|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Steam Sterilization & Integrity Testing Procedures|
|Sterile Filtration of Gases by Membrane Filters|
Leahy, Timothy J., and Raymond Gabler
Vol. XXVI: 836-843. 1984
|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.
|Can I mount my tank vent filter horizontally?||Millipore recommends that you mount your vent filter vertically because it will facilitate the draining of any condensate that may collects in the bottom of the housing. If condensate builds up in the housing, it can cause part of the filter to becomes wet which will prevent air from passing through.|
Optiseal Sanitary Cartridge Housings European VersionThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.
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Aervent–50 Disposable Filters with Hydrophobic Aervent MembraneThis sterilizing-grade filter is designed for critical small scale gas line and air venting applications.
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Optiseal–M Cartridge Filters with Hydrophobic Aervent MembraneDesigned for sterilizing applications, removing particles and microorganisms from gases and solvents.
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Optiseal Sanitary Cartridge HousingsThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.
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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent|
Optiseal filters with Aervent membrane are 0.2 µm hydrophobic cartridges. They are designed for sterilizing applications, removing particles and microorganisms from gases and solvents. They are made with PTFE membrane and polypropylene components for broad application compatibility. Optiseal filters with Aervent membrane are designed to be used with Optiseal housings.
Each unit is 100% integrity tested during manufacturing to guarantee integrity.
The sterilizing grade rating is based on ASTM liquid bacterial retention challenge. In gases this filter will remove contamination down to 0.01 µm. Optiseal Aervent hydrophobic cartridges will remove particles and microorganisms from gases and liquids for low flow rates.
- Sterile tank venting
- Fermentation air applications
- Bioreactor inlet and outlet filtration
- Sterile process gases
Cartridges will also sterilize alcohol streams.
|Materials of Construction|
|Filtration Area||0.18 m²|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 4.1 bar (60 psid)|
|Bacterial Retention||Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Toxicity||Component materials meet the requirements of the USP Class VI Biological Test for Plastics. The cartridges also meet the requirements of the USP General (Mouse) Safety Test.|
|Sterilization||80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave cycles of 30 min @ 135 °C|
|Bubble Point||≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water|
|Diffusion||≤6 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water|
|HydroCorr Test||≤0.20 mL/min with water @ 2.6 bar (38 psig)|