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KHGLG10TT1 Opticap® Gamma Compatible Multilayer XL10 Durapore® 0.45/0.22 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGLG10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKHGLG10TT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Multilayer XL10 Durapore® 0.45/0.22 µm 1-1/2 in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)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
      MediaMultilayer Durapore®
      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 Size0.45 / 0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤15.0 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 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 Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Durapore® 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, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
      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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.55 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
      Support MaterialPolyester/Polyethylene
      Vent Cap MaterialPolypropylene (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 ≥1.5 L
      Global Trade Item Number
      Catalog Number GTIN
      KHGLG10TT1 04053252352249

      Documentation

      Material Qualification Dossier

      TitleVersion
      2.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      OPTICAP XL 10 Capsule Multilayer Durapore Membrane C3JB34732
      Opticap XL 10 Capsule Durapore Membrane C1SB09737
      Opticap XL 10 Capsule Multilayer C0EB60692Z
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7EA12182
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7EA18173
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7KA52918
      Opticap XL 10 Capsule Multilayer Durapore Membrane C8DA48030
      Opticap XL 10 Capsule Multilayer Durapore Membrane C8PA41316
      Opticap XL 10 Capsule Multilayer Durapore Membrane - C0AB23487Z
      Opticap XL 10 Capsule Multilayer Durapore Membrane - C7DA07296
      Show more

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules