CGEP72TE3

Cartouche Millipore Express^® SHF

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 7

• Code UNSPSC : 23151806

Propriétés

• Matériaux: EPDM rubber seal; polypropylene support
• 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: EMPROVE^® Filter; Millipore Express^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipore Express^®
• Paramètres: ≤60 mL/min air diffusion at 2.75 bar (40 psig) (in water); 0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward); 2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse); 340 mbar max. differential pressure (5 psi) at 135 °C (Forward); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward); 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)
• Technique(s): sterile filtration: suitable
• Longueur: 20 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 20 in. (50 cm)
• Diam. du filtre: 2.7 in. (6.9 cm)
• Taille du filtre: 20 in.
• Surface de filtration: 1.08 m²
• Impuretés: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Millipore Express^® SHF
• Dimension de pores: 0.2 μm pore size
• Point de bulle: ≥4000 mbar (58 psig), air with water
• Code de la cartouche: Code 7

Description

Description générale

Cartridge Type: Liquid

Device Configuration: Cartridge

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C; 25 autoclave cycles of 60 min at 126 °C

This product was manufactured with a MILLIPORE EXPRESS^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Remarque sur l'analyse

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Informations légales

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

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany