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MPGL06CB1 Millipak®-60 Filling Machine Filter Unit 0.22 µm 1/4 in. NPT-1/4 in.HB

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MPGL06CB1
1  Double Easy-Open bag
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      개요

      Replacement Information
      Description
      Catalogue NumberMPGL06CB1
      Trade Name
      • Millipak®
      DescriptionMillipak®-60 Filling Machine Filter Unit 0.22 µm 1/4 in. NPT-1/4 in.HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet6 mm (1/4 in.) NPTM/6 mm (1/4 in.) Hose Barb
      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)5.2 bar (75 psi) @ 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Stacked Discs60 discs
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      Sterilization3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
      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 Size0.22 µm
      Inlet ConnectionNPT
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate7.6 L/min @ 2.9 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 2 mg per 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 Area300 cm²
      Process Volume30 L
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polycarbonate
      Support MaterialPolycarbonate
      Vent Cap MaterialPolyvinylidene fluoride (PVDF)
      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
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
      Global Trade Item Number
      카탈로그 번호 GTIN
      MPGL06CB1 04053252354717

      Documentation

      Certificates of Quality

      Title
      Millipak 60 Capsule Durapore Membrane
      Millipak 60 Capsule Durapore Membrane C2PB40220Z
      Millipak 60 Capsule Durapore Membrane C4CB93426
      Millipak 60 Capsule Durapore Membrane C4EB25907
      Millipak 60 Capsule Durapore Membrane C4PB10986
      Millipak 60 Capsule Durapore Membrane C9PA20044
      Millipak 60 Capsule Durapore Membrane - C8JA00269
      Millipak 60 Capsule Durapore Membrane - C8PA51221
      Millipak 60 Capsule Durapore Membrane C1BB03563
      Millipak 60 Capsule Durapore Membrane C1KB85668

      Technical Info

      Title
      Best Practices for Managing Reverse Pressure Filter Impact
      Integrity Test Troubleshooting - Beyond Rewet and Retest

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane