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Clean Room definition: what is it? What are the guidelines?

Clean Rooms: definition

What is a Clean Room? A “Clean Room” is a controlled contamination environment. The purpose of a clean room is to provide a working environment with a limited presence of particles/particulate thanks to a special air filtration system.

The parameters subject to constant monitoring are temperature, humidity and pressure, whose values vary depending on the system’s destination of use. Clean rooms are therefore working areas where air is 10,000 to 50,000 times cleaner than normal air.

Clean rooms must comply with some structural requirements, including:

  • materials must not release particles;
  • surfaces must be smooth and easy to clean;
  • joints must have rounded edges;
  • sockets and frames must be flush;
  • pipes must pass outside the room.

The air treatment system is of fundamental importance. It prevents outside micro-organisms or dust from entering, thus maintaining the internal environment completely sterile and aseptic.

One of the main sources of contamination inside a clean room is represented by the production process, together with the machinery. Particular attention must in fact be paid when moving the products and when cleaning and maintaining the clean room itself. But there is more, as operators can emit millions of particles that represent a hazard for a sterile environment (particle contamination) simply by walking. In addition to being accurately trained, personnel entering a clean room must in fact wear sterilized or disposable clothing following a precise sequence. In addition, this dressing procedure must be carried out in a changing room located close to the clean room to avoid external contamination. By complying with the precise purity standards required, it is possible to guarantee a completely sterile production.

Clean Room guidelines

The reference guideline for clean rooms is standard UNI EN 14644 which replaced the US Federal Standards in Europe and the Good Manufacturing Practice (GMP).
For a classification of clean rooms, refer to standard UNI EN 14644. This standard defines particle numbers and concentrations within the volume of air (cubic metres). Depending on particle value, it is possible to classify a clean room starting from cleanliness class ISO 1, which represents the highest, to class ISO 9. In addition, the standard establishes that the cleanliness class can be measured in three different operating conditions: as built, at rest and operational. The GMP, Annex 1, “Manufacture of Sterile Medicinal Products” identifies instead a series of guidelines on means and methods, equipment and production management for reaching specific quality standards.

Why invest in a Clean Room

The use of Clean Rooms is not only gaining importance, we are actually witnessing their expansion to new sectors of use. While only the micro-electronics and semiconductor sectors welcomed this idea at first, nowadays companies part of the food production, optical, pharmaceutical-medical and aerospace industries, and even injection moulding companies and research institutes, choose to invest in clean rooms.
As the economy develops, in fact, high-technology and high-precision industrial processes are more and more in demand. Clean rooms are in fact the perfect answer to these new needs, not only when it comes to product quality, efficiency and fluidity of the production process, but also in relation to a high state of health and comfort of operators.