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SPGEA25NB6 Millipore Express® PHF Optiscale® 25mm 0.2 µm NB

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SPGEA25NB6
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      Overview

      Replacement Information
      Description
      Catalogue NumberSPGEA25NB6
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® PHF Optiscale® 25mm 0.2 µm NB
      References
      Product Information
      HS Code8421 22 00
      Device ConfigurationCapsule
      Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
      Maximum Inlet Pressure, bar (psi)4.1 bar (60 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® PHF
      Sterilization1 autoclave cycle of 60 min @ 123 °C
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionFemale Luer Lok
      Outlet ConnectionMale Luer Lok
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Pressure60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
      Non-Fiber ReleasingThis product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      Non-Particle ReleasingThis product was tested and passes the USP <788> test for particulates in injectables.
      TOC/ConductivityAfter sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length1.52 in. (39 mm)
      Length3.9 cm (1.52 in.)
      Diameter3.1 cm (1.2 in.)
      Filtration Area3.5 cm²
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene
      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 Size6
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      SPGEA25NB6 04055977295634

      Documentation

      Certificates of Quality

      Title
      OptiScale 25 Capsule Millipore Express PFH Membrane C9AA79421
      OptiScale 25 Capsule Millipore Express PHF Membane C8MA27153
      OptiScale 25 Capsule Millipore Express PHF Membrane C1AB96351
      OptiScale 25 Capsule Millipore Express PHF Membrane C3JB44250
      OptiScale 25 Capsule Millipore Express PHF Membrane - C7EA10807
      OptiScale 25 Capsule Millipore Express PHF Membrane - C7JA45879
      OptiScale 25 Capsule Millipore Express PHF Membrane - C8AA14112
      OptiScale 25 Capsule Millipore Express PHF Membrane - C8BA34668
      OptiScale 25 Capsule Millipore Express PHF Membrane - C8BA34670
      OptiScale 25 Capsule Millipore Express PHF Membrane - C8MA29731

      Data Sheet

      Title
      Millipore Express®PHF Hydrophilic Filters
      Millipore Express®SHC Hydrophilic Filters
      Millipore Express®SHR Hydrophilic Filters

      User Guides

      Title
      OptiScale 25 Capsule Filter User Guide
      OptiScale®-25 Capsule Filter with Millipore Express® PHF Membrane
      User Guide - Filters with Millipore Express®Membrane

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      Categories

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      Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express