Design of Classified Production Areas

For many years, NIRAS has acquired an in-depth knowledge of the pharma and life science industry as well as the regulatory areas to which it is subjected. On the basis of this in-depth knowledge, we can help to ensure that the entire production facility for pharma and life science companies is in full compliance with all regulatory requirements.

NIRAS specifies production rooms with associated layout and ventilation which ensures that all requirements for hygienic and climatic conditions are met.

NIRAS can deliver solutions in the establishment of new classified production areas or when upgrading existing facilities.

Our knowledge of the industry and our experienced specialists ensure that the facilities we design meet all compliance and regulatory requirements. We work purposefully to minimise all risks of contamination in production.

Sustainability and the UN  17 Sustainable Development Goals are an integral part of our services, and we take pride in ensuring that the chosen solutions are optimised with regard to quality, quantity and production costs without compromising the compliance of production.

NIRAS can assist with:

• Prepare risk-based requirements for the production area
• Specification and design of rooms and critical facilities
• Insulators, LAF units, safety benches
• Tendering and contracting with suppliers
• Factory acceptance test (FAT), site acceptance test (SAT) and commissioning of production facilities
• Qualification and validation
• Testing of classified areas