Viresolve® Pro Device

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 Device Modus 1.3 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.
• 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/ConductivityAfter 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
• 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.