A “controlled environment” typically refers to a separate space where temperature, humidity, air flow, lighting, or access are controlled to meet a specific need such as manufacturing, testing, research, or material storage. They do not require a specific particle count per volume or filtration. To certify a controlled environment, the temperature and humidity are measured and logged to ensure the environment is meeting required specification.
A “cleanroom” refers to a space which meets ISO14644-1 or FED Std 209E cleanroom classification standard. The ISO cleanroom standard includes particles per cubic meter and air changes per hour. The FED cleanroom standard includes particle per cubic foot and air changes per hour. The standards are roughly equivalent but use different units. To certify a cleanroom, the room is particle tested to ensure the designed cleanroom classification is being achieved, air pressure is measured continuously via magnehelic gauges, and filtration is working properly to achieve the required air changes per hour. In pharmaceutical and medical device cleanrooms, it common to use settling plates to measure “viable” contamination.
Cleanrooms can be thought of as “controlled environments” with added requirement of filtration / particle control.
Common Applications for Controlled Environments:
- Life science laboratories
- Engineering laboratories
- Laser labs
- High energy physics facilities
- Hospitals
- Cannabis grow rooms
- Clean manufacturing
- Food processing rooms
- Pharmacies
- Quality labs
Common Applications for Cleanrooms:
- ISO-5/class 100 or ISO-6/class 1000 cleanroom classification
- Semiconductor manufacturing cleanroom
- Pharmaceutical manufacturing cleanroom
- Research and development cleanroom
- Laser and optics cleanroom
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