Ventilation for Pharmaceutical Cleanrooms: Challenges, Regulation, and Tailored Solutions

In the pharmaceutical industry, in research labs, and in any activity requiring a controlled atmosphere, the cleanroom plays a central role: it is the enclosure where medicines, vaccines, viruses, trial materials and tests, as well as medical devices, are manufactured, controlled, and stored. Every procedure carried out in a cleanroom may, or may not, be a source of particulate and/or bacteriological contamination. Its role extends beyond pharma — hospitals, food processing, microelectronics, aerospace — but it is in pharma that regulatory requirements (GMP) and health stakes are the most stringent. This is the level of rigor behind cleanroom ISO classes (ISO 4/5/6/7).

Behind every cleanroom is a precisely engineered ventilation system. Here are the specific challenges of this environment, and how SEAT Ventilation addresses them.

The Challenges of Ventilation in Pharmaceutical Cleanrooms

A Dual Contamination Risk

A cleanroom must guard against two directions at once: preventing unfiltered outside air from entering and introducing particles, pollutants, or micro-organisms, and preventing contaminants generated inside from escaping. Thanks to the airtightness class and decontamination airlocks managed in a pressure cascade, containment is maintained effectively: a constant-pressure regulation principle inside the room, combined with a pressure differential (Delta P) in the airlocks, keeps containment under control.

• Insufficient or undersized extraction remains the most frequent and most dangerous cause of malfunction in these environments.

Materials Built to Withstand Chemical Corrosion

Gases and vapors extracted from fume hoods, glove boxes, or extraction arms are often aggressive toward standard materials. Polypropylene's resistance is superior to that of polyethylene, PVC, or even stainless steel: it withstands a broader spectrum of chemical agents, in both gas and liquid phase, than any other material. This resistance to the extracted chemicals is a key factor in the service life of a fan installed on a rooftop or in a technical gallery, continuously exposed to corrosive gas discharge.

ATEX Risk

Certain pharmaceutical processes involve handling flammable solvents or powders, creating potentially explosive atmospheres. These environments require ATEX-certified fans, with an electrical and mechanical design specifically engineered to eliminate any ignition source.

Precision in Extraction (Flow Rate/Pressure)

Every cleanroom relies on an air handling unit (AHU) to supply fresh air, and on dedicated fans to extract corrosive gases. The AHU and the centrifugal extraction fan(s) are key components of the process: they maintain the correct flow rate/pressure balance between supply and extracted air. Even a slight imbalance can compromise the cleanroom's airtightness or the pressure differential in the airlocks — a parameter that is central to maintaining the room's cleanliness class.

The SEAT Ventilation Approach

A Rigorous Selection Process for a Critical Environment

SEAT Ventilation fans are regularly installed in pharmaceutical cleanrooms and similar environments. They are selected through a rigorous technical evaluation that accounts for the required flow rate and pressure, as well as integration constraints.

Specific process regulation requirements, such as maintaining constant pressure at a given setpoint, are standard practice for us. Our fans support a wide range of flow rates at a given pressure, allowing for fine-tuned adjustment of cleanroom operation.

Polypropylene as the Reference Material

SEAT Ventilation's polypropylene fans create a safe working environment by evacuating harmful gases and contaminants generated by operations in the room. Installed on rooftops or in technical galleries, their quality and long-term durability against aggressive chemical flows are far superior to those of other materials.

ATEX Versions for Hazardous Zones

• ATEX-certified fans, Zone 2 (marking II 3G c T4), for explosion-risk environments
• Design compliant with current ATEX standards
• Integration possible without compromising safety in sensitive zones