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KHGES003FB3 | Opticap® Sterile XL 300 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC-9/16 in. HB with Bell

KHGES003FB3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHGES003FB3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Sterile XL 300 Millipore Express® SHC 0.5/0.2 µm 3/4 in. TC-9/16 in. HB with Bell
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange / 14 mm (9/16 in.) Hose Barb with Filling Bell
      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 with Bell
      Air Diffusion at 23 °C≤1.9 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 2.0 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 Length4.7 in. (11.9 cm)
      Length11.9 cm (4.7 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area290 cm²
      Inlet to Outlet Width11.9 cm (4.7 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

      Certificates of Quality

      Title
      Opticap XL 300 Capsule MIllipore Express SHC Membr
      Opticap XL 300 Capsule Millipore Express SHC Membr
      Opticap XL 300 Capsule Millipore Express SHC Membrane - C3HA70331
      Opticap XL 300 Capsule Millipore Express SHC Membrane - C4AA96666
      Opticap XL 300 Capsule Millipore Express SHC Membrane - C4DA53447
      Opticap XL 300 Capsule Millipore Express SHC Membrane - C4EA62800
      Opticap XL 300 Capsule Millipore Express SHC Membrane C4NA29033
      Opticap XL 300 Capsule Millipore Express SHC Membrane C5MA58435
      Opticap XL 300 Capsule Millipore Express SHC Membrane C6BA24707
      Opticap XL 300 Capsule Millipore Express SHC Membrane C6KA06163
      Opticap XL 300 Capsule Millipore Express SHC Membrane C6NA18383
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane C5KA53584
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane C6CA35178
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane C6EA60898
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane C6HA79593
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane - C4MA10013
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane - C4MA18929
      Opticap® XL 300 Capsule Millipore Express® SHC Membrane - C4PA33336
      Opticap® XL 3000 Capsule Millipore Express® SHC Membrane - C5DA92731

      Data Sheet

      Title
      Millipore Express® SHC Hydrophilic Filters

      User Guides

      Title
      Vmax Constant Pressure

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      Categories

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