Guidance on Clean Room Validation

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Cleanroom Validation

🏭 Where Are Cleanrooms Used?

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out in order to provide the cleanest area possible.

The ISO 22000:2018 standard outlines Food Safety Management System Requirements for any organization in the food chain, and is one of a family of standards focused at the development, implementation and improvement of a food safety management system.

🏢 How Does It Work?

Essentially, cleanrooms work to remove pollutants, particles, and contaminants from outside ambient air, Outside air is first circulated to a filter system. The filters (either HEPA or ULPA) then clean and decontaminate this outside air according to their specifications. The filtered air is then forced into the cleanroom Additionally, contaminated air within the cleanroom is forced outside the room by registers, or it is recirculated back into the filters, and the process restarts.

💡Who Needs A Cleanroom?

There are a wide variety of reasons that a company may need a cleanroom. If you're manufacturing something that is easily affected by contaminants or particles in the air for example, it's likely that you'll need a cleanroom. Here are some common industries that regularly use cleanrooms.

  • ✅ Manufacturing companies
  • Medical laboratories
  • Electronic part production
  • Research facilities
  • Aerospace industry
  • Nanotechnology production
  • Pharmaceutical companies
  • Optics and lens manufacturing
  • Military applications