eShop » Process Filtration » Sterile Filtration » Purcise™ MLE 0.1 μm PES Bricap L Capsule Filter for Mycoplasma Removal

Purcise™ MLE 0.1 μm PES Bricap L Capsule Filter for Mycoplasma Removal

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Part No. L02SSMLEBA1P
Filter Size
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Sterility
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*Not for medical use

Bricap™ L capsule filters are designed for large-scale production with robust construction and high flow rates. They are available in six filtration area options ranging from 0.12 m² to 1.65 m².

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 Bricap™ L Capsule Filter
Scale Production Scale
Filtration Area 0.12 m², 0.16 m², 0.28 m², 0.55 m², 1.1 m², 1.65 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
Operating Conditions Max. Differential Pressure (Forward) 0.55 MPa at 25 °C, 0.1 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 Sterilization Method Autoclavable: 25 cycles for 30 min at 130 °C (SIP not compatible)

Gamma Compatible: can be sterilized by gamma irradiation or autoclaved 5 cycles for 60 min at 126 °C

Pre-sterilized: by gamma irradiation at 25–45 kGy

Pre-sterilized: by autoclaved packed in cleansteam bag
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag