A cleanroom is a controlled, enclosed environment that is usually constructed inside of an existing building space. At minimum, hardwall cleanroom construction packages will include walls, windows, doors, a ceiling grid, ample lighting, and fan filter units to supply HEPA filtered air.
A cleanroom provides a controlled, isolated environment for handling contaminationsensitive substances or for protecting the exterior environment from dangerous substances in the controlled area. The density of submicron and larger airborne particle contamination inside a cleanroom is kept within tightly controlled limits by forcing clean, filtered air into the cleanroom.
If you've ever inspected the feet and casters of typical office equipment, most are inhabited by a fine layer of dust, organic matter, and detritus. In most environments, objects that come in contact with the floor are expected to be dirty. In cleanrooms, maintaining ultra clean flooring is a key battleground in preventing the continual spread of contamination from one workstation or work area to another.
The appropriate choice of cleanroom chairs, carts, ladders and other free-standing equipment will ultimately affect the lifespan, ease of cleaning, and overall aesthetic of a cleanroom floor. Casters and leveling feet are particularly important for cleanroom floors with sensitive antibacterial or ESD surface coatings.
Terra Universal’s cleanroom doors are designed for quick and easy installation into operating rooms, surgical suites, stick-built or modular cleanrooms. Designed for health care, pharmaceutical, and CGMP facilities, Terra’s cleanroom doors are easy-to-sterilize, maintain room pressure and resist common biocides and hospital-grade disinfectants.
Cleanroom monitoring systems are quickly becoming a feature expected for all modular cleanrooms, especially given the cGMP and GLP requirements for environmental reporting.
Not every facility requires arrays of sensors for temperature, particulate, humidity, and pressure differential. The cost of a monitoring system is derived from several factors including the number and type of sensors, sampling rate, instrument sensitivity, and any value-added features such as WIFI, alarms, and automation of feedback controls. Determining the best option requires balancing a facility's needs today with the possibility of growth and expansion years down the line.
In the United States, ISO 14644-1 is regarded as the gold standard for cleanroom construction. Cleanroom standards help define and measure expected outcomes but do not always provide a clear roadmap on how to achieve them. In parallel, GMP, IEST, USP, EU, and ASHRAE standards may provide more specific methodologies for air quality classification, testing equipment, and validation methods.
The cleanroom ceiling grid (shown above) is completely filled with HEPA-filtered fan units, lights, and ceiling tiles. A construction team installing or retrofitting this room – whether the room is stick-built or modular – will face major challenges. Each FFU and light must be individually hard-wired for operation; since the ceiling isn’t walkable, this task is costly, labor-intensive, and inefficient. A cleanroom maintenance crew will face similar obstacles in the event of room reconfiguration or relocation, or FFU change-out and filter replacement.
Compare cleanroom fan filter types and FFU features including airflow design, size, motors, construction, control systems, and compatible accessories.
Laminar flow air and positive pressure cleanroom design are ideal for non-hazardous, ultra-clean applications. Positive pressure mitigates dirt from entering the cleanroom when opening doors or pass-through chambers. Laminar airflow design ensures that air maintains a singular, uniform direction and velocity from intake to exhaust port. Terra's positive pressure cleanrooms include HEPA filtration systems capable of ISO Class 3 - ISO Class 8 air quality conditions. ULPA filtration units are available for the most sensitive ISO 3 - ISO 5 product applications including pharmaceutical compounding, semiconductor wafer processing, sterile packaging, and micro-nanofabrication.
The difference between isolation and containment typically identifies the type of airflow design within the environment. In practice, a cleanroom may require both positive and negative pressure systems within a single cleanroom suite.
- An isolation cleanroom is a positive pressure room appropriate for ultra-clean processes, aseptic workflows, pharmaceutical compounding, and biologically sensitive applications.
- A containment cleanroom is a negative or neutral pressure room that typically exhausts contaminated air to an outside area to prevent operational exposure to toxic, potent, or noxious substances.