Clean Rooms: maximum hygiene

The need to work in environments that are adequately decontaminated, or, more precisely, that have a controlled level of contamination, is, today, an essential requirement, not only during some production processes but also within specific research laboratories. Consequently, guaranteeing sterility is a must in this type of environment.

The chemical/pharmaceutical industry was one of the first to rise to the challenge of operating in zones where the level of con­tamination from environmental pollutants was extremely low and kept under control. Consequently clean rooms were created. These are rooms specifically designed to ensure the absolute lowest possible pre­sence of impurities in the air.

Many regulations regarding the classifica­tion of these environments have developed over the past twenty years. At present the main reference is provided by European standard ISO 14644-1, which is also widely used in the rest of the world. This standard, also replaced the well-known American standard FED STD 209E in 2001.

According to ISO 14644-1 clean rooms are divided into classes, depending on the le­vel of contamination present within them. In particular the classification relates to the number of airborne particles with a diame­ter that is the same as, or greater than, an established size measured in tenths of mi­crons (for example 0.5 μm) and detected in a volume of air that is equal to a cubic me­tre. Those classes with smaller index num­bers, such as, ISO 4 and ISO 3 for example, define clean rooms where there is a lower level of contamination, while class areas ISO 8 and ISO 9 define “less clean” envi­ronments.

In addition, when considering that quali­ty systems in the pharmaceutical industry are largely based on Good Manufacturing Practices (GMPs, see Chapter 1), it should also be noted that there is a third classi­fication of environments designed for manufacturing pharmaceutical products, including clean rooms. GMPs divide phar­maceutical manufacturing processes into four phases, associating each single pha­se to a class: A, B, C and D. For example, an asepsis operation moves from class D, which is the handling of components fol­lowing washing, to class A, which is the filling phase.

For more information  the table shows a correspondence between the different re­gulations.

It is clear, that the essential elements of a clean room are filters for high (HEPA) and ultra high efficiency (ULPA), depending on the nature of the contaminants to be con­trolled. In this case too, Nilfisk-CFM strives to offer its services as a company that ke­eps up with the times, providing machines that are suitable for working in the most severe ISO 4 clean rooms.