Sartopure® GA

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Sartopure® GA Sartopure® GA Sartopure® GA
 

Sartopure® GA is your high performance air filter. It is also used to expand the service life time of sterilizing grade air filters. Therefore it is a perfect complement for the Sartofluor® GA.

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Product Information

Sartopure® GA offers an outstanding flow rate at low differential pressure and are the ideal choice for air filtration in the biopharmaceutical industry. Sartopure® GA filters expand the service life time of sterilizing grade air filter systems by removal of particles from the air stream. In addition they can be used for all venting purposes that do not necessarily require an integrity testable membrane filter.

Applications

  • Particle removal from air streams, e.g. pressure supplies
  • Prefiltration in front of Sartofluor® GA membrane filters or any other membrane air filter
  • Venting of non-pressure resistant vessels

Retention Efficiency

The excellent retention and therefore superior protection has been proven by particle retention filtration and bacterial challenge tests (aerosol tests) performed under worst case conditions. Sartopure® GA has got a LRV of 7/cm² with Bacillus subtilis var niger spores and a LRV of 6,8/cm² with Brevundimonas diminuta. Featuring a retention of 0.2 µm for gas, Sartopure® GA efficiently protects stored products, e.g. water, liquid sugar, oral solutions etc., in the pharmaceutical industry as well as the food and beverage industry.

Flow Rate

Due to the large filter area of 0.7 m²|10”, Sartopure® GA delivers a flow rate of nearly 40 m³/h at a differential pressure of 10 mbar. This means Sartopure® GA is the perfect product for high performance filling or draining of tanks and vessels.

Optimized Filter Material

Sartopure® GA’s hydrophobic material guarantees an air flow recovery of 60-80% within 30 seconds after the filter has been wetted with water. The water prevents high differential pressures, ensuring fast recovery of air flow rate e. g. after cleaning the tank with hot water | agents.

Documentation

Sartopure® GA cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System.

Regulatory Compliance

  • Filter material bacteria challenge tested with Bacillus subtilis var niger spores and Brevundimonas diminuta
  • Non pyrogenic according to USP Bacterial Endotoxins
  • Pass USP Plastic Class VI Test

Applications

  • Application
    Air/Gas Filtration
  • Industry
    Pharma / Biotech / F&B

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
  • 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".

Features

  • Venting Filter
    Yes

Materials of Construction

  • Filter Material
    Glass Fiber (GF) hydrophobic
  • Housing Material
    Polypropylene (PP)
  • Material o-ring | seal
    Silicone (SI)
  • Membrane Material
    Glass Fiber (GF) hydrophobic
  • Support Fleece
    Polypropylene (PP)

Physicochemical Information

  • Gamma Stable
    No
  • Pore Size
    0.2 µm

Product Information

  • Brand
    Sartopure® GA
  • Type
    Air/Gas Filter

Sterility/Purity

  • Sterilization Method
    Autoclavable & In-Line Steam Sterilizable
  • Sterilizing Grade
    Yes

Usage Protocols

  • Sterilization Procedures
    • In-Line Steam Sterilization at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7 psi, sterilization cycles min. 50
    • Autoclaving at 134°C, 2 bar | 29 psi, 30 min.
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