Fogging Validation ensures that aerosolized disinfectants effectively reduce microbial contamination in cleanrooms, controlled environments, warehouses, dispensing areas, and high-risk zones. PrimeGMP provides comprehensive fogging validation services to verify disinfectant efficacy, droplet distribution, exposure time, and compatibility with facility surfaces and HVAC systems.

Objective of Fogging Validation

• Demonstrate the effectiveness of aerosolized disinfectants in microbial reduction
• Establish validated concentration, contact time, and exposure period
• Confirm uniform distribution of fog across the cleanroom
• Evaluate compatibility of disinfectant with facility materials
• Support contamination control and aseptic assurance strategy
• Strengthen environmental control for Grades A/B/C/D areas

Scope

Fogging validation is performed for:

• Cleanrooms & controlled environments
• Sterile manufacturing suites (background & critical areas)
• Warehouses & material storage zones
• Garment rooms, CNC areas, sampling & dispensing rooms
• Post-maintenance recovery and bioburden control

Fogging Validation Methodology

1. Pre-Validation Assessment

• Review disinfectant type, formulation, and recommended fogging method
• Assessment of room volume, HVAC status, and leak tightness
• Identification of critical, worst-case, and high-risk areas
• Verification of equipment, nozzles, and droplet generation systems

2. Preparation & Safety Controls

• Verification of correct disinfectant dilution
• Calibration of fogging equipment
• Ensuring area closure, signage, and personnel evacuation
• Environmental monitoring baseline sampling (optional)
• Review of PPE, ventilation control, and safety measures

3. Fogging Distribution Study

• Placement of settle plates, contact plates, or agar coupons to capture disinfectant exposure
• Fog dispersion monitoring at high, mid, and low levels
• Visual verification of droplet spread uniformity
• Measurement of fog contact time and exposure period
• Room re-entry validation time

4. Microbial Efficacy Testing

Using standard challenge organisms such as:

• Staphylococcus aureus
• Pseudomonas aeruginosa
• Bacillus subtilis spores
• Candida albicans
• Facility-specific environmental isolates

Acceptance Criteria:

• Demonstrated ≥ 3 log to 5 log microbial reduction, depending on disinfectant type & regulatory expectations
• Uniform efficacy across all tested positions

5. Post-Fogging Assessment

• HVAC restart validation
• Removal of residues (if any)
• Environmental monitoring after fogging (optional)
• Area clearance verification

Documentation Provided

• Fogging Validation Protocol
• Pre-validation risk assessment
• Distribution study maps & photos
• Microbial challenge test reports
• Log reduction summary & graphical trend
• Safety evaluation & re-entry conditions
• Final Fogging Validation Report
• SOPs for fogging operation, dilution, safety & frequency

Regulatory Standards Followed

• EU GMP Annex 1
• USP <1072> Disinfectants & Antiseptics
• WHO TRS 961 / 1019
• ISO 14698 – Biocontamination Control
• ICH Q9 – Risk Management

Why Choose PrimeGMP for Fogging Validation?

• Expertise in sterile, non-sterile, and high-risk cleanroom environments
• Use of validated disinfectants and aerosolization technologies
• Testing with site-specific environmental isolates
• Scientific evaluation of droplet distribution & microbial reduction
• Detailed, audit-ready documentation
• Clear recommendations for routine fogging frequency and disinfectant rotation