KGW1A1TTT1

Polysep^™ II 1,0/0,2/0,1 µm de dimension de pores nominale, Capsule Opticap^® XLT

Opticap^® XLT 10, pore size 1.0/0.2/0.1 μm, cartridge nominal length 10 in. (25 cm)

• Code UNSPSC : 23151806

Propriétés

• Matériaux: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Niveau de qualité: 400
• Conformité réglementaire: FDA 21CFR177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible
• Gamme de produits: Opticap^® XLT 10
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Opticap^®
• Paramètres: 1 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Technique(s): prefiltration: suitable
• Longueur nominale des cartouches: 10 in. (25 cm)
• device L: 37.6 cm (14.8 in.)
• device size: 10 in.
• filter filtration area: 0.42 m²
• Diam. du raccord d'entrée: 1-1/2 in.
• inlet to outlet width: 15.2 cm (6.0 in.)
• Diam. du raccord de sortie: 1-1/2 in.
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• Raccords: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

Description générale

Device Configuration: Capsule

Caractéristiques et avantages

Triple Layer

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Remarque sur l'analyse

Gravimetric Extractables: ≤ 145 mg per capsule after a 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 ≥ 5 L

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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Informations légales

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

Polysep is a trademark of Sigma-Aldrich Co. LLC