Safesure AFB Sterilizing-Grade Filter Cartridge 0.2μm, Gas Filtration
*Not for medical use
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Specifications
| Materials | Membrane | Hydrophobic Polytetrafluoroethylene(PTFE) |
| Support | Polypropylene(PP) | |
| Core/Cage/End Cap | Polypropylene(PP) | |
| Cartridge End Cap Inserts | Polybutylene terephthalate (PBT) | |
| Cartrdige End Cap O-rings | Silicone/EPDM/Fluoroelastomer/PFA encapsulated O-rings | |
| Pore Size | 0.2 μm | |
| Filtration Area | A-Standard Cartridge (10")-0.80m² |
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| Operating Conditions | Max. Operating Temperature | 80°C |
| Max. Differential Pressure (Forward) | A-Standard Cartridge: 0.69 MPa @ 25°C 0.40 MPa @ 60°C 0.24 MPa @ 80°C |
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| Max. Differential Pressure (Reverse) | 0.30 MPa @25°C 0.10 MPa @ 80°C |
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| Sterilization Option | A-Standard Cartridge | Can be steam sterilized for 30 minutes at 145 °C in forward direction(＜30kPa) with 100 cycles plus in reverse direction(＜10kPa), 150 cycles in total; Can be autoclaved 200 cycles for 30 minutes at 130°C |
| Quality Standards | Integrity | 100% Integrity testing |
| Traceability | Each filter with a unique serial number | |
| QMS | ISO 9001:2015 | |
| Package | Pack Size | 1/pk |
| Packaging | Double PE bag |
Features
- PTFE is inherently hydrophobic and further processed for even more hydrophobic, maintaining sterilizing capacity in both unwet and wet condition
- Oleo-phobic
- High retention rates, low-pressure differential
- Use of heat-resistant thickened PP as core, better heat resistance and pressure resistance
- Heat resistance, can be steamed in line and autoclaved repeatedly
Applications
- Vent filter for fermentation, storage tanks
- Sterile filtration for compressed air, oxygen, nitrogen
- Single-use system application
Regulatory Compliance
- Effluent meets the USP<788> requirement of particulate matter in large volume injection.
- Component materials meet the criteria for a “Non-fiber-releasing filter”as defined in 21 CFR 210.3(b)(6).
- Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
- Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
- Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
- Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
- Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
- Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.
*Contact us for more specification details.