Cleanroom Health Check & Validation

Pharmintech offers end-to-end Cleanroom Health Checkup and Validation Services to ensure your controlled environments remain compliant, efficient, and contamination-free. 

Our process is designed to identify risks, validate performance, and provide corrective measures that safeguard both product quality and regulatory compliance.

Process Highlights:

• Initial Assessment: Detailed inspection of cleanroom layout, airflow systems, and pressure differentials.
• Performance Testing: Measurement of air velocity, recovery time, and HEPA filter integrity (DOP/PAO testing).
• Environmental Monitoring: Particle count analysis, microbial sampling, and evaluation of temperature, humidity, and noise levels.
• Validation: Comprehensive documentation aligned with ISO 14644, EU GMP, and US FDA standards.
• Corrective Action Guidance: Recommendations for system improvements, preventive maintenance, and operational best practices.

Why It’s Needed:

• Ensures compliance with international regulatory standards
• Identifies hidden risks before they escalate into costly failures.
• Keeps facilities audit-ready with complete validation records.
• Enhances operational efficiency and prolongs equipment life.