CLVL01TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 10 in. (25 cm), Code 0

• UNSPSC Code: 23151806

Properties

• material: PVDF membrane; polypropylene support; silicone O-ring
• Quality Level: 400
• reg. compliance: meets FDA 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^® II
• technique(s): sterile filtration: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• filtration area: 1.1 m²
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤30 mg/cartridge
• matrix: Durapore^® High Area
• pore size: 0.1 μm pore size
• code: Code 0

Description

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

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 ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 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

ASTM is a registered trademark of American Society for Testing and Materials

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