Cleanroom certification is an important milestone, but true contamination control requires much more than a one-time test. In this case study, you’ll see how effective, risk-based monitoring can transform your cleanroom from simply meeting compliance requirements to maintaining a truly controlled environment, every day.
“Without effective monitoring, your cleanroom is operating blind.”
Haşim Solmaz, Cleanroom Design & Management Expert
Whether you’re managing a new facility or refining existing protocols, this guide will give you practical insights into why monitoring is essential—and how to do it right.
Certification may prove that your cleanroom is compliant at a single moment, but day-to-day operations can introduce new variables and risks. Modern cleanroom management relies on continuous or periodic monitoring to maintain air cleanliness, pressure, temperature, humidity, and other critical factors.
Starting with a User Requirements Specification (URS) helps you define which processes, products, and risk points need to be monitored and why—ensuring monitoring strategies fit your specific application.
Airborne Particle Counting (per ISO 14644-1)
Surface Cleanliness Testing
Differential Pressure Monitoring
Temperature and Humidity Sensors
Airflow & Pattern Testing
Electrostatic Discharge (ESD)
Microbial Sampling
Gas and Chemical Detection
Certification vs. Commissioning: Certification verifies a cleanroom’s performance, while commissioning ensures it’s built and functioning as designed. Monitoring is what keeps the cleanroom in control between audits.
Risk-Based, Real-Time Strategies: Monitoring should reflect your actual operational risk—focusing on critical zones, worst-case scenarios, and periods of peak activity.
Beyond the Snapshot: Certification is just a “school photo”; only real-time or well-planned periodic monitoring shows the real story.
Optimize Placement & Frequency: Monitoring should be tailored to personnel flow, production schedules, and product sensitivities—not just 24/7 by default.
Automate When Possible: Automated systems provide consistent data and reduce human error, supporting better compliance and faster response to deviations.
Continuous Improvement: Regular training, protocol reviews, and investigations into anomalies help maintain ongoing compliance and product safety.
By the end of this case study, readers will understand how to:
Distinguish between commissioning, certification, and monitoring.
Establish a monitoring program that goes beyond compliance to deliver ongoing process control.
Implement practical, risk-based monitoring for sustained cleanroom performance.