Description
General description Device Configuration: Capsule Packaging Double Easy-Open bag 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). 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 water at controlled room temperature Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL 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. Legal Information ASTM is a registered trademark of American Society for Testing and Materials Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany
