Description
General description Device Configuration: Capsule Packaging Double Easy-Open bag Preparation Note Sterilization Method: 3 autoclave cycles of 60min at 126°C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 21CFR210.3(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: ≤ 25 mg per capsule after 24 hours in water at controlled room temperature. Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L 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 Legal Information ASTM is a registered trademark of American Society for Testing and Materials Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
