Cleanrooms are rooms designed to minimise contamination as much as possible whilst maintaining a sterile environment. Although they cannot achieve absolute sterility, when used correctly, they keep contamination at a controlled and known level, specified by the number of particles per cubic metre of air. This figure is several thousand times lower than that found outdoors, thereby creating a biosecure space in which to work on projects requiring very specific environmental conditions.
When discussing what a cleanroom is, it is often overlooked that each cleanroom must be designed for a specific purpose and, therefore, they differ from one another. Depending on the industry or sector in which they are to be used, both their purposes and their structure will differ. However, in addition to the structural design and layout of the components—since the most likely source of contamination is the room operator themselves—an essential part of using a cleanroom is the development of appropriate cleanliness protocols to ensure they remain aseptic.
With regard to current legislation on cleanrooms, it is the ISO 14644 standard, comprising 12 sections covering various aspects, which establishes the standardisation of these facilities.
Cleanrooms must meet very specific requirements, which is why their specifications are so precise. There are many ways to control the operating conditions inside these spaces:
In short, cleanrooms are essential in environments that require exceptional sterility and hygiene. Across various industries, this includes cleanrooms in the food industry, the pharmaceutical industry, and the cosmetics industry, where they play a crucial role in ensuring the airtightness of work and production environments. If you have any questions, feel free to contact us—we’re here to help.
In practice, there is no difference between a white room and a cleanroom. Although some people believe that white rooms go a step further in eliminating contaminants and have more sophisticated facilities, in reality there is no separate standard for white rooms and another for cleanrooms; it is simply a matter of terminology.
Both terms are used interchangeably, so we can say that there is no difference between cleanrooms and white rooms; the only thing to be concerned about is whether they comply with regulations.
To define what cleanrooms are and what they are used for, it is important to note that their primary function is to reduce the likelihood of contamination within a sterile, aseptic, or hygienic process. This protects both workers and products from the risks associated with handling such materials. In summary, the following applications can be identified:
The sectors that require the use of cleanrooms are all those related to the research or technical fields of the natural sciences. In many of these sectors, aseptic conditions are necessary to ensure safe working conditions. Asepsis refers to protection against potentially infectious or hazardous elements. This applies to the chemical, pharmaceutical, and biological industries, as well as in human and veterinary hospitals, universities, and research laboratories, with the aim of minimizing biological or chemical contamination.
However, cleanrooms are also used in sectors that require very specific and clean conditions to carry out production processes. Thus, they are also used in nanotechnology and optical manufacturing, where even a low level of dust is sufficient to affect the final quality of the product.
Generally speaking, cleanrooms meet their own definition in most cases. In many other cases, however, there are different types of cleanrooms. For example, many of them are not as strict when it comes to air purity, whilst others have high standards designed to prevent the occurrence of electromagnetic fields.
We can include within the subtypes of cleanrooms those spaces where machinery is used that is highly sensitive to various types of disturbances. In short, every cleanroom is different and has specific characteristics to adapt it to the work and tasks to be carried out within it, although they all comply with certain standards and regulations.
At Labsom, we design and build cleanrooms tailored to the specific needs of each project. We have a multidisciplinary team that provides solutions for all GMP environments.
We have offices in Madrid and Barcelona. Feel free to contact us with no obligation, and we’ll be happy to assist you.
Critical processes are carried out in cleanrooms under controlled conditions, such as:
The duties of a cleanroom operator include various key tasks in controlled environments, such as:
We refer to a “gray room” as a conventional cleanroom with all the standard features and specifications, but without an air filtration or purification system.
Different types of cleanrooms vary in terms of the level of safety and cleanliness they provide. For processes that do not require an extremely high level of safety, cleanrooms with a higher concentration of airborne particles may be used, while others require stricter conditions.
