A few months ago, we received a special order from one of our clients; he wanted us to carry out the design and execution of the air conditioning installations of a clean room (Class 7 according to the UNE 14644-1 standard), intended for the manufacture of surgical masks.

The experience acquired in previous projects carried out is the basis of the construction of these facilities.

The facility design process

To achieve the objective of environmental quality inside the clean room, we define in the project the processes and operations to be carried out, establishing the different flow diagrams that best adapt to the demanded aspects of functionality, maintenance, and control.

Depending on the criticality of the process and what is established in the different regulations, according to the manufacturing process, different levels of technical specifications are set for its correct operation.

The process begins by setting the parameters that must be controlled within the room:

• Number and dimensions of particles in the air.
• Temperature.
• Moisture.
• CO2 concentration.
• Air flow: its speed and direction, as well as its distribution in the room.
• Internal air pressure.

In the Technical Office of Arce Clima, our engineers carry out the design of the facilities to follow the ISO 14644 and GMP regulations. Once the conceptual design of the room has been made, the installation plans are sent to the client and to the company in charge of the validations (consulting chosen by the client).

A tailor-made project marked by environmental requirements

For this project, Arce Clima has adopted the air conditioning system according to the construction characteristics and use of the premises, demanding from it a correct functional response according to updated criteria of efficiency and quality.

The VRV condensing units of the LG brand will be located outside the building, performing the exchange of condensing air directly with the outside. They shall be mounted on anti-vibration elements.

The clean room air handling unit is located above it, supported by a metal structure made of standard steel profiles. In this case, to get a simple installation, but fully functional, we ask the manufacturer of the UTA that it came equipped with battery direct-expansion to greatly simplify the primary circuit of production of cold/heat, thus eliminating the need to install thermometers, pressure gauge, sensors, regulating valves, etc., which we would have to install in a hydraulic circuit. The UTA also comes equipped with a humidifier and three filtration stages using high-efficiency F7, F9, and HEPA filters.

Both in the network of supply ducts and the air return, flow regulation gates have been planned, which will act according to the room’s differential pressure but maintaining the airflow necessary to comply with the required renovations/hour.

A regulation gate was also installed in the air renewal duct to vary the external renewal flow according to the CO2 concentration measured inside the room.

Control system

The installation has a centralized control system capable of controlling the entire installation incorporating combined probes of humidity, temperature, and CO2 in a distributed environment, airflow probes, and differential pressure probes.

Room qualification and validation

The start-up and validation of all its components are carried out by the consulting to ensure that all equipment, processes, and facilities work according to the established specifications.

Chamber certification

After the commissioning and validation of the installed components, the specific parameters were checked to ensure that the set of requirements set at the beginning of the project is met.

To certify the room for the class required by the customer, a series of tests were carried out to verify that the ISO parameters of that class are met or exceeded.

These tests include:

• Particle count test.
• Air pressure difference test.
• Air flow test.
• Leak test of the installed filter.
• Containment leak test.
• Room recovery time.

In Arce Clima, we offer customized solutions with a comprehensive service in all phases of the project, from development, execution to maintenance. We continue to work on new challenges, and we want to invite you to be part of them, telling you all the work behind each project. What did you think of this blog post? Leave your opinion in the comments.