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KWSCA2THH1 Opticap® XLT20 Milligard® 1.2/0.5 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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KWSCA2THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKWSCA2THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT20 Milligard® 1.2/0.5 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
      European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
      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 / 0.5 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 110 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 Length20 in. (50 cm)
      Length62.5 cm (24.6 in.)
      Filtration Area1.38 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size20 in.
      Inlet Connection Diameter5/8 in.
      Nominal Pore Size1.2 / 0.5 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 ≥10 L
      Global Trade Item Number
      Catalogue Number GTIN
      KWSCA2THH1 04053252563577

      Documentation

      Opticap® XLT20 Milligard® 1.2/0.5 µm 5/8 in. HB/HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      OPTICAP XLT 20 capsule Milligard media C3MB53532
      Opticap XLT 20 Capsule Milligard Media C7PA80271
      Opticap XL 20 Capsule Milligard Media C0SB33755
      Opticap XLT 20 Capsule Milligard Media C1JB34665
      Opticap XLT 20 Capsule Milligard Media C7SA04852
      Opticap XLT 20 Capsule Milligard Media C8CA10714
      Opticap XLT 20 Capsule Milligard Media C9AA81231
      Opticap XLT 20 Capsule Milligard Media C9KA73240
      Opticap XLT 20 Capsule Milligard Media - C0BB28666
      Opticap XLT 20 Capsule Milligard Media - C8KA87887
      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