Durapore® CVDI Cartridge Filter 20 in.0.2 µm Code 0 fluoroelastomer

General description
Device Configuration: Cartridge

Preparation Note
This product was manufactured with a Durapore® 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 of the Durapore® membrane used in this cartridge were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature

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 for Filter Units with Durapore® Membrane 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
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
SUPER-Q is a registered trademark of Merck KGaA, Darmstadt, Germany