HVAC and Cleanroom Qualification Checklist

Design and Classification

Confirm the design basis and grade.

• Is each room assigned an air cleanliness grade (A/B/C/D) or ISO class appropriate to the operations performed? *
• Is airborne particle classification performed at rest and in operation per ISO 14644-1? *
• Are HEPA filters installed, tested for integrity, and leak-tested in place? *
• Record the design air change rate per hour for the critical area.

Pressure Cascade and Airflow

• Is a documented pressure cascade maintained between adjacent rooms of differing grades (typically 10-15 Pa)? *
• Are airflow visualization (smoke) studies performed for Grade A and unidirectional flow zones? *
• Is air velocity at the working position verified for unidirectional airflow? *
• Are room recovery times measured to confirm restoration of classification? *

Environmental Parameters

• Are temperature and relative humidity controlled and verified against defined limits? *
• Is microbial monitoring (settle plates, active air, surface) integrated with qualification? *

Requalification and Monitoring

• Is periodic requalification scheduled per the required frequency for each grade? *
• Is a continuous monitoring program in place for Grade A and Grade B viable and non-viable particles? *
• Are HVAC changes managed through change control with impact assessment on classification? *