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VBMSPDKNB9 Viresolve® Barrier Micro Process Development Kit

Process Development Kit

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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VBMSPDKNB9
9  
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      Overview

      Replacement Information
      Description
      Catalogue NumberVBMSPDKNB9
      Trade Name
      • Viresolve®
      DescriptionViresolve® Barrier Micro Process Development Kit
      OverviewThe Viresolve® Barrier Micro Filter PD kit is ideally suited for performing your evaluation, optimization and scaling studies. Viresolve® Barrier Micro Filters are built with two layers of membrane that demonstrate retention of virus, mycoplasma and bacteria. Each kit contains 9 Micro filters from one membrane lot, a user guide and certificate of quality. The air vent prevents air locking within the device.
      References
      Product Information
      Device ConfigurationMicro
      Connections, Inlet/OutletInlet – Female Luer fitting;
      Outlet – Male Luer fitting
      Device ColorTeal
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      ApplicationProcess Development Kit
      Key Applications
      • Process development studies
      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 40 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
      Height3.83 cm (1.51 in.)
      Diameter3.07 cm (1.21 in.)
      DimensionsHeight: 3.83 cm (1.51 in.); Diameter: 3.07 cm (1.21 in.)
      Filtration Area3.3 cm2
      Device SizeMicro
      Materials Information
      Materials of ConstructionMembrane – Polyethersulfone (PES); Molded parts – Polypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size9
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      VBMSPDKNB9 04055977360042

      Documentation

      Certificates of Quality

      Title
      Viresolve Barrier Process Development Kit C1SB00987
      Viresolve Barrier Process Development Kit C2EB78077
      Viresolve Barrier Process Development Kit - C0CB40257
      Viresolve Barrier Process Development Kit - C7MA60700
      Viresolve Barrier Process Development Kit - C8EA71984
      Viresolve Barrier Process Development Kit - C8EA72604
      Viresolve Barrier Process Development Kit - C8KA17945
      Viresolve Barrier Process Development Kit C2CB49950
      Viresolve Barrier Process Development Kit C7EA09798
      Viresolve Barrier Process Development Kit- C9KA77756

      User Guides

      Title
      Viresolve® Barrier Micro Filter