KTGRA02FF3 | Opticap Sterilizing Grade XL2 Aervent 0.2 µm 3/4 in. TC/TC

KTGRA02FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Spec Table

      Description
      Catalogue NumberKTGRA02FF3
      ReplacesKTGR04FF3
      Trade Name
      • Opticap®
      DescriptionOpticap Sterilizing Grade XL2 Aervent 0.2 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: 4.1 bar (60 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
      MediaAervent®
      Sterilization30 autoclave cycles of 30 min @ 135 °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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.12 mL/min @ 2.6 bar (38 psig)
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a PTFE 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 Length5.3 in. (13.5 cm)
      Length13.5 cm (5.3 in.)
      Diameter8.4 cm (3.3 in.)
      Filtration Area0.1 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
      • Polytetrafluoroethylene (PTFE)
      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

      Documentation

      Certificates of Quality

      Title
      Opticap XL 2 Capsule Aervent Membrane C6SA48457
      Opticap XL 2 Capsule Aervent Membrane
      Opticap XL 2 Capsule Aervent Membrane
      Opticap XL 2 Capsule Aervent Membrane C7EA11620
      Opticap XL 2 Capsule Aervent Membrane C7MA62422
      Opticap XL 2 Capsule Aervent Membrane C4PA40814
      Opticap XL 2 Capsule Aervent Membrane C4SA46524
      Opticap XL 2 Capsule Aervent Membrane C5DA82568
      Opticap XL 2 Capsule Aervent Membrane C7EA14656
      Opticap XL 2 Capsule Aervent Membrane C7KA47744

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent