FAQ - Pharmaceutical/Life Sciences Particle Counting

Question
Specifically, what is the number of leak tests per year, velocity, cleanliness, and other items required for HVAC Systems?

Answer

GMP is linked to ISO14644 for certification purposes. Therefore:

Particle counting - ISO5 = 12 months

Airflow Volume & Velocity = 12 months

Air Pressure = 12 Months

Filter Leakage = 24 months

Airflow Visualisation = 24 Months

Room Recovery = 24 months

Containment leakage = 24 months