Cleanrooms are essential in a wide range of sectors beyond the usual ones, such as laboratories and hospitals. In industries such as food production, research and pharmaceuticals, various types of cleanrooms are also used, tailored to their specific processes. At Labsom, we explain which industries use cleanrooms and what they are used for.
The biosanitary industry includes the pharmaceutical, veterinary, biosafety, cosmetics, and medical device industries and is the most typical sector when discussing the types of industries that use cleanrooms. In the cleanrooms of this sector, sterile products are manufactured, and their integrity is fundamental for the end consumer, especially in the case of pharmaceuticals. They must be manufactured aseptically, so the production of biological medicines through the manipulation of live microorganisms (biosafety) requires special conditions.
Many of the processes related to the manufacture of medicines require access to a cleanroom. On the one hand, operators must be safe while handling substances that are potentially hazardous to their health, and on the other hand, consumers must be able to take different medications with complete safety guarantees. Therefore, cleanrooms are very common in pharmacies.
Another industry that requires the use of cleanrooms is the veterinary industry. A cleanroom for veterinary use is a type of cleanroom designed for the manufacture of high-potency hormonal, antibiotic, oncology, or cytostatic products. Therefore, complete sterilization must be maintained to ensure the safety of the activities and the handling of sterile, lyophilized, semi-solid, solid, liquid, or pre-filled syringe products.
The types of cleanrooms used in the R&D sector are regulated by ISO 14644. This standard requires a system to regulate the cleanroom's operation, establishes the required clothing to prevent human contamination, controls procedures performed inside the room, and defines cleaning protocols. It also mandates adequate staff training.
While cleanrooms in the innovation industry already require a high level of safety, this is even more critical in the biotechnology sector. The types of cleanrooms used in the biotechnology industry require environments where the concentration of airborne particles, humidity, pressure, and temperature are controlled. They must be protected on all sides: floor, walls, ceiling, and doors. Their design must ensure compliance with specific requirements for resistance, ergonomics, and fire performance.
The use of cleanrooms in sectors like the food industry is far less well-known. Cleanrooms are essential in the food industry because certain processes, such as those in the meat industry, require an exceptionally high level of safety. It's important to remember that meat products will be consumed by the general public, so no precaution is too much to guarantee their safety. The types of cleanrooms used in the meat industry must comply not only with the requirements and regulations applicable to all cleanrooms, but also with the specific Good Manufacturing Practices (GMP) of the food sector.
And, in addition to all these, when we consider what other industries use cleanrooms, we shouldn't forget that there are other lesser-known sectors, such as microelectronics, photovoltaics, aerospace, automotive, and optics, where sterile environments are also employed.
Yes, because the different industries that use cleanrooms have to carry out very different processes. Therefore, when designing a cleanroom, it's necessary to consider what will be done inside so that the design is as practical as possible, and this can vary depending on the sector.
In addition to the requirements established for all cleanrooms in the ISO14644 standard, other industries have specific regulations such as good manufacturing practices, which must be met in each case to guarantee biosafety.
No, the classification we use to organize the different types of cleanrooms doesn't depend on the sector in which they will be used, but rather on their level of safety. Specifically, the different types of cleanrooms are distinguished by the maximum permissible limit of airborne particles. Depending on the type of industry and the processes to be carried out, a specific level of safety will be required.
The need for a cleanroom depends less on the sector and more on the processes involved. However, all industries that carry out processes requiring a sterile environment for manufacturing will need a cleanroom. This includes everything from the pharmaceutical and meat industries to veterinary medicine, hospitals, and photovoltaics.
