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KHGLS10FH1 Sterile Multilayer Durapore® Opticap® XL 10 in. 0.45 / 0.22 µm

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGLS10FH1
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      概述

      Replacement Information
      Description
      Catalogue NumberKHGLS10FH1
      Trade Name
      • Opticap®
      DescriptionSterile Multilayer Durapore® Opticap® XL 10 in. 0.45 / 0.22 µm
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/OutletSanitary Flange/Hose Barb
      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
      MediaMultilayer Durapore®
      SterilitySterile
      Sterilization3 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 ConnectionHose Barb
      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)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      产品目录编号 GTIN
      KHGLS10FH1 04053252379482

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