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KMP4G10TT1 Milligard® PES Opticap® XL 10 1.2/0.45 µm Capsule

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KMP4G10TT1
1  Double easy open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKMP4G10TT1
      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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 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
      KMP4G10TT1 04061839737433

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Miligard PES Opticap XL 10 Capsule C4KB80535
      Milligard PES Opticap XL 10 Capsule C0JB01049
      Milligard PES Opticap XL 10 Capsule C1EB07790
      Milligard PES Opticap XL 10 Capsule C1MB69003
      Milligard PES Opticap XL 10 Capsule C2BB26156
      Milligard PES Opticap XL 10 Capsule C3CB00497
      Milligard PES Opticap XL 10 Capsule C3DB09884
      Milligard PES Opticap XL 10 Capsule C4BB98590
      Milligard PES Opticap XL 10 Capsule C4PB01435
      Milligard PES Opticap XL 10 Capsule C9KA84870

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