Gas filter cartridge Optiseal®

sterilizationpolypropylenemembrane

Device Configuration: Cartridge Packaging Double Easy-Open bag Preparation Note Sterilization Method 80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °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 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. These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.