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CMP473TS1 Milligard® PES 30" 1.2/0.45 µm Cartridge

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CMP473TS1
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      概要

      Replacement Information
      Description
      Catalogue NumberCMP473TS1
      Trade Name
      • Milligard®
      DescriptionMilligard® PES 30" 1.2/0.45 µm Cartridge
      References
      Product Information
      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 and 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 / 0.45 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 Length30 in. (75 cm)
      Length952.5 mm (37.5 in.)
      Diameter69 mm (2.71 in.)
      Filtration Area1.8 m²(19 ft²)
      Device Size30 in.
      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
      カタログ番号 GTIN
      CMP473TS1 04054839618017

      Documentation

      Material Qualification Dossier

      タイトルバージョン
      1.0

      Operational Excellence Dossier

      Title

      品質証明書

      タイトル
      Certificate of Quality CMP473TS1-P020013510
      Certificate of Quality CMP473TS1-P070021A20
      Certificate of Quality CMP473TS1-P070022B08
      Certificate of Quality CMP473TS1-P070034803
      Certificate of Quality CMP473TS1-P070043B30

      技術情報

      タイトル
      How Membrane Prefilters Enhance Bioprocessing Efficiency
      Processing mAb streams - How a bioburden reduction filter can improve process efficiency
      Steam-in-Place Sterilization of Filtration Trains containing Milligard®PES Prefilters

      ユーザーガイド

      タイトル
      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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