Device Configuration: Cartridge
Features and Benefits
Double Easy-Open bag
Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C
Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 15 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 first page of Visual Inspection 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
Polysep is a trademark of Merck KGaA, Darmstadt, Germany