Cartridge Type: Liquid
Filter Grade: Standard MILLIGARD® Media
Device Configuration: Cartridge
Format: Double Layer
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Gravimetric Extractables: The extractables level was ≤140 mg per 4-inch cartridge after a 2 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 and wetting sections of OPTISCALE® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTISCALE is a registered trademark of Merck KGaA, Darmstadt, Germany