CGW6N4S03

Cartouche Polysep^™ II 1,0/0,5 µm de dimension de pores nominale

pore size 1.0/0.5 μm, cartridge nominal length 4 in. (10 cm)

• Synonyme(s) : Polysep II Cartridge Filter 4 in. 0.5 μm Code N
• Code UNSPSC : 23151806
• eCl@ss : 32031610

Propriétés

• Matériaux: borosilicate glass fiber (BGF) prefilter; mixed cellulose esters (MCE) ; polypropylene ; polypropylene support (Spun bonded); silicone seal
• Niveau de qualité: 400
• Conformité réglementaire: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); meets FDA Indirect Food Additive requirements cited in 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: 4 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 4 in. (10 cm)
• Diamètre: 7.1 cm (2.8 in.)
• Surface de filtration: 0.19 m²
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Extractibles par gravimétrie: ≤56 mg/cartridge
• Matrice: Polysep^™ II
• pore size: 1.0/0.5 μm nominal pore size; 1.0/0.5 μm pore size
• Entrée: sample type liquid
• Code de la cartouche: Code N

Description

Description générale

Device Configuration: Cartridge

Caractéristiques et avantages

Format: Double Layer

Conditionnement

Double Easy-Open bag

Autres remarques

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

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

Notes préparatoires

Sanitization Protocol
30 min with hot water @ 80 °C

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

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

Remarque sur l'analyse

Gravimetric Extractables: after 24 hours in water at controlled room temperature

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

Informations légales

Polysep is a trademark of Sigma-Aldrich Co. LLC

Informations sur la sécurité

• Pictogrammes: GHS02
• Mention d'avertissement: Danger
• Mentions de danger: H228
• Conseils de prudence: P210 - P240 - P241 - P280 - P370 + P378
• Classification des risques: Flam. Sol. 1
• Code de la classe de stockage: 4.1B - Flammable solid hazardous materials
• Classe de danger pour l'eau (WGK): WGK 2