Sartofluor®

Tech Support Documents
Sartofluor®
 

The Sartorius Sartofluor® Air Filter ensures sterile air with a single-layer PTFE membrane, offering high flow rates and validated sterility across various conditions, with a cost-effective performance for air/gas and solvent filtration.

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Product Information

Sartofluor® is especially suited to demanding venting applications with high volume gas streams, extreme humidity, and stringent Steam In Place regimes. The hydrophobic PTFE membranes used in Sartofluor® filters offer reliability, process security, and a long service life.

Introduction

The Sartofluor® family of filters has been on the market for over three decades and has improved over time in response to changing customer needs. Today, experience and filtration expertise are combined in our best sterile venting device ever. Sartofluor® contains PTFE membrane making it the most hydrophobic vent filter available. The inherent hydrophobicity of the PTFE membrane is unaffected by repeated autoclaving or steaming and guarantees sterile filtration of both dry and moist gases. Sartofluor® filters show superior air flow rates throughout all sizes and formats.

Applications

  • Bioreactors (inlet | outlet)
  • Storage tank venting
  • Filling equipment venting
  • Freeze dryer
  • Autoclave venting

Benefits

The Most Reliable Sterile Venting Device

The 0.2 μm single-layer hydrophobic PTFE membrane offers superior moisture repellence and exceptional gas flow rates at low differential pressures.


All components were developed and are produced under the full control of Sartorius.


In addition, the following critical requirements are met:

  • Retention of ≥ 10⁷ Brev. diminuta/cm² in aerosol and liquid
  • Retention of ≥ 10⁷ Bacteriophage MS2/cm² in aerosol
  • Retention of particles sizes 0.005 μm | 0.3 μm
  • Bi-directional sterility proven by worst case liquid Bacterial Challenge Test in forward and reverse direction
  • 100% integrity tested prior to release
  • Clear labelling with Lot. number and individual unit number. All information laser marked on each filter housing.

Regulatory Compliance

  • Each individual element is tested for integrity by Bubble Point and Diffusion test
  • Fully validated as sterilizing grade filters according to current ASTM F-838 guidelines
  • Designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System
  • USP Plastic Class VI Test
  • Non-fiber releasing: This product was manufactured with a membrane which meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6) and 211.72.
  • Oxidizable Substances: The filtrate of these filter elements shows a negative reaction when tested according to the current USP

Applications

  • Application
    Air/Gas Filtration
  • Application Area
    • Bioreactors (Inlet | Outlet)
    • Storage tank venting
    • Filling equipment venting
    • Freeze dryer autoclave venting
  • Industry
    Pharma / Biotech

Biological Information

  • Bacterial Retention
    Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

Compliance Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • Biocompatibility (USP Class VI)
    USP<88>
  • Biological Reactivity
    All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
  • Extractables
    The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

General Specifications

  • Maximum Allowable Back Pressure
    • Cartridges GA | Mini Cartridges | Junior at 3 bar | 43.5 psi at 20 °C
    • Cartridges LG | Maxicaps® | Midicaps® | Capsules at 2 bar | 29 psi at 20 °C
  • Minimum Required Bubble Point
    1.0 bar | 14.5 psi

Materials of Construction

  • Filter Material
    Polytetrafluorethylene (PTFE)
  • Housing Material
    Polypropylene (PP)
  • Membrane Material
    Polytetrafluorethylene (PTFE)
  • Support Fleece
    Polypropylene (PP)

Physicochemical Information

  • Gamma Stable
    No
  • Non-Fiber Releasing
    This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
  • Pore Size
    0.2 µm

Product Information

  • Brand
    Sartofluor®
  • Filter Type
    Membrane Filters

Sterility/Purity

  • Sterilizing Grade
    Yes

Usage Protocols

  • Sterilization Procedures
    • Cartridges (GA & LG) | Mini Cartridges | Junior: Autoclaving at 134 °C, 2 bar | 29 psi, 30 min, sterilization cycles: min. 25 or In-Line Steam Sterilization at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7.25 psi, sterilization cycles: max. 150, min. 25 (Mini Cartridges)
    • Maxicaps® | Midicaps® | Capsules: Autoclaving at 134 °C, 2 bar | 29 psi, 30 min, sterilization cycles: min. 25 (Maxicaps® | Midicaps®), min. 5 (Capsules)