VBMSPDKNB9

Viresolve^® Barrier Capsule

Process Development Kit

• Synonym(e): Viresolve^® Barrier Micro Process Development Kit
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: molded polypropylene component(s); polyethersulfone membrane; teal device
• Hersteller/Markenname: Viresolve^®
• Parameter: 4.1 bar max. inlet pressure (60 psig)
• dilution: (process development studies)
• H × Durchm.: 3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)
• Höhe: 3.83 cm (1.51 in.)
• Durchmesser: 3.07 cm (1.21 in.)
• Filtrationsfläche: 3.3 cm²
• Verunreinigungen: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Fitting: female Luer inlet fitting; male Luer outlet fitting

Beschreibung

Allgemeine Beschreibung

Device Configuration: Micro

Anwendung

Process Development Kit

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 see the user guide 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

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Hinweis zur Analyse

TOC/Conductivity
After a controlled water flush of 40 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

Rechtliche Hinweise

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