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Safesure™ AFBB 0.2 μm PTFE Sterilizing-Grade Filter Cartridge Gas Filtration

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Part No. AAFBB102SP
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*Not for medical use

Safesure™ AFBB0.2 μm filters are constructed with a hydrophobic and oleophobic PTFE membrane. Designed for high-temperature resistance, Safesure™ AFBB filters are compatible with repeated in-line and autoclave steam sterilization cycles, making them suitable for demanding bioprocess applications. They are widely used for sterile gas filtration, including air and process gas venting systems.

Features

  • Hydrophobic and Oleophobic Polytetrafluoroethylene (PTFE) 0.2 μm Membrane. Maintaining sterilizing capacity in both unwet and wet conditions.
  • Heat-resistant thickened PP core: better heat resistance and pressure resistance.
  • Sterilizing -grade Filter: Bacterial Retention validated according to ASTM F838, each filter is integrity tested prior to release.
  • Linear Scale Up: Available in small-scale capsule filter for process development, and large-scale capusle filter and filter cartridge for commercial GMP manufacturing.

Applications

  • Vent filter for fermentation, storage tanks
  • Sterile filtration for compressed air, oxygen, nitrogen
  • Single-use system application

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • Unique serial number for full traceability
  • COA/COQ provided with shipment
  • Validation documents are available upon request
Physical Properties Filter Format Filter Cartridge
Scale Production Scale
Filtration Area 0.2 m², 0.4 m², 0.8 m², 1.6 m², 2.4 m², 3.2 m²
Pore Size 0.2 μm
Pre-filter /
Water Flow Test (per 0.8 m²) ≤0.84 mL/min at 0.25 Mpa @20°C
Materials Membrane Material Polytetrafluoroethylene (PTFE)
Support Fleece Polypropylene (PP)
Housing Material Polypropylene (PP)
O-ring / Seal Silicone
Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa @25°C, 0.4 MPa @60°C, 0.24 MPa @80°C
Max. Differential Pressure (Reverse) 0.3 MPa @25°C, 0.1 MPa @80°C
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6)
Sterility Delivery Condition Non-sterile
Sterilization Method Can be SIP for 30 min @135°C 50 cycles (<30kPa)

Can be autoclaved 50 cycles for 30 min @130°C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 
How to choose the materials for gas filters?

Gas filters are generally made from hydrophobic materials, such as PTFE and PVDF.

Is gas filtration precision the same as liquid filtration precision?

Because the filtration mechanisms differ between gases and liquids, gas filtration generally removes smaller particulate contaminants, so gas filtration precision is relatively higher than that of liquid filtration.

How to prevent premature clogging of gas filters?

1. Select appropriate filter materials and pore sizes based on product compatibility and impurity profile.
2. Adding a pre-filtration step to remove large particulates and extend the service life of the final sterilizing-grade filter.
3. Design and control the process to prevent premature filter wetting.

How to perform integrity testing for gas filters?

For most gas filters, water intrusion can be used for integrity testing. For gas filters with smaller surface areas or low water intrusion flow rates, organic solvents may also be used for wetting to conduct bubble point or difffusion flow tests.

What are the advantages and benefits of Cobetter gas filters?

1. A variety of materials to meet specific process requirements are available.
2. Different filtration precision configurations, such as single-layer, double-layer, and multi-layer setups, can enhance filtration flux and extended service life.
3. Hydrophobic and oleophobic properties improve resistance to clogging.
4. Strong chemical compatibility and high-temperature resistance.