VPMD103NB1

Viresolve^® Pro Modus 1.3

• Synonym(s): Viresolve^® Pro Modus 1.3 Device
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF housing; polyethersulfone membrane; silicone gasket
• Quality Level: 400
• product line: EMPROVE^® Filter
• manufacturer/tradename: Viresolve^®
• parameter: 60 psig max. inlet pressure
• H: 13.56 cm (5.34 in.)
• L: 18.62 cm (7.33 in.)
• W: 9.22 cm (3.63 in.)
• device size: 1.3 in.
• filtration area: 0.22 m²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• fitting: 1/4 in. integrated vent hose barb (with double O-ring seal); 3/4 in. sanitary TC inlet/outlet fitting(s)

Description

General description

The Viresolve^® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction. This proven viral clearance solution delivers the highest levels of retention assurance and productivity across a broad range of feed stream characteristics.

Viresolve Pro Modus Devices are typically used for filtration of pilot to mid-scale batch volumes of proteins. The Viresolve^® Pro Modus 1.3 Device offers a filtration area of 0.22 m² and has a primary use in pilot/small-volume processing.

Features and Benefits

• Large scale manufacturing
• Two different size formats
• Integrated gaskets
• Units are stackable in the Viresolve^® Pro/Pro+ Magnus Holder (up to 7 units)
• Alignment keys on each unit to minimize errors during installation
• Fully disposable single-use fluid path
• Devices 100% tested with air/water diffusion and Binary Gas Test
• Shield / Shield H 100% aerosol tested

Other Notes

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

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.

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 50 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

Legal Information

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

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

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.