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KPGES3TTT1 Opticap® XLT 30 Millipore Express® PHF Sterile 0.2 µm 1-1/2 in. TC

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KPGES3TTT1
1  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKPGES3TTT1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XLT 30 Millipore Express® PHF Sterile 0.2 µm 1-1/2 in. TC
      OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      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
      SterilitySterile
      Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤98.2 mL/min @ 2.8 bar (40 psig) in water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Inlet Pressure (psig)80 psig
      Maximum Differential Pressure5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C
      Maximum Inlet Temperature25 °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).
      TOC/ConductivityAfter sterilization and a controlled water flush of 33 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.71 m²
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size30 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
      Global Trade Item Number
      Número de referencia GTIN
      KPGES3TTT1 04055977295627

      Documentation

      Certificados de calidad

      Cargo
      Opticap XLT 30 Capsule Millipore Express PHF Membrane
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C0NB03978
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C9EA37158
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C0HB60630
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C1HB81114
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C1SB48684
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C2CB19261
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C4CB20567
      Opticap XLT 30 Capsule Millipore Express PHF Membrane C4NB89497
      Opticap XLT 30 Capsule Millipore express PHF Membrane C9DA57094

      Licencias necesarias e Información técnica

      Cargo
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Ficha técnica

      Cargo
      Millipore Express®PHF Hydrophilic Filters

      Manuales del usuario

      Cargo
      User Guide - Filters with Millipore Express®Membrane

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      Categorías

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
      Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express