Cleanrooms

The Construction Quality Improvement Collaborative (CQIC) define the primary use of cleanrooms as

'The primary use for cleanrooms is to limit contamination from dust, vapour, microbes, fibres, or other biological hazards. Cleanroom systems can also be used to regulate temperature, humidity, airflow, filtration, and pressure. They have complex systems to achieve these requirements which are time consuming and expensive to set up, commission and calibrate. Going back into a cleanroom facility to rectify defects would have severe consequences for the environment and consequently the processes, which are carried out in them, would have to stop. This would have enormous repercussions for the operator of the facility.'

As such the CQIC further describe the 4 stages of developing a cleanroom below.

'Planning, planning, planning! Cleanrooms take years to plan and the designs for these are agreed upon long before a piece of steel is installed, or a brick is laid. There is a strict process for cleanroom construction which is the Qualification Process. This process is made up of 4 stages and these should be followed strictly with work not being allowed to move to the next stage until the one before it has been completed and validated by competent professionals experienced in this field of work.'

The 4 stages are:

• Design Qualification – This is the first and most important stage in the whole process. In this stage, there will be a requirement to provide proof that the design of the cleanroom and all its component parts is compliant with regulatory requirements and the process needs. To ensure that no errors are allowed to pass this stage the designs are reviewed and approved to then allow materials and products to be procured for the cleanroom build.
• Installation Qualification – In this stage, the installation is checked to ensure that what was signed off at the design stage is exactly what was built on site. If the approved design drawing required 10 sockets to be installed in a room at a certain height and spacing centre, then this is what will be checked against to ensure that is what has been installed. Again, the purpose of this stage, like all of the others, is built on evidence to prove that the installation is compliant and confirms that the installed cleanroom is consistent with what was specified. There can be no deviation and those charged with doing the work are aware that this is the case.
• Operational Qualification – means showing it works as intended in all respects. This could be in the form of a door opening and closing, a ventilation fan running or a piece of equipment operating. The evidence of this operational check is recorded to allow the process to move into the final step.
• Performance Qualification – As with all of the earlier steps, the proving of these items isn’t in the form of testing but relies on showing (which is a fundamental of auditing – you could argue that each stage of the qualification is audited before the next stage is allowed to progress with any corrective actions being rectified before moving on). This stage means showing that the cleanroom delivers the overall desired performance together in an operating state when integrated with all other elements of the build from air-locks, EMS (environmