Introduction:
Risk Assessment for Pressure differential not maintained in Classified Areas ensure unidirectional airflow, which prevents contaminants (particles, microbes, or dust) from migrating from lesser-classified or unclassified areas into critical clean zones. Regulatory guidelines, including those from EU GMP Annex 1, WHO TRS, and US FDA, require a minimum differential pressure—typically 10–15 Pascals—to be sustained between adjoining rooms to protect product integrity and maintain GMP compliance.
Failure to maintain pressure differentials may result from several causes, including:
- Malfunctioning AHUs (Air Handling Units) or VAV (Variable Air Volume) systems
- Door interlock failures or doors left open
- Damaged HEPA filters or duct leakage
- Inadequate facility design or balancing
- Incorrect monitoring, alarm settings, or delayed corrective actions
Risk assessment for Pressure differential not maintained in Classified Areas designed to systematically evaluate the causes, consequences, and controls related to the loss of pressure differential in classified areas. Using structured tools like 6M analysis (Man, Machine, Method, Material, Measurement, Milieu) and FMEA (Failure Mode and Effects Analysis), the assessment aims to:
- Identify failure modes in HVAC and facility controls
- Evaluate the impact on product, environment, and compliance
- Assess detection systems and response protocols
- Recommend preventive and corrective measures
- Strengthen environmental monitoring and alarm management practices