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KPHLS10TT1 Opticap® Sterile XL10 Durapore® 0.45 µm TC/TC

  • 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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KPHLS10TT1
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      Replacement Information
      Description
      Catalogue NumberKPHLS10TT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterile XL10 Durapore® 0.45 µm TC/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: 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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 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
      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
      Référence GTIN
      KPHLS10TT1 04055977275827

      Documentation

      Material Qualification Dossier

      TitreVersion
      2.0

      Certificats de qualité

      Titre
      OPTICAP XL 10 Capsule Durapore Membrane C3CB97538
      OPTICAP XL 10 Capsule Durapore Membrane C3KB30033
      OPTICAP XL 10 Capsule Durapore Membrane C4KB85241
      Opticap XL 10 Capsule Durapore Membrane C7SA10116
      Opticap XL 10 Capsule Durapore Membrane C0CB42399
      Opticap XL 10 Capsule Durapore Membrane C0JB88703
      Opticap XL 10 Capsule Durapore Membrane C0KB09315
      Opticap XL 10 Capsule Durapore Membrane C1CB07711
      Opticap XL 10 Capsule Durapore Membrane C1EB88700
      Opticap XL 10 Capsule Durapore Membrane C1SB03041
      Show more

      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 > STERILE Durapore XL