CVDR01PP3

Durapore^® Cartridge Filter

cartridge nominal length 10 in. (25 cm), Code 0

属性

• reg. compliance: meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food); meets FDA 21 CFR 177-182 (all component materials)
• Quality Level: 400
• feature: hydrophilic
• mfr. no.: Durapore^®
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤20 mg/cartridge
• matrix: Durapore^®
• pore size: 0.65 μm pore size
• code: Code 0

说明

General description

Device configuration: Cartridge
Cartridge type: Liquid

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

Gravimetric Extractables: The extractables level was ≤ 20 mg per 10-inch cartridge 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 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

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany