Solutions for a Highly Regulated Industry
Cleanrooms, or controlled environments, have been used in healthcare settings for years to ensure patient and product safety. They are found in hospitals, pharmacies, medical device manufacturing plants and other facilities. The information on this page focuses on healthcare cleanrooms in hospitals and treatment centers.
In addition to the healthcare cleanrooms in surgical suites and hospital pharmacies designed to control airborne contaminants and maintain antimicrobial environments, cleanrooms are found in burn units, sterile areas, isolation areas and other locations with the potential for exposure to biohazardous materials.
Isolation Rooms. During a healthcare crisis, such as the Covid-19 pandemic, cleanrooms are more important than ever. An airborne infection isolation room (AIIR) is required to isolate patients with a suspected or confirmed airborne infectious disease and is mandated by the Centers for Disease Control and Prevention (CDC) to protect the public and hospital staff from the spread of disease. In addition to Covid-19, patients are isolated when they appear with tuberculosis, SARs and other dangerous, highly contagious illnesses.
Isolation rooms require that negative pressure be achieved and maintained. Negative pressure means that the exhaust air exceeds the supply air, and the room is well-sealed (the only opening is the gap under the door). The exhaust air must be directed away from walkways or building openings. A permanent room pressure monitor is installed to make sure the AIIR is always operating under negative pressure.
Protective Testing Booths. These allow healthcare workers to administer testing from behind a protective panel. Not only does this configuration keep the worker safe, but a protective booth also reduces the need to change masks and personal protective equipment (PPE) between patients. This modular, portable booth is ideal for drive-through or walk-through testing sites.
Meeting Rigorous Standards
Because so much is at stake, healthcare cleanrooms must meet stringent standards. Standard cleanrooms are subject to ISO 14644 requirements regarding air cleanliness as determined by the concentration of airborne particulates.
Isolation rooms must comply with ASHRAE Standard 170, which mandates negative air pressure and an air change hourly rate of 6 – 12 ACH, provides temperature guidance, and specifies that exhaust air be directed outside the building or recirculated via a HEPA filter.
Our professionals design and build cleanrooms in accordance with current good manufacturing practices (cGMP). Using prefabricated components, our cleanrooms are installed quickly and can easily be expanded, upgraded and relocated.
We engineer and install quality ventilation equipment and HEPA filtration to ensure that your isolation room meets all negative pressure and directed air flow requirements. We use a gasketed ceiling grid for a proper seal, and ceiling and wall surfaces are smooth and easy to clean. Self-closing doors help keep contamination at bay.
Count on CE for all your cleanroom planning, engineering, installation and certification needs.