Enkonduko:
A HEPA filter is defined as a filter capable of capturing **≥99.97% of particles ≥0.3 μm** in size. It serves as the terminal filtration device in pharmaceutical cleanrooms to supply purified air. The ability of a cleanroom to achieve and maintain its designated cleanliness classification depends on the performance and proper installation of HEPA filters. Therefore, conducting integrity testing (leak testing) on HEPA filters is a critical measure to ensure compliance with standards and sustain a controlled clean environment.
The FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) specifies that leak testing must be performed post-installation to verify the integrity of seals, including gaskets, frames, and filter media. For aseptic manufacturing facilities, periodic integrity testing of HEPA filters is mandatory.
Application:
Pharmaceutical Industry
Used in sterile workshops, Grade A clean zones (e.g., filling lines), raw material preparation, and other processes to prevent cross-contamination.
Electronics & Optics
Ensures ultra-clean environmental standards for semiconductor manufacturing and precision instrument assembly.
Food & Chemical Engineering
Dust control in food processing workshops; explosion prevention and hazardous gas management in chemical production.
Healthcare & Laboratories
Air purification systems for operating rooms, ICU wards, and biosafety laboratories.
