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KMP4G10HH1 Milligard® PES Opticap® XL 10 1.2/0.45 µm Capsule

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KMP4G10HH1
1  Double easy open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP4G10HH1
      Trade Name
      • Milligard®
      DescriptionMilligard® PES Opticap® XL 10 1.2/0.45 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
      European Pressure Equipment DirectiveEMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, this product does not bear the CE mark.
      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 / 0.45 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥ 2290 mbar (33.3 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
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.60 m² (6.4 ft²)
      Device Size10 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
      Catalogue Number GTIN
      KMP4G10HH1 04061839737457

      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 Capsul C0HB80390
      Milligard PES Opticap XL 10 Capsule C3DB11340
      Milligard PES Opticap XL 10 Capsule C0DB60703
      Milligard PES Opticap XL 10 Capsule C1MB51511
      Milligard PES Opticap XL 10 Capsule C2KB94159
      Milligard PES Opticap XL 10 Capsule C3CB00496
      Milligard PES Opticap XL 10 Capsule C3PB79204
      Milligard PES Opticap XL10 Capsule C3BB93593

      Technical Info

      Title
      Bioburden Reduction and Particulate Retention Using Milligard®PES Filters
      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
      User Guide - Filters with Milligard®PES Membrane

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