CV0372TP3
Multimedia Durapore® 0.2/0.22 µm, Cartridge
Quality Level
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General description
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method: 6 autoclave or SIP cycles of 30 min at 123°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).
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 were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
Gravimetric Extractables: The extractables level was ≤ 45 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 ≥ 10 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 10 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 to 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
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Storage Class Code
4.1B - Flammable solid hazardous materials
WGK
WGK 2
Regulatory Information
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Certificates of Analysis (COA)
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