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Purcise™ MEC 0.1 μm PES Standard Filter Cartridge for Mycoplasma Removal

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Part No. AMECB102SP
Filter Size
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O-ring Material
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*Not for medical use

Cobetter Filter cartridges are available in a complete range of lengths from 2.5" to 40", providing flexible scale-up solutions from laboratory development and pilot studies to full-scale manufacturing. Designed with excellent compatibility and scalability, the cartridge filters support seamless process transfer and linear scale-up while maintaining consistent filtration performance across different stages.

Purcise™ MEC 0.1 μm features an advanced double-layer hydrophilic PES membrane specifically designed for cell culture media mycoplasma filtration applications. The membrane combines low cytotoxicity and low adsorption characteristics to minimize the loss of critical media components while maintaining excellent cell compatibility.

Features

  • Double Layer Hydrophilic Polyethersulfone (PES) Membrane: 0.2 μm pre-filter + 0.1 μm final filter membrane. Reliable retention of mycoplasma, bacteria and particles. Low cytotoxicity. Low adsorption
  • Sterilizing -grade Filter: Bacterial Retention validated according to ASTM F838, each filter is integrity tested prior to release
  • Linear Scale Up: Available in syringe filter for filterability study, small-scale capsule filter for process development, and large-scale capusle filter and filter cartridge for commercial GMP manufacturing.

Applications

  • Mycoplasma filtration of culture media

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • Unique serial number for full traceability
  • COA/COQ provided with shipment
  • Validation documents are available upon request
Physical Properties Filter Format Cartridge Filter
Scale Production Scale
Filtration Area 0.14 m², 0.28 m², 0.55 m²,1.1 m², 1.65 m², 2.2 m²
Pore Size 0.1 μm (final-filter)
Pre-filter 0.2 μm
Bubble Point (per 0.55 m²） ≥0.27 MPa at 20 °C, air, wetted with water
Air Diffusion (per 0.55 m²） ≤30 mL/min at 0.35 MPa at 20 °C, wetted with water
Materials Membrane Material Polyethersulfone (PES)
Support Fleece Polypropylene (PP)
Housing Polypropylene (PP)
O-ring / Seal Silicone / EPDM / Fluoroelastomer
Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa at 25 °C
0.4 MPa at 60 °C
0.24 MPa at 80 °C
Max. Differential Pressure (Reverse) 0.3 MPa at 25 °C
0.1 MPa at 80 °C
Max. Operating Temperature 80 °C
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 Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6)
Sterility Delivery Condition Non-sterile
Sterilization Method Can be steam-in-place for 30 minutes at 135°C with 50 cycles (<30kPa)
Can be autoclaved 50 cycles for 30 minutes at 130°C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag