65 |
25 46 70 |
0.16 - 0.31 m2 0.32 - 0.65 m2 0.51 - 1.0 m2 |
KrosFlo® |
||||||||
 |
Production-scale TFF | 10 – 100L | 3" TC | 1.5" TC | 1 x FL 2 x FL 3 x FL |
20 41.5 65 |
23 46 69 |
0.78 - 1.6 m2 1.65 - 3.25 m2 2.55 - 5.10 m2 |
KrosFlo® MAX |
||||||||
 |
Production-scale TFF | 100L – 1000+L | 6" TC | 1.5" TC | R65 3 x FL R85 |
49.9 67.9 107.5 |
73.5 91.5 131.1 |
4.30 - 10.40 m2 7.10 - 17.10 m2 11.30 - 11.35 m2 |
Scalable from benchtop to production
The KrosFlo® family of TFF Systems for perfusion cell culture supports scale up from process development to commercial manufacturing.
KrosFlo® KML System
1.5L - 100L
KrosFlo® KPS Systems
500L - 5000L
Components
- Software: Proficy HMI/SCADA-IFIX
- Ethernet port for connection to central data acquisition system
- 15" Color touch screen computer/display
- Sequences available in semi-Automated or automated mode
- Ultrasonic non-invasive Retentate Flow Meter (Permeate Flow Meter optional)
- Nema 4X rated enclosure
- Controller displayed reading and renderings of the flow path
- Visual and audible alarms with safety interlocks
- Retentate control valve that is non-invasive to the process stream
- USB port for connection flash drive to transfer data
- USB port can be used for connecting an external mouse or keyboard