PVDN - Hydrophilic PVDF Membrane Cartridge Filter

PVDN - Hydrophilic PVDF Membrane Cartridge Filter

Masterfilter PVDN series filter cartridges are manufactured from an inherently hydrophilic PVDF membrane that offers a broad chemical and temperature resistance. Characterised by its low protein binding properties, the PVDN series is ideal for bioburden reduction, clarification and sterilisation of pharmaceutical and biological solutions. The PVDN cartridges are available in multiple pore sizes with single-layer PVDF membrane. The membranes are easily wettable and fully integrity testable to meet the pharmaceuticals levels for sterility assurance.

Features

  • Inherently hydrophilic membrane
  • Low in protein binding, extractables and non-fibre shedding
  • Easily wettable
  • High flowrate with low pressure drop

Markets

  • Pharmaceuticals & Biologicals

Applications

  • Active Pharmaceutical Ingredients - API
  • Ophthalmics
  • Large Volume Parenterals - LVP
  • Fermentation
  • Pharmaceutical Water Treatment
  • Small Volume Parenterals - SVP

Technical Specification

Materials of construction Operating parameters
Membrane: Hydrophilic Polyvinylidene fluoride (PVDF) Max. differential pressure forward: 6.9 bar at 25 °C, 4.0 bar at 60 °C, 2.4 bar at 80 °C
Support layers: Polypropylene Max. differential pressure reverse: 3.0 bar at 25 °C, 1.0 bar at 80 °C
Inner core: Polypropylene Steam sterilisation: 20 cycles for 30 min at 125 °C (< 0.3 bar, 5 psi) in forward direction
Outer cage: Polypropylene Autoclave: 30 cycles for 30 min at 125 °C
End caps: Polypropylene Filtration area 10” module : 0.58 m²
O-Rings: EPDM/Silicone/Viton

Filter Properties

  • Tested with Brevundimonas Diminuta (ATCC 19146) at 107 CFU/cm² according with ASTM-F838
  • Cartridge is marked with unique serial number for identification and traceability
  • All components meet the criteria for Non-Fibre releasing as defined in 21 CFR 210.3 (b) (6) - PVDN Duofluor is manufactured under ISO 9001:2015 GMP
  • Extraction samples < 0.25 EU/mL as determined by the LAL, USP <85>
  • Meets the USP <88> Biological Toxicity Reactivity Test in vivo for Class VI-121 °C in plastics
  • Meets USP <87> in vitro cytotoxicity test and autoclaved filter effluent meets the USP <788> for LVP
  • All components meet the FDA indirect food additive requirements cited in 21 CFR 177-182"

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