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MPGL2GCL3 Sterile Millipak®-200 Filter Unit 0.22 µm 1-1/2 in. TC/TC

Sterile Millipak®-200 Filter Unit 0.22 µm 1-1/2 in. TC/TC: Malzeme Güvenlik Bilgi Formu (MSDS) veya SDS, Analiz Sertifikası (COA) ve Kalite Uygunluk Sertifikası (COQ), dosyalar, broşürler ve diğer dokümanlar.
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MPGL2GCL3
3  Blister
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL2GCL3
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-200 Filter Unit 0.22 µm 1-1/2 in. TC/TC
      References
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      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.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilitySterile
      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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate19 L/min @ 2.8 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 5 mg per sterilized device after a 200 mL flush and 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 Area1000 cm²
      Process Volume100 L
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 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 Size3
      Material PackageBlister
      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
      Catalogue Number GTIN
      MPGL2GCL3 04053252257520

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Miillpak 200 Gamma gold capsule Durapore membrane C3NB64664
      Millipak 200 Gamma Gold Capsule Durapore Membrane C3PB67088
      Millipak 200 Gamma Gold Capsule Durapore Membrane C1EB85240Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0BB19708
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0CB26292
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0DB52671
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0KB07790
      Millipak 200 Gamma Gold Capsule Durapore Membrane C1JB85179Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C3CB00446
      Millipak 200 Gamma Gold Capsule Durapore Membrane C3CB00519
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      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