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KVGLS10TH1 | Opticap® Sterile XL10 Durapore® 0.22 µm TC/HB

KVGLS10TH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGLS10TH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterile XL10 Durapore® 0.22 µm TC/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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
      MediaDurapore®
      SterilitySterile
      Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤14 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      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 Durapore® membrane 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)
      Length33.3 cm (13.1 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.73 m²
      Inlet to Outlet Width33.3 cm (13.1 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable 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 ≥1 L

      Documentation

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Durapore Membrane C6HA71618
      Opticap XL 10 Capsule Durapore Membrane C6PA36324
      Opticap XL 10 Capsule Durapore Membrane - C3BA52095
      Opticap XL 10 Capsule Durapore Membrane - C3CA88872
      Opticap XL 10 Capsule Durapore Membrane - C3HA39923
      Opticap XL 10 Capsule Durapore Membrane - C4AA97154
      Opticap XL 10 Capsule Durapore Membrane - C6AA05270
      Opticap XL 10 Capsule Durapore Membrane C5KA44139
      Opticap XL 10 Capsule Durapore Membrane C5SA97814
      Opticap XL 10 Capsule Durapore Membrane C6DA50647
      Opticap XL 10 Capsule Durapore Membrane C6EA60112
      Opticap XL 10 Capsule Durapore Membrane C6JA89239
      Opticap XL 10 Capsule Durapore Membrane C6NA24784
      Opticap XL 10 Cpasule Durapore Membrane - C6AA08404
      Opticap® XL 10 Capsule Durapore® Membrane C5NA74296
      Opticap® XL 10 Capsule Durapore® Membrane C5PA86725
      Opticap® XL 10 Capsule Durapore® Membrane C6BA18063
      Opticap® XL 10 Capsule Durapore® Membrane C6BA21855
      Opticap® XL 10 Capsule Durapore® Membrane - C5DA92952
      Opticap® XL 10 Capsule Durapore® Membrane - C5EA08706
      Sterile Opticap XL 10 Capsule Filter with Hydrophilic Durapore Membrane - C2DA04995

      Data Sheet

      Title
      Sterile and Gamma Compatible Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Filters
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters