CVDR02TP3

Durapore^® (w/Prefilter) 0.65 µm, Cartridge

pore size 0.65 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonyme(s) : Durapore Cartridge Filter with prefilter 20 in. 0.65 m Code 0
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF ; mixed cellulose esters (MCE) prefilter; polypropylene ; polypropylene support; 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: Durapore^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Durapore^®
• Paramètres: ≤20 mL/min air diffusion at 620 mbar (9 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 25 °C (Reverse); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• Technique(s): prefiltration: suitable
• Longueur: 20 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 20 in. (50 cm)
• Diamètre: 6.9 cm (2.7 in.)
• Surface de filtration: 1.38 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: ≤90 mg/cartridge
• Matrice: Durapore^® (w/Prefilter)
• Dimension de pores: 0.65 μm pore size
• Entrée: sample type liquid
• Point de bulle: ≥965 mbar (14 psig), air with water at 23 °C
• Code de la cartouche: Code 0 (2-222; O-rings)

Description

Description générale

Device Configuration: Cartridge

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Notes préparatoires

Sterilization Method
8 SIP cycles of 30 min or 8 autoclave cycles of 60 min @ 121 °C

This product was manufactured with a Durapore^® membrane 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 ≥1 L

Informations légales

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

Informations sur la sécurité

• Code de la classe de stockage: 4.1B - Flammable solid hazardous materials
• Classe de danger pour l'eau (WGK): WGK 3