Merck, KVEPS1TBB1, Opticap® XLT 10 CapsuleMedia: Sterile Millipore Express® SHR 0.1 µm

General description Device Configuration: Capsule T-line/Gauge Port: T-line Packaging Double Easy-Open bag Preparation Note Sterilization Method: 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 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 11 L, samples exhibited 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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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 MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany