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Cleanroom Design to Acceptance: EPC One-Stop Delivery Process Explained

Created on 11.21
Learn about the EPC one-stop delivery process for cleanrooms, covering design, procurement, construction, equipment installation, and final acceptance to ensure projects are efficient, safe, and compliant with ISO 14644 standards.
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Introduction

With increasing requirements for controlled environments in pharmaceuticals, electronics, food, and research laboratories, cleanroom construction projects are becoming more complex. The EPC (Engineering, Procurement, Construction) one-stop delivery model integrates the entire project from design to acceptance, improving efficiency, reducing risk, and ensuring quality. This article provides a detailed explanation of the EPC cleanroom delivery process, helping companies and contractors understand each key stage.

1. Preliminary Needs Analysis

Client Requirement Survey: Identify cleanroom class, functional areas, size, temperature and humidity control, personnel flow, and equipment layout.
Feasibility Study: Analyze site conditions, existing pipelines, load-bearing capacity, and airflow characteristics to ensure the design is practical.
Compliance Check: Determine design standards and acceptance criteria according to ISO 14644, GMP, FDA, or other industry regulations.

2. Cleanroom Design Phase

Conceptual Design: Plan functional areas, airflow patterns, airlocks, pass-through chambers, and pressure gradients.
Detailed Design: Complete architectural, structural, HVAC, plumbing, electrical, and control system drawings.
BIM or 3D Simulation (Optional): Identify potential conflicts and optimize pipeline layout in advance to reduce construction risks.

3. Material Procurement and Equipment Selection

Material Selection: Walls, ceilings, floors, and sealed doors/windows must meet cleanroom requirements (corrosion-resistant, dust-proof, easy to clean).
Equipment Procurement: Select FFUs, HEPA filters, air showers, pass-through chambers, clean benches, and monitoring systems according to design specifications.
Supply Chain Management: EPC unified procurement reduces costs, ensures material consistency, and guarantees timely delivery.

4. Construction and Installation

Civil Work: Install walls, floors, ceilings, doors, and windows following standardized procedures.
HVAC System Installation: Install and commission ducts, supply/exhaust systems, FFUs, air filters, and control systems.
Cleanroom Equipment Installation: Install and test critical equipment, such as pass-through chambers, air showers, clean benches, and biosafety cabinets.
Construction Monitoring and Quality Inspection: Conduct on-site inspection for key stages to ensure workmanship, airtightness, and cleanliness meet standards.

5. System Commissioning and Validation

Air Cleanliness Verification: Use particle counters, airflow velocity measurements, and pressure differential checks to ensure the cleanroom meets the target class.
Temperature, Humidity, and Pressure Adjustment: Ensure HVAC systems operate stably within design parameters.
Equipment Functional Testing: Confirm operation of all cleanroom devices and monitoring systems for sustained performance.

6. Final Acceptance

Comprehensive Acceptance: Perform full inspection according to ISO 14644, GMP, or client standards, including air cleanliness, temperature/humidity, pressure, equipment function, and safety.
Documentation and Reporting: Generate detailed acceptance reports, operation manuals, and maintenance guides.
Client Training: Train operational staff to ensure long-term, efficient operation of the cleanroom.

7. Post-Construction Maintenance and Optimization

Scheduled Maintenance: Replace air filters, clean surfaces, and check monitoring systems regularly.
Performance Evaluation: Periodically measure air cleanliness and environmental parameters, addressing issues promptly.
Optimization: Adjust airflow organization and system operation based on performance data to reduce energy consumption and improve efficiency.

Conclusion

The EPC one-stop delivery model integrates cleanroom design, procurement, construction, commissioning, and acceptance, improving project efficiency, reducing management costs, and ensuring quality. Understanding each stage from design to acceptance ensures cleanroom projects are delivered successfully, providing safe, reliable, and efficient controlled environments for clients.
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