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KPHLS10HH1 Opticap® Sterile XL10 Durapore® 0.45  HB/HB

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KPHLS10HH1
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKPHLS10HH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterile XL10 Durapore® 0.45  HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb Inlet and Outlet
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @25 ˚C. Reverse: 2.1 bar (30 psid) @ 4-40 °C
      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
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Application
      • Prefiltration / Bioburden reduction in single use assemblies
      • Bioburden reduction before final sterilization
      • Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilitySterile
      SterilizationGamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤15 mL/min @ 3.9 bar (56 psig) in water
      Bubble Point at 23 °C≥1930 mbar (28 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
      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
      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 Length13.2 in. (33.5 cm)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.62 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 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
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
      Global Trade Item Number
      Número de referencia GTIN
      KPHLS10HH1 04055977275810

      Documentation

      Material Qualification Dossier

      CargoVersión
      2.0

      Certificados de calidad

      Cargo
      OPTICAP XL 10 Capsule Durapore Membrane C3KB31527
      Opticap XL 10 Capsule Durapore Membrane C0JB92513
      Opticap XL 10 Capsule Durapore Membrane C0NB37860
      Opticap XL 10 Capsule Durapore Membrane C1EB98525
      Opticap XL 10 Capsule Durapore Membrane C1KB51510
      Opticap XL 10 Capsule Durapore Membrane C7EA12235
      Opticap XL 10 Capsule Durapore Membrane C7HA25763
      Opticap XL 10 Capsule Durapore Membrane C8JA94044
      Opticap XL 10 Capsule Durapore Membrane - C9KA76748
      Opticap XL 10 Capsule Durapore Membrane - C9SA81003

      Licencias necesarias e Información técnica

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

      Ficha técnica

      Cargo
      Durapore® Family Guide

      Productos y aplicaciones relacionados

      Familias de productos

      Productos relacionados por: Brand Facete

      Categorías

      Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore
      Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Durapore
      Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore > STERILE Durapore XL