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KHGES2TTB1 Opticap® Sterile XLT 20 Millipore Express® SHC 0.5/0.2 µm 1-1/2 in. TC-1 in. HB

Ficha de dados de segurança do material (FDSM) ou ficha de segurança do material (FSM), certificado de análise (CA) e certificado de qualidade (CQ), dossiês e outros documentos disponíveis.
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KHGES2TTB1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKHGES2TTB1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Sterile XLT 20 Millipore Express® SHC 0.5/0.2 µm 1-1/2 in. TC-1 in. HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/25 mm (1 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 25 °C; 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.
      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® SHC
      SterilitySterile
      Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.5 / 0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤62.5 mL/min @ 2.8 bar (40 psig) in water
      Bubble Point at 23 °C≥4000 mbar (58 psig) air with 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 Pressure80 psi (5.5 bar) continuous
      100 psi (6.9 bar) intermittent
      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 42 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 Length20 in. (50 cm)
      Length62.5 cm (24.6 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.09 m²
      Inlet to Outlet Width17.5 cm (6.9 in.)
      Device Size20 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • 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 L
      Global Trade Item Number
      Número de catálogo GTIN
      KHGES2TTB1 04053252343384

      Documentation

      Material Qualification Dossier

      TítuloVersão
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C0DB60414
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C7KA47354
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C9EA30012
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C2BB32588
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C3PB66038

      Informações técnicas

      Título
      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 de dados

      Título
      Millipore Express®SHC Hydrophilic Filters

      Manuais do usuário

      Título
      Opticap® XL Capsules and Opticap® XLT Capsules
      User Guide - Filters with Millipore Express®Membrane
      Vmax Constant Pressure

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      Categorias

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