Recent Projects
How to Plan a Large-Scale Pharmaceutical Modular Cleanroom Project
2026-06-08
AIRKEY designed and constructed a large-scale modular cleanroom system for an animal vaccine pharmaceutical manufacturer in South Africa. Covering a total area of 4,962㎡, the project was developed to support vaccine production processes requiring strict environmental control and pharmaceutical-grade cleanliness.
The modular cleanroom was engineered in accordance with GMP and FDA requirements, providing a stable, safe, and highly efficient production environment for the pharmaceutical facility.
To accommodate different functional zones and building limitations, the cleanroom was customized with multiple internal heights, including 2.2m, 2.3m, 2.65m, 2.8m, and 3m.
The project utilized 50mm rock wool sandwich wall panels and 50mm glass magnesium sandwich ceiling panels. The overall structure provides smooth, flush, dust-resistant surfaces with excellent thermal insulation and fire resistance performance.
All cleanroom structures and connections were designed with seamless integration to meet stringent GMP cleanroom standards. The cleanroom accessories and corner treatments were optimized for easy cleaning, effectively preventing dust accumulation and eliminating dead corners that may lead to contamination risks.
Due to varying building height restrictions within the facility, AIRKEY implemented customized cleanroom height solutions to maximize space utilization and maintain operational efficiency.
The modular cleanroom adopted zonal management and integrated airflow control systems. Different clean areas maintain smooth airflow transitions between varying pressure and wind speed zones, ensuring stable pressure differentials while improving energy efficiency.
Based on pharmaceutical production requirements and contamination control standards, the cleanroom areas were classified into Grade B, Grade C, and auxiliary zones.
The airflow system follows a unidirectional airflow principle, allowing air to move from higher-grade clean areas to lower-grade areas. This design maintains a stable pressure gradient and effectively reduces cross-contamination risks during vaccine production.
The project includes GMP-compliant changing rooms and clean corridors for personnel gowning and buffer transitions before entering clean production areas.
AIRKEY designed separate and unidirectional personnel and material flow lines to minimize contamination risks and improve operational safety and efficiency within the modular cleanroom system.
To meet the environmental requirements of different pharmaceutical production processes, separate HVAC systems were configured for individual cleanroom zones.
The HVAC system precisely controls temperature, humidity, and air change rates, helping prevent product loss, microbial growth, process deviations, and production interruptions caused by environmental fluctuations. Independent system operation also significantly reduces the possibility of cross-contamination.
The project was equipped with a VHP dynamic pass box system featuring an interlock mechanism. The low-temperature vaporization technology generates highly penetrating dry mist particles capable of sterilizing even hard-to-reach packaging gaps.
The system supports one-touch automated operation with full parameter recording, including concentration, temperature, and pressure data, fully complying with FDA 21 CFR Part 11 requirements.
The cleanroom also includes Laminar Air Flow (LAF) units constructed with 304 stainless steel frames, providing stable vertical unidirectional airflow to ensure high cleanliness levels in critical operating areas.
Additional pharmaceutical cleanroom facilities include stainless steel dispensing booths, storage cabinets, and shoe-changing benches designed for easy cleaning, corrosion resistance, and contamination prevention.
All on-site columns were fully encapsulated using the same high-quality sandwich panels as the cleanroom walls, forming smooth and seamless curved surfaces that comply with GMP and FDA cleanroom requirements.
The project also adopted an integrated BFU and clean lighting system. BFUs continuously deliver ISO-grade clean air for effective dust and microorganism removal, while clean flat panel lights provide uniform, soft, flicker-free illumination with brightness levels ranging from 300–500 lux.
