Cleanrooms are critical environments where high levels of cleanliness, environmental control, and process precision are necessary, especially in industries like pharmaceuticals, biotechnology, and advanced technologies. The process of cleanroom commissioning is fundamental to ensuring that the cleanroom operates at peak performance and meets regulatory standards.
What is Cleanroom Commissioning?
Cleanroom commissioning is the systematic process of verifying and documenting that a cleanroom’s design, construction, and operational systems meet the required specifications. This includes environmental control parameters such as particle counts, temperature, humidity, pressure, and airflow patterns, ensuring that the room operates within the defined limits.
The goal is to create an environment that minimizes contamination risk while ensuring safety and compliance with regulatory standards. Commissioning is typically performed before the cleanroom is used for manufacturing or research purposes and includes a series of tests, inspections, and validations.
Why is Cleanroom Commissioning Important?
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Compliance with ISO 14644 & GMP Standards
Cleanrooms are subject to strict regulations and standards depending on the industry (e.g., ISO 14644 for general cleanrooms, Good Manufacturing Practice (GMP) for pharmaceutical facilities). A thorough commissioning process ensures compliance with these standards.
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Preventing Contamination & Ensuring Product Quality
A cleanroom’s success in preventing contamination depends on various factors such as air quality, airflow, filtration, and temperature regulation. Proper commissioning ensures that these systems are functioning as expected, minimizing the risk of contamination that could compromise product quality or safety.
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Improving Long-Term Cleanroom Efficiency
Effective commissioning doesn’t just assess initial conditions—it helps to identify potential issues that could affect the cleanroom's ongoing performance. By detecting problems early, commissioning ensures the cleanroom operates efficiently and remains cost-effective over its lifespan.
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Protecting Personnel & Product Safety
Cleanroom commissioning verifies that systems are in place to protect both the product and the personnel working inside. Safety protocols for ventilation, emergency power, fire safety, and other environmental factors are critical in maintaining a safe working environment.
Key Steps in the Cleanroom Commissioning Process
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Design Review for Regulatory & Performance Requirements
Before construction or installation begins, a thorough review of the cleanroom’s design ensures that the layout, equipment, and materials selected will meet the specific cleanliness and operational requirements. The design review also ensures that the cleanroom is engineered to support the necessary HVAC systems, filtration, and controls for particle and contamination control.
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Construction & Installation Verification
During the construction phase, it is important to verify that all components (e.g., walls, ceiling, HVAC systems, flooring, and doors) are installed correctly according to the design. Any discrepancies or issues identified during this stage must be rectified before moving forward.
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Operational Performance Testing (Airflow, Pressure, Particle Counts)
After installation, cleanroom systems undergo performance testing. These include:
- Airflow Validation: Ensuring airflow patterns meet the required specifications, including air changes per hour (ACH) and the direction of airflow to maintain a sterile environment.
- Pressure Differential Testing: Verifying that the pressure between cleanrooms or areas with different cleanliness levels is correct to prevent cross-contamination.
- Temperature and Humidity Testing: Ensuring that the room’s temperature and humidity levels are within the specified limits.
- Particle Count Testing: Using particle counters to confirm that the cleanroom meets the required cleanliness levels.
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System Integration & Calibration
During this phase, all the cleanroom’s systems, including HVAC, filtration, lighting, and monitoring equipment, are integrated and calibrated to work together. This step ensures that all components of the cleanroom interact seamlessly to provide the necessary environment.
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Training Staff & Documenting Compliance
Once the cleanroom has passed all commissioning tests, it’s crucial to train the operators and maintenance staff on the proper use and maintenance of the facility. Proper documentation is essential to ensure traceability, regulatory compliance, and operational continuity. Documentation includes commissioning reports, test results, equipment specifications, and maintenance schedules.
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Ongoing Monitoring, Maintenance & Revalidation
Commissioning doesn’t stop once the cleanroom is in use. Regular monitoring, maintenance, and revalidation are critical to ensuring ongoing compliance and performance. Routine checks should be scheduled for equipment calibration, particle counts, air quality, and system integrity to keep the cleanroom running efficiently.
Best Practices for Successful Cleanroom Commissioning
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Work with qualified HVAC & contamination control experts
Cleanroom commissioning should be performed by specialists with expertise in HVAC systems, contamination control, and regulatory compliance. Having qualified personnel ensures that every aspect of the commissioning process is handled with precision.
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Build commissioning plans that support future validation
Commissioning should lay the groundwork for future validation. Building a system that can be easily revalidated and ensuring that documentation supports periodic checks will make it easier to maintain compliance in the long run.
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Collaborate Across Disciplines
Cleanroom commissioning often involves collaboration between design engineers, contractors, operators, and quality assurance teams. Cross-functional communication is essential to catch potential problems early and ensure the cleanroom’s long-term performance.
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Align commissioning with ISO 14644 & GMP guidelines
Always follow established standards and guidelines, such as ISO 14644 for cleanroom classification and GMP for pharmaceutical manufacturing. These documents provide a clear framework to ensure that the cleanroom meets both industry-specific and international requirements.
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Build Clean Protocols
Following build clean protocols is essential in the construction of a cleanroom. Establishing cleaning protocols thru all phases of construction for personnel traffic, materials and tools, tack mats, gowning and shoe covering are all critical aspects in establishing a cleanroom build clean protocol. Keeping up with and maintaining the cleanroom cleaning throughout the construction is far more effective than just performing a deep cleaning at the end of construction
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Leverage Commissioning for Validation and Certification
Most cleanrooms will require even further testing or performance verification to meet regulatory requirements or product specifications. Incorporating these requirements into the commissioning process can further guarantee that these requirements are easily achieved at the time of validation or certification.
Conclusion: Commissioning Ensures Cleanroom Performance & Compliance
The commissioning process is the foundation for creating a cleanroom environment that meets both operational and regulatory requirements. By following a rigorous commissioning protocol, organizations can ensure that their cleanrooms operate efficiently, remain contamination-free, and provide safe environments for both products and personnel. Proper commissioning not only mitigates risk but also enhances the long-term value of the cleanroom by ensuring compliance, optimizing performance, and supporting operational sustainability.
About the Author
Keith Sheldon is the Commissioning Manager for Hallam-ICS. Keith started his Hallam career in the Hallam-ICS Vermont office and now works out of both the Hallam-ICS Massachusetts and Connecticut offices. Keith has a Bachelor’s of Science degree in Engineering and Management from Clarkson University, and holds a certificate in project management from Worchester Polytechnic Institute. Keith is a member of the ISPE International Society of Pharmaceutical Engineers, and has performed commissioning and qualification projects in the pharmaceutical industry for over 15 years.
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About Hallam-ICS
Hallam-ICS is an engineering and automation company that designs MEP systems for facilities and plants, engineers control and automation solutions, and ensures safety and regulatory compliance through arc flash studies, commissioning, and validation. Our offices are located in Massachusetts, Connecticut, New York, Vermont and North Carolina, Texas and Florida and our projects take us world-wide.