CVHL01PP3

Durapore^® 0,45 µm, Cartucho

pore size 0.45 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Sinónimos: Durapore Cartridge Filter without prefilter 10 in. 0.45 μm Code 0
• Código UNSPSC: 23151806
• eCl@ss: 32031690

Propiedades

• Materiales: PVDF ; polypropylene ; polypropylene support; silicone seal
• Nivel de calidad: 400
• cumplimiento norm.: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); meets FDA Indirect Food Additive requirements cited in 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: ≤15 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 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: bioburden reduction: suitable
• Longitud: 10 in.
• Anchura: 2.7 in.
• longitud nominal del cartucho: 10 in. (25 cm)
• Diámetro: 6.9 cm (2.7 in.)
• filtración área: 0.69 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: ≤20 mg/cartridge
• Matriz: Durapore^®
• tamaño de poro: 0.45 μm pore size
• entrada: sample type liquid
• punto de burbuja: ≥1930 mbar (28 psig), air with water at 23 °C
• código del cartucho: Code 0 (2-222; O-rings)

Descripción

Descripción general

Device Configuration: Cartridge

Envase

Double Easy-Open bag

Otras 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 preparación

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °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: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Información legal

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