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CMP272TS1 Milligard® PES 20" 1.2/0.2 µm nominal Cartridge

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CMP272TS1
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      Overview

      Replacement Information
      Description
      Catalogue NumberCMP272TS1
      Trade Name
      • Milligard®
      DescriptionMilligard® PES 20" 1.2/0.2 µm nominal Cartridge
      References
      Product Information
      FormatDouble Layer
      HS Code8421 29 90
      Device ConfigurationCartridge
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.52 bar (80 psid) at 4-25°C
      Reverse: 1.38 bar (20 psid) at 25°C
      Cartridge CodeCode 7 (2-226 O-ring + spear)
      Good Manufacturing PracticesThe product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.
      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
      SterilizationAutoclave wet 25x, 60 minute cycles at 128°C. In-line steam (wet): 10 forward cycles, 30 min.,
      135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles,
      30 min., 135 °C at ≤0.07 bar (<1 psid)*.
      *Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
      Physicochemical Information
      Pore Size1.2 / 0.2 µm
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Non-Fiber ReleasingThis product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      Dimensions
      Cartridge Nominal Length20 in. (50 cm)
      Length635 mm (25 in.)
      Diameter69 mm (2.71 in.)
      Filtration Area1.2 m²(13 ft² )
      Device Size20 in.
      Nominal Pore Size1.2/0.2 µm
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polyethersulfone
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      CMP272TS1 04054839617973

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Certificate of Quality CMP272TS1-P070013426
      Certificate of Quality CMP272TS1-P070013516
      Certificate of Quality CMP272TS1-P070013610
      Certificate of Quality CMP272TS1-P070022A18
      Certificate of Quality CMP272TS1-P070023808
      Certificate of Quality CMP272TS1-P070044304
      Certificate of Quality CMP272TS1-P070044425
      Certificate of Quality CMP272TS1-P070084125

      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
      User Guide - Filters with Milligard®PES Membrane

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