Fully automate hollow fiber tangential flow filtration (TFF) processes in downstream applications such as concentration-diafiltration-concentration up to 500 L with configurable hardware components.
leverage integrated peristaltic pump for general applications
The KrosFlo® KMPi TFF System achieves an unparalleled combination of integration, configurability and automation through modular, plug-and-play hardware. All components, either directly or indirectly, connect to the main KrosFlo® KMPi peristaltic pump, which then communicates with the KF Comm 2 software for control and monitoring.
- Configure a minimal number of components for simple applications such as concentration (C) or diafiltration (D)
- Plug-and-play additional components for fractionation (F) and multi-step processes (i.e. CDC/D/C)
KrosFlo® KMPi TFF SYSTEM: HARDWARE, SOFTWARE AND FLOW PATH
The fully integrated KrosFlo® KMPi TFF System consists of hardware, software and flow path components. Key hardware components include: a digital peristaltic pump, auxiliary pumps and an automatic back pressure valve. The KF Comm 2 software features a multi-language interface for complete monitoring and control and an optional 21 CFR Part 11 environment. Add tubing and sanitize/sterilize your own flow path around a Spectrum hollow fiber filter or build a closed and gamma-irradiated ProConnex® Flow Path from over 250 components.
Fully integrated
Includes filters, pumps, process monitors, software and graphic display
Configurable
Modular design provides flexibility enabling optimal resource utilization and low hold-up volume
Scalable
Compatible with KrosFlo® TFF Systems from Lab (>0.5 mL) to commercial manufacturing (500L)
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.
KrosFlo® KMPi Proprietary Differentiating Functions
Automatic Back Pressure Control Valve
A Repligen-exclusive technology, the Automatic Back Pressure Control Valve adds transmembrane pressure (TMP) control to every TFF process, reducing operator hands-on-time and improving process reproducibility.
- Automatically adjust tubing pinch distance according to user-defined set-points
- Maintain uniform TMP throughout process run, decreasing membrane fouling
- Control permeate pressure and flow during microfiltration applications
- Use with compatible tubing sizes 13, 14, 16, 25, HP15, 17, HP24, 18, HP35, 36, and HP36
- Activate automatically using inlet, retentate, permeate or transmembrane pressures
Transfer bi-directional data through
proprietary board
An advanced microprocessor-based controller is integrated into the main KrosFlo® FS System pumps, enabling plug-and-play hardware component behavior. Bi-directional communication is established between the KF Comm 2 software and hardware components, such as the Automatic Back Pressure Control Valve, scales, auxiliary pumps and the Konduit device.
Menu-driven software for optimized TFF
KF Comm 2 Software provides a modern, graphically driven interface for process monitoring and control. Create new experiments based on 13 programmed modes, customize batch reports and plug-and-play hardware components. Add an optional 21 CFR Part 11 feature package for regulated environments.
- Start a run in only 4 clicks
- Select from 13 pre-programmed modes
- Operate securely on Microsoft SQL® database for stability
Ideal for Gene therapy from Lab to manufacturing
Run TFF development experiments and compliant small scale manufacturing runs on a single platform. Start with the KrosFlo® KR2i System and hold-up volumes as low as 10 mL. Scale up to 500 L with the KrosFlo® KMPi System while maintaining pump design, system architecture and software.
- Scale-up and scale-down with a single platform
- Configurable across applications (C, D and CFC/D/C)
- Modern 21 CFR Part 11 compliance software built on secure Microsoft® SQL Server
CONFIGURABLE ProConnex® FLOW PATH
Take a flow path idea to an engineering drawing in minutes with an on-line digital configurator and expert consultation. ProConnex® Flow Paths are configurable from over 250 components, are assembled ISO 7 clean rooms and arrive gamma-irradiated.
Build a ProConnex® Flow Path around:
- Spectrum® Hollow Fiber Filters
- TangenX® Cassettes
- ProConnex® TFDF® Filters
- Basic flow path assemblies
COMPATIBLE KrosFlo® KMPi 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 |
KONDUiT add-on Monitor
The standard KrosFlo® KR2i, KMPi, FS-15 and FS-500 can use time and weight/flow rate as process control set points. Add the Konduit and expand automated process control to include conductivity, UV and temperature for automated process controls. The Konduit integrates with the main pump and KF Comm 2 software with plug-and-play ease.
Konduit adds:
- End point conductivity control for UF /DF
- End point UV control for diafiltering free drug from drug delivery particles
- End point UV control for concentration of certain molecules
- UV alarm for membrane breakthrough
- A260 and A280 light sources available
*UV components sold separately
| Conductivity Range | 0.1 to 100 mS/cm |
| Temperature Range | 0-70° |
| Pressure Range | up to 75 psi (5 bar) |
| Dimensions | (L x W x H): 7¾" x 4¾" x 4½" |
| Weight | 1.6 kg |
Scalable from benchtop to production
The KrosFlo® family of TFF Systems for ultrafiltration and diafiltration supports scale up from process development to commercial manufacturing.
KrosFlo® KR2i TFF System
2ml - 10L
KrosFlo® KMPi TFF System
1L - 500L
KrosFlo® KTF TFF System
500L - 5000L
KrosFlo® KMPi ACCESSORIES AND COMPONENTS
- IP 66 and NEMA 4X Enclosure
- 650 RPM pump drive with reversible motor
- 90 to 260 Vrms @ 50/60 Hz
- Standard 13 LPM Pump Head
- High Performance 17 LPM pump head (optional)
- ETL Listed and CE/UL/cUL marked
- Dimensions: 17.5 in x 11in x 13in
(445 x 230 x 330 mm) - Shipping weight: 40 lbs (18kg)
Transducers
- Measures and displays 4 pressures: Inlet Pressure, Outlet Pressure, Permeate Pressure, Transmembrane Pressure (TMP)
- User-defined pressure alarm and stop set-points
- Available with many different connector types and materials of construction
Scales
Maintain user-defined feed weight set-points, and total permeate mass during TFF processes.
Monitor
User-defined pressure alarms help ensure maximum sample recovery and membrane integrity.
KrosFlo® KR1 Auxiliary Pump
Auxiliary pumps automatically increase or decrease buffer/product addition to feed reservoir.
Resources
|
Description |
Specification |
|---|---|
| Process volume | Up to 500L |
| Filter surface area | Up to 5.1 m2 |
| Main drive/Feed pump | Up to 11LPM (650 RPM) |
| Pressure transducers | Up to 3 Leur-style, polysulfone single-use (-0.48 to 5.2bar) |
| Scales | 60Kg (included); Optional: 60Kg, 200Kg, 500Kg and 1000Kg |
| Auxiliary pumps | KrosFlo® Research I, 600 RPM |
| Tubing | PharmaPure, TPE, size #26, #73 and #82 |
| TMP control | Automatic backpressure control valve (Non-invasive/No-product contact) |
| Reservoirs | 10L polypropylene with 4-port cap and drain |
| Tablet as HMI | Microsfot Surface Pro |
| Software | KFComm 2 with optional 21CFR part 11 package |
| Compliance | UL and CE certified |