GCC Cleanroom provides professional cleanroom validation and commissioning services as part of EPC projects. Through strict performance testing and compliance certification, we ensure your cleanroom meets ISO, GMP, and FDA standards.
Validation and Commissioning in EPC Services
In cleanroom EPC projects, Validation and Commissioning are the critical final stages that ensure the facility complies with international standards and can operate reliably.
At GCC Cleanroom, we deliver end-to-end EPC services, culminating in rigorous validation and commissioning to guarantee compliance and long-term performance.
Why Validation and Commissioning Are Essential
Ensure compliance with ISO 14644, GMP, FDA, and EU standards
Verify key parameters such as air cleanliness, pressure differentials, and temperature/humidity control
Confirm that all equipment and systems operate according to design specifications
Reduce operational risks and accelerate audit and certification approvals
Cleanroom Validation and Commissioning Process
We follow a structured process to ensure every project is ready for certification and stable operation upon delivery.
| Stage |
Description |
Key Outcome |
| Design Qualification (DQ) |
Review design documents to confirm compliance with client requirements and regulations |
Solid compliance-based design |
| Installation Qualification (IQ) |
Verify that equipment and systems are installed according to specifications |
Proper installation aligned with standards |
| Operational Qualification (OQ) |
Validate system performance under operational conditions (airflow, pressure, alarms) |
Systems operate as intended |
| Performance Qualification (PQ) |
Confirm long-term stability of cleanroom under actual or simulated production use |
Sustained reliable performance |
| Commissioning & Handover |
Final optimization, testing, and client delivery |
Audit-ready and fully operational cleanroom |
Key Tests During Cleanroom Commissioning
Airflow and Pressure Differential Testing – Ensure cleanliness levels are achieved
Particle Count and Microbiological Testing – Guarantee a contamination-free environment
Temperature & Humidity Control – Maintain comfort and compliance
Integrated System Testing – HVAC, electrical, alarms, and safety systems
Our Quality and Compliance Commitment
Strict adherence to ISO, GMP, FDA, and EU standards
Delivery of comprehensive validation documentation and reports
Professional engineering team supporting commissioning at every stage
Assurance of smooth third-party audits and regulatory certification
Advantages of Choosing GCC Cleanroom
| Our Strengths |
Your Benefits |
| End-to-end EPC including validation |
Reduced project timelines, simplified management |
| Proven validation & commissioning expertise |
Higher chance of first-time certification success |
| Rigorous quality management |
Minimized operational risks and maintenance costs |
| Complete documentation & reports |
Fully compliant for audits and inspections |
Industries We Serve
Pharmaceutical & Biotechnology
Semiconductors & Electronics
Food & Beverage
Medical Devices
Research Laboratories
Partner with GCC Cleanroom for Compliance-Ready Delivery
Through our Validation and Commissioning services, GCC Cleanroom ensures that your cleanroom is not only constructed but also fully compliant with the highest standards, enabling smooth operations and faster regulatory approval.
Contact Us for a Free Consultation
Get in touch with GCC Cleanroom today to learn more about our Validation and Commissioning services and discover how we can deliver efficient, compliant EPC solutions for your cleanroom project.
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