CVDR53TP3

Durapore^® (w/Prefilter) 0.65 µm, Cartridge

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 5

• Código UNSPSC: 23151806

Propiedades

• Materiales: mixed cellulose esters (MCE) prefilter; polypropylene device; polypropylene support; silicone seal
• Nivel de calidad: 400
• cumplimiento norm.: meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food); 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^®
• Parámetros: ≤30 mL/min air diffusion at 620 mbar (9 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 121 °C (forward); 1.7 bar max. differential pressure (25 psid) at 25 °C (reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 1.7 bar max. inlet temp. (25 psi) at 25 °C (reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (forward)
• técnicas: prefiltration: suitable
• Longitud: 30 in.
• Anchura: 2.7 in.
• longitud nominal del cartucho: 30 in. (75 cm)
• Tamaño de la unidad: 30 in.
• diám. del filtro: 2.7 in. (6.9 cm)
• Área de filtración del filtro: 2.07 m²
• impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíbles gravimétricos: ≤45 mg/cartridge
• Matriz: Durapore^® (w/Prefilter)
• tamaño de poro: 0.65 μm pore size
• punto de burbuja: ≥965 mbar (14 psig), air with water
• Código: Code 5

Descripción

Descripción general

Device configuration: Cartridge
Cartridge type: Liquid

Envase

Double Easy-Open bag

Nota de preparación

Sterilization Method: 8 SIP cycles of 30 min or 8 autoclave cycles of 60 min at 121°C

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

Gravimetric Extractables: The extractables level was ≤ 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

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

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