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KPHLS3TTT1 Opticap® Sterile XLT30 Durapore® 0.45 µm TC/TC 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

SDB (Sicherheitsdatenblätter), Analysenzertifikate und Qualitätszertifikate, Dossiers, Broschüren und andere verfügbare Dokumente.
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KPHLS3TTT1
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      Übersicht

      Replacement Information
      Description
      Catalogue NumberKPHLS3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterile XLT30 Durapore® 0.45 µm TC/TC without gauge port
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange 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.
      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®
      SterilitySterile
      SterilizationMinimum sterilization up to 25 kGy. 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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
      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 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 ≥4500 mL
      Global Trade Item Number
      Bestellnummer GTIN
      KPHLS3TTT1 04055977275971

      Documentation

      Material Qualification Dossier

      TitelVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Qualitätszertifikate

      Titel
      Opticap XLT 30 Capsule Duapore Membrane C3NB32530
      Opticap XLT 30 Capsule Durapore Membrane C0AB88211
      Opticap XLT 30 Capsule Durapore Membrane C0EB50576
      Opticap XLT 30 Capsule Durapore Membrane C1BB94953
      Opticap XLT 30 Capsule Durapore Membrane C1SB00955
      Opticap XLT 30 Capsule Durapore Membrane C2SB53066
      Opticap XLT 30 Capsule Durapore Membrane C7KA58817
      Opticap XLT 30 Capsule Durapore Membrane C8AA09360
      Opticap XLT 30 Capsule Durapore Membrane C8EA57271
      Opticap XLT 30 Capsule Durapore Membrane C8HA68196
      Show more

      Technische Informationen

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

      Verwandte Produkte & Anwendungen

      Produktfamilien

      Durapore® 0.45 µm Capsule Filters

      Autoclavable, Gamma compatible or Presterilized bioburden reduction filters for process protection and prefiltration in single use applications
      Weitere Informationen >>

      Verwandte Produkte nach: Brand Facete

      Opticap®

      Kategorien

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