CHVE71HF3

Millipore Express^® SHR High Area with prefilter 0.5/0.1µm Cartridge 10

Code 7 Fluoroelastomer, Autoclavable and SIP

• Code UNSPSC : 23151806

Propriétés

• Nom du produit: Millipore Express^® SHRP High Area, Cartridge, cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 7
• Matériaux: polyethersulfone device; polypropylene device; polypropylene support; rubber seal (fluorocarbon)
• 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: Millipore Express^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipore Express^®
• Paramètres: ≤54.2 mL/min air diffusion at 3.45 bar (50 psig) (in water); 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward); 1700 mbar max. inlet pressure (25 psi) at 80 °C (Forward); 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse); 2100 mbar max. inlet pressure (30 psi) at 25 °C (Reverse); 340 mbar max. differential pressure (5 psi) at 135 °C (Forward); 340 mbar max. inlet pressure (5 psi) at 135 °C (Forward); 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse); 69 mbar max. inlet pressure (1 psi) at 135 °C (Reverse); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward); 6900 mbar max. inlet pressure (100 psi) at 25 °C (Forward)
• Technique(s): sterile filtration: suitable
• Longueur: 10 in.
• Largeur: 2.8 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diam. du filtre: 2.7 in. (6.9 cm)
• Surface de filtration du filtre: 1.0 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^® SHR (w/Prefilter High Area)
• pore size: 0.5/0.1 μm pore
• Point de bulle: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• Code de la cartouche: Code 7

Description

Description générale

Device Configuration: Cartridge
Cartridge Type: Liquid

Conditionnement

Double Easy-Open Bag

Notes préparatoires

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

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

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.

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

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