Gravimetric filter Durapore®

bacterialmembranewater

Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL General description Device Configuration: Gamma Gold Capsule 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 Wetting Instructions for Filter Units with Durapore® Membrane user 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. Packaging Blister Preparation Note Sterilization Method 3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). impurities ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) gravimetric extractables ≤5 mg/device matrix Durapore® pore size 0.22 μm fitting inlet hose barb outlet hose barb (14 mm (9/16 in.) Hose Barb Inlet and Outlet) Quality Level 400