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KWSSA04TT3 Opticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWSSA04TT3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKWSSA04TT3
      ReplacesKWSS04TC3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      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.
      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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 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 Length4 in. (10 cm)
      Length19.6 cm (7.7 in.)
      Diameter12.5 cm (4.9 in.)
      Filtration Area0.16 m²
      Inlet to Outlet Width19.6 cm (7.7 in.)
      Device Size4 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size0.5 / 0.2 µm
      Outlet Connection Diameter1-1/2 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 Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
      Global Trade Item Number
      Catalog Number GTIN
      KWSSA04TT3 04053252572982

      Documentation

      Opticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      OPTICAP XL 4 Capsule Durapore Membrane C3HB26758
      Opticap XL 4 Capsule Milligaed Media C7JA39762
      Opticap XL 4 Capsule Milligard Media C7PA84013
      Opticap XL 4 Capsule Milligard Media C7SA05042
      Opticap XL 4 Capsule Milligard Media C7HA24922
      Opticap XL 4 Capsule Milligard Media C7HA24924
      Opticap XL 4 Capsule Milligard Media C7NA71571
      Opticap XL 4 Capsule Milligard Media C7NA76961
      Opticap XL 4 Capsule Milligard Media C7NA80279
      Opticap XL 4 Capsule Milligard Media C9KA69337
      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