Cleanroom Qualification

What We Do ?

Pharma Active offers a full suite of cleanroom qualification services designed to ensure compliance with international regulatory standards as per area classification, including GMP, ISO 14644, and FDA guidelines

Our Expertise

Our qualifications cover environmental and functional parameters essential for maintaining controlled area integrity including non-viable, temperature and humidity control, differential pressure between classified zones, air velocity, air volume, and the calculation of air changes per hour (ACH), smoke tests and HEPA filter integrity testing

Accuracy & Compliance

All testing is conducted using calibrated, validated instruments, fully supported by comprehensive documentation, including protocols, test reports, and deviation handling where applicable.

AHU and HVAC System

  • Includes HEPA filter integrity testing (PAO), air balancing, air volume (grills and ductwork), air velocity, air changes per hour (ACH), and smoke testing (airflow visualization) considering fresh air if available.

Utility and Equipment Performance Testing

  • Includes quality testing for compressed air (H₂O, CO, CO₂, NO₂, SO₂, oil content), water, hot water, steam, gases.

Differential Pressure Measurements

  • Differential pressure between adjacent areas

Light and Noise Measurements

  • Light intensity, noise levels for clean rooms

Temperature and Humidity Measurements

  • Temperature, humidity measurements for clean rooms

Particle Count

  • Particle count monitoring

Pharma Active ensures that cleanroom environments meet the highest standards of performance, safety, and regulatory readiness.