Core conditions for modular cleanroom construction
The primary prerequisite for building a modular cleanroom is clearly defining process requirements and compliance definitions. Cleanliness levels must be determined according to the ISO 14644-1 international standard, combined with industry-specific standards such as pharmaceutical GMP and food GB 14881, to match production processes and regulatory requirements. Simultaneously, core environmental parameters such as temperature, humidity, pressure differential, noise, and illuminance must be clearly defined. A pollution risk assessment and layout plan must be completed, and personnel and material flow channels, airflow organization, and functional zoning must be rationally designed to avoid cross-contamination and establish a solid foundation for defense.
Environmental control is crucial for ensuring cleanliness performance, requiring precise control of various core indicators. Through professional ventilation systems and linked monitoring equipment, a reasonable pressure gradient must be maintained between clean and non-clean areas, and between areas of different cleanliness levels, to prevent external contamination from intruding. Airflow organization and air exchange rates should be adapted according to the cleanliness level, and the layout should be optimized using CFD airflow simulation to avoid contamination accumulation. A high-precision constant temperature and humidity air conditioning system should be equipped, balancing process requirements and personnel comfort, and configuring fresh air volume according to standards to ensure fresh and clean indoor air.
The selection of structures and materials must meet the core requirements of "dust-free, dust-free, seamless, disinfection-resistant, and easy to clean," while also complying with fire prevention and anti-static safety standards. Fire-resistant Class A color steel plates are preferred for the enclosure structure; stainless steel wall panels can be used in high-cleanliness or special areas, with tight-sealed joints. For flooring, epoxy self-leveling or anti-static PVC roll materials should be selected based on industry characteristics; materials that easily accumulate dust and are difficult to clean are strictly prohibited. Doors, windows, and transfer facilities must have good sealing performance, with rounded transitions at corners and connections to avoid dust accumulation dead zones and build a solid cleanliness barrier.
Stable operation relies on the reasonable configuration of core equipment, requiring the provision of air purification, HVAC systems, and various auxiliary facilities. The air purification system is equipped with three-stage filtration, with high-efficiency HEPA/ULPA filters at the terminal; leak testing is required after installation to ensure no leaks. The HVAC system achieves联动 control of temperature, humidity, airflow, and differential pressure; duct installation must meet sealing requirements. Simultaneously, auxiliary facilities such as anti-static, anti-vibration, and microbial monitoring facilities are configured according to industry needs to meet diverse production and experimental requirements.
Construction and acceptance processes must be standardized and controlled to ensure compliance. During construction, closed-loop operations should be implemented, employing a "modular prefabrication + on-site rapid assembly" model. Strict control over construction precision and sealing quality is crucial, along with thorough acceptance and recording of concealed works. The acceptance phase proceeds in four steps: self-inspection and commissioning, preliminary acceptance by five parties, third-party testing, and formal acceptance. A qualified organization should be commissioned to conduct comprehensive testing, avoiding common pitfalls such as incomplete documentation and non-compliant testing, ensuring process compliance, data compliance, and closed-loop documentation.
Long-term maintenance of cleanliness relies on comprehensive operation and maintenance management. An equipment maintenance plan must be established, including regular filter replacement, core equipment overhaul, and cleanroom cleaning. Daily monitoring and recording should be strengthened to monitor environmental parameters in real time and promptly identify potential pollution hazards. Personnel training and management should be implemented, standardizing operating procedures to ensure all personnel entering the cleanroom strictly adhere to cleanliness requirements, establishing a long-term mechanism to extend the cleanroom's lifespan.