Clean Room Validation Tests

Cleanroom verification is provided by a series of tests to determine whether a controlled environment complies with the process requirements and the principles of the ISO 14644-1 standard.

The ISO 14644-1 standard, developed by the International Standards Organization (ISO), classifies air cleanliness in terms of the concentration of airborne particles in clean rooms and clean areas. This standard only considers the cumulative distributions of particles ranging from 0,1-5 µm.

Concentrations of ultrafine particles, ie particles smaller than 0,1 µm, are addressed in a separate standard to indicate air cleanliness with nanoscale particles. The ISO 14644-1 standard is not used to characterize the physical, chemical, radiological, living or other nature of airborne particles.

This standard has been published by TSE in our country with the following title: TS EN ISO 14644-1 Clean rooms and their related controlled environments - Part 1: Classification of air cleanliness by particle concentration.

To validate a cleanroom environment, it is necessary to prove:

• The air supplied to the clean room should be sufficient to remove the pollution inside
• The air supplied to the clean room must be of a quality that does not contribute to the pollution levels inside
• Indoor air must move from clean to less clean areas
• Air movement inside indicates that the room is not an area with a high concentration of pollution
• Production operations can be performed in an environment that meets microbial contamination levels

In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. Among the numerous tests carried out in this context, there are also clean room validation testing services.