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MPGL10CB1 Gamma Compatible Millipak®-100 Filter Unit 0.22 µm 1/4 in. NPTM

MPGL10CB1
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL10CB1
      Trade Name
      • Millipak®
      DescriptionGamma Compatible Millipak®-100 Filter Unit 0.22 µm 1/4 in. NPTM
      References
      Product Information
      Device ConfigurationCapsule
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Stacked Discs100 discs
      Quality LevelMQ400
      Applications
      Biological Information
      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 ConnectionNPT
      Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 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
      Length13 cm (5.12in.)
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      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
      MPGL10CB1 04053252253584

      Documentation

      Certificates of Quality

      Title
      Millipak 100 Capsule Durapore Membrane C0KB04036
      Millipak 100 Capsule Durapore C1BB02087
      Millipak 100 Capsule Durapore Membrane C2KB85961Z
      Millipak 100 Capsule Durapore Membrane C3CB00516
      Millipak 100 Capsule Durapore Membrane C3CB08873
      Millipak 100 Capsule Durapore Membrane C3CB96509
      Millipak 100 Capsule Durapore Membrane C9PA23335
      Millipak 100 Capsule Durapore Membrane C1MB85784Z
      Millipak 100 Capsule Durapore Membrane C1PB85905Z
      Millipak 100 Capsule Durapore Membrane C2EB68853Z

      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