Air filter cartridge Aerex®

for gassterilizationpolypropylene

Device Configuration: Cartridge Features and Benefits This product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C. Packaging Double Easy-Open bag Preparation Note Sterilization Method 200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 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 Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature HydroCorr: ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig) The membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 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.