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KN03A10HH1 Opticap® XL10 Polygard®-CN 0.3 µm 9/16 in. HB/HB

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KN03A10HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKN03A10HH1
      ReplacesKN0301HB1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Polygard®-CN 0.3 µm 9/16 in. HB/HB
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)4.8 bar (70 psid) @ 20 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolygard®-CN
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size0.3 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature.
      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
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 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 Area0.42 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size0.3 µm
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polypropylene (PP)
      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 ≥5 L
      Global Trade Item Number
      Catalogue Number GTIN
      KN03A10HH1 04053252567650

      Documentation

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Polygard CN Media C3CB98830
      Opticap XL 10 Capsule Polygard - CN Media - C0BB98985
      Opticap XL 10 Capsule Polygard -CN Media C7CA77571
      Opticap XL 10 Capsule Polygard -CN Media C9HA50234
      Opticap XL 10 Capsule Polygard -CN Media C2PB36438
      Opticap XL 10 Capsule Polygard -CN Media C4KB69015
      Opticap XL 10 Capsule Polygard -CN Media C4NB02366
      Opticap XL 10 Capsule Polygard -CN Media C7KA28947
      Opticap XL 10 Capsule Polygard -CN Media C8JA93918
      Opticap XL 10 Capsule Polygard CN Media C7NA57122
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      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules