Pharmaceutical Cleanroom Design and Construction
CE specializes in building cleanrooms — from pharmacy cleanroom concept through pharmacy cleanroom certification — that improve your business productivity while meeting precise standards. We have designed, engineered and built many controlled environments in this highly regulated industry, including cleanrooms for community, hospital, clinical, industrial, compounding and other types of pharmacies.
We work with clients that manufacture various pharmaceuticals, including oral solid dose, injectables, liquids, active pharmaceutical ingredients (API) and nutraceuticals, as well as PET and blow/fill/seal products. Some of our clients perform drug trials while others undertake research and development (R&D) projects.
Meeting Cleanroom Regulations
The goal of pharmacy cleanroom design is to ensure that the cleanroom complies with USP <797> and USP <800> regulations for preventing contamination and ensuring product sterility. These regulations were created specifically to reduce patient infections transmitted through the drug manufacturing process and to eliminate the exposure of pharmacy staff to pharmaceuticals. These aims are accomplished through proper air flow and pressure, controlled temperature and humidity, particle counts, and appropriate gowning and cleaning protocols.
CE understands other relevant standards, too. We design and build cleanrooms that comply with current good manufacturing practice (cGMP) standards, the GMP European standard, FDA cleanroom standards, and ISO classes.
Materials and Construction Methods
Reducing particulate contamination through HVAC and other mechanical systems is of particular importance in this industry. However, once the cleanroom is operating, monitoring and controlling the air flow and pressure, temperature and humidity are vital. CE’s Prism Monitoring System is ideal for pharmaceutical cleanrooms. This single, easy-to-use unit provides communication and system support for up to six rooms, is configurable to match your facility layout needs, and monitors differential pressure, temperature and relative humidity.
In addition to the HVAC and mechanical systems installed to eliminate contaminants from the cleanroom, building materials play an important role. Materials must be compliant with USP <797> and USP <800> regulations. Floor, ceiling and wall surfaces — whether traditional, panel or modular construction — must be smooth, impervious, free from cracks and crevices, non-shedding and resistant to damage by disinfecting agents.
Flexible, Modular Cleanroom Solutions
CE specializes in pre-engineered construction techniques for cleanliness, speed and flexibility. If your needs change, modular construction makes expansion, relocation or reconfiguration easy. CE’s cleanrooms are designed for various sizes and layouts and can be built in your choice of hardwall or softwall materials. Our USP <797> and/or USP <800> compliant cleanrooms are designed to meet specific ISO classifications.