Design of Clean Rooms for a Pharmaceutical Manufacturing Facility

Brief Project Description

The project involved preparation of mechanical installation design documentation for a new pharmaceutical production facility. The building includes numerous clean production rooms of different cleanliness classes, laboratories, technical, and auxiliary spaces.

We designed comprehensive heating, cooling, and ventilation systems, a technological steam generation and distribution system, cold storage cooling, and domestic hot water preparation. Design was carried out in accordance with GMP guidelines and national and international technical standards.

Challenge

The main challenge was ensuring extremely stringent cleanroom conditions, particularly regarding air quality, filtration levels, stability of temperature and humidity, and precisely defined pressure differentials between rooms.

Special attention was paid to preventing cross-contamination and ensuring repeatable conditions for validated processes, while also achieving energy efficiency and rational investment despite high requirements for reliability, redundancy, and continuous operation.

Solution and Benefits

Dedicated air handling units for cleanrooms with multi-stage filtration and HEPA filters were designed to ensure required air change rates and cleanliness classes. Pressure cascades were precisely defined and controlled to prevent contamination. Non-classified spaces are ventilated via separate systems, improving energy efficiency and operational safety.

Heating and cooling systems are based on a combination of air-to-water and water-to-water heat pumps with waste heat recovery. Domestic hot water is prepared using a high-temperature booster heat pump, while technological steam is produced by electric steam boilers suitable for pharmaceutical environments. The result is regulatory compliance, high operational reliability, and long-term energy- and cost-optimized building operation.

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