CLVL71TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Sinônimo(s): Durapore^® II Cartridge Filter 10 in. 0.1 m Code 7
• Código UNSPSC: 23151806
• eCl@ss: 27293007

Propriedades

• Materiais: PVDF
• Nível de qualidade: 400
• conformidade reg.: meets FDA Indirect Food Additive requirements cited in 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: 10 in.
• Largura: 2.7 in.
• comprimento nominal do cartucho: 10 in. (25 cm)
• área de filtração: 1.1 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
• entrada: sample type liquid
• código do cartucho: Code 7 (2-226; O-rings w/locking-tabs)

Descrição

Descrição geral

Device Configuration: Cartridge

Outras notas

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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 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.

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: after a 1.5 L flush and 24 hours in water at controlled room temperature

Informações legais

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

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