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

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Part No. AMLEB022SP
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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™ MLE 0.1 μm features an advanced double-layer hydrophilic PES membrane. The unique membrane structure combines high retention efficiency with optimized flow performance, providing robust removal of mycoplasma, bacteria, and other microorganisms while maintaining process throughput.

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. Good chemical compatibility. Low leachables.
  • 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

  • Typical mycoplasma removal applications
  • Removal of mycoplasma in buffer solution
  • Filtration of intermediate products/stock solutions
  • Sterile filtration of terminal products

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) ≥0.25 MPa at 20 °C, 60% IPA 40% water, air
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) 0.21 MPa at 25 °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 SIP for 30 min at 135 °C 50 cycles (<30kPa)

Can be autoclaved 50 cycles for 30 min at 130 °C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag