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VPMKVALNB9 Viresolve® Pro Micro 40 Device Kit

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VPMKVALNB9
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      Overview

      Replacement Information
      Description
      Catalogue NumberVPMKVALNB9
      Trade Name
      • Viresolve®
      DescriptionViresolve® Pro Micro 40 Device Kit
      OverviewThe Viresolve® Pro Micro 40 Kit is ideally suited for performing your filter sizing and viral clearance evaluations. Each kit contains 3 sets of 3 Micro 40 Devices from three different membrane layering combinations* and certificate of quality. Every Viresolve® Pro Micro Device undergoes a Binary Gas Test before product release ensuring optimum quality and performance consistency.
      *Viresolve® Pro Devices are built with two membrane layers. Each Viresolve® Pro Micro 40 Device is packaged in a blister pack and labeled with the device lot and the top layer membrane lot/roll number.
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationMicro
      Connections, Inlet/OutletInlet – Female Luer fitting;
      Outlet – Male Luer fitting
      Connections, Vent/DrainVent – Female Luer fitting
      Device ColorWhite
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Key Applications
      • Process development studies
      • viral clearance evaluations
      Biological Information
      Physicochemical Information
      Maximum Inlet Pressure (psig)4.1 bar (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
      Height4.03 cm (1.59 in.)
      Diameter4.37 cm (1.72 in.)
      Filtration Area3.4 cm²
      Materials Information
      Materials of ConstructionMembrane – Polyethersulfone (PES); Molded parts – Polyvinylidene Diflouride (PVDF)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Storage Conditions4°C - 30°C
      Packaging Information
      Material Size9
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      VPMKVALNB9 04061842095919

      Documentation

      Protocols

      Title
      Vmax™ Constant Pressure Test for Sizing Viral Clearance Filters

      Certificates of Quality

      Title
      Viresolve Pro Micro 40 Device Kit C0BB24516
      Viresolve Pro Micro 40 Device Kit C0NB42373
      Viresolve Pro Micro 40 Device Kit C1BB06927
      Viresolve Pro Micro 40 Device Kit C1BB96631
      Viresolve Pro Micro 40 Device Kit C1CB70860
      Viresolve Pro Micro 40 Device Kit C1EB83801
      Viresolve Pro Micro 40 Device Kit C1HB83802
      Viresolve Pro Micro 40 Device Kit C1JB83803
      Viresolve Pro Micro 40 Device Kit C1MB83807
      Viresolve Pro Micro 40 Device Kit C1NB33529
      Show more

      Technical Info

      Title
      Scalability of the Viresolve®Pro Solution using the Micro 40 Scaling Tool

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