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KWSCA05HH1 | Opticap® XL5 Milligard® 1.2/0.5 µm 9/16 in. HB/HB

KWSCA05HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKWSCA05HH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Milligard® 1.2/0.5 µm 9/16 in. HB/HB
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 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.
      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 ConnectionHose Barb
      Outlet ConnectionHose Barb
      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 Area0.28 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size1.2 / 0.5 µm
      Outlet Connection Diameter9/16 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 Milligard Media
      Opticap XL 5 Capsule Milligard Media - C3EA09040
      Opticap XL 5 Capsule Milligard Media - C3JA81090
      Opticap XL 5 Capsule Milligard Media - C3PA70162
      Opticap XL 5 Capsule Milligard Media - C6NA26733
      Opticap XL 5 Capsule Milligard Media C4MA08494
      Opticap XL 5 Capsule Milligard Media C4NA21139
      Opticap XL 5 Capsule Milligard Media C5CA74803
      Opticap XL 5 Capsule Milligard Media C5DA03925
      Opticap XL 5 Capsule Milligard Media C5JA31246
      Opticap XL 5 Capsule Milligard Media C5NA66681
      Opticap XL 5 Capsule Milligard Media C5NA79118
      Opticap XL 5 Capsule Milligard Media C5SA88258
      Opticap XL 5 Capsule Milligard Media C6CA27386
      Opticap XL 5 Capsule Milligard Media C6DA50752
      Opticap XL 5 Capsule Milligard Media C6KA99413
      Opticap XL 5 Capsule Milligard Media C6NA27282
      Opticap XL Capsule Filter with Milligard Media - C0AA90669
      Opticap XL Capsule Filter with Milligard Media - C0BA92668
      Opticap XL Capsule Filter with Milligard Media - C0BA92672
      Opticap XL Capsule Filter with Milligard Media - C1KA14406
      Opticap XL Capsule Filter with Milligard Media - C2EA15059
      Opticap® XL 5 Capsule Milligard® Media - C4CA33663
      Opticap® XL 5 Capsule Milligard® Media - C4KA07133
      Opticap® XL 5 Capsule Milligard® Media - C4PA30182
      Opticap® XL 5 Capsule Milligard® Media - C4SA42703
      Opticap® XL 5 Capsule Milligard® Media - C4SA49127
      Opticap® XL 5 Capsule Milligard® Media - C5DA95162
      Opticap® XL Capsule Filter with Milligard® Media - C1CA51754

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      Categories

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