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CTGB01TP3 Aerex CTGB Cartridge Filter 10 in. 0.2 µm Code 0

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CTGB01TP3
3  Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCTGB01TP3
      Trade Name
      • Aerex®
      DescriptionAerex CTGB Cartridge Filter 10 in. 0.2 µm Code 0
      References
      Product Information
      HS Code8421 99 99
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 145 °C. Reverse: 5.2 bar (75 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 145 °C; Reverse - 5.2 bar (75 psi) @ 25 °C
      Cartridge CodeCode 0 (2-222) O-rings
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaAerex®
      Sterilization200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °C
      Bacterial Grow-ThroughThe membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 10⁷ CFU/cm².
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.2 µm
      Bubble Point at 23 °C≥900 mbar (13 psig) nitrogen with 60/40 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig)
      Nitrogen Diffusion at 23 °C≤15 mL/min @ 690 mbar (10 psig) in 60/40 % IPA/water
      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 RetentionThis product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C.
      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)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.65 m²
      Device Size10 in.
      Materials Information
      Chemistry
      • Polytetrafluoroethylene (PTFE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageEasy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      CTGB01TP3 04053252494956

      Documentation

      Certificates of Quality

      Title
      AEREX CARTRIDGE C3EB16434
      AEREX CARTRIDGE C3MB59839
      AEREX CARTRIDGE C4HB43416
      Aerex Cartidge C8JA97161
      Aerex Cartridge C0CB48104
      Aerex Cartridge C7NA78018
      Aerex Cartridge C0BB36004
      Aerex Cartridge C1JB25922
      Aerex Cartridge C8MA22473
      Aerex Cartridge C9CA00549

      Data Sheet

      Title
      Aerex®Cartridge Filters

      FAQ

      QuestionAnswer
      What is the difference between Aerex and Aervent?Aervent cartridges have a 0.2µ PTFE membrane and are used in pharmaceutical applications where it is critical to use a phobic filter that has proven bacterial and viral retention capabilities. Common applications for Aervent are fermentation air applications, bioreactor inlet and outlet filtration and sterile process gases. Aervent filters have a liquid bacterial retention claim as well as a virus aerosol retention claim.

      Aerex filters also have a 0.2µ PTFE membrane but they do not come with a liquid bacterial retention claim. Common applications for Aerex include bulk intermediate manufacturing and non-pharamaceutical applications such as industrial fermentation. Aerex filters do have a virus aerosol retention claim.