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KrosFlo® KMPi TFF System

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

KF COMM 2 SOFTWARE

 

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:

ProConnex® Flow Paths

COMPATIBLE KrosFlo® KMPi FILTER MODULES

  Primary
Application
Volume Inlet/ Outlet Side
Port
Scale
Length
Effective Length (cm) Total
Length (cm)
Surface
area

MiniKros Sampler

               
MiniKros-Sampler.png 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

               
MiniKros.png 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®

               
KrosFlo.png 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

KONDUiT_data.png

 

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® KMPi ACCESSORIES AND COMPONENTS

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                         KMPipump.jpg

  • 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

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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