KHVEG1TTB1H

Millipore Express^® SHR High Area with prefilter 0.5/0.1µm, Opticap^® XLT 10 Capsule

Fittings 1-1/2 in. TC- 1 in. HB, Gamma Compatible

• Code UNSPSC : 23151806

Propriétés

• Nom du produit: Millipore Express^® SHRP High Area, Opticap^® XLT Capsule, Opticap^® XLT 10, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)
• Matériaux: polyester support; polypropylene housing; silicone seal; vent cap (gamma stable polypropylene)
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: gamma compatible
• Gamme de produits: Opticap^® XLT 10
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipore Express^®
• Paramètres: ≤54.2 mL/min air diffusion at 3.45 bar (50 psig) (in water); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 1 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet pressure; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psig max. inlet pressure
• Technique(s): sterile filtration: suitable
• Longueur: 14.8 in.
• Largeur: 4.2 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diam. du filtre: 4.2 in. (10.7 cm)
• Taille du filtre: 10 in.
• Surface de filtration: 1.0 m²
• Impuretés: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
• Matrice: Millipore Express^® SHR ((w/Prefilter High Area))
• pore size: 0.5/0.1 μm pore size
• Point de bulle: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• Raccords: 1/4 in. drain/vent connection ( hose barb with double o-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)
• Application(s): filtration

Description

Description générale

Device Configuration: Capsule

Caractéristiques et avantages

T-line/Gauge Port: T-line

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 123 °C; not in-line steam sterilizable

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

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

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