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KW19A05TT1 | Opticap® XL5 Milligard® 1.2 µm 1-1/2 in. TC/TC

KW19A05TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKW19A05TT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Milligard® 1.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      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.
      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
      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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.34 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size1.2 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 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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Miligard Media C4JA76165
      Opticap XL 5 Capsule Milligard Media - C2NA74287
      Opticap XL 5 Capsule Milligard Media - C3CA77551
      Opticap XL 5 Capsule Milligard Media - C3KA91736
      Opticap XL 5 Capsule Milligard Media - C3PA66540
      Opticap XL 5 Capsule Milligard Media - C3SA83432
      Opticap XL 5 Capsule Milligard Media - C4BA22563
      Opticap XL 5 Capsule Milligard Media - C6CA28661
      Opticap XL 5 Capsule Milligard Media C4SA44844
      Opticap XL 5 Capsule Milligard Media C5BA62047
      Opticap XL 5 Capsule Milligard Media C5MA60326
      Opticap XL 5 Capsule Milligard Media C6MA09576
      Opticap XL 5 Capsule Milligard Media/C5CA82524
      Opticap XL Capsule Filter with Milligard Media - C0CA02710
      Opticap XL Capsule Filter with Milligard Media - C1CA49635
      Opticap XL Capsule Filter with Milligard Media - C1DA66902
      Opticap XL Capsule Filter with Milligard Media - C2AA75868
      Opticap XL Capsule Filter with Milligard Media - C2CA94547
      Opticap XL Capsule Filter with Milligard Media - C2JA35267

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      Categories

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