CLVL02TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 20 in. (50 cm), Code 0

• Synonym(e): Durapore^® 0.1 µm, High Area, Cartridge
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Durapore^® High Area Cartridge, Chemistry: 0.1 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 0
• Quality Segment: 400
• material: PVDF membrane, polypropylene support, silicone O-ring
• 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: 20 in.
• W: 2.7 in.
• cartridge nominal length: 20 in. (50 cm)
• device size: 20 in.
• filtration area: 2.2 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

Beschreibung

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