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VPPS101NB1 Viresolve® Pro Modus 1.1 Shield

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VPPS101NB1
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      Overview

      Replacement Information
      Description
      Catalogue NumberVPPS101NB1
      DescriptionViresolve® Pro Modus 1.1 Shield
      References
      Product Information
      Device ConfigurationModus 1.1 Shield
      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
      • Pilot/medium volumes
      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 100 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
      Device Size1.1 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      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
      VPPS101NB1 04053252250279

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Viresolve Pro Magnus 1.1 Shield C2AB71111
      Viresolve Pro Modus 1.1 Shield
      Viresolve Pro Modus 1.1 Shield C1SB35892
      Viresolve Pro Modus 1.1 Shield C1JB84191
      Viresolve Pro Modus 1.1 Shield C1KB35889
      Viresolve Pro Modus 1.1 Shield C1SB84188
      Viresolve Pro Modus 1.1 Shield C2AB84187
      Viresolve Pro Modus 1.1 Shield C3PB78644
      Viresolve Pro Modus 1.1 Shield C9JA62789V
      Viresolve Pro Modus 1.1 Shield - C7EA95133