CGW674S03

Polysep^™ II 1.0/0.5 µm nominal, Cartridge

pore size 1.0/0.5 μm, cartridge nominal length 100 cm (40 in.), filter diam. 7.1 cm (2.8 in.)

• Code UNSPSC : 23151806

Propriétés

• Matériaux: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene prefilter; polypropylene support; silicone seal
• 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: Polysep^™
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Polysep^™
• Paramètres: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• Technique(s): prefiltration: suitable
• Longueur: 40 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 100 cm (40 in.)
• Diam. du filtre: 7.1 cm (2.8 in.)
• filter filtration area: 1.84 m²
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• Matrice: Polysep^™ II
• pore size: 1.0/0.5 μm nominal pore size; 1.0/0.5 μm pore size
• Code de la cartouche: Code 7

Description

Description générale

Device Configuration: Cartridge

Caractéristiques et avantages

Double Layer

Conditionnement

Double Easy-Open bag

Notes préparatoires

Non-Fiber Releasing: 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).

Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

Remarque sur l'analyse

Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 20 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

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

Informations légales

Polysep is a trademark of Sigma-Aldrich Co. LLC