Water filter cartridge Millipore Express® SHR

sterilizationpolyethersulfone

Device Configuration: Cartridge Packaging Double Easy-Open bag Preparation Note Sterilization Method 25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °C 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 Bacterial Retention Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. TOC/Conductivity After sterilization and a controlled water flush of 30 L, samples exhibited less than 500 ppb TOC per USP and less than 1.3 µS/cm per USP at 25 °C. Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 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 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.