|Opticap® 4-inch Capsule Filter with Aervent® Membrane Comparison|
|Sterilizing-grade Aervent® Filters|
|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.|
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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Sterilizing-Grade Aervent Cartridge FiltersThe 0.2 µm hydrophobic Aervent® polytetrafluoroethylene (PTFE) membrane provides sterility assurance, high flow rates and throughput.
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Optiseal Cartridge Filters with Hydrophobic Aervent MembraneOptiseal filters with Aervent membrane are designed for sterilizing applications, removing particles and microorganisms from gases and solvents.
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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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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent|
Superior Filters for the Sterile Filtration of Gases
The 0.2 µm hydrophobic Aervent® polytetrafluoroethylene (PTFE) membrane provides sterility assurance, high flow rates and throughput. The Aervent membrane contributes to clean processes due its non-fiber releasing properties.
Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness.
Filters with hydrophobic Aervent membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each Opticap capsule filter is integrity tested during manufacturing and is supported by a comprehensive Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is labeled with the product name, lot number and serial number.
Multiple Formats Available
Opticap XL capsule filters with hydrophobic Aervent membrane are available in multiple filtration areas, providing an optimal choice for every application.
|Opticap XL 2||Opticap XL 4||Opticap XL 5||Opticap XL 10|
|Filtration Area||0.1 m²||0.21 m²||0.32 m²||0.65 m²|
|Materials of Construction|
|Filter media||Polytetrafluoroethylene (PTFE)|
|Vent O-ring||Silicone (SI)|
|Vent/Drain||1/4 in. hose barb with double O-ring seal|
|Bubble Point||≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water|
|Diffusion||—||≤9 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water||≤12 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water||≤24 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water|
|HydroCorr Test||≤0.12 mL/min @ 2.6 bar (38 psig)||≤0.25 mL/min @ 2.6 bar (38 psig)||≤0.38 mL/min @ 2.6 bar (38 psig)||≤0.75 mL/min @ 2.6 bar (38 psig)|
|Maximum Inlet Pressure, bar (psi)||5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 4.1 bar (60 psid) @ 25 °C, intermittent|
|NVR Gravimetric Extractables||The extractables level was equal to or less than 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.||The extractables level was equal to or less than 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.||The extractables level was equal to or less than 28 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.||The extractables level was equal to or less than 45 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.|
|Bacterial Endotoxins||Aqueous extraction contains Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Bacterial Retention||Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology|
|Sterilization||30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable|
|Toxicity||Non-toxic per MEM elution ISO® 10993-5|
|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).|
|European Pressure Equipment Directive||EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.|
|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.|