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KHGEG3TTT1H Gamma Compatible High Area Opticap® XLT 30 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC

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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KHGEG3TTT1H
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKHGEG3TTT1H
      Trade Name
      • Millipore Express®
      DescriptionGamma Compatible High Area Opticap® XLT 30 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC
      References
      Product Information
      HS Code8421 22 00
      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 Differential Pressure, bar (psid)Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 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
      Key Applications
      • Laboratory Filtration
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      SterilityNon-sterile, Gamma compatible
      SterilizationGamma compatible to 45 kGy; 3 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 ConnectionSanitary Flange
      Air Diffusion at 23 °C≤169.2 mL/min @ 2.75 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
      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 63 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      Dimensions
      Cartridge Nominal Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 in. (4.2 cm)
      Filtration Area30000 cm2
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size30 in.
      Outlet Connection Diameter1.5 in.
      Materials Information
      Chemistry
      • Hydrophilic 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 ≥6 L
      Global Trade Item Number
      Número de catálogo GTIN
      KHGEG3TTT1H 04054839167898

      Documentation

      Material Qualification Dossier

      TítuloVersão
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      OPTICAP XLT 30 Capsule Millipore Express SHC Area membrane C3CB04898
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane - C9PA13177
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C2KB07534
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C0AB82251
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C0JB84307
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C1DB22031
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C1PB84095
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C3DB85426
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C3SB66009
      Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C4PB15999
      Show more

      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
      User Guide - Polygard®and Clarigard® Cartridges
      User Guide - Filters with Millipore Express®Membrane
      User Guide - Opticap® XL Capsules and Opticap® XLT Capsules

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      Categorias

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