CLVL02TP3

Durapore^® 0.1 µm, High Area, Cartridge

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

• Codice UNSPSC: 23151806

Proprietà

• Materiali: PVDF membrane; polypropylene support; silicone O-ring
• Livello qualitativo: 400
• Conformità normativa: meets FDA 21 CFR 177-182 (all component materials)
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible; steam-in-place compatible
• Nome Commerciale: Durapore^®
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Durapore^® II
• tecniche: sterile filtration: suitable
• Lunghezza: 20 in.
• Larghezza: 2.7 in.
• Lunghezza nominale della cartuccia: 20 in. (50 cm)
• Dimensioni del dispositivo: 20 in.
• Superficie filtrante: 2.2 m²
• Impurezze: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Estraibili (gravimetria): ≤30 mg/cartridge
• Matrice: Durapore^® High Area
• Dimensione pori: 0.1 μm pore size
• Codice: Code 0

Descrizione

Descrizione generale

Device configuration: Cartridge
Cartridge type: Liquid

Nota sulla preparazione

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).

Risultati analitici

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. 

Altre note

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

Note legali

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

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