What are the differences??
Do you know what a Cleanroom (clean room) is?It’s a controlled environment that restricts the number of pollutants or contamination to a specific number of particles per cubic foot or cubic meter. Cleanrooms are regularly tested to ensure they meet the required standards, and measures are taken to limit dust, chemical vapors, airborne microbes, and aerosol particles. These environments are used by manufacturing companies when a high level of cleanliness is necessary to prevent any adverse effects on the product being manufactured. Different industries use cleanrooms that are customized to their specific needs.
A Controlled Environment refers to a space where specific equipment is used to closely monitor and regulate various environmental factors such as particulates, humidity, temperature, pressure, and segregation. Unlike a cleanroom, controlled environments are less restrictive and require less stringent controls. The impact of cleanliness on the product outcome is also less significant in these environments.
What Are the Standards for a Cleanroom?
Cleanroom standards are determined by measuring the number of particles in one cubic foot or one cubic meter of air. The classification of cleanrooms is categorized by either the Federal Standard 209E of the USA or ISO 14644-1 standard. The Federal Standard 209E uses classifications such as “class 1,000″ or “class 10,000,” which are based on the number of particles measuring 0.5 μm or larger permitted in one cubic foot of air. On the other hand, the ISO 14644-1 standard uses smaller numbers like “3,” and classifications are determined by the decimal logarithm of the number of particles measuring 0.1 μm or larger allowed in one cubic meter of air.
Specific equipment and supplies are required to ensure a cleanroom meets the necessary standards. These include High-Efficiency Particulate Air (HEPA) filters, Ultra-Low Particulate Air (ULPA) filters, airlocks, air showers, specialized gowning to trap contaminants, environmental monitoring, and validated cleanroom cleaning supplies.