CLVL01TP3

Durapore^® 0.1 µm, High Area, Cartridge

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

• Código UNSPSC: 23151806

Propiedades

• Materiales: PVDF membrane; polypropylene support; silicone O-ring
• Nivel de calidad: 400
• cumplimiento norm.: meets FDA 21 CFR 177-182 (all component materials)
• esterilidad: non-sterile
• Compatibilidad de esterilización: autoclavable compatible; steam-in-place compatible
• Línea del producto: Durapore^®
• Características: hydrophilic
• fabricante / nombre comercial: Durapore^® II
• técnicas: sterile filtration: suitable
• Longitud: 10 in.
• Anchura: 2.7 in.
• longitud nominal del cartucho: 10 in. (25 cm)
• device size: 10 in.
• filtración área: 1.1 m²
• impurezas: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíbles gravimétricos: ≤30 mg/cartridge
• matriz: Durapore^® High Area
• tamaño de poro: 0.1 μm pore size
• código: Code 0

Descripción

Descripción general

Device configuration: Cartridge
Cartridge type: Liquid

Nota de preparación

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).

Nota de análisis

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. 

Otras notas

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

Información legal

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

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