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KHGLG3TTT1 Opticap® Gamma Compatible Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
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KHGLG3TTT1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKHGLG3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      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; 1.05 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMultilayer Durapore®
      SterilityNon-sterile, Gamma compatible
      SterilizationGamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; 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 Size0.45 / 0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤45.0 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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.81 m²
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size30 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
      Support MaterialPolyester/Polyethylene
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
      Global Trade Item Number
      Référence GTIN
      KHGLG3TTT1 04053252496677

      Documentation

      Material Qualification Dossier

      TitreVersion
      2.0

      Operational Excellence Dossier

      Title

      Certificats de qualité

      Titre
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C2BB15142Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C3SB68140
      Opticap XLT 30 Capsule Mulitlayer Durapore Membrane C4CB01516
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C2NB29528Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C2NB31212Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C7HA08233
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C0DB60614Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C1DB80653Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C1JB17715Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C2AB86175Z
      Show more

      Informations techniques

      Titre
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

      Fiche technique

      Titre
      Durapore® Family Guide

      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules