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KVVLA02FF3 | Opticap® XL2 Durapore® 0.1 µm 3/4 in. TC/TC

KVVLA02FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVVLA02FF3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL2 Durapore® 0.1 µm 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      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; 1.0 bar (15 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®
      Sterilization3 autoclave cycles of 60 min @ 126 °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 Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤3.5 mL/min @ 3.9 bar (56 psig) in water
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 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 Length2 in. (5 cm)
      Length13.5 cm (5.3 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.09 m²
      Inlet to Outlet Width13.5 cm (5.3 in.)
      Device Size2 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      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 ≥500 mL

      Documentation

      Certificates of Quality

      Title
      Opticap XL 2 Capsule Durapore Membrane
      Opticap XL 2 Capsule Durapore Membrane
      Opticap XL 2 Capsule Durapore Membrane - C2PA09979
      Opticap XL 2 Capsule Durapore Membrane - C2SA22456
      Opticap XL 2 Capsule Durapore Membrane - C3BA38172
      Opticap XL 2 Capsule Durapore Membrane - C3CA79082
      Opticap XL 2 Capsule Durapore Membrane - C3NA59761
      Opticap XL 2 Capsule Durapore Membrane - C6MA84208
      Opticap XL 2 Capsule Durapore Membrane C5NA62493
      Opticap XL 2 Capsule Durapore Membrane C5PA82172
      Opticap XL 2 Capsule Durapore Membrane C6HA77345
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0EA34996
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1MA15710
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA20418
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2KA50845
      Opticap® XL 2 Capsule Durapore® Membrane C5NA73783
      Opticap® XL 2 Capsule Durapore® Membrane C5SA02684
      Opticap® XL 2 Capsule Durapore® Membrane - C4DA46586
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1PA41746
      Opticaqp XL 2 Capsule Durapore Membrane C6BA17002

      Data Sheet

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