CZRV71TP1

Viresolve^® NFR Cartridge Filter

Retrovirus removal

• Synonym(e): Viresolve NFR Cartridge Filter 10 in. Code 7
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: polyethersulfone ; polypropylene ; silicone seal
• Qualitätsniveau: 400
• Leistungsmerkmale: holdup volume 175 mL
• Hersteller/Markenname: Viresolve^®
• Parameter: ≤16 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 600-1200 L process volume
• Methode(n): protein purification: suitable
• Nennlänge Kartusche: 10 in. (25 cm)
• Filtrationsfläche: 0.43 m²
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤35 mg/cartridge
• Matrix: Viresolve^® NFR
• Kartuschencode: Code 7

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Anwendung

Abscheidung von Retroviren

Verpackung

Leicht zu öffnender Doppelbeutel

Sonstige Hinweise

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

Directions for Use

• Organism Retention: Retrovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please see the user guide (pg. 3) shipped with this product
• Storage Statement: Store at room temperature
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

Sterilization Method
After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C,

using liquid cycle, slow exhaust.

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).

Hinweis zur Analyse

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥4 l Wasser

Gravimetric Extractables: after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature

Rechtliche Hinweise

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