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

Aerex CTGB Cartridge Filter 10 in. 0.2 µm Code 0 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CTGB01TP3
3  Easy-Open bag
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      Overview

      Description
      Catalogue NumberCTGB01TP3
      Trade Name
      • Aerex®
      DescriptionAerex CTGB Cartridge Filter 10 in. 0.2 µm Code 0
      Product Information
      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
      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
      Packaging Information
      Material Size3
      Material PackageEasy-Open bag
      Global Trade Item Number
      Catalogue Number GTIN
      CTGB01TP3 04053252494956