Aerex® Cartridge Filters
Sterilizing-grade filters manufactured from PTFE membrane and polypropylene components. Cartridges are 100% integrity tested during manufacturing to guarantee filter integrity and sterility assurance.
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Sterilizing-grade filters manufactured from PTFE membrane and polypropylene components. Cartridges are 100% integrity tested during manufacturing to guarantee filter integrity and sterility assurance. 表示を少なく
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概要
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FAQ（よくある質問と回答）
| 質問 | 回答 |
|---|---|
| What is the difference between Aerex and Aervent? | Aervent cartridges have a 0.2µ PTFE membrane and are used in pharmaceutical applications where it is critical to use a phobic filter that has proven bacterial and viral retention capabilities. Common applications for Aervent are fermentation air applications, bioreactor inlet and outlet filtration and sterile process gases. Aervent filters have a liquid bacterial retention claim as well as a virus aerosol retention claim. Aerex filters also have a 0.2µ PTFE membrane but they do not come with a liquid bacterial retention claim. Common applications for Aerex include bulk intermediate manufacturing and non-pharamaceutical applications such as industrial fermentation. Aerex filters do have a virus aerosol retention claim. |
関連製品＆アプリケーション
関連製品: Application Facete
| Antibody Purification |
| Process Water Analysis |
| Dialysis and Filtration |
関連製品: Brand Facete
| Aerex™ |
カテゴリー
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aerex |
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.
| per 10-inch Cartridge | |
| Materials of Construction | |
| Filter Membrane | Polytetrafluoroethylene (PTFE) |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone (SI) |
| Pore Size | 0.2 µm |
| Filtration Area | 0.65 m² |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 bar (100 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 145 °C. Reverse: 5.2 bar (75 psid) @ 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 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