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KHGLA10FF1 Opticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGLA10FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKHGLA10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC
      References
      Product Information
      HS Code8421 22 00
      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: 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®
      SterilityOther
      Sterilization3 autoclave cycles of 60 min @ 126 °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≤10.8 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 Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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
      KHGLA10FF1 04053252453182

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Operational Excellence Dossier

      Title

      Opticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7JA41684
      Opticap XL 10 Capsule Multilayer Durapore Membrane C0DB63318Z
      Opticap XL 10 Capsule Multilayer Durapore Membrane C1BB07719
      Opticap XL 10 Capsule Multilayer Durapore Membrane C3JB30028
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7EA11611
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7HA23486
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7KA50240
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7NA78734
      Opticap XL 10 Capsule Multilayer Durapore Membrane C8KA19555
      Opticap XL 10 Capsule Multilayer Durapore Membrane C9PA13403
      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
      Wetting Instructions for Filter Units with Durapore Membrane