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
  • Micromechanics
  • Optics
  • Nanotechnology
  • Biotechnology
  • Pharmaceutical
  • Sterile Compounding
  • Medical Devices
  • Food and Drink

MECART Cleanrooms

MECART’s cleanrooms are designed and installed to meet all applicable regulations: FDA, GMP, ISO, EMEA and USP. At MECART, we don’t simply manufacture a cleanroom, we can take on the entire project for a turnkey service. With our in-house team of engineers, architects and technicians, we can support you from the early stages on in determining your specific requirements up until full completion, commissioning and validation of the cleanroom.

MECART’s modular cleanrooms are built using 100% prefabricated panels, which include pre-wired outlets, lighting fixtures and integrated utilities.  Doing so not only reduces on-site disruption and installation time, it also allows consistent quality, flexibility and prompt delivery. With its integrated approach, proven system and track record, MECART guarantees the compliance and performance of every cleanroom it delivers. If you have a cleanroom construction project in mind, give us a call to discuss how MECART can help you.

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Source: Whyte, W. (2010). Cleanroom Technology: Fundamentals of Design, Testing and Operation. Wiley; 2 edition.