Gas filter cartridge Aervent®

sterilizationPTFEdisposable

Device Configuration: Cartridge Features and Benefits 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. Packaging Double Easy-Open bag Preparation Note Sterilization Method 150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). Analysis Note Bacterial Retention Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature HydroCorr: ≤0.38 mL/min @ 2.6 bar (38 psig) per 5 in cartridge Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm² Other Notes Directions for Use ■Organism Retention: Microorganism ■Mode of Action: Filtration (size exclusion) ■Application: BioProcessing ■Intended Use: Reduction or removal of microorganism/bioburden ■Instructions for Use: Please refer Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide ■Storage Statement: Store in dry location ■Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.