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MCVL10S03 Millidisk® Cartridge 10-stack 0.1 µm Hydrophilic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MCVL10S03
3  Double Easy-Open bag
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      概述

      Replacement Information
      Description
      Catalogue NumberMCVL10S03
      Trade Name
      • Millidisk®
      DescriptionMillidisk® Cartridge 10-stack 0.1 µm Hydrophilic
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 psi) @ 25 °C
      Stack Design10 Stak
      Cartridge CodeNot Applicable
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      Sterilization5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.1 µm
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Flow Rate3.8 L/min @ 2.1 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 mg per sterilized device after 24 hours in water at controlled room temperature.
      Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Filtration Area500 cm²
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolysulfone
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
      Global Trade Item Number
      产品目录编号 GTIN
      MCVL10S03 04053252500893

      Documentation

      Operational Excellence Dossier

      Title

      质量证书

      标题
      Milidisk 10 Cartridge Durapore Membrane C4DB24152
      Millidik 10 Cartridge Durapore Membrane C4MB85048
      Millidisk 10 Cartridge Durapore Membrane C8SA70267
      Millidisk 10 Cartridge Durapore Membrane C0SB82280Z
      Millidisk 10 Cartridge Durapore Membrane C4AB85674
      Millidisk 10 Cartridge Durapore Membrane C4HB55001
      Millidisk 10 Cartridge Durapore Membrane - C0DB52732
      Millidisk 10 Cartridge Durapore Membrane C1PB85143Z
      Millidisk 10 Cartridge Durapore Membrane C1PB85144Z
      Millidisk 10 Cartridge Durapore Membrane C2DB53852Z
      Show more

      技术信息

      标题
      Best Practices for Managing Reverse Pressure Filter Impact
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest

      数据表

      标题
      Durapore® Family Guide

      用户指南

      标题
      Hydrophilic Durapore® Cartridges and Capsules User Guide
      Wetting Instructions for Filter Units with Durapore Membrane