VBMSPDKNB9

Viresolve^® Barrier Capsule

Process Development Kit

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

Eigenschaften

• material: molded polypropylene component(s), polyethersulfone membrane, teal device
• manufacturer/tradename: Viresolve^®
• parameter: 4.1 bar max. inlet pressure (60 psig)
• dilution: (process development studies)
• H × diam.: 3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)
• H: 3.83 cm (1.51 in.)
• diam.: 3.07 cm (1.21 in.)
• filtration area: 3.3 cm²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• fitting: female Luer inlet fitting, male Luer outlet fitting

Beschreibung

General description

Device Configuration: Micro

Application

Process Development Kit

Preparation Note

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).

Analysis Note

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>.

Other Notes

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.

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

Legal Information

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