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SVPVSMLNB9 OptiScale-25 with Viresolve NFP Validation Kit, single membrane lot

Parvovirus removal

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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SVPVSMLNB9
9  
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      Overview

      Replacement Information
      Description
      Catalogue NumberSVPVSMLNB9
      Trade Name
      • OptiScale®
      DescriptionOptiScale-25 with Viresolve NFP Validation Kit, single membrane lot
      References
      Product Information
      Device ConfigurationValidation Kit
      Connections, Inlet/OutletFemale Luer-Lok/Male Luer slip
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid). Reverse: 0.7 bar (10 psid)
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      ApplicationParvovirus removal
      Key Applications
      • Protein Purification
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaViresolve® NFP
      SterilizationWater wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
      Physicochemical Information
      Inlet ConnectionFemale Luer Lok
      Outlet ConnectionMale Luer Slip
      Non-Fiber ReleasingThis product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Length2.2 cm (0.87 in.)
      Filtration Area3.5 cm²
      Process Volume70 mL
      Materials Information
      Chemistry
      • Modified Polyvinylidene Fluoride (Modified PVDF)
      Device Material
      • PVDF
      Seal MaterialSilicone (SI)
      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
      Catalog Number GTIN
      SVPVSMLNB9 04053252392788