CLVL03TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 30 in. (75 cm), Code 0

• Código UNSPSC: 23151806

Propriedades

• Materiais: PVDF membrane; polypropylene support; silicone O-ring
• Nível de qualidade: 400
• conformidade reg.: meets FDA 21 CFR 177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible; steam-in-place compatible
• linha de produto: Durapore^®
• Características: hydrophilic
• fabricante/nome comercial: Durapore^® II
• técnica(s): sterile filtration: suitable
• Comprimento: 30 in.
• Largura: 2.7 in.
• comprimento nominal do cartucho: 30 in. (75 cm)
• device size: 30 in.
• área de filtração: 3.3 m²
• Impurezas: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíveis gravimétricos: ≤30 mg/cartridge
• matriz: Durapore^® High Area
• tamanho de poro: 0.1 μm pore size
• código: Code 0

Descrição

Descrição geral

Device configuration: Cartridge
Cartridge type: Liquid

Nota de preparo

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 análise

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. 

Outras 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

Informações legais

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

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