Sartofluor® GA Capsule 0.2 µm Size 4

Sartofluor® 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.

Item No.: 
5181307T4--SO--B
Pieces
5

*Custom/bulk order quotes are provided within 72 hours of request.

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 B. diminuta/cm² in aerosol and liquid
  • Retention of ≥ 10⁷ MS2 coliphage/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".  

Connections (Physical)

  • Connector Inlet
    3/4" Tri-Clamp 25 mm  
  • Connector Outlet
    1/4" Multiple Stepped Hose Barb  

Dimensions

  • Filter Size
    size 4 (0.015 m² / 0.16 ft²)  
  • Filtration Area
    0.015 m²  
  • Outer Diameter
    46 mm without venting screw, 61 mm with closed venting screw  

General Specifications

  • Capsule/Cartridge Format
    Capsules  
  • 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  
  • Maximum Diffusion
    0.8 mL/min at 0.7 bar  
  • Minimum Required Bubble Point
    1.0 bar | 14.5 psi  

Materials of Construction

  • Filter Material
    Polytetrafluorethylene (PTFE)  
  • Housing Material
    Polypropylene (PP)  
  • Material o-ring | seal
    Silicone (SI)  
  • Membrane Material
    Polytetrafluorethylene (PTFE)  
  • Support Fleece
    Polypropylene (PP)  

Operating Conditions

  • Maximum Differential Pressure
    4 bar  

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  
  • Pack Size
    5  

Sterility/Purity

  • Delivery Condition
    Sterile - Autoclaved  
  • Sterilization Method
    Autoclavable  
  • 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)  
  • Sartofluor®
    Item no.
    M_Sartofluor

    Sartofluor® 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.

  • Confidence® Validation Services
    Item no.
    M_Confidence_Validation_Services

    Confidence® offers a wide range of validation studies according to regulatory requirements and customer's needs.