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KGW6A02FH3 | Opticap® XL2 Polysep® II 1.0/0.5 µm 3/4 in. TC-9/16 in. HB

KGW6A02FH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGW6A02FH3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL2 Polysep® II 1.0/0.5 µm 3/4 in. TC-9/16 in. HB
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
      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.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolysep™ II
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 45 mg per capsule after a 600 mL 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 Length2 in. (5 cm)
      Length14.2 cm (5.6 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.06 m²
      Inlet to Outlet Width14.2 cm (5.6 in.)
      Device Size2 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size1.0 / 0.5 µm
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 2 Capsule Polysep II Media
      Opticap XL 2 Capsule Polysep II Media C5NA66678
      Opticap XL 2 Capsule Polysep II Media - C4DA48989
      Opticap XL 2 Capsule Polysep II Media - SAMPLE1507
      Opticap XL 2 Capsule Polysep II Media C4KA95879
      Opticap XL 2 Capsule Polysep II Media C4NA25529
      Opticap XL 2 Capsule Polysep II Media C5AA52961
      Opticap XL 2 Capsule Polysep II Media C5EA15790
      Opticap® XL 2 Capsule Polysep™ II Media - C5DA95152
      Opticap® XL 2 Capsule Polysep™ II Media - C3MA26755