Sartofluor® GA Mini Cartridge 0.2 µm Size 8

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.

Price (USD):
$775.00
Item No.: 
5181207T8------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 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

Accessories Information

  • Adapter
    12 (1/2" screw adapter)  

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".  

Dimensions

  • Filter Size
    size 8 (0.1 m² / 1.1 ft²)  

General Specifications

  • Capsule/Cartridge Format
    Mini Cartridges  

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
    20 °C: 5 bar, 80 °C: 2 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.  

Product Information

  • Brand
    Sartofluor®  
  • Filter Type
    Membrane Filters  

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable | Steamable  
  • Sterilization Method
    Autoclavable & In-Line Steam Sterilizable  
  • Sterilizing Grade
    Yes  
  • Sartocheck® 5 Plus Filter Tester
    Item no.
    26787---FT---P

    The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.

  • Sartocheck® 5 Filter Tester
    Item no.
    26787---FT

    The Sartocheck® 5 Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.

  • 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.