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SMP8A25NB6 OptiScale® 25 Milligard PES 1.2/0.8 µm NB

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SMP8A25NB6
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      Overview

      Replacement Information
      Description
      Catalogue NumberSMP8A25NB6
      Trade Name
      • OptiScale®
      DescriptionOptiScale® 25 Milligard PES 1.2/0.8 µm NB
      References
      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
      Applications
      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)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size6
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalog Number GTIN
      SMP8A25NB6 04054839564413

      Documentation

      Certificates of Quality

      Title
      OptiScale 25 Capsule Millgard PES Membrane C2CB54394
      OptiScale 25 Capsule Milligard PES Membrane C0AB93511
      OptiScale 25 Capsule Milligard PES Membrane C0MB15330
      OptiScale 25 Capsule Milligard PES Membrane C1BB12945
      OptiScale 25 Capsule Milligard PES Membrane C1EB02389
      OptiScale 25 Capsule Milligard PES Membrane C1NB77909
      OptiScale 25 Capsule Milligard PES Membrane C9SA42305
      OptiScale 25 Capsule Milligard PES Membrane - C0AB89540
      OptiScale 25 Capsule Milligard PES Membrane - C8HA81561
      OptiScale 25 Capsule Milligard PES Membrane - C8MA27235

      Technical Info

      Title
      Bioburden Reduction and Particulate Retention Using Milligard®PES Filters
      How Membrane Prefilters Enhance Bioprocessing Efficiency
      Processing mAb streams - How a bioburden reduction filter can improve process efficiency

      User Guides

      Title
      User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules
      User Guide - Filters with Milligard®PES Membrane

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