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KMP2G05TT1 Milligard® PES Opticap® XL 5 1.2/0.2 µm nominal Capsule

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KMP2G05TT1
1  Double easy open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP2G05TT1
      Trade Name
      • Milligard®
      DescriptionMilligard® PES Opticap® XL 5 1.2/0.2 µm nominal 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 / 0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥ 2700 mbar (39.2 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 Area0.30 m² (3.2 ft²)
      Device Size5 in.
      Inlet Connection Diameter1.5 in.
      Outlet Connection Diameter1.5 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
      KMP2G05TT1 04061839737662

      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 10 Capsule C9KA78717
      Milligard PES Opticap XL 5 Capsule C0AB15731
      Milligard PES Opticap XL 5 Capsule C1KB03526
      Milligard PES Opticap XL 5 Capsule C1KB03535
      Milligard PES Opticap XL 5 Capsule C2EB68874
      Milligard PES Opticap XL 5 Capsule C2KB10221
      Milligard PES Opticap XL 5 Capsule C3BB87785
      Milligard PES Opticap XL 5 Capsule C3JB35178
      Milligard PES Opticap XL 5 Capsule C3KB59015
      Milligard PES Opticap XL 5 Capsule C3PB79222
      Show more

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