CLVL03TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 30 in. (75 cm), Code 0

• Code UNSPSC : 23151806

Propriétés

• Matériaux: PVDF membrane; polypropylene support; silicone O-ring
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible; steam-in-place compatible
• Gamme de produits: Durapore^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Durapore^® II
• Technique(s): sterile filtration: suitable
• Longueur: 30 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 30 in. (75 cm)
• device size: 30 in.
• Surface de filtration: 3.3 m²
• Impuretés: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Extractibles par gravimétrie: ≤30 mg/cartridge
• Matrice: Durapore^® High Area
• Dimension de pores: 0.1 μm pore size
• Code: Code 0

Description

Description générale

Device configuration: Cartridge
Cartridge type: Liquid

Notes préparatoires

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).

Remarque sur l'analyse

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. 

Autres remarques

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

Informations légales

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

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