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KPHLG3TTT1 Opticap® Gamma Compatible 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

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KPHLG3TTT1
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      개요

      Replacement Information
      Description
      Catalogue NumberKPHLG3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible 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®
      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 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
      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 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
      카탈로그 번호 GTIN
      KPHLG3TTT1 04055977275797

      Documentation

      Material Qualification Dossier

      TitleVersion
      2.0

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Duarpore Membrane C0BB94043
      Opticap XLT 30 Capsule Durapore Membrane C8MA14829
      Opticap XLT 30 Capsule Durapore Membrane C7DA08610
      Opticap XLT 30 Capsule Durapore Membrane C2DB58846
      Opticap XLT 30 Capsule Durapore Membrane C4JB65415
      Opticap XLT 30 Capsule Durapore Membrane C8HA45924
      Opticap XLT 30 Capsule Durapore Membrane - C8SA64239
      Opticap XLT 30 Capsule Durapore Membrane C1HB80883
      Opticap XLT 30 Capsule Durapore Membrane C1NB82685
      Opticap XLT 30 Capsule Durapore Membrane C3NB35415
      Show more

      Technical Info

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

      Data Sheet

      Title
      Durapore® Family Guide

      관련 제품 및 어플리케이션

      제품 패밀리

      Durapore® 0.45 µm Capsule Filters

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

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      Opticap®

      카테고리

      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