CLGL71TP3

Cartouche Durapore^® 0,22 µm High Area (grande surface)

cartridge nominal length 10 in. (25 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonyme(s) : Durapore^® II Cartridge Filter 10 in. 0.22 m Code 7
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF ; polypropylene ; polypropylene support; silicone seal
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA Indirect Food Additive requirements cited in 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^®
• Paramètres: ≤20.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
• Technique(s): sterile filtration: suitable
• Longueur: 10 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 6.9 cm (2.7 in.)
• Surface de filtration: 1.1 m²
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <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: 0.22 μm
• Entrée: sample type liquid
• Point de bulle: ≥3450 mbar (50 psig), air with water at 23 °C
• Code de la cartouche: Code 7 (2-226; O-rings w/locking-tabs)

Description

Description générale

Device Configuration: Cartridge

Autres remarques

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.

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: after a 1.5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL

Informations légales

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

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