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KVGLG04HH3 Opticap® Gamma Compatible XL4 Durapore® 0.22 µm 9/16 in. HB/HB

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KVGLG04HH3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKVGLG04HH3
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XL4 Durapore® 0.22 µm 9/16 in. HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.8 bar (40 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
      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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityNon-sterile, Gamma compatible
      Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤4.6 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °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).
      TOC/ConductivityAfter sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length4 in. (10 cm)
      Length7.7
      Diameter3.3”
      Filtration Area0.18 m²
      Device Size4 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable polypropylene
      Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
      Global Trade Item Number
      Número de referencia GTIN
      KVGLG04HH3 04053252260889

      Documentation

      Material Qualification Dossier

      CargoVersión
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de calidad

      Cargo
      OPTICAP XL 4 Capsule Durapore Membrane C3HB27544
      OPTICAP XL 4 Capsule Durapore Membrane C3KB38408
      OPTICAP XL 4 Capsule Durapore Membrane C3KB54050
      OPTICAP XL 4 Capsule Durapore Membrane C3MB60901
      OPTICAP XL 4 Capsule Durapore Membrane C4BB74507
      OPTICAP XL 4 Capsule Durapore Membrane C4HB36426
      OPTICAP XL 4 Capsule Durapore Membrane C4PB04759
      Opticap XL 2 Capsule Durapore Membrane C2MB23015Z
      Opticap XL 4 Capsule Durapore Membrane C1PB47067Z
      Opticap XL 4 Capsule C0HB81538Z
      Show more

      Licencias necesarias e Información técnica

      Cargo
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Ficha técnica

      Cargo
      Durapore® Family Guide

      Manuales del usuario

      Cargo
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Opticap®

      Categorías

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore