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KHGLA3TTT1 Opticap® Autoclavable Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC

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KHGLA3TTT1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKHGLA3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Autoclavable Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC
      References
      Product Information
      HS Code8421 29 90
      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®
      SterilityOther
      Sterilization3 autoclave cycles of 60 min @ 126 °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≤32.4 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 Area1.75 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 MaterialSilicone (SI)
      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 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
      Número de catálogo GTIN
      KHGLA3TTT1 04053252300707

      Documentation

      Material Qualification Dossier

      TítuloVersão
      4.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C4BB68083
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C0JB93407Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C0NB40305Z
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C2MB10091
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C7EA75311
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C7JA20823
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C7MA58816
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C8AA06823
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C8AA18022
      Opticap XLT 30 Capsule Multilayer Durapore Membrane C8AA20252

      Informações técnicas

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

      Ficha de dados

      Título
      Durapore® Family Guide

      Manuais do usuário

      Título
      Opticap® XL Capsules and Opticap® XLT Capsules