2021/12/01

HVAC systems for cleanrooms

The cleanrooms are areas designed and built to limit the contaminant particles present in the air. The air system or HVAC must meet the objectives mentioned below:
– Supply the airflow with enough quantity and quality to obtain and preserve the conditions of cleanliness required.
– Control and preserve relative temperature and humidity conditions, required by the production process, or simply for human comfort.
– Provide the zone with an adequate ventilation level according to the regulations in force.
– Control and preserve the overpressure level according to the different degrees of cleanliness in each room, in GMP classified zones.
Although the current regulations ISO 14644-1 does not qualitatively specify the degree of cleanliness in non-sterile product manufacturing zones, it does require the following conditions:
– The non-existence of contamination through the air among the different production zones, and between these and other areas.
– Must filter the air introduced.
– Guarantee good air sweeps.
The cleanrooms in biosanitary environment must preserve the air free from contaminants, mainly through an HVAC system.

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Airflows and HEPA filters

The HVAC systems for cleanrooms are critical in the layout and construction of the cleanrooms. The cleanrooms must comply with the regulations through the air circuits, the control of the room pressure, the humidity, or the temperature.
The air system must resolve the following points:
– Preserve the airflow in an adequate amount and cleanliness
– Avoid the existence of areas in which the flow could stagnate, accumulating particles
– Filter the air from the exterior and recirculate it through HEPA filters
– Preserve the temperature, pressure and humidity levels required
The entire air introduced in the controlled areas must be treated to separate the contaminating particles to ensure the sterility of the area. The most common way to do it is through filters in the HVAC system.
In this respect, at STE Engipharm we work with HEPA filters, which guarantee the elimination of particles and extremely small microbes. In this way, we assure
a controlled environment in critical applications, such as the manufacturing of pharmaceutical products, research, or in medical installations.
The HEPA filters (High Efficiency Particulate Air) for cleanrooms eliminate the particles suspended in the air by diffusion.

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The importance of HVAC systems in biosanitary production plants

In medicine manufacturing, food supplements, or cosmetics industry, it is decisive to guarantee the safety and maximum quality of the products. In the pharmaceutical industry, the HVAC systems guarantee the quality of the manufacturing processes assuring the elimination of particles and monitoring critical parameters such as the temperature, humidity, or pressure to avoid crossed contamination.


At STE Engipharm we build all the HVAC installations, strictly following ISO 14661 regulations for cleanrooms.


Why is it important to control humidity and temperature? The medicine production usually requires different temperature. On the one hand, as we know, the pathogens thrive rapidly in hot and humid environments. Therefore, in accordance with the process or machinery, excessive heat could be generated, which needs to be eliminated for both the final product’s security, and the employees or the machinery. In addition, the storage of certain products also needs to be done in cold to preserve the properties. All this is controlled through the HVAC for cleanrooms.

In conclusion, the HVAC system could be considered as the heart of a cleanroom. We hope this article was useful to understand the important role this system plays
in the architecture of a cleanroom, and we invite you to contact us in case you consider carrying out a project such as this one or in case you need any advice.






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