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KWLCA05FF1 Opticap® XL5 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWLCA05FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKWLCA05FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      Filter GradeLow Protein Binding 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® LPB
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size1.2 / 0.5 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 145 mg per capsule after a 2 L flush and 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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.28 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size1.2 / 0.5 µm
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Low Protein-Binding 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 ≥2 L
      Global Trade Item Number
      Catalogue Number GTIN
      KWLCA05FF1 04053252450679

      Documentation

      Opticap® XL5 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC MSDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Millgard LPB Media C0NB26110
      Opticap XL 5 Capsule Milligard LPB Media C7NA71195
      Opticap XL 5 Capsule Milligard LBP Media C7NA76963
      Opticap XL 5 Capsule Milligard LPB Media C8KA13425
      Opticap XL 5 Capsule Milligard LPB Media C7CA81576
      Opticap XL 5 Capsule Milligard LPB Media C0DB54036
      Opticap XL 5 Capsule Milligard LPB Media C0DB55333
      Opticap XL 5 Capsule Milligard LPB Media C7JA36235
      Opticap XL 5 Capsule Milligard LPB Media C7SA05041
      Opticap XL 5 Capsule Milligard LPB Media - C7HA16348
      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