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Biophsep™ Column Max Hollow Fiber Filter Stainless Steel Housing, Autolclavable

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Part No. HFECM006R1060AP
Fiber ID
Length
MWCO
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*Not for medical use

By offering various lengths, membrane filtration areas, and module diameters, Cobetter hollow fiber modules can facilitate a smooth and predictable scale-up from laboratory to pilot-scale and eventually manufacturing-scale. Available from Mini, Minilab, Lab, Pilot, Pilot+, Process and Max.

Cobetter hollow fiber modules are made of modified polyethersulfone membranes(m-PES), which have high flow flux and low protein binding. They are easy to install, clean and sanitize, and are widely used in cell harvest, clarification, perfusion, diafiltration and concentration in upstream and downstream bioprocessing.

Compared with TFF Cassettes' tortuous and complicated flow path, hollow fiber filtration has a linear flow path which creates a smooth flow for more gentle separation.

Effective Length and Scale-Up

The process scale-up feature of hollow fibers is that direct process scale-up can be carried out as long as the effective length is kept the same.

On the contrary, due to the significant pressure drop difference between inlet and outlet that exists in different lengths, the internal pressure and flow velocity distribution of the flow channel also change correspondingly, so linear scale-up can not be performed on devices with different lengths. When processing with more fouling and high viscosity products, it is preferred to choose a module with shorter length.

Features

  • Aseptic Process Assurance: For processes where bioburden cannot be sufficiently reduced using a 0.2 μm sterilizing-grade filter, heat sterilization hollow fiber filter can ensure aseptic operation
  • Reusable Design: The membranes can be cleaned and reused for multiple times, reducing overall operating costs
  • High Temperature and Pressure Resistance: Supports steam-in-place or autoclave

Applications

  • Yeast, oncolytic bacteria, and other cell harvesting/purification
  • Polycystic liposome concentration and diafiltration
  • Continuous cell perfusion culture
  • Aseptic concentration of lentivirus and adenovirus vaccines
  • Aseptic purification of monoclonal antibodies and recombinant proteins

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available
Physical Properties Filter Format Column Max Hollow Fiber
Scale Commercial Manufacturing
Fiber ID 1.0 mm
Flow Path 60 cm (ODxLength: 10.15 * 62.2 cm)
MWCO

Ultrafiltration*: 6 kD-R/ 10 kD-R/ 100 kD-R/ 500 kD-R/ 750 kD-R

Microfiltration*: 0.1 μm/ 0.2 μm-R/ 0.45 μm/ 0.65 μm
Applications Typical Application

Oncolytic bacteria concentration (750 kDa / 0.22 μm)

Cell harvest and clarification, Perfusion cell culture (0.22/ 0.45 μm)

Multilamellar liposome concentration and purification (0.22 μm)
Materials Membrane Material Modified Polyethersulfone (mPES)
Housing Material Polysulfone
Seals (internal) Epoxy Resin
Ports Feed/Retentate Port 2.0" TC (compatible with 2" TC fitting)
Permeate Port 1.5" TC (compatible with 1-1/2" TC fitting)
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Usage Protocols Reusable Yes
Pre-use Treatment Autoclavable for 30 minutes at 121°C, at least 10 cycles of SIP
Sterility Non-sterile
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

*The -R type hollow fibers provide enhanced mechanical strength and improved resistance to SIP (steam-in-place) sterilization.


Key Operating Parameters

Fiber ID Length EFA Process Volume Number of Fibers Flow Rate @2000s-1 (mL/min) Flow Rate @6000s-1 (mL/min)
1.0 mm 60 cm 4.20 m² < 400 L 2,550 30,000 90,000


Choose Fiber ID

  • Module with fiber of 0.5mm ID is widely used in most application scenarios to improve mass transfer efficiency.
  • Module with fiber of 1.0mm ID is ideal for products with high cell density or high solid content or high viscosity.
  • Only module with fiber of 1.0mm ID is autoclavable, as steam cannot enter the fiber of 0.5mm ID effectively.
  • Cobetter_Biophsep_Hollow_Fiber_Modules_20250627 Download
  • Biophsep_Hollow_Fiber_Cleaning_and_Reuse_Guidelines Download
What are the advantages of hollow fiber compared to cassette (flat-sheet) modules?

1. More open flow channels and relatively lower shear.
2. High packing density and large surface area per module enable a compact system footprint with minimal hold-up volume.
3. Robust handling of challenging feed streams, including high solids content or viscosity.
4. Suited for large-volume, high-flow continuous processing in drug manufacturing, such as for insulin and animal vaccines.

What are the applications of hollow fiber technology?
  • Concentration and buffer exchange of viral vaccines
  • Concentration and diafiltration of Cell and Gene Therapy (CGT) products
  • Purification, concentration, and buffer exchange of mRNA products
  • Biomass harvesting from bacterial fermentation, and clarification/removal of cell debris from cell culture lysates
  • Cell retention in perfusion culture (ATF system)
What materials and cut-offs are available for Cobetter ultrafiltration hollow fiber?

Material: m-PES.
Ultrafiltration hollow fiber filters are available with cut-offs ranging from 3–750 kDa.
Microfiltration hollow fiber filters are available in pore sizes ranging from 0.1–0.65 µm.

Can Cobetter‘s hollow fiber modules be sterilized?

Specific series are compatible with sterilization procedures, for example, 50 kDa, 750 kDa, and 0.2 μm modules.