Merck, VPMG202NB1, Viresolve® Pro Device Magnus 2.2

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 Magnus Devices are typically used for filtration of mid to large scale batch volumes of proteins. The Viresolve® Pro Device Magnus 2.2 offers a filtration area of 1.53 m2 and has a primary use in large-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 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 and less than 1.3 µS/cm per USP . 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 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.