|The science of managing change for filters|
|Aerex® Cartridge Filters|
|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.
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.
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
- Sterile process gases
Cartridges will also sterilize alcohol streams.
|per 10-inch Cartridge|
|Materials of Construction|
|Filter Membrane||Polytetrafluoroethylene (PTFE)|
|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|
|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.|