Guide: Clean Rooms & Clean room ventilation – why and when you need it

What is clean room ventilation? 

Clean room ventilation is one of the most complex, but also most important, challenges for air treatment. It is a ventilation with a special type of air treatment, specially designed to handle sealed areas that need dust-free room air & need to be without microbiological contamination. The manufacturing process requires ambient air to be free of particulates.  

Why is this so important? Without clean room ventilation in  pharmaceutical or microelectronics production sites there is a high risk of contamination from dust or airborne particles. Without clean rooms these particles can attach themselves to whatever is being produced, in the case of nano technology this could affect the usability or with pharma products it could create risk for patients who would be at risk of contamination. Air is a vehicle for airborne contaminants. The particles can come from outside, from within the facility, from the material and tools we use, from people or from a product being manufactured in the space.  

A clean room must be free from contamination and depending on the use of the products made there meet all international standards and ISO classification and/or meet GMP (Good Manufacturing practice) standards.  

The 4 requirements for clean rooms: 

(According to Federal industry standard 209 and ISO 14644-1) 

• Contaminants from the outside can’t be allowed into the controlled environment. 
• The equipment in the controlled environment cannot be part of generating contaminants.  
• Contaminants cannot accumulate in the clean room. 
• If there are existing contaminants in the room, they must be eliminated. 

In other words, clean room ventilation is a sophisticated air treatment that must be done by experts, and with great care. It must meet the strictest hygienic requirements, to secure the health of others and the material that is used in that space. 

 

Which areas require clean room ventilation? 

For  hospitals, biotechnology, pharmaceutical industries and electronic production, clean room ventilation can be vital. 

7 institutions and industries that need clean room ventilation: 

Clean Rooms should meet GMP (Good Manufacturing practice):

- Laboratories
- Pharmaceutical industries
- BioTech industries

Clean Rooms should meet ISO 14644:

- Companies working in the aerospace industry 
- In production and research for optics and laser technology 
- In production for electronic hardware such as integrated circuits, hard drives and displays 

Also, Hospitals; they rely on the same techniques, but the standards here are different. 


The common denominator for all of these spaces; ‘controlled airflow’ . The air must be dust-free or hygienic and free from micro-biological contamination. This is either because of the highly sensitive manufacturing processes or for the sake of the health of the people in that space. For instance, medical devices that are used while “working” on human body’s must be sterile, produced inside the Clean Rooms where the environment is free from viruses and bacteria. 
  

Which components are needed for a clean room ventilation system? 

Clean rooms require one of the most advanced ventilation systems there is. And there are many components that must be taken to account. 

The air within the closed environment does not only have to be clean, but it also needs to meet the correct temperature, velocity and humidity, be without any odor and contain the correct amount of fresh air. All surfaces inside of the room should be smooth and easy to clean – for example, have rounded corners, reduced numbers of joints. How the air is introduced to the room is also important to do correctly. 

 

So how do you build and maintain a clean room? 

For a built-in clean room solution, you need a comprehensive system that includes the right: 

- Room air handling 
- Air filtration 
- Building Elements (Wall panels, Wall lining, Doors, Windows, Ceilings) 
- Pass-through boxes 
- Laminar fields 
- Ceiling air outlets 
- Monitoring and documentations systems 
- Light fixtures 
- Room pressure management devices 
- HVAC air handling components  

The HVAC (Heating, Ventilation and Air Conditioning) solution is an important part of the clean room. You could say that it is the heart of its functionality.

HVAC handles the indoor air quality, such as the temperature, the humidity, CFM, airflow streams, room pressurization and the air change per hour. So, it is important that your HVAC solution can do this with the best precision. And it requires vast technology. The supply air needs to be filtered in three stages with a HEPA filter at the third stage. The overpressure of neighboring rooms needs to be maintained at ca 15Pa.

A clean room must also be able to maintain a monitored level of contamination. This is specified by several particles per cubic meter with a specified particle size and/or viable bacteria (CFU’s - colony forming units). It might sound complex, and it is.

Here is an example for you to see how many particles an operation room vs a typical urban environment may contain:

An operation room requires a minimum of ISO class 7, which allows 438,130 particles per cubic meter in the size range from 0.5 μm to 5.0 μm. In comparison, the ambient air outside in a typical urban environment contains 35 million such particles. So, the clean room has to cut down the particles vastly.

The most important aspect of creating a clean room is to do it together with experts, who know clean room ventilation well. An expert who understands the technical challenges and the interrelations and can manage every detail. You want someone who can bring you the entire process-dedicated package solution that work for your sector. So, the installation is correct and flawless.

Do you want to know more about clean rooms and how this type of solution would work for your sector?

Read more on our website: Clean Room Ventilation Solutions