Pharmaceutical Grade Hydrophobic PTFE Pleated Filter Cartridge | Sterilizing Grade, FDA Compliant

Our sterilizing-grade hydrophobic PTFE pleated filter cartridge is engineered for critical pharmaceutical applications requiring absolute bacterial retention (>99.99% efficiency at 0.1μm). Compliant with FDA 21 CFR Part 211 and EU GMP Annex 1, it ensures bioburden-free processes in sterile water systems, fermentation, and aseptic filling.

✅ Zero Risk of Microbial Contamination

Hydrophobic PTFE membrane repels water while allowing gas/vent filtration, preventing biofilm formation.
✅ Validated for Sterilizing Grade
Passes ASTM F838-15 bacterial challenge tests, supporting integrity testing (e.g., bubble point, diffusion flow).
✅ Customizable Solutions
Available in 5″, 10″, 20″, 30″ lengths with options for single/double open ends, 316L housings, and validation documentation.

✅ Global Compliance
Certifications: ISO 90001, USP Class VI, FDA on file.