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

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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SHGLA25NB6
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      Overview

      Replacement Information
      Description
      Catalogue NumberSHGLA25NB6
      Trade Name
      • OptiScale®
      DescriptionMultilayer Durapore® 0.45 µm/0.22 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
      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)
      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
      SHGLA25NB6 04053252679766

      Documentation

      Certificates of Quality

      Title
      Millipore Express SHC Cartridge - C0AB18265Z
      OPTISCALE 25 Multilayer Durapore membrane C4HB38899
      OptScale 25 Capsule Multilayer Durapore Membrane C8DA65859
      OptScale 25 Capsule Multilayer Durapore Membrane C8JA05666
      OptiScale 25 Capsule Multilayer Durapore Membrane C0PB46616Z
      OptiScale 25 Capsule Multilayer Durapore Membrane C1BB12947Z
      OptiScale 25 Capsule Multilayer Durapore Membrane C1DB81125Z
      OptiScale 25 Capsule Multilayer Durapore Membrane C1EB02386Z
      OptiScale 25 Capsule Multilayer Durapore Membrane C1EB02387Z
      OptiScale 25 Capsule Multilayer Durapore Membrane C4EB28436
      Show more

      User Guides

      Title
      OptiScale 25 Capsule Filter User Guide