SVPVSMLNB9

Optiscale^® 25 Viresolve^® NFP

Parvovirus removal

• Synonym(e): OptiScale-25 with Viresolve NFP Validation Kit, single membrane lot
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF (modified); silicone seal
• Hersteller/Markenname: OptiScale^®
• Parameter: 0.7 bar max. differential pressure (10 psid) (Reverse); 5.5 bar max. differential pressure (80 psid) (Forward); 70 mL process volume
• Methode(n): protein purification: suitable
• Länge: 2.2 cm (0.87 in.)
• Filtrationsfläche: 3.5 cm²
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Viresolve^® NFP
• Fitting: female Luer-Lok^® inlet connection; male Luer outlet slip

Beschreibung

Allgemeine Beschreibung

Device Configuration: Validation Kit

Anwendung

Abscheidung von Parvoviren

Sonstige Hinweise

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

Directions for Use

• Organism Retention: Parvovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please refer ′Installation and Operation′ section of the user guide shipped with this product
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

Sterilization Method
Filter 5 min bei 3,4 bar wässern; Flüssigkeitszyklus mit langsamer Entlüftung anwenden (maximal 60 min bei 123 °C)

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

Rechtliche Hinweise

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

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