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KWSSA2THH1 | Opticap® XLT20 Milligard® 0.5/0.2 µm 5/8 in. HB/HB

KWSSA2THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKWSSA2THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT20 Milligard® 0.5/0.2 µm 5/8 in. HB/HB
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 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.
      T-line/Gauge PortT-line
      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 110 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 Length20 in. (50 cm)
      Length62.5 cm (24.6 in.)
      Filtration Area1.38 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size20 in.
      Inlet Connection Diameter5/8 in.
      Nominal Pore Size0.5 / 0.2 µm
      Outlet Connection Diameter5/8 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 ≥10 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 20 Capsule Milligard Media
      Opticap XLT 20 Capsule Milligard Media C6PA34428
      Opticap XLT 20 Capsule Milligard Media - C2NA70285
      Opticap XLT 20 Capsule Milligard Media - C2PA90132
      Opticap XLT 20 Capsule Milligard Media - C3DA02103
      Opticap XLT 20 Capsule Milligard Media - C3JA78309
      Opticap XLT 20 Capsule Milligard Media - C3JA80103
      Opticap XLT 20 Capsule Milligard Media - C3PA75616
      Opticap XLT 20 Capsule Milligard Media - C4BA25236
      Opticap XLT 20 Capsule Milligard Media - C4CA38971
      Opticap XLT 20 Capsule Milligard Media - C6BA24716
      Opticap XLT 20 Capsule Milligard Media C4KA94010
      Opticap XLT 20 Capsule Milligard Media C4NA10676
      Opticap XLT 20 Capsule Milligard Media C4NA20452
      Opticap XLT 20 Capsule Milligard Media C5HA12496
      Opticap XLT 20 Capsule Milligard Media C6DA51875
      Opticap XLT Capsule Filter with Milligard Media - C0AA83925
      Opticap XLT Capsule Filter with Milligard Media - C0DA27414
      Opticap XLT Capsule Filter with Milligard Media - C0MA84715
      Opticap XLT Capsule Filter with Milligard Media - C0NA95314
      Opticap XLT Capsule Filter with Milligard Media - C1BA39001
      Opticap XLT Capsule Filter with Milligard Media - C1DA65545
      Opticap XLT Capsule Filter with Milligard Media - C1KA09594
      Opticap XLT Capsule Filter with Milligard Media - C1PA46415
      Opticap XLT Capsule Filter with Milligard Media - C2BA78114
      Opticap XLT Capsule Filter with Milligard Media - C2EA22199
      Opticap XLT Capsule Filter with Milligard Media - C2JA40983
      Opticap XLT Capsule Filter with Milligard Media - C2KA48460
      Opticap XLT Capsule Filter with Milligard Media - C2KA53995
      Opticap XLT Capsule Filter with Milligard Media - C2MA66146
      Opticap XLT Capsule Filter with Milligard Media - C9NN59529
      Opticap® XLT Capsule Filter with Milligard® Media - C1JA00431

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      Categories

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