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KWSSA3THH1 Opticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWSSA3THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKWSSA3THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
      Filter GradeStandard Milligard® Media
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      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
      MediaMilligard®
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size0.5 / 0.2 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      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
      Non-Fiber ReleasingThis product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      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)
      Length87.1 cm (34.3 in.)
      Filtration Area2.07 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Nominal Pore Size0.5 / 0.2 µm
      Outlet Connection Diameter5/8 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      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 ≥15 L
      Global Trade Item Number
      Catalog Number GTIN
      KWSSA3THH1 04053252654923

      Documentation

      Opticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Durapore Membrane C0EB65799
      Opticap XLT 30 Capsule Milligard Media C7NA80267
      Opticap XLT 30 Capsule Milligard Media C8EA44456
      Opticap XLT 30 Capsule Milligard Media C1DB92940
      Opticap XLT 30 Capsule Milligard Media C8CA08761
      Opticap XLT 30 Capsule Milligard Media C8JA58535
      Opticap XLT 30 Capsule Milligard Media C8KA12186
      Opticap XLT 30 Capsule Milligard Media C8KA87891
      Opticap XLT 30 Capsule Milligard Media C9AA59823
      Opticap XLT 30 Capsule Milligard Media C9CA70264
      Show more

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard