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KHVEG006FF3 | Opticap® Gamma Compatible XL 600 Millipore Express® SHR with Prefilter 0.5/0.1 µm 3/4 in. TC/TC

KHVEG006FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHVEG006FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 600 Millipore Express® SHR with Prefilter 0.5/0.1 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® SHR w/Prefilter
      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 / 0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤3.7 mL/min @ 3.45 bar (50 psig) in water
      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 3.0 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 Length6.5 in. (16.5 cm)
      Length16.5 cm (6.5 in.)
      Diameter10.9 cm (4.3 in.)
      Filtration Area600 cm²
      Inlet to Outlet Width16.5 cm (6.5 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 MaterialPolyester
      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
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0BA94569
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0DA11424
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0JA61941
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0KA76921
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0PA14452
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0PA16475
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1HA93227
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1KA11083
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C2CA94812
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C2JA24855
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C9MN34697
      Gamma Opticap XL 600 Capsule Filter with Millipore express SHR Hydrophilic Membrane with Prefilter - C0AA91496
      Gamma opticap XL 600 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1HA62461
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5MA52203
      Opticap XL 600 Capsule Express SHR w/Prefilter Membrane C4NA25553
      Opticap XL 600 Capsule Millipore Express SHR w/ Prefilter Membrane/ C4MA07366
      Opticap XL 600 Capsule Millipore Express SHR w/Pre
      Opticap XL 600 Capsule Millipore Express SHR w/Pre
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C3PA66351
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C4CA42628
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C4DA51599
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C6AA98814
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C6JA84379
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - SL0607O065
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane C4JA83084
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane C5DA94500
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane C5JA34829
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter Membrane C5KA40630
      Opticap XL 600 Capsule Millipore Express SHR w/Prefilter membrane C4SA52093
      Opticap® XL 600 Capsule Millipore Express® SHR w/Prefilter Membrane - C3NA30719
      Opticap® XL 600 Capsule Millipore Express® SHR w/Prefilter Membrane - C5BA65535
      Opticap® XL 600 Capsule Millipore Express® SHR w/Prefilter Membrane - C5CA74002
      Opticap® XL 6000 Capsule Millipore Express® SHR w/Prefilter Membrane - C5CA79322
      Opticpa XL 600 Capsule Millipore Express SHR w/Prefilter Membrane - C4BA30172

      Technical Info

      Title
      Demonstrating Millipore Express® SHR mycoplasma clearance capability at pilot and production scale over an extended filtration time (EMD)
      Protect Your Process from Mycoplasma Contamination
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      User Guides

      Title
      Vmax Constant Pressure

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      Categories

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