What is HEPA Filter?
High-Efficiency Particulate Air filter: removes at least 99.97% of airborne particles 0.3 microns or larger. Essential for maintaining ISO classified cleanroom environments.
HEPA filtration is what makes ISO-classified air possible: primary engineering controls bathe the critical site in HEPA-filtered first air, and cleanroom HVAC supplies HEPA-filtered air at the exchange rates the classification requires.
Filters and the controls that house them must be certified periodically (typically every six months for PECs) including integrity (leak) testing. Certification records, airflow measurements, and any repairs are standard inspection requests.
See how CompliRx handles this in practice:
Environmental monitoring softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.