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KMP8G3TTT1 Milligard® PES 1.2/0.8 µm, Opticap® T-line 30, TC/TC

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KMP8G3TTT1
1  PE Bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP8G3TTT1
      Trade Name
      • Milligard® PES
      DescriptionMilligard® PES 1.2/0.8 µm, Opticap® T-line 30, TC/TC
      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 Size1.2/0.8 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C990 mbar (14.3 psi) air with water
      Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
      Dimensions
      Filtration Area1.73 m2 (18.6 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
      Catalogue Number GTIN
      KMP8G3TTT1 04065267513645

      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 KMP8G3TTT1-2KJ1927
      Certificate of Quality KMP8G3TTT1-2KP0101
      Certificate of Quality KMP8G3TTT1-3B31035
      Certificate of Quality KMP8G3TTT1-3JD1167
      Certificate of Quality KMP8G3TTT1-3JG0739
      Certificate of Quality KMP8G3TTT1-3JG0739
      Certificate of Quality KMP8G3TTT1-3NG0170
      Certificate of Quality KMP8G3TTT1-4GS1884
      Certificate of Quality KMP8G3TTT1-4NK2742

      Technical Info

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

      User Guides

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

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