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KMP4G2STT1 Milligard® PES 1.2/0.45 µm, Opticap® T-line 20, TC/TC with gauge port

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KMP4G2STT1
1  PE Bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP4G2STT1
      Trade Name
      • Milligard® PES
      DescriptionMilligard® PES 1.2/0.45 µm, Opticap® T-line 20, TC/TC with gauge port
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1.5 in.) Sanitary Flange Inlet and 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 ConnectionSanitary Flange
      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 Area1.20 m2 (12.8 ft2)
      Inlet Connection Diameter1.5 in.
      Outlet Connection Diameter38 mm (1.5 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
      Catalog Number GTIN
      KMP4G2STT1 04065267513577

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Operational Excellence Dossier (Second Sterilization)

      Title

      Certificates of Quality

      Title
      Certificate of Quality KMP4G2STT1-4BH0437
      Certificate of Quality KMP4G2STT1-4GB1960

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