CVGL53TP3

Cartouche Durapore^® de 0,22 µm

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 5 (2-222; O-rings and spear)

• Synonyme(s) : Durapore Cartridge Filter 30 in. 0.22 μm Code 5
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF ; 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^®; EMPROVE^® Filter
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Durapore^®
• Paramètres: ≤40 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward); 50 L/min flow rate at 460 mbar (ΔP)
• Technique(s): sterile filtration: suitable
• Longueur: 30 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 30 in. (75 cm)
• Diamètre: 6.9 cm (2.7 in.)
• Surface de filtration: 2.07 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: Durapore^®
• Dimension de pores: 0.22 μm pore size
• Entrée: sample type liquid
• Point de bulle: ≥3450 mbar (50 psig), air with water at 23 °C
• Code de la cartouche: Code 5 (2-222; O-rings and spear)

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
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
After sterilization and a controlled water flush of 16.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

Informations légales

ASTM is a registered trademark of American Society for Testing and Materials

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

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