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What is a cleanroom?

19 May 2021

A cleanroom installation is increasingly important within the manufacturing processes. These man made environmentally controlled rooms are perfect for production in industries such as pharmaceuticals, biotechnology, life sciences, microelectronics and food packaging, even more so in these Covid times where we want everything to be as sterile as possible for the sake of human health. At Rompa Group we have been working with cleanrooms for many years and we always seek for innovative solutions where cleanrooms are increasing in importance. Read about it in this week's article!

What is a cleanroom?

A cleanroom is the cleanest space possible. These cleanrooms are environmentally controlled and all particles are filtered out. Particles such as dust, airborne microbes and aerosol particles. The room can be adjusted to different classifications due to the fact that the cleanroom is environmentally controlled. These classification levels are depending on for example the amount of particles allowed in the area. But also temperature, airflow, pressure and humidity are different variables which decide the classification level of the room. 

We use a cleanroom for manufacturing things such as pharmaceutical products, medical equipment and/or electronics. But almost every industry has products that need to be produced in a cleanroom due to the interference of small particles that can have an effect on the manufacturing process.

Employees at Rompa Group will first need to be trained before using the cleanroom. When entering the cleanroom they go through airlocks, air showers and gowning rooms. They also wear special clothing with a unique design to trap all contaminants which the body and skin generate naturally. Also the clothing itself cannot release any particles or fibres, so the suits are carefully selected with this feature in mind. What clothing our employees wear in the cleanroom is also decided by the classification level as mentioned above. Sometimes a hairnet and a lab coat are enough, but in most cases it’s a full suit that they wear.

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HEPA and ULPA filters

High-end filters are being used to trap the particles that are inside or come inside through the airflow. High-efficiency particulate air filters are essential for controlling contamination with very small particles. A common standard requirement for a HEPA filter is that the air filter removes at least 99.95% of the particles that are 0.3 micron or larger from the air flown through. But it also makes sure that the airflow that comes into the room, the outside air coming in, is filtered. The ULPA, Ultra Low Particulate Air filters, come in when a higher level of cleanliness is necessary. The filtered air is blown into the cleanroom and the air in the room is being forced out or it’s circulated back through these filters. This process goes round and round and keeps all pollutants, particles and contaminants outside.

The classifications

As mentioned above, the cleanrooms are divided into classifications depending on the product that is being produced and its needs. The classifications measure the amount of particles with a certain size within one cubic foot of air inside the room. The particular requirements are set by the International Standards Organization (ISO). The association ranks the cleanrooms on a scale from 1 to 9. ISO class 1 stands for the highest possible cleanliness and air purity where ISO class 9 stands for the lowest requirements. 

Design considerations for a cleanroom

The design of a cleanroom at Rompa Group has been carefully considered. Below we give you several topics that are important for the design of a cleanroom. We kept flexibility in mind during the whole process as this helps us with possible expansion or modifications for the future. New technologies and equipment are being launched regularly. We want to stay on top of the game and be as innovative as possible, hence the amount of space the mechanical equipment takes up is important to consider.

All our cleanrooms have a high room flexibility. This means that the design is made in order for us to make a quick change-over of equipment for different manufacturing processes. A quick change-over makes our process very efficient and we reduce time which translates into saving costs but also minimises the risk of contamination in the long term.

Our airlocks prevent change of pressure in the room but is also a very protected environment that catches a lot of dust, harmful chemicals and dirt particles.

By implementing proper grounding we prevent any electrostatic discharge. During the use of a cleanroom electric charges can be created. We prevent this by proper grounding but also correct packaging. Our specialist conducts a static audit for us to identify potential problems that may occur and can be prevented.

A very obvious but important consideration is the function of controlling temperature and humidity. To create an environmentally controlled area the instruments to control the temperature and humidity are a must. Humidity is being controlled so we can prevent corrosion and reduce static electricity. We also want our employees to work in a comfortable environment so temperature and humidity for both our staff and the production process are important.

Wind flow in our rooms is being controlled by pressurisation. All cleanrooms are being maintained at a static pressure which is higher than atmospheric pressure. When the pressure is higher than atmospheric pressure we prevent infiltration of wind. Also the flow of air should be set up in a way that it moves from clean to less clean areas.

One consideration is already explained above but worth mentioning again. A cleanroom is not a cleanroom without the proper HEPA and ULPA filters.

Purity at Rompa Group

Our cleanrooms at Rompa Group are ready for your idea or product. With the many years of experience and high quality of cleanrooms we are always eager to improve and accommodate the different types of production processes. Would you like to speak to our specialists about this? Don’t hesitate and contact us! We are always happy to answer all of your questions and give you additional advice.