Never Apply Pressure to HEPA Filters During Cleaning in GMP Facilities

Never Apply Pressure to HEPA Filters During Cleaning Activities

Remember: Applying pressure or physical contact with HEPA filters damages them and undermines GMP cleanroom contamination control.

Why This Matters in GMP

HEPA filters are critical in maintaining cleanroom classifications by removing 99.97% of particles ≥0.3 microns from the air. Applying pressure during cleaning can compromise the filter’s delicate pleats or aluminum frame, creating micro-leaks or structural deformities that allow particles to bypass filtration. Damaged HEPA filters reduce cleanroom efficiency and can lead to uncontrolled particle counts or microbial contamination. GMP demands validated and gentle cleaning practices to ensure filter integrity. Maintaining HEPA function is essential in sterile areas, where airborne contamination poses serious product safety risks.

Also Read: Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

Regulatory and Compliance Implications

EU GMP Annex 1 and FDA 21 CFR Part 211.42 require proper maintenance of air filtration systems. WHO GMP and Schedule M stress periodic inspection and qualification of HVAC and HEPA systems. Auditors check HVAC maintenance logs, HEPA integrity test reports, and SOPs related to cleaning procedures. Damaging HEPA filters during cleaning may result in contamination incidents, batch failure, and regulatory citations. Maintaining filter integrity through non-contact methods demonstrates control over facility cleanliness and environmental monitoring.

Implementation Best Practices

Use HEPA-safe tools like low-velocity vacuum cleaners with soft nozzles for surface dust removal.
Do not touch HEPA filter face or prefilters directly with hands or abrasive materials.
Instruct cleaning staff to avoid spraying disinfectants directly onto HEPA surfaces.
Conduct periodic integrity tests (smoke challenge or DOP/PAO) as per qualification schedule.
Include filter cleaning methods and precautions in HVAC SOPs and cleaning protocols.

Also Read: How to Leverage PMDA GMP to Enhance Drug Safety in Japan

Regulatory References

FDA 21 CFR Part 211.42 – Design and Construction Features
EU GMP Annex 1 – Air Filtration Systems
WHO GMP – Cleanroom HVAC and HEPA Guidelines
Schedule M – HEPA Filter Maintenance and Validation