|The science of managing change for filters|
|Bubble Point Test Method Using Aervent 0.2 µm Hydrophobic Membrane with 60/40 IPA|
|Millipore Steam Sterilization & Integrity Testing Procedures|
|Sterilizing-grade Aervent® Filters|
Opticap XL Disposable Capsule Filters with Hydrophobic Aervent MembraneProviding sterility assurance, high flow rates and throughput.
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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 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.
Hydrophobic Aervent cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
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 cartridge 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
A full range of filtration areas is available to suit varying application requirements and a variety of connection options are offered to meet your application and housing requirements.
|Per 10-inch Cartridge Filter|
|Filtration Area||0.65 m²|
|Materials of Construction|
|Filter media||Polytetrafluoroethylene (PTFE)|
|Outer support ring||Stainless steel|
|Bubble Point||≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water|
|Diffusion||≤24 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water|
|HydroCorr Test||≤0.75 mL/min @ 2.6 bar (38 psig)|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 4.1 bar (60 psid), intermittent|
|NVR Gravimetric Extractables||The extractables level was equal to or less than 35 mg per 10-inch cartridge 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||150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C|
|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).|
|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.|