A controlled environment is one in which multiple environmental factors are monitored and controlled using controlled environment equipment. The controlled parameters typically include:
- Particulates
- Humidity
- Temperature
- Pressure
- Segregation
What is a Cleanroom?
Cleanrooms are controlled environments that limit the number of pollutants, or contamination, to a specified number of particles (by size) per cubic foot or cubic meter. Cleanrooms are tested regularly to ensure standards are met and systems are in place to control the environment by limiting dust, chemical vapors, airborne microbes and aerosol particles.
Cleanrooms are used by manufacturing companies when a high level of sterility is necessary to avoid adversely affecting the product being manufactured. Cleanroom solutions vary based on the manufacturer’s needs and are used in a variety of industries, including:
- Pharmaceutical
- Biotech
- Medical device
- Life sciences
- Aerospace
- Semiconductor manufacturing
- Optics
- Military
- Department of Energy
The Standards for a Cleanroom
The standards for a cleanroom are based on the number of particles measured in one cubic foot or one cubic meter of air. Cleanrooms are classified using either the Federal Standard 209E of the USA or ISO 14644-1 standard.
Federal Standard 209E classifies cleanrooms with numbers like “class 1,000” or “class 10,000,” and classifications are based on the number of particles of size 0.5 μm or larger allowed in one cubic foot of air.
ISO 14644-1 standard classifies cleanrooms with smaller numbers like “3” and classifications are based on a decimal logarithm of the number of particles 0.1 μm or larger allowed in one cubic meter of air.
What Lab Equipment and Supplies You Need
The equipment and supplies required for a controlled environment depend on the cleanroom’s classification and compliance standards. Common cleanroom equipment and supplies include:
- High-Efficiency Particulate Air (HEPA) filters
- Ultra-Low Particulate Air (ULPA) filters
- Airlocks
- Air showers
- Special gowning designed to trap contaminants
- Environmental monitoring
