VPPS103NB1

Viresolve^® Pro Modus 1.3

• Synonym(s): Viresolve^® Pro Modus 1.3 Shield
• eCl@ss: 32031690

Properties

• material: polyethersulfone
• Quality Level: 400
• product line: EMPROVE^® Filter
• parameter: 60 psig max. inlet pressure
• device size: 1.3 in.
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

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 Shield offers a filtration area of 0.22 m² and has a primary use in pilot/small-volume processing.

Features and Benefits

• Pilot and mid scale manufacturing
• Three different size formats
• Fully self contained (hardware holder not required)
• 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.

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 100 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.