pall,颇尔,Cadence 一次性 TFF 膜柱,

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Cadence 一次性 TFF 膜柱
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pall,颇尔,Cadence 一次性 TFF 膜柱,
pall,颇尔,Cadence 一次性 TFF 膜柱

Cadence 一次性 TFF 膜柱

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

Cadence single-use tangential flow filtration (TFF) modules are ready-to-use gamma irradiated cassette modules designed for single-use in 颇尔 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.

Cadence 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 颇尔 Omega™ polyethersulfone (PES) membrane, Cadence single-use TFF modules 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.

 
特点 优势
  • Cadence 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
  • 无化学处理
  • Reduction of buffer or WFI consumption
  • Designed for fully single-use operation, Cadence 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
  • Cadence 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 Cadence 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 Cadence modules



Product Platform

Cadence 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 颇尔 Omega polyethersulfone (PES) membranes to offer high flux and selectivities.The Omega membranes have been specifically modified to minimize protein binding.

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

The single-use TFF modules can be installed and torqued into specially designed Cadence 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 颇尔
  • 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>
 

Typical applications for Allegro single-use TFF solutions with Cadence 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.

The Cadence single-use TFF 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



 

Technical Specifications

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

 
Cadence single-use TFF module component Material of construction
聚醚砜
支持 Polyolefin
Screens 聚丙烯
Encapsulant Polyurethane with white pigment (TiO2)
密封圈 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
推荐切向流流速 5 – 7 L/min/m² (0.5 – 0.7 L/min/ft²)
Typical operating time 8 hours
 

Cadence 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) 25 (1.0) 50 (2.0) 50 (2.0)
-Inner diameter H 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 25 (1.0) 25 (1.0) 25 (1.0)
-Inner diameter 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




 

完整性检测

 
Parameter 价值
Test pressure 2 barg (30 psig)
Maximum air forward flow ‹ 1600 mL/min/m²
(‹ 150 mL/min/ft²) at 20°C
 

The part number structure for Cadence single-use TFF modules is as follows:

[CSU] [M] [     ]   [     ]  
 
Cadence Single-Use Module Omega 膜 Code Nominal Molecular Weight Cutoff (NMWC) Code Effective Membrane Filtration Area (EFA)
    010 10 kD T001 93 cm2 (0.1 ft2)
030 30 kD T002 186 cm2 (0.2 ft2)
100 100 kD T010 0.1 m2 (1.1 ft2)
  T050 0.5 m2 (5.4 ft2)
T250 2.5 m2 (27 ft2)

For example, the part number CSUM030T010 is a Cadence single-use TFF module with Omega membrane, 30 kD NMWC, 0.1 m² membrane area

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

 


pall,颇尔,Cadence 一次性 TFF 膜柱
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