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SVEPA25NB6 Millipore Express® SHR Optiscale® 25mm 0.1 µm NB

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SVEPA25NB6
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      Übersicht

      Replacement Information
      Description
      Catalogue NumberSVEPA25NB6
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHR Optiscale® 25mm 0.1 µm NB
      References
      Product Information
      HS Code8421 29 90
      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® SHR
      Sterilization1 autoclave cycle of 60 min @ 123 °C
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.1 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
      Bestellnummer GTIN
      SVEPA25NB6 04053252679698

      Documentation

      Qualitätszertifikate

      Titel
      OptiScale 25 Capsule Millipore Express SHR Membrane C8MA18278
      OptiScale 25 Capsule Millipore Express SHR Membrane C0MB15345
      OptiScale 25 Capsule Millipore Express SHR Membrane C1KB56775
      OptiScale 25 Capsule Millipore Express SHR Membrane C8MA29734
      OptiScale 25 Capsule Millipore Express SHR Membrane - C0AB18268Y
      OptiScale 25 Capsule Millipore Express SHR Membrane - C7DA06277
      OptiScale 25 Capsule Millipore Express SHR Membrane - C7KA51055
      OptiScale 25 Capsule Millipore Express SHR Membrane - C8MA18275
      OptiScale 25 Capsule Millipore Express SHR Membrane - C9NA03165
      OptiScale 25 Capsule Millipore Express SHR Membrane C2CB51028
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      Technische Informationen

      Titel
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      Datenblatt

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

      Posters

      Titel
      Quality by Design (QbD) Principles in Aseptic Processing

      Gebrauchsanleitungen

      Titel
      OptiScale 25 Capsule Filter User Guide

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      Millipore Express®
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      Kategorien

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHR