Description
General description
Device Configuration: Cartridge
Stack Design: 10 Stak
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
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
Gravimetric Extractables: using sterilized device after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
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
MILLIDISK is a registered trademark of Merck KGaA, Darmstadt, Germany