Sartopore® Air filters feature a hydrophobic 0.2 µm PES membrane for sterile air filtration and efficient flow rates. Ideal for single-use applications like bioreactors and storage tank vents, they ensure reliable particle retention, meeting regulatory compliance in biopharmaceutical processes.

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Sartopore® Air
Sartopore® Air

Sartopore® Air filters feature a hydrophobic 0.2 µm PES membrane for sterile air filtration and efficient flow rates. Ideal for single-use applications like bioreactors and storage tank vents, they ensure reliable particle retention, meeting regulatory compliance in biopharmaceutical processes.

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Sartopore® Air Filters: Advanced Single-Use Venting Solutions for Biopharmaceutical Applications

Product Information:

Sartopore® Air filters are designed to meet the demanding requirements of the biopharmaceutical industry, providing efficient and reliable sterile air filtration solutions. These filters are equipped with hydrophobic 0.2 µm polyethersulfone (PES) membranes, ensuring effective particle retention and compliance with industry standards. Available in various formats, Sartopore® Air filters cater to diverse applications, enhancing process security and efficiency.

Formats:

  • Midicaps®: Available in filtration areas ranging from 0.05 m² to 0.34 m², ideal for small-scale to medium-scale applications such as laboratory air filtration and single-use bioreactors.
  • Maxicaps®: Available in filtration areas of 0.53 m² and 1.06 m², suitable for large-scale processes like storage bag vents and fill-finish assemblies.
  • Capsules: Available with a filtration area of 0.016 m², designed for specific applications such as small-scale venting and exhaust filtration in biopharmaceutical processes.

Applications:

  • Bioreactors: Ensures sterile air filtration for optimal cell growth and process integrity.
  • Storage Vents: Provides reliable venting solutions for mixing and storage bags, maintaining sterility.
  • Fill-Finish Assemblies: Supports exhaust filtration, ensuring product compliance.
  • Small-Scale Venting: Ideal for compact applications requiring efficient sterile air filtration.

Materials Used:

  • Membrane: Hydrophobic PES membrane for efficient air flow and particle retention.
  • Housing: Durable polypropylene construction for robust performance.
  • O-Rings: Silicone materials ensuring secure sealing and compatibility with various sterilization methods.

Retention Rates:

  • Bacteria Retention: Proven retention of ≥ 10⁷ Brevundimonas diminuta/cm² in aerosol and liquid forms.
  • Phage Retention: Effective retention of ≥ 10⁷ Bacteriophage MS2/cm² in aerosol forms.
  • Particle Retention: Retention of particle sizes 0.005 μm | 0.3 μm.

Advantages:

  • Efficient Filtration: Hydrophobic PES membrane ensures effective sterile air filtration and high flow rates.
  • Reliable Retention: Proven retention capabilities for bacteria, phages, and particles, meeting stringent regulatory standards.
  • Quality Assurance: 100% factory integrity testing guarantees performance reliability and traceability.
  • Versatile Applications: Suitable for a wide range of biopharmaceutical processes, enhancing operational flexibility.
  • Robust Construction: Durable materials ensure compatibility with biopharmaceutical environments and processes.
  • Convenient Sterilization: Compatible with gamma irradiation, simplifying integration into existing workflows.

Sartopore® Air filters offer a comprehensive solution for sterile air filtration in biopharmaceutical applications, ensuring process security and efficiency. Explore the range of formats and applications to find the perfect fit for your needs. For more information visit the Sartopore® Air webpage.

Applications

  • Application
    Air/Gas Filtration
  • Application Area
    • Single-use bioreactors (Sparge | Overlay filter assemblies | Exhaust filter assemblies)
    • Single-use mixing and storage bag vents
    • Single-use liquid filter assemblies requiring PUPSIT (Post Sterilization Pre-Use Integrity Testing)
    • Fill-finish
  • 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).

Materials of Construction

  • Filter Material
    Single-layer polyethersulfone (PES) membrane
  • Housing Material
    Polypropylene (PP)
  • Membrane Material
    Polyethersulfone, Hydrophobic (PES)

Physicochemical Information

  • Gamma Stable
    Yes
  • Pore Size Final-filter
    0.2 µm

Product Information

  • Brand
    Sartopore® Air

Sterility/Purity

  • Delivery Condition
    Non sterile - Gamma irradiatable
  • Sterilization Method
    Gamma Irradiatable
  • Sterilizing Grade
    Yes

Usage Protocols

  • Sterilization Procedures
    Gamma irradiation with max. 50 kGy.