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KMP4G1STH1 Milligard® PES 1.2/0.45 µm, Opticap® T-line 10, TC/HB with gauge port

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KMP4G1STH1
1  PE Bag
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      Replacement Information
      Description
      Catalogue NumberKMP4G1STH1
      Trade Name
      • Milligard® PES
      DescriptionMilligard® PES 1.2/0.45 µm, Opticap® T-line 10, TC/HB with gauge port
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1.5 in.) Sanitary Flange Inlet and 19 mm (6/8 in.) Hose Barb Outlet.
      Maximum Differential Pressure, bar (psid)Forward: 4.5 bar (65 psid) at 4-25°C; 1.7 bar (25 psid) at 80°C, Reverse: 1.4 bar (20 psid) at 25°C
      Maximum Inlet Pressure, bar (psi)4.5 bar (65 psi) at 25 °C
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      MediaMilligard® PES
      SterilityAutoclavable/Gamma Compatible
      Sterilization3 autoclave cycles of 60 min @ 123 °C; gamma exposure up to 40 kGy
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size1.2/0.45 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C2290 mbar (33.3 psi) air with water
      Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
      Dimensions
      Filtration Area0.60 m2 (6.4 ft2)
      Inlet Connection Diameter1.5 in.
      Outlet Connection Diameter19 mm (6/8 in)
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Hydrophilic polyethersulfone
      Support MaterialPolyester
      Vent Cap MaterialSilicone
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackagePE Bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Número de catálogo GTIN
      KMP4G1STH1 04065267513690

      Documentation

      Material Qualification Dossier

      TítuloVersão
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Operational Excellence Dossier (Second Sterilization)

      Title

      Informações técnicas

      Título
      How Membrane Prefilters Enhance Bioprocessing Efficiency
      Processing mAb streams - How a bioburden reduction filter can improve process efficiency

      Manuais do usuário

      Título
      User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules

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