Aerex Hydrophobic Cartridge Filters
Description
Aerex hydrophobic cartridges are sterilizing-grade filters
manufactured from PTFE membrane and polypropylene components for broad chemical
compatibility and low gravimetric extractables. Cartridges are 100% integrity
tested during manufacturing to guarantee filter integrity and sterility
assurance. The Aerex filter production process has been validated and the
manufacturing plant meets ISO® 9001 standards.
Millipore's
qualification of Aerex membrane filters includes a challenge regime designed to
test virus and bacterial retention by three challenge mechanisms: aerosol, and
grow through. Aerex filters have been validated to withstand at least 150 steam
cycles at 145 °C, the equivalent of over two years use.
Typical Applications
Aerex hydrophobic cartridges will remove particles and
microorganisms from gases and solvents. In gases this filter will remove
contamination down to 0.01 µm.
- Sterile tank
venting
- Fermentation air applications
- Bioreactor inlet and
outlet filtration
- Autoclaves
- Sterile process gases
Cartridges will also sterilize alcohol streams.
Specifications
| per 10-inch Cartridge | |
| Materials of Construction | |
| Filter Membrane | Hydrophobic PTFE |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone |
| Pore Size (µm) | 0.2 |
| Filtration Area, m² | 0.65 |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 (100) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 145 °C. Reverse: 5.2 (75) @ 25 °C, intermittent |
| Integrity Testing | |
| Bubble Point at 23 °C | ≥900 mbar (13 psig) nitrogen with 60/40 % IPA/water |
| Nitrogen Diffusion at 23 °C | ≤15 mL/min @ 690 mbar (10 psig) in 60/40 % IPA/water |
| HydroCorr | ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig) |
| Viral Retention | Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge. |
| Bacterial Aerosol Growth | Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 107 CFU/cm2. |
| Sterilization | 200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| Certificate of Quality | Each cartridge is shipped with a Certificate of Quality which summarizes our stringent manufacturing and quality standards. |
Service Life
10-inch Cartridge
5-inch Cartridge with 0.2 µm Aervent Membrane—Code 7
10-inch Cartridge with 0.2 µm Aervent Membrane—Code 0 and 5
10-inch Cartridge Filter, Code 7
20-inch Cartridge with 0.2 µm Aervent Membrane—Code 0 and 5
20-inch Cartridge with 0.2 µm Aervent Membrane—Code 7
30-inch Cartridge with 0.2 µm Aervent Membrane—Code 0 and 5
30-inch Cartridge with 0.2 µm Aervent Membrane— Code 7
40-inch Cartridge with 0.2 µm Aervent Membrane— Code 0 and 5
40-inch Cartridge with 0.2 µm Aervent Membrane— Code 7
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