Airkey, a China-based cleanroom manufacturer with extensive experience in self-supporting modular systems, has successfully designed and delivered a custom ISO 8 modular cleanroom for a Spanish medical device company with over 45 years of experience in health technologies. The project reflects the growing demand for flexible, rapidly deployable cleanroom solutions that meet stringent GMP standards for medical manufacturing.
A compact, self-supporting structure
The cleanroom measures 11,050 mm in length, 4,430 mm in width, and 2,500 mm in internal height, providing approximately 49 square meters of workspace. It achieves ISO 8 (Class 100,000) cleanliness, a classification that permits up to 3,520,000 particles per cubic meter for particles ≥0.5 μm. This level of cleanliness is suitable for a range of medical device assembly and packaging applications.
One of the defining features of the project is its fully self-supporting modular structure. The cleanroom uses an aluminum alloy frame with smooth, flush-mounted sandwich panels, designed to operate independently of the building's structural framework. This approach eliminated the need for ceiling suspension or internal support columns, making it particularly suitable for installation in existing buildings where structural modifications would be costly or impractical. The self-supporting design also allows for future reconfiguration or relocation without extensive demolition.
Designed for GMP compliance
The client required the cleanroom to meet local GMP certification standards for medical device manufacturing. To achieve this, Airkey engineered the cleanroom with several features aligned with GMP principles for contamination control:
Airflow strategy: The cleanroom is configured to support a "top supply, bottom return" airflow pattern, which is recognised as best practice for minimising particle accumulation and ensuring effective contamination removal. The top-mounted FFUs deliver filtered air downward, while the bottom return path draws contaminants away from the work zone.
Environmental control: A dedicated constant-temperature and humidity HVAC system maintains the internal environment at 20–24°C and 40–65% relative humidity, with controlled pressure differentials to prevent cross-contamination. These parameters are essential for stable medical device production and align with GMP expectations for controlled environments.
Fume extraction: An exhaust hood was installed at a designated location, pre-punched at the Airkey factory to simplify on-site installation. This hood connects to the client's existing activated carbon filtration system, effectively removing hazardous gases generated during certain manufacturing processes.
Prefabricated components for rapid assembly
As with Airkey's established practice for international projects, the cleanroom was fully prefabricated at the company's factory in China. All components—including frames, wall panels, doors, windows, and ductwork—were manufactured to exact specifications. The ductwork was prefabricated and labeled, eliminating the need for on-site cutting or welding and significantly reducing installation time. The cleanroom was pre-assembled and subjected to comprehensive factory acceptance testing before shipment. The testing regime included:
- Airborne particle counts to certify ISO 8 classification
- Illumination level measurements
- Noise level assessments
All measurements were carried out using calibrated instruments from internationally recognised brands, with results documented to confirm compliance with ISO 14644-1 standards.
Smart access and versatile configuration
The cleanroom incorporates a 2.5 m x 1.2 m changing room for personnel gowning, along with a pass-through chamber for contamination-free material transfer. The PVC flooring provides a cleanable, durable surface suitable for medical manufacturing environments.
Multiple door types are configured to meet different operational requirements:
- Hinged cleanroom doors for standard personnel access
- Emergency exit doors with panic bars for safety compliance
Energy-efficient air management
The cleanroom ceiling is equipped with fan filter units (FFUs), each using EC (electronically commutated) motors. These motors offer significant advantages over conventional AC alternatives, including lower power consumption, reduced heat output, and quieter operation—important considerations for a medical manufacturing environment where staff may work extended hours.
All FFUs support group control, allowing operators to adjust airflow across the entire ceiling grid from a single interface, simplifying system management while maintaining uniform air distribution.
