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KMP8G05HH1 Milligard® PES Opticap® XL 5 1.2/0.8 µm Capsule

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KMP8G05HH1
1  Double easy open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP8G05HH1
      Trade Name
      • Milligard®
      DescriptionMilligard® PES Opticap® XL 5 1.2/0.8 µm Capsule
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psi) at 4-25°C
      1.7 bar (25 psi) at 80°C
      Reverse: 1.4 bar (20 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
      SterilizationGamma irradiation up to 40 kGy and 3 wet autoclave cycles of 60 minutes at 123°C
      Physicochemical Information
      Pore Size1.2 / 0.8 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥ 990 mbar (14.3 psi) air with water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 based on information provided by raw material suppliers.
      Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
      Dimensions
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.29 m² (3.1 ft²)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polyethersulfone
      Support MaterialPolyester
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble easy open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalog Number GTIN
      KMP8G05HH1 04061839737747

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Milligard PES Opticap XL 5 Capsule C0NB37886
      Milligard PES Opticap XL 5 Capsule C0BB26839
      Milligard PES Opticap XL 5 Capsule C0MB19976
      Milligard PES Opticap XL 5 Capsule C1BB05626
      Milligard PES Opticap XL 5 Capsule C1CB78976
      Milligard PES Opticap XL 5 Capsule C2KB99669
      Milligard PES Opticap XL 5 Capsule C2NB16375
      Milligard PES Opticap XL 5 Capsule C3EB09886
      Milligard PES Opticap XL 5 Capsule C3ab75931

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