What is a cleanroom?

What is a cleanroom?

More than a room that is clean or a controlled environment, according to ISO Standard 14644-1 cleanroom definition, a cleanroom is defined 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, eg., temperature, humidity, and pressure, are controlled as necessary”

Minimizing the introduction, generation and retention of particles in a cleanroom is done in three (3) ways:

  • Supplying the room with a large quantity of air filtered with high efficiency filters (HEPA filter or ULPA).  The filtered air will dilute and remove particles, bacteria and chemicals from within the room.  The air is also used to pressurize the room and ensure a non-contaminated cleanroom air circulation.
  • 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 fibres, etc.  In fact, operator base contamination accounts for 70% to 80% of cleanroom contamination.  To minimize the risk of contamination, the cleanroom operators will usually get dressed in a gowning room, also referred as anteroom.  Air shower can also be used.

Why would you need a cleanroom?

Maximizing 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 system.  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
  • Micromechanics
  • Optics
  • Nanotechnology
  • Biotechnology
  • Pharmaceutical
  • Sterile Compounding
  • Medical Devices
  • Food and Drink
  • Hospital