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KVEPS03TT3 Opticap® Sterile XL 3 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC/TC

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KVEPS03TT3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKVEPS03TT3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Sterile XL 3 Millipore Express® SHR single layer 0.1 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 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 @ 23 °C; 5.5 bar (80 psi) @ 23 °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® SHR
      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 Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/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 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
      • Polypropylene
      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
      KVEPS03TT3 04053252260230

      Documentation

      Material Qualification Dossier

      CargoVersión
      6.0

      Certificados de calidad

      Cargo
      OPTICAP XL 3 Capsule Millipore Express SHR Membrane C3KB39759
      Opticap XL 3 Capsule Express SHR Membrane C8PA46652Y
      Opticap XL 3 Capsule Millipore Express SHR Membrane C8NA47576Y
      Opticap XL 3 Capsule Millipore Express SHR Membrane C0MB04022
      Opticap XL 3 Capsule Millipore Express SHR Membrane C7EA18740
      Opticap XL 3 Capsule Millipore Express SHR Membrane C7KA50845
      Opticap XL 3 Capsule Millipore Express SHR Membrane C7SA05602
      Opticap XL 3 Capsule Millipore Express SHR Membrane C8CA35671
      Opticap XL 3 Capsule Millipore Express SHR Membrane C8JA01968
      Opticap XL 3 Capsule Millipore Express SHR Membrane - C7CA92032

      Manuales del usuario

      Cargo
      Opticap® XL Capsules and Opticap® XLT Capsules