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SMP8A25NB6 OptiScale® 25 Milligard PES 1.2/0.8 µm NB

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SMP8A25NB6
6  
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      Overview

      Description
      Catalogue NumberSMP8A25NB6
      Trade Name
      • OptiScale®
      DescriptionOptiScale® 25 Milligard PES 1.2/0.8 µm NB
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
      Maximum Inlet Pressure, bar (psi)60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
      Cartridge CodeNot Applicable
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      MediaMilligard® PES
      SterilizationCapsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size1.2 / 0.8 µm
      Inlet ConnectionFemale Luer Lok
      Outlet ConnectionMale Luer Lok
      Maximum Differential PressureForward: 4.14 bar (60 psi) at 25 °C
      Reverse: 0 bar
      Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
      Non-Particle ReleasingThis product was tested and passes the USP test for particulates in injectables.
      Dimensions
      Length3.9 cm (1.52 in.)
      Diameter3.1 cm (1.2 in.)
      Filtration Area3.5 cm²
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Packaging Information
      Material Size6
      Global Trade Item Number
      Catalogue Number GTIN
      SMP8A25NB6 04054839564413