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KHGES015FH3 | Opticap® Sterile XL 150 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC-9/16 in. HB

KHGES015FH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKHGES015FH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Sterile XL 150 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 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 @ 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.
      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≤1.0 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 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 1.0 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 Length3.8 in. (9.7 cm)
      Length9.7 cm (3.8 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area140 cm²
      Inlet to Outlet Width9.7 cm (3.8 in.)
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyethylene
      Vent Cap MaterialGamma stable polypropylene (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

      Documentation

      Certificados de calidad

      Cargo
      Opticap XL 150 Capsule Millipore Express SHC Membr
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3JA83454
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3SA77263
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4JA90598
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4NA28973
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4PA40586
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5EA03955
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5MA54096
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5NA80305
      Opticap XL 150 Capsule Millipore Express SHC Membrane C6KA99464
      Opticap XL 150 Capsule Millipore Express SHR Membrane - C3CA08638A
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4KA07362
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane C6EA40062
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane C6EA60899
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4BA23633
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4CA41782
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4CA43119
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4DA41696
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4MA15068
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4NA20632
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4NA22450
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C4PA33331
      Opticap® XL 150 Capsule Millipore Express® SHC Membrane - C5DA92737
      Opticap® XL 150 Capsule Millipore Express® SHR Membrane - C5CA74760
      Opticap® XL 150 Capsule Millipore Express® SHc Membrane - C4MA10621

      Ficha técnica

      Cargo
      Millipore Express® SHC Hydrophilic Filters

      Manuales del usuario

      Cargo
      Vmax Constant Pressure

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      Categorías

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