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KPGEG03TT3 Opticap® XL 3 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC/TC

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KPGEG03TT3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKPGEG03TT3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 3 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC/TC
      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
      European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
      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
      SterilityGamma
      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≤9.5 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 3.5 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 Length3 in. (7.5 cm)
      Length17.3 cm (6.8 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.17 m²
      Inlet to Outlet Width17.3 cm (6.8 in.)
      Device Size3 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 Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
      Global Trade Item Number
      Número de referencia GTIN
      KPGEG03TT3 04055977295146

      Documentation

      Certificados de calidad

      Cargo
      OPTICAP XL 3 Capsule Millipore Express PHF Membrane C3JB47609
      Opticap XL 3 Capsule Millipore Expres PHF Membrane C9EA35333
      Opticap XL 3 Capsule Millipore Express PHF Membrane C8AA20812
      Opticap XL 3 Capsule Millipore Express PHF Membrane C0SB37864
      Opticap XL 3 Capsule Millipore Express PHF Membrane C3EB17346
      Opticap XL 3 Capsule Millipore Express PHF Membrane C4AB71668
      Opticap XL 3 Capsule Millipore Express PHF Membrane C8CA40561
      Opticap XL 3 Capsule Millipore Express PHF Membrane C9CA75038
      Opticap XL 3 Capsule Millipore Express PHF Membrane C9HA52036
      Opticap XL 3 Capsule Millipore Express PHF Membrane C0HB81648
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      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®
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