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SHGLA25NB6 Multilayer Durapore® 0.45 µm/0.22 µm Optiscale® 25mm NB

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SHGLA25NB6
6  
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      Overview

      Description
      Catalogue NumberSHGLA25NB6
      Trade Name
      • OptiScale®
      DescriptionMultilayer Durapore® 0.45 µm/0.22 µm Optiscale® 25mm NB
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
      Maximum Inlet Pressure, bar (psi)4.1 bar (60 psi) @ 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMultilayer Durapore®
      SterilityOther
      Sterilization1 autoclave cycle of 60 min @ 123 °C
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 / 0.22 µm
      Inlet ConnectionFemale Luer Lok
      Outlet ConnectionMale Luer Lok
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Pressure60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
      Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      Non-Particle ReleasingThis product was tested and passes the USP <788> test for particulates in injectables.
      TOC/ConductivityAfter sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Length3.9 cm (1.52 in.)
      Diameter3.1 cm (1.2 in.)
      Filtration Area3.5 cm²
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Packaging Information
      Material Size6
      Global Trade Item Number
      Catalogue Number GTIN
      SHGLA25NB6 04053252679766