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KPHLG3THH1 Opticap® Gamma Compatible XLT30 Durapore® 0.45 µm HB/HB without gauge port


  • Prefiltration / Bioburden reduction in single use assemblies
  • Bioburden reduction before final sterilization
  • Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
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KPHLG3THH1
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      Replacement Information
      Description
      Catalogue NumberKPHLG3THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XLT30 Durapore® 0.45 µm HB/HB without gauge port
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb Inlet and Oulet
      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.
      T-line/Gauge PortT-line
      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®
      SterilityNon-sterile, Gamma compatible
      SterilizationGamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤45 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
      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).
      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 Length34.3 in. (87.1 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.86 m²
      Inlet to Outlet Width87.1 cm (34.3 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Outlet Connection Diameter5/8 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 ≥4500 mL
      Global Trade Item Number
      Référence GTIN
      KPHLG3THH1 04055977275759

      Documentation

      Material Qualification Dossier

      TitreVersion
      2.0

      Certificats de qualité

      Titre
      Opticap XLT 30 Capsule Durapore Membrane C8JA87873
      Opticap XLT 30 Capsule Durapore Membrane - C0DB33372
      Opticap XLT 30 Capsule Durapore Membrane C1SB82694
      Opticap XLT 30 Capsule Durapore Membrane C3CB93226
      Opticap XLT 30 Capsule Durapore Membrane C8SA22880
      Opticap XLT 30 Capsule Durapore Membrane- C9EA38599
      Opticap XLT 30 Capsule Durapore membrane C3BB79041

      Informations techniques

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

      Fiche technique

      Titre
      Durapore® Family Guide

      Produits & Applications associés

      Familles de produits

      Durapore® 0.45 µm Capsule Filters

      Autoclavable, Gamma compatible or Presterilized bioburden reduction filters for process protection and prefiltration in single use applications
      En savoir plus >>

      Produits associés classés par : Brand Facete

      Opticap®

      Catégories

      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 > GAMMA Durapore XLT