Single-Use TFF Modules product photo Primary L

Single-Use TFF Modules

A simpler, easier and safer single-use TFF solution for R&D, clinical or commercial manufacturing

Pall's single-use tangential flow filtration (TFF) modules are ready-to-use gamma-irradiated cassette modules designed for single-use in Pall Allegro™ single-use TFF systems and can also be integrated into other single-use TFF set-ups. They provide ease-of-use, quick turnaround and increased flexibility, safety and containment in cGMP operations.

Our single-use TFF modules can be easily implemented in single-use TFF systems for concentration and diafiltration steps from R&D to commercial production of biotech products or vaccines.

Integrating the process-proven Pall Omega™ polyethersulfone (PES) membrane, our are available in scalable formats from 93 cm² up to 2.5 m² of membrane area.

Key Attributes

  • Simpler and easier solutions: preassembled, ready-to-use modules for easy integration into single-use TFF systems.
  • Safer solutions: single-use, gamma irradiated, contained modules for product and operator safety.
 
Feature Benefit
  • Pall's single-use TFF modules are delivered as preassembled modules that have been gamma irradiated at ≥ 25 kGy
  • Ease of installation and integration in single-use TFF systems
  • Supplied preconditioned, stored in water and gamma irradiated, the modules do not require comprehensive conditioning steps prior to use (see schematic 1). Typically less than 20 L/m² flush volumes are required to reach TOC levels below 1 ppm.
  • Improved productivity, reducing downtime and allowing focus on product processing operations only
  • No chemical handling
  • Reduction of buffer or WFI consumption
  • Designed for fully single-use operation, our single-use TFF modules can provide post-use containment during the single-use fluid flow path disassembly.
  • Increased process, product and operator safety
  • No cross contamination
  • Post-use containment of hazardous product
  • Our single-use TFF modules integrate the process-proven Omega PES membrane and are scalable.
  • Scalable formats, streamlining product development and process optimization
  • Tests have shown that the process performances of the our single-use TFF modules are comparable to reusable Omega T-series cassettes, thus offering the flexibility to switch from single-use to reuse TFF options and vice-versa with limited validation work.
  • Improved process robustness
  • Improved process robustness
 

Schematic 1: Comparison of TFF operations, reusable cassettes versus single-use with Pall's modules



Product Platform

Pall's single-use TFF modules are available in five formats with the following membrane areas:

  • 93 cm²
  • 186 cm²
  • 0.1 m²
  • 0.5 m²
  • 2.5 m²

They integrate process-proven Pall Omega polyethersulfone (PES) membranes to offer high flux and selectivities. The Omega membranes have been specifically modified to minimize protein binding.

Our single-use TFF modules are available with Omega membrane in three different nominal molecular weight cutoffs (NMWC) - 10 kDa, 30 kDa and 100 kDa - meeting the majority of the needs for single-use TFF applications in the biotech and vaccines industries.

They can be installed and torqued into Pall's specially designed holders and operated with the Allegro single-use TFF systems or with other single-use set-ups.





Quality Standards

  • Manufactured in a controlled environment
  • Manufactured under a quality management system certified to ISO 9001 standards
  • Supplied with a Certificate of Quality confirming the quality standards and quality control tests performed by Pall
  • The fluid path meets all regulatory requirements for:
    • Biological Reactivity Tests (in vivo) for Class VI-70°C Plastics, USP <88>
    • Biological Reactivity Tests (in vitro) for Cytotoxicity, USP <87>


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Modules

NMWC 10 kD, EFA 0.1m²(1.1 ft²)"
List Price
$ 744.00
NMWC 30 kD, EFA 93 cm² (0.1 ft²)
List Price
$ 435.00
NMWC 30 kD, EFA 186 cm² (0.2 ft²)
List Price
$ 521.00
NMWC 30 kD, EFA 0.1 m² (1.1 ft²)
List Price
$ 744.00
NMWC 100 kD, EFA 93 cm² (0.1 ft²)
List Price
$ 435.00
NMWC 100kD, EFA 186 cm² (0.2 ft²)
List Price
$ 521.00
NMWC 100 kD, EFA 0.1m², (1.1 ft²)
List Price
$ 706.00
NMWC 10 kD, EFA 93 cm² (0.1 ft²)
List Price
$ 435.00
NMWC 10 kD, EFA 185cm², (0.2 ft²)
List Price
$ 521.00
Description

A simpler, easier and safer single-use TFF solution for R&D, clinical or commercial manufacturing

Pall's single-use tangential flow filtration (TFF) modules are ready-to-use gamma-irradiated cassette modules designed for single-use in Pall Allegro™ single-use TFF systems and can also be integrated into other single-use TFF set-ups. They provide ease-of-use, quick turnaround and increased flexibility, safety and containment in cGMP operations.

Our single-use TFF modules can be easily implemented in single-use TFF systems for concentration and diafiltration steps from R&D to commercial production of biotech products or vaccines.

Integrating the process-proven Pall Omega™ polyethersulfone (PES) membrane, our are available in scalable formats from 93 cm² up to 2.5 m² of membrane area.

Key Attributes

  • Simpler and easier solutions: preassembled, ready-to-use modules for easy integration into single-use TFF systems.
  • Safer solutions: single-use, gamma irradiated, contained modules for product and operator safety.
 
Feature Benefit
  • Pall's single-use TFF modules are delivered as preassembled modules that have been gamma irradiated at ≥ 25 kGy
  • Ease of installation and integration in single-use TFF systems
  • Supplied preconditioned, stored in water and gamma irradiated, the modules do not require comprehensive conditioning steps prior to use (see schematic 1). Typically less than 20 L/m² flush volumes are required to reach TOC levels below 1 ppm.
  • Improved productivity, reducing downtime and allowing focus on product processing operations only
  • No chemical handling
  • Reduction of buffer or WFI consumption
  • Designed for fully single-use operation, our single-use TFF modules can provide post-use containment during the single-use fluid flow path disassembly.
  • Increased process, product and operator safety
  • No cross contamination
  • Post-use containment of hazardous product
  • Our single-use TFF modules integrate the process-proven Omega PES membrane and are scalable.
  • Scalable formats, streamlining product development and process optimization
  • Tests have shown that the process performances of the our single-use TFF modules are comparable to reusable Omega T-series cassettes, thus offering the flexibility to switch from single-use to reuse TFF options and vice-versa with limited validation work.
  • Improved process robustness
  • Improved process robustness
 

Schematic 1: Comparison of TFF operations, reusable cassettes versus single-use with Pall's modules



Product Platform

Pall's single-use TFF modules are available in five formats with the following membrane areas:

  • 93 cm²
  • 186 cm²
  • 0.1 m²
  • 0.5 m²
  • 2.5 m²

They integrate process-proven Pall Omega polyethersulfone (PES) membranes to offer high flux and selectivities. The Omega membranes have been specifically modified to minimize protein binding.

Our single-use TFF modules are available with Omega membrane in three different nominal molecular weight cutoffs (NMWC) - 10 kDa, 30 kDa and 100 kDa - meeting the majority of the needs for single-use TFF applications in the biotech and vaccines industries.

They can be installed and torqued into Pall's specially designed holders and operated with the Allegro single-use TFF systems or with other single-use set-ups.





Quality Standards

  • Manufactured in a controlled environment
  • Manufactured under a quality management system certified to ISO 9001 standards
  • Supplied with a Certificate of Quality confirming the quality standards and quality control tests performed by Pall
  • The fluid path meets all regulatory requirements for:
    • Biological Reactivity Tests (in vivo) for Class VI-70°C Plastics, USP <88>
    • Biological Reactivity Tests (in vitro) for Cytotoxicity, USP <87>
Applications

Typical applications for Allegro single-use TFF solutions with our single-use TFF modules are in the downstream processing operations for the concentration and/or diafiltration of biological products in the biotech and vaccines industries.

Our modules can be implemented from R&D lab to commercial production. Fully scalable, the drug product development and validation steps can be streamlined.

Purpose-designed for single-use, they are especially recommended for multipurpose facilities or CMOs, for clinical material or for commercial production with batch sizes up to several hundred liters.

For further application details, please read this application note, co-authored with Rentschler Biotechnologie GmbH:

Allegro™ Single-Use TFF System Integrating Cadence™ Single-Use TFF Modules



Specifications

Technical Specifications

Pall's TFF modules are single-use and supplied after receiving a gamma irradiation dose of ≥ 25 kGy.

 
Module component Material of construction
Membrane Polyethersulfone
Support Polyolefin
Screens Polypropylene
Encapsulant Polyurethane with white pigment (TiO2)
Seals Platinum cured silicone and thermoplastic elastomer
Manifold plates Glass bead reinforced polypropylene with white pigment (TiO2)/td>
Port caps Polypropylene for luer lock connections, polyethylene for sanitary fittings
Covers High impact polystyrene
 

Operating Parameters

 
Recommended maximum operating feed pressure 4 barg (58 psig)
Maximum transmembrane pressure (TMP) 4 barg (58 psig)
Temperature range during processing 4-40 °C
Temperature range during pre-use sanitization 18-25 °C
Recommended cross flow rate 5 – 7 L/min/m² (0.5 – 0.7 L/min/ft²)
Typical operating time 8 hours
 

Pall's single-use TFF modules must be used in an appropriate holder. They are integrated in single-use TFF systems. The operating limits of the system should also be considered.



