Description
General description Device Configuration: Capsule Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. T-line/Gauge Port: T-line Packaging Double Easy-Open bag Preparation Note Sterilization Method 3 autoclave cycles of 60 min @ 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 33 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 ≥4.5 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 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. 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
