CLGL01TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Sinónimos: Durapore II Cartridge Filter 10 in. 0.22 m Code 0
• Código UNSPSC: 23151806
• eCl@ss: 27293007

Propiedades

• Materiales: PVDF
• Nivel de calidad: 400
• cumplimiento norm.: 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^® II
• técnicas: sterile filtration: suitable
• Longitud: 10 in.
• Anchura: 2.7 in.
• longitud nominal del cartucho: 10 in. (25 cm)
• filtración área: 1.1 m²
• impurezas: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíbles gravimétricos: ≤30 mg/cartridge
• matriz: Durapore^® High Area
• tamaño de poro: 0.22 μm pore size
• entrada: sample type liquid
• código del cartucho: Code 0 (2-222; O-rings)

Descripción

Descripción general

Device Configuration: Cartridge

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

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

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

Información legal

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

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