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SGEPA25NB6 Millipore Express® SHF Optiscale® 25mm 0.2 µm NB

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SGEPA25NB6
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      Replacement Information
      Description
      Catalogue NumberSGEPA25NB6
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHF Optiscale® 25mm 0.2 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® SHF
      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
      Número de catálogo GTIN
      SGEPA25NB6 04053252679711

      Documentation

      Certificados de qualidade

      Título
      Opitscale 25 Capsule Millipore Express SHF Membrane C0EB74484
      OptiScale 2 Capsule Millipore Express SHF Membrane C0AB18271
      OptiScale 25 Capsule Millipore Express SHF Membrane C0CB32402
      OptiScale 25 Capsule Millipore Express SHF Membrane C0HB81080
      OptiScale 25 Capsule Millipore Express SHF Membrane C0KB10764
      OptiScale 25 Capsule Millipore Express SHF Membrane C0PB60571
      OptiScale 25 Capsule Millipore Express SHF Membrane C1EB09132
      OptiScale 25 Capsule Millipore Express SHF Membrane C3AB57708
      OptiScale 25 Capsule Millipore Express SHF Membrane C9PA22639
      OptiScale 25 Capsule Millipore Express SHF Membrane C9SA80089
      Show more

      Informações técnicas

      Título
      Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
      Scalable Process Filtration with Opticap® XL 150, 300 and 600 Capsules with Millipore Express® Membranes

      Ficha de dados

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

      Pôster

      Título
      Quality by Design (QbD) Principles in Aseptic Processing

      Manuais do usuário

      Título
      OptiScale 25 Capsule Filter User Guide

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      Categorias

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