At ISCleanrooms, we design and implement the most suitable ventilation, filtration, and air conditioning system for each cleanroom project, always in compliance with GMP regulations and other standards.

The mechanical HVAC (Heating, Ventilation, and Air Conditioning) filtration system aims to maintain the controlled atmosphere essential for cleanrooms. For those classified with Grade 4 air purity—the highest level—access is only possible through sealed airlocks. This is necessary to maintain specific environmental conditions of humidity, temperature, and differential pressure.

Thanks to the HVAC system, a forced circulation of ultra-filtered air occurs. This mechanism involves ceiling fans operating at low speed to introduce a laminar airflow into each room. The air is then extracted through return grilles. The sterile air is renewed multiple times per hour, ensuring that the concentration of airborne microparticles never exceeds the limits established by relevant regulations for each industry (biomedical research, surgical, food processing, etc.).

GMP and ISO standards classify cleanrooms according to the concentration of particles of various sizes. Particles larger than 0.5 µm can carry microorganisms. This is why cleanrooms must be equipped with high-efficiency HEPA filters, which block 99.97% of 0.3-micron particles (most microorganisms are larger).

Regarding pressure control, cleanrooms must maintain a pressure differential relative to their surroundings. This helps prevent air exchange when airlocks are opened, ensuring no contamination enters or exits.

The HVAC systems implemented by ISCleanrooms undergo rigorous validation through Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ).