For use in pilot to large-scale perfusion cell culture, the KrosFlo® KPS Systems are integrated tangential flow filtration (TFF) systems.
• 500L - 5000L volume
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 Pro-Connex 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 Pro-Connex® 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 Pro-Connex® flow path, complete TFF system mounted on a mobile cart
custom flow path
Fully integrated with sterile,custom-engineered Pro-Connex® flow path
Scalable
Compatible with KrosFlo® TFF perfusion systems from process development to commercial manufacturing
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
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 Pro-Connex® 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, Pro-Connex® 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 |
||||||||
 |
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