Biophsep™ Pilot Hollow Fiber Filter Set with Bag Ultrafiltration Pre-sterilized Single-Use

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Part No. HFEPI00030530SP
Fiber ID
Length
MWCO
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*Not for medical use

Designed for single use, eliminating the need for post-use ClP cleaning, regeneration, and cleaning validation. This significantly saves operational time and avoids the risk of cross-contamination.

Pre-treated to reduce TOC and conductivity levels, effectively minimizing endotoxin and bioburden. No need for pre-use alkaline washing to remove pyrogens, enabling rapid experimental setup. Each filter is individually packaged and gamma-irradiated before shipment to ensure sterility.

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 opposite, due to the significant pressure drop difference between inlet and outlet existed 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 length. When processing with more fouling and high viscosity product, it is preferred to choose module with shorter length.

Features

  • Pre-sterilized with gamma irradiation at an intensity of 25-45 kGy
  • Pre-treated to reduce conductivity and TOC residue, minimizing wetting and shortening installation time
  • Single-use design eliminates the need for post-use ClP cleaning

Applications

  • Yeast, oncolytic bacteria, and other cell harvesting/purification
  • Continuous cell perfusion culture
  • Aseptic concentration of plasmids and mRNA in CGT applications
  • Aseptic purification of 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 Pilot Hollow Fiber
Scale Large-scale Process Development
Fiber ID 0.5 mm and 1.0 mm
Flow Path

30 cm (ODxLength: 3.3 * 36.1 cm)

60 cm (ODxLength: 3.3 * 66.1 cm)

110 cm (ODxLength: 3.3 * 116.1 cm)
MWCO 3/ 5/ 10/ 30/ 50/ 100/ 300/ 500/ 750 kDa
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 1.5" TC (compatible with 1-1/2" TC fitting)
Permeate Port 0.5" TC (compatible with 3/4" 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 No, single-use
Pre-use Treatment No need, pre-sterilized
Sterility Sterile by gamma irradiation at 25-45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 

Key Operating Parameters

Fiber ID Length EFA Process Volume Number of Fibers Flow Rate @2000s-1 (mL/min) Flow Rate @6000s-1 (mL/min)
0.5 mm 30 cm 0.15 m² < 15 L 320 471 1,413
0.5 mm 60 cm 0.30 m² < 30 L 320 471 1,413
0.5 mm 110 cm 0.55 m² < 50 L 320 471 1,413
1.0 mm 30 cm 0.15 m² < 15 L 160 1,884 5,652
1.0 mm 60 cm 0.30 m² < 30 L 160 1,884 5,652
1.0 mm 110 cm 0.55 m² < 50 L 160 1,884 5,652


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
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.