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KHGEG015FF1 | Opticap® Gamma Compatible XL 150 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC/TC

KHGEG015FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKHGEG015FF1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 150 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHC
      SterilityGamma
      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≤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 Diameter3/4 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 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 ≥1 L

      Documentation

      Certificados de calidad

      Cargo
      Opticap XL 150 Capsule Millipore Express SHC Membrane
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4PA34352
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5MA54094
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3JA84021
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3KA90901
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3NA28526
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C3SA82434
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C4EA61886
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C6BA18496
      Opticap XL 150 Capsule Millipore Express SHC Membrane - C6EA61326
      Opticap XL 150 Capsule Millipore Express SHC Membrane - SL0605O073
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4JA91717
      Opticap XL 150 Capsule Millipore Express SHC Membrane C4SA52085
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5BA65906
      Opticap XL 150 Capsule Millipore Express SHC Membrane C5MA60333
      Opticap XL 150 Capsule Millipore Express SHC Membrane C6AA09084
      Opticap XL 150 Capsule Millipore Exprss SHC Membrane C4NA28969
      Opticap® XL 150 Capsule Millipore Express® Membrane - C4SA46590

      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® SHR