Clean Room Validation

Clean rooms are rooms with controlled atmosphere in terms of microclimate and quality

Clean rooms are classified into ISO categories. The regulation sets out the verification and control methods of the following factors: temperature, relative humidity, room ventilation, hourly air replacement, particle concentration (air and surfaces), microbiological contamination (air and surfaces)

In the production processes of the aerospace, pharmaceutical, medical, sanitary, electronics, microelectronics, nanotechnology and food industries, there is a need for facilities with a stringent control of environments and contact surfaces, as polluting particles can compromise the processing or infect the products

The cleanliness classes of clean rooms are the following:

  • ISO 1
  • ISO 2
  • ISO 3
  • ISO 4
  • ISO 5
  • ISO 6
  • ISO 7
  • ISO 8
  • ISO 9

What we do:

Our company employs specialized technicians who are able to perform performance tests on the plants, analysing: air quality, microclimatic characteristics, particle and microbiological contamination on both air and surfaces

The results of the tests, complete with the identification of the ISO class obtained, are specified in the final report, with the reports and documentation of the activities carried out

Microclimatic quality of the air

With certified and calibrated instruments, we analyze: temperature, relative humidity, differential pressure between adjacent spaces, clean room air replacement

Particle and microbiological contamination

With certified and calibrated instruments, we analyze: particle pollution in the air (with particle counter) and on surfaces (with swabs analyzed in a qualified laboratory), microbiological pollution in the air and on surfaces (samples analyzed in a qualified laboratory)

With respect to air quality, we analyze:

The pressure (static, dynamic, total)

in air ducts with Pitot tubes

The relative temperature and humidity

with thermo-hygrometric probes, immersion and/or contact thermometer probes, and infrared thermometers

The air flow in ducts

with both duct and outdoor probes (vane anemometers)

The environmental microclimate

is detected with an omnidirectional globe probe

The rotational speed of a motor

with an optical and/or contact tachometer probe

Absolute pressure

with barometers

With regard to particle contamination:

We measure particle pollution in the air

with a particle counter

We measure surface particle contamination

with test swabs

We carry out the sampling and analysis

of yeasts and molds