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KHVEG015HH3 Opticap® Gamma Compatible XL 150 Millipore Express® SHR with Prefilter 0.5/0.1 µm 9/16 in. HB/HB

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KHVEG015HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKHVEG015HH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 150 Millipore Express® SHR with Prefilter 0.5/0.1 µm 9/16 in. HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 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.
      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 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 ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤1.0 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 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.)
      Diameter10.9 cm (4.3 in.)
      Filtration Area200 cm²
      Inlet to Outlet Width9.7 cm (3.8 in.)
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 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

      Material Qualification Dossier

      TitleLot Number
      1.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane C7AA48596
      Opticap XL 150 Capsule Millipore Express Millipore SHR w/Prefilter Membrane C8BA29923
      Opticap XL 150 Capsule Millipore Express Millipore SHR w/Prefilter Membrane C8DA51957
      Opticap XL 150 Capsule Millipore Express SHF w/Prefilter Membrane - C7AA55327
      Opticap XL 150 Capsule Millipore Express SHR Membrane C0PB23971
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane C5JA22864
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane C9JA49797Y
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane - C8AA01155
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane - C8AA19254
      Opticap XL 150 Capsule Millipore Express SHR w/Prefilter Membrane - C8EA78896

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Performance of High-Area Millipore Express®Cartridge Filters
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules
      User Guide - Filters with Millipore Express®Membrane
      Vmax Constant Pressure