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KHVEG1TTB1H Gamma Compatible High Area Opticap® XLT 10 Millipore Express® SHR with prefilter 0.5 µm/0.1 µm 1-1/2 in. TC-1 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHVEG1TTB1H
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKHVEG1TTB1H
      Trade Name
      • Millipore Express®
      DescriptionGamma Compatible High Area Opticap® XLT 10 Millipore Express® SHR with prefilter 0.5 µm/0.1 µm 1-1/2 in. TC-1 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/25 mm (1 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 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 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.
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Key Applications
      • Laboratory Filtration
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      SterilityNon-sterile, Gamma compatible
      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 ConnectionHose Barb
      Air Diffusion at 23 °C≤54.2 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
      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 20 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      Dimensions
      Cartridge Nominal Length10 in (25 cm)
      Length37.6 cm (14.8 in)
      Diameter10.7 cm (4.2 in)
      Filtration Area10000 cm²
      Inlet to Outlet Width17.5 cm (6.9 in)
      Device Size10 in.
      Inlet Connection Diameter1.5 in
      Outlet Connection Diameter1 in
      Materials Information
      Chemistry
      • Hydrophilic 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 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 ≥2 L
      Global Trade Item Number
      Catalogue Number GTIN
      KHVEG1TTB1H 04054839167904

      Documentation

      Material Qualification Dossier

      TitleVersion
      6.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C0HB84298
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C1DB75074
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C3CB99955
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C9MA85896
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C9PA16894
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area Membrane C2MB10108
      Opticap XLT 10 Capsule Millipore Express SHR w/Prefilter High Area membrane C1KB36463
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter High Area Membrane C7NA18439

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Cell Culture Media Microfiltration and Mixing: Reducing Risk with Single-use Technology
      Mycoplasma clearance by Millipore Express SHR filters at pilot and production scales
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      Data Sheet

      Title
      Millipore Express®SHR Hydrophilic Filters

      User Guides

      Title
      User Guide - Filters with Millipore Express®Membrane