CCGL53TP1

Cartouche Durapore^® chargée de 0,22 µm

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 5

• Code UNSPSC : 23151806

Propriétés

• Matériaux: polypropylene device; polypropylene support; silicone seal
• Niveau de qualité: 400
• 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: ≤30 mL/min air diffusion at 2.1 bar (30 psig) (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 temp. (50 psi) at 25 °C (reverse); 45 L/min flow rate at 400 mbar (ΔP); 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): sterile filtration: suitable
• Longueur: 30 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 30 in. (75 cm)
• device size: 30 in.
• Diam. du filtre: 2.7 in. (6.9 cm)
• filter filtration area: 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)
• Extractibles par gravimétrie: ≤20 mg/cartridge
• Matrice: Charged Durapore^®
• Dimension de pores: 0.22 μm pore size
• Point de bulle: ≥2760 mbar (40 psig), air with water
• Code: Code 5

Description

Description générale

Device configuration: Cartridge
Cartridge type: Liquid

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method: 10 SIP cycles of 30 min at 135°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.

Gravimetric Extractables: The extractables level was ≤ 20 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 ≥ 500 mL

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 to 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

Informations légales

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

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