What is a Cleanroom ?
More than a room that is clean, a cleanroom is defined in the ISO standard 14644-1 as:
“A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary”
Minimizing the introduction, generation and retention of particles in a cleanroom is done in 3 ways:
- Supplying the room with a large quantity of air filtered with high efficiency filters (HEPA or ULPA) to dilute and remove particles, bacteria and chemicals from within the room. The air is also used to pressurize the room and ensure that no contaminated air flows into the cleanroom
- The cleanroom itself must be built with materials that do not generate contaminants, particles, or outgas airborne chemical and must also be easy to clean.
- Cleanroom operators must wear garments that minimize dispersion of particles and micro-organisms generated by people such as hair, skin flakes, clothing fibers, etc. In fact, operator base contamination accounts for 70% to 80% of cleanroom contamination.
Why would you need a cleanroom?
Maximising product yield, improving quality control and ensuring safety are common reasons to use a cleanroom. Cleanliness is only one of the aspects controlled within a cleanroom. Cleanrooms can also control temperature, humidity, sound, lighting, and vibration when necessary. The operations being conducted will determine which variables must be controlled. Here are some industries and applications that use cleanrooms:
- Electronics, Semiconductors
- Sterile Compounding
- Medical Devices
- Food and Drink
Source: Whyte, W. (2010). Cleanroom Technology: Fundamentals of Design, Testing and Operation. Wiley; 2 edition.