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CTGB01TP3 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.
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
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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.