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VPMG201NB1 Viresolve® Pro Magnus 2.1 Device

Viresolve® Pro Magnus 2.1 Device MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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VPMG201NB1
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      Overview

      Replacement Information
      Description
      Catalogue NumberVPMG201NB1
      Trade Name
      • Viresolve®
      DescriptionViresolve® Pro Magnus 2.1 Device
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationMagnus 2.1 Device
      Connections, Inlet/OutletDisposable 1.5" sanitary TC fittings
      Connections, Vent/DrainVent: disposable 3/4" sanitary TC fitting for the port
      European Pressure Equipment DirectiveEMD 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.
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Key Applications
      • Large volume processing
      Biological Information
      Physicochemical Information
      Maximum Inlet Pressure (psig)60 psig
      Non-Fiber ReleasingThis product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      TOC/ConductivityAfter a controlled water flush of 50 L/m², samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Height4.42 cm (1.74 in.)
      Width20.96 cm (8.25 in.)
      Length34.29 cm (13.50 in.)
      Filtration Area0.51 m²
      Device Size2.1 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Materials of ConstructionMembrane: Polyethersulfone (PES); Gaskets: Silicone; Housing: Polyvinylidene fluoride (PVDF)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      VPMG201NB1 04053252654336

      Documentation

      Material Qualification Dossier

      TitleVersion
      6.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      C8EA82285
      Viresolve Pro Device C5HB78262
      Viresolve Pro Device Magnus 2.1 C5CB47370
      Viresolve Pro Device Magnus 2.1 C5CB47373
      Viresolve Pro Device Magnus 2.1 C5CB59298
      Viresolve Pro Device Magnus 2.1 C4SB08548
      Viresolve Pro Device Magnus 2.1 C4SB08558
      Viresolve Pro Device Magnus 2.1 C4SB19432
      Viresolve Pro Device Magnus 2.1 C5AB28085
      Viresolve Pro Device Magnus 2.1 C5AB30238
      Show more

      Technical Info

      Title
      Multi-Tier Approach to Assuring Virus Retention and Integrity of Viresolve®Pro Devices

      User Guides

      Title
      Viresolve® Pro Solution User Guide