Sartofluor® HR

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Sartofluor® HR Sartofluor® HR
 

Sartofluor® has been synonomous with reliable air | gas filtration for decades. Employing the proven single-layer ePTFE membrane technology, Sartofluor® HR is specifically designed for long-term, high-temperature applications, such as Water For Injection (WFI) loop venting.

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Products (3)

  • Sartofluor® HR Cartridge
    Sartofluor® HR Cartridge

    • Product Information

    Sartofluor® has been synonomous with reliable air | gas filtration for decades. Employing the proven single-layer ePTFE membrane technology, this latest addition to the Sartofluor® broad offering of filter cartridges is specifically designed for long-term, high-temperature applications, such as Water For Injection (WFI) loop venting. Bacterial, phage and particle retention validation make Sartofluor® HR a valuable addition to the Sartofluor® product family.

    Designed for High Temperature Applications

    Sartofluor® HR filter cartridges can be used for an extended time period of at least six months at a temperature of 90°C. Incorporating the proven hydrophobic 0.2 μm Sartofluor® ePTFE membrane (sterilizing grade according to current ASTM F-838 guideline), Sartofluor® HR also provides a validated retention of particles (sizes 0.005 μm | 0.3 μm), which is of the utmost importance for these types of applications. Integrity testing by Water Intrusion Test (WIT) allows in-situ integrity testing and circumvents the use of alcohol for wetting. Multiple in-line steaming | autoclaving cycles can be conducted without any loss of performance.

    Applications

    • Water For Injection (WFI) tanks | loops (80 – 90°C)
    • Autoclaves
    • Permanently heated filter housings
    • All applications where hot air (approx. 90°C) is used over long periods

    Inherent Quality Provides Full Confidence

    The 0.2 μm hydrophobic ePTFE membrane is self dewetting and, therefore, provides high air flow rates even at very low differential pressures over an extended process time.

    Validated by various retention tests, Sartofluor® HR filter cartridges ensure sterile filtration of air | gas. The following indispensable requirements are fulfilled:

    • Retention of ≥ 107 Brev. diminuta/cm2
    • Retention of ≥ 107 Bacteriophage MS2/cm2
    • Retention of particles: sizes 0.005 μm | 0.3 μm
    • Clear labeling with filter type, lot number, individual unit serial number, 2D data matrix code
    • Developed, produced and distributed under a quality management system certified to DIN/ISO 9001
    • USP Plastic Class VI Test

    Sterilization

    In-Line Steam Sterilization: 134°C, 30 min. at max. differential pressure of 0.5 bar | 7.25 psi in forward and reverse direction, max. 100 sterilization cycles

    or Autoclaving: 134°C, 2 bar, 30 min, max. 100 sterilization cycles

    Datasheet

    Sartofluor® HR - Heat Resistant Air | Gas Filter
    en 333.2 kB

    Accessories Information

    • Adapter
      2-Flange Bayonet Adapter with 226 Double O-ring (25)  

    Applications

    • Application
      Air/Gas Filtration  
    • Application Area
      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).  

    Features

    • Venting Filter
      Yes  

    General Specifications

    • Capsule/Cartridge Format
      Cartridges  
    • Filter Format
      Cartridges  
    • Maximum Allowable Back Pressure
      2 bar | 29 psi at 20°C and 1.5 bar | 22 psi at 90°C  
    • Minimum Required Bubble Point
      1.0 bar | 14.5 psi  
    • Test Pressure
      5 bar | 72.5 psi at 20°C and 2 bar | 29 psi at 90°C  

    Materials of Construction

    • Filter Material
      hydrophobic expanded polytetrafluoroethylene (ePTFE)  
    • Housing Material
      Polypropylene (PP)  
    • Material o-ring | seal
      Silicone (SI)  
    • Membrane Material
      hydrophobic expanded polytetrafluoroethylene (ePTFE)  

    Operating Conditions

    • Maximum Differential Pressure
      20 °C: 5 bar, 90 °C: 2 bar  

    Physicochemical Information

    • Gamma Stable
      No  
    • Pore Size
      0.2 µm  
    • Pore Size Final-filter
      0.2 µm  

    Product Information

    • Brand
      Sartofluor® HR  
    • Type
      Air Filter  

    Sterility/Purity

    • Delivery Condition
      Non sterile - Autoclavable | Steamable  
    • Sterilization Method
      Autoclavable & In-Line Steam Sterilizable  
    • Sterilizing Grade
      Yes  

    Usage Protocols

    • Sterilization Procedures
      • Autoclaving: 134°C, 2 bar, 30 min, max. 100 Sterilization Cycles  
      • In-Line Steam Sterilization: 134°C, 30 min. at max. differential pressure of 0.5 bar | 7.25 psi in forward and reverse direction, max. 100 Sterilization Cycles  
  • Confidence® Validation Services
    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.

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