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SPHLA25NB6 Durapore® 0.45 µm Optiscale® 25mm NB

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SPHLA25NB6
6  
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      Overview

      Replacement Information
      Description
      Catalogue NumberSPHLA25NB6
      Trade Name
      • OptiScale®
      DescriptionDurapore® 0.45 µm Optiscale® 25mm NB
      References
      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
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      Sterilization1 autoclave cycle of 60 min @ 123 °C
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 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 15 mL, 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
      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)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size6
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalog Number GTIN
      SPHLA25NB6 04053252679841

      Documentation

      Certificates of Quality

      Title
      OptScale 25 Capsule Durapore Membrane C8DA65861
      OptiScale 25 Capsule Durapore Membrane - C8HA96391
      OptiScale 25 Capsule Durapore Membrane C0EB74487
      OptiScale 25 Capsule Durapore Membrane C0HB76857
      OptiScale 25 Capsule Durapore Membrane C0MB15343
      OptiScale 25 Capsule Durapore Membrane C1HB17134
      OptiScale 25 Capsule Durapore Membrane C8AA23433
      OptiScale 25 Capsule Durapore Membrane C8MA29732
      OptiScale 25 Capsule Durapore Membrane C9CA06061
      OptiScale 25 Capsule Durapore Membrane C9SA80079
      Show more