Integrated engineering for complex projects

Cleanroom design is primarily governed by the ISO 14644 series, the international standard for cleanrooms and associated controlled environments.

These standards cover air cleanliness classification, testing methods, monitoring, design and operational requirements. Pharmaceutical projects also incorporate cGMP requirements and EU GMP Annex 1, which link environmental classifications to the various stages of the manufacturing process. In practical terms, these requirements inform layout, HVAC design,
HEPA filtration, pressure differentials and material selection.

UNI EN 17141 addresses microbiological contamination control in cleanrooms and controlled environments.

It is particularly relevant to the life sciences, pharmaceutical, biomedical and food sectors. It establishes criteria for risk assessment, microbiological monitoring plans, sampling locations, interpretation of results and data integrity.

At the design stage, it influences accessibility, sample logistics, airflow and spatial organisation.

BSL indicates a laboratory’s Biosafety Level. BSL-2 laboratories handle biological agents presenting a moderate risk and require controlled access, PPE, decontamination procedures and the use of biological safety cabinets for activities that may generate aerosols.

BSL-3 laboratories handle higher-risk agents and require more advanced containment measures, such as negative pressure, directional airflow, dedicated containment areas, tightly controlled access and on-site waste sterilisation.

The design must therefore integrate building safety measures, HVAC systems and controlled circulation routes.

One of the principal standards applicable to healthcare environments is UNI EN ISO 7396-1, which covers medical gas pipeline systems and vacuum systems.

The standard addresses the design, installation, testing, monitoring and safety of pipeline systems supplying oxygen, medical air, vacuum and other medical gases.

For operating theatres, intensive care units and technical departments, it is a key reference for ensuring operational continuity and patient safety.

The main cost drivers are the size of the space, the required cleanliness level (ISO class), the number of required air changes and the complexity of the HVAC systems. The need to control environmental parameters such as temperature, humidity and pressure can also increase design complexity as well as construction and operating costs.