KVVLA3STT1

Durapore^® 0,1 µm, Capsule Opticap^® XLT

Opticap^® XLT 30, cartridge nominal length 30 in. (15 cm), filter diam. 5.7 in. (14.5 cm), pore size 0.1 μm

• Code UNSPSC : 23151806

Propriétés

• Matériaux: polypropylene device; polypropylene housing; polypropylene support; polypropylene vent cap
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible
• Gamme de produits: Opticap^® XLT 30
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Opticap^®
• Paramètres: max. inlet temp. at 25 °C; ≤60 mL/min air diffusion at 3.9 bar (56 psig) (in water); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Technique(s): sterile filtration: suitable
• Longueur: 34.3 in.
• Largeur: 6.0 in.
• Longueur nominale des cartouches: 30 in. (15 cm)
• device size: 30 in.
• Diam. du filtre: 5.7 in. (14.5 cm)
• filter filtration area: 2.1 m²
• inlet to outlet width: 34.3 in. (87.1 cm)
• 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: 0.1 μm pore size
• Point de bulle: ≥4830 mbar (70 psig), air with water at 23 °C
• Raccords: 1/4 in. drain/vent connection (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

Description générale

Device Configuration: Cartridge
Cartridge Type: Liquid

Caractéristiques et avantages

T-line/Gauge Port: T-line

Notes préparatoires

Sterilization Method: Capsule integrity was maintained after 3 autoclave cyclces of 60 minutes at 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.

Gravimetric Extractables: ≤ 75 mg per capsule after 24 hours in water at controlled room temperature.

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 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

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

Informations légales

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

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

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