Area Qualification

How a newly built area is qualified?

General sequence:

  1. Visual inspection- Civil (floor, coving, ceiling,door,wall, view glass), electrical-flame proof, phase connection, fire extinguisher-smoke detector, saftey-(exit plan, announciation panel) and utelities requirement-type Water, compressed air, nitrogen etc. as per the equipment, process and CGMP requirement.
  2. HVAC system qualification and certification (Temp, RH, DP, air-balancing, leak test, smoke studies, recovery study, air changes per hour, air velocity, non-viable particle monitoring)
  3. Temperature, RH, DP monitoring trend analysis.
  4. Fumigation & defumigation
  5. Environmental monitoring-Viable 15 days.
  6. Area qualification report and release.