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KN12A3TTT1 Opticap® XLT 30" Polygard® CN 1.2 um 1.5" TC/TC 1/pk

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KN12A3TTT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKN12A3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT 30" Polygard® CN 1.2 um 1.5" TC/TC 1/pk
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Housing MaterialPolypropylene (PP)
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      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 Size1.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 165 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 Length30 in. (75 cm)
      Device Size30 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size1.2 µm
      Outlet Connection Diameter1-1/2 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
      Global Trade Item Number
      Catalogue Number GTIN
      KN12A3TTT1 04053252570865

      Documentation

      Certificates of Quality

      Title
      OPTICAP XLT 30 capsule Polygard CN media C4SB08710
      Opticap XLT 30 Capsule Polygard - CN Media - C0AB88223
      Opticap XLT 30 Capsule Polygard -CN Media C1PB60190
      Opticap XLT 30 Capsule Polygard -CN Media C7HA19537
      Opticap XLT 30 Capsule Polygard -CN Media C7PA80210
      Opticap XLT 30 Capsule Polygard -CN Media C5HB79008
      Opticap XLT 30 Capsule Polygard CN Media C0SB33746
      Opticap XLT 30 Capsule Polygard CN Media C3MB59372
      Opticap XLT 30 Capsule Polygard-CN Media C8JA94165
      Opticap XLT 30 Capsule Polygard-CN Media C9KA73163
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      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules