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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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 ≥ 107Brev. 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, min. 100 sterilization cycles

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


*Note = No tests are conducted beyond the specified sterilization cycles; Sartorius is not liable for any additional cycles initiated by the customer.

Datasheet

Sartofluor® HR - Heat Resistant Air | Gas Filter
en 362.9 kB

Accessories Information

  • Adapter
    25 (S-adapter top, locking 2-flange bayonet adapter with 226 double O-ring bottom)

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

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