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KHGES2FTT1 Sterile Opticap® XLT 20 Millipore Express® SHC 0.5/0.2 µm TC/TC 1pk w/3/4" TC top

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGES2FTT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKHGES2FTT1
      Trade Name
      • Millipore Express®
      DescriptionSterile Opticap® XLT 20 Millipore Express® SHC 0.5/0.2 µm TC/TC 1pk w/3/4" TC top
      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; 3/4 in. Gauge Port
      Housing MaterialPolypropylene (PP)
      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 with 3/4 in. Gauge Port
      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 @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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
      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 PressureForward: 5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C; 6900 mbar (100 psi) @ 25 °C, intermittent. Reverse: 2100 bar (30 psi) @ 25 °C, 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.)
      Diameter19.8 cm (7.8 in.)
      Filtration Area1.09 m²
      Device Size20 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 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
      Catalog Number GTIN
      KHGES2FTT1 04053252606847

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C0HB79312
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C2SB40317
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C4CB01515
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C7DA00878
      Opticap XLT 20 Capsule Millipore Express SHC Membrane C7HA27485
      Opticap XLT 20 Capsule Millipore Express SHC Membrane- C9HA52223

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules
      Vmax Constant Pressure