Description
General description Device Configuration: Capsule Features and Benefits T-line/Gauge Port: T-line Packaging Double Easy-Open bag Preparation Note Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 123 °C; not in-line steam sterilizable This product was manufactured with a MILLIPORE EXPRESS® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). Analysis Note Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology. 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 of Filters with MILLIPORE EXPRESS® Membrane user guide Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide 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 MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