Nominal Dimensions

 
Part number (1)   CSUMxxxT001 CSUMxxxT002 CSUMxxxT010 CSUMxxxT050 CSUMxxxT250
Reference drawing   Drawing 1 Drawing 1 Drawing 2 Drawing 3 Drawing 3
Nominal dimensions   mm (in) mm (in) mm (in) mm (in) mm (in)
Length A 212 (8.4) 212 (8.4) 212 (8.4) 218 (8.6) 218 (8.6)
Overall length B 212 (8.4) 212 (8.4) 212 (8.4) 232 (9.2) 232 (9.2)
Thickness (for reference only) C 44 (1.7) 44 (1.7) 55 (2.2) 74 (2.9) 130 (5.1)
Overall thickness (for reference only) D 44 (1.7) 44 (1.7) 60 (2.4) 86 (3.4) 142 (5.6)
Width E 62 (2.4) 62 (2.4) 62 (2.4) 186 (7.3) 186 (7.3)
Overall width F 76 (3.0) 76 (3.0) 112 (4.4) 245 (9.6) 245 (9.6)
Feed /retentate fitting   Female luer Female luer ½ in. sanitary flange 1 in. sanitary flange 1 in. sanitary flange
-Outer diameter G NA (2) NA 25 (1.0) 50 (2.0) 50 (2.0)
-Inner diameter H NA NA 11 (0.4) 22 (0.9) 22 (0.9)
Permeate fitting   Female luer Female luer ½ in. sanitary flange 3⁄4 in. sanitary flange 3⁄4 in. sanitary flange
-Outer diameter J NA NA 25 (1.0) 25 (1.0) 25 (1.0)
-Inner diameter K NA NA 10 (0.4) 16 (0.6) 16 (0.6)
Retentate port location L 175 (6.9) 175 (6.9) 177 (7.0) 182 (7.2) 182 (7.2)
Retentate port location M 20 (0.8) 20 (0.8) 20 (0.8) 18 (0.7) 18 (0.7)
Retentate port location N 11 (0.4) 11 (0.4) 9 (0.3) 13 (0.5) 13 (0.5)
Permeate port location P 169 (6.7) 169 (6.7) 168 (6.6) 161 (6.3) 161 (6.3)
Permeate port location Q 20 (0.8) 20 (0.8) 23 (0.9) 28 (1.1) 28 (1.1)
Permeate port location R 11 (0.4) 11 (0.4) 9 (0.4) 15 (0.6) 15 (0.6)
Notch diameter S 10 (0.4) 10 (0.4) 10 (0.4) 16 (0.6) 16 (0.6)
Notch locations T 13 (0.5) 13 (0.5) 13 (0.5) 89 (3.5) 89 (3.5)
Notch locations U 24 (1.0) 24 (1.0) 24 (1.0) 49 (1.9) 49 (1.9)
 
(1) xxx is corresponding to the cutoff code (see ordering information for actual part numbers)
(2) Not applicable


The dimensions provided are nominal. Actual dimensions may vary slightly.

Dimensional Drawings




Performance

Integrity Testing

 
Parameter Value
Test pressure 2 barg (30 psig)
Maximum air forward flow ‹ 1600 mL/min/m²
(‹ 150 mL/min/ft²) at 20°C
 
Ordering Information
Pall's single-use TFF modules with Omega membrane:

 
Pall Part Number Nominal Molecular Weight Cutoff (NMWC) Effective Membrane Filtration Area (EFA)
CSUM010T001

10 kDa

93 cm2 (0.1 ft2)

CSUM010T002

10 kDa

186 cm2 (0.2 ft2)

CSUM010T010

10 kDa

0.1 m2 (1.1 ft2)

CSUM010T050

10 kDa

0.5 m2 (5.4 ft2)

CSUM010T250

10 kDa

2.5 m2 (27 ft2)

CSUM030T001

30 kDa

93 cm2 (0.1 ft2)

CSUM030T002

30 kDa

186 cm2 (0.2 ft2)

CSUM030T010

30 kDa

0.1 m2 (1.1 ft2)

CSUM030T050

30 kDa

0.5 m2 (5.4 ft2)

CSUM030T250

30 kDa

2.5 m2 (27 ft2)

CSUM100T001

100 kDa

93 cm2 (0.1 ft2)

CSUM100T002

100 kDa

186 cm2 (0.2 ft2)

CSUM100T010

100 kDa

0.1 m2 (1.1 ft2)

CSUM100T050

100 kDa

0.5 m2 (5.4 ft2)

CSUM100T250

100 kDa

2.5 m2 (27 ft2)

 

For more information on these products or on Pall's holders for single-use TFF and on our Allegro single-Use TFF systems, please contact your Pall representative.

Application
Membranes