KTGRA05TT1 Aervent KTGR Opticap XL5 Capsule

KTGRA05TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKTGRA05TT1
      Trade Name
      • Aervent®
      DescriptionAervent KTGR Opticap XL5 Capsule
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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), intermittent
      Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C; Reverse - 4.1 bar (60 psi), Intermittent
      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.
      Applications
      Biological Information
      MediaAervent®
      Sterilization30 autoclave cycles of 30 min @ 135 °C
      Bacterial Grow-ThroughRetains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²
      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 28 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.38 mL/min @ 2.6 bar (38 psig) per sample
      Nitrogen Diffusion at 23 °C≤12 mL/min @ 970 mbar (14 psig) in 70/30 % IPA/water
      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).
      Virus Aerosol RetentionRated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.
      USP Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      Dimensions
      Cartridge Nominal Length5 in. (13 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.32 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 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 Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications

      Documentation

      Aervent KTGR Opticap XL5 Capsule SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      KTRGA05TT1 - C3AA46552
      Opticap XL 5 Caosule Aervent Membrane C8CA13071
      Opticap XL 5 Capsule Aervent Membrane
      Opticap XL 5 Capsule Aervent Membrane
      Opticap XL 5 Capsule Aervent Membrane C6PA40529
      Opticap XL 5 Capsule Aervent Membrane C6BA77360
      Opticap XL 5 Capsule Aervent Membrane C6HA67361
      Opticap XL 5 Capsule Aervent Membrane C7BA65179
      Opticap XL 5 Capsule Aervent Membrane C7HA11627
      Opticap XL 5 Capsule Aervent Membrane C7JA48365

      Technical Info

      Title
      Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Bubble Point Test Method Using Aervent 0.2 µm Hydrophobic Membrane with 60/40 IPA
      Filter Integrity Test Methods

      Data Sheet

      Title
      Solvex Solvent Filtration Cartridge Filters (MilliporeSigma)

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Categories

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