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KWSCA10TT1 | Opticap® XL10 Milligard® 1.2/0.5 µm 1-1/2 in. TC/TC

KWSCA10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKWSCA10TT1
      ReplacesKWSC01TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Milligard® 1.2/0.5 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatDouble 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 55 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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size1.2 / 0.5 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 ≥5 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Milligard Media - C2NA70279
      Opticap XL 10 Capsule Milligard Media - C2NA91796
      Opticap XL 10 Capsule Milligard Media - C2PA07857
      Opticap XL 10 Capsule Milligard Media - C2PA95910
      Opticap XL 10 Capsule Milligard Media - C3KA95761
      Opticap XL 10 Capsule Milligard Media - C3SA83805
      Opticap XL 10 Capsule Milligard Media - C4AA95372
      Opticap XL 10 Capsule Milligard Media - C4EA58827
      Opticap XL 10 Capsule Milligard Media - C6CA31242
      Opticap XL 10 Capsule Milligard Media - C6DA41254
      Opticap XL 10 Capsule Milligard Media - SAMPLE1857
      Opticap XL 10 Capsule Milligard Media C4PA36505
      Opticap XL 10 Capsule Milligard Media C4PA37897
      Opticap XL 10 Capsule Milligard Media C4SA44799
      Opticap XL 10 Capsule Milligard Media C5AA56421
      Opticap XL 10 Capsule Milligard Media C5CA72892
      Opticap XL 10 Capsule Milligard Media C5HA19243
      Opticap XL 10 Capsule Milligard Media C5JA31253
      Opticap XL 10 Capsule Milligard Media C5NA54808
      Opticap XL 10 Capsule Milligard Media C5SA97099
      Opticap XL 10 Capsule Milligard Media C6NA13994
      Opticap XL 10 Capsule Milligard Media/C6JA89978
      Opticap XL 10 Capsule Millipore Media - C3JA81091
      Opticap XL Capsule Filter with Milligard Media - C0AA87362
      Opticap XL Capsule Filter with Milligard Media - C0CA00120
      Opticap XL Capsule Filter with Milligard Media - C0HA48116
      Opticap XL Capsule Filter with Milligard Media - C0MA82144
      Opticap XL Capsule Filter with Milligard Media - C1BA41778
      Opticap XL Capsule Filter with Milligard Media - C1CA55181
      Opticap XL Capsule Filter with Milligard Media - C1DA68539
      Opticap XL Capsule Filter with Milligard Media - C1NA36164
      Opticap XL Capsule Filter with Milligard Media - C2AA71903
      Opticap XL Capsule Filter with Milligard Media - C2DA11189
      Opticap XL Capsule Filter with Milligard Media - C2HA22117
      Opticap XL: 10 Capsule Milligard Media - C4BA18796
      Opticap® SL Capsule Filter with Milligard® Media - C1HA94269
      Opticap® XL 10 Capsule MIlligard® Media - C4BA26954
      Opticap® XL 10 Capsule Milligard® Media - C3AA37890
      Opticap® XL 10 Capsule Milligard® Media - C4CA41412
      Opticap® XL 10 Capsule Milligard® Media - C4KA08489
      Opticap® XL 10 Capsule Milligard® Media - C5DA95159
      Opticap® XL 10 Capsule Milligard® Media - C5EA04524
      Opticap® XL Capsule Filter with Milligard® Media - C1PA43653
      Opticap® XL Capsule Filter with Milligard® Media - C2MA62089

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      Categories

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