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KW19A3THH1 Opticap® XLT30 Milligard® 1.2 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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KW19A3THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKW19A3THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT30 Milligard® 1.2 µm 5/8 in. HB/HB
      References
      Product Information
      FormatSingle 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 Size1.2 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 Area2.4 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Nominal Pore Size1.2 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
      Catalogue Number GTIN
      KW19A3THH1 04053252391118

      Documentation

      Opticap® XLT30 Milligard® 1.2 µm 5/8 in. HB/HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Milligard Media C1HB07970
      Opticap XLT 30 Capsule Milligard Media C3KB51613
      Opticap XLT 30 Capsule Milligard Media C7DA95235
      Opticap XLT 30 Capsule Milligard Media C7JA31836
      Opticap XLT 30 Capsule Milligard Media C7PA89831
      Opticap XLT 30 Capsule Milligard Media C8BA08760
      Opticap XLT 30 Capsule Milligard Media C8DA32356
      Opticap XLT 30 Capsule Milligard Media - C9CA03199
      Opticap XLT 30 Capsule Milligard Media - C9SA82239
      Opticap XLT 30 Capsule Milligard Media C0MB13640
      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