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KR10A05HH1 Opticap® XL5 Polygard®-CR 10.0 µm 9/16 in. HB/HB

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KR10A05HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKR10A05HH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Polygard®-CR 10.0 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®-CR
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size10.0 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 30 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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size10.0 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 ≥2.5 L
      Global Trade Item Number
      Catalog Number GTIN
      KR10A05HH1 04053252574214

      Documentation

      Opticap® XL5 Polygard®-CR 10.0 µm 9/16 in. HB/HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Polygard - CR Media C7HA18743
      Opticap XL 5 Capsule Polygard - CR Media - C9CA94361
      Opticap XL 5 Capsule Polygard -CR Media C0DB61182
      Opticap XL 5 Capsule Polygard -CR Media C1KB51445
      Opticap XL 5 Capsule Polygard -CR Media C2KB00152
      Opticap XL 5 Capsule Polygard -CR Media C8HA84747
      Opticap XL 5 Capsule Polygard CR Media C3BB96780
      Opticap XL 5 Capsule Polygard-CN Media C3HB27498
      Opticap XL 5 Capsule Polygard-CR Media C7CA77574
      Opticap XL 5 Capsule Polygard-CR Media C7SA85213

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Depth Filter based > Polygard CR
      Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters > Polygard CR