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VPMG201NB1 Viresolve® Pro Magnus 2.1 Device

Viresolve® Pro Magnus 2.1 Device : FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
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VPMG201NB1
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      Aperçu

      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
      Référence GTIN
      VPMG201NB1 04053252654336

      Documentation

      Material Qualification Dossier

      TitreVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificats de qualité

      Titre
      C8EA82285
      Viresolve Pro Magns 2.1 Device C1NB66858
      Viresolve Pro Magnus 2.1 Device
      Viresolve Pro Magnus 2.1 Device C0BB33754
      Viresolve Pro Magnus 2.1 Device C0CB33758
      Viresolve Pro Magnus 2.1 Device C0CB43321
      Viresolve Pro Magnus 2.1 Device C0EB66883
      Viresolve Pro Magnus 2.1 Device C0HB66884
      Viresolve Pro Magnus 2.1 Device C0JB72590
      Viresolve Pro Magnus 2.1 Device C0JB74471
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      Informations techniques

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

      Manuels d'utilisation

      Titre
      Viresolve® Pro Modus and Magnus Devices User Guide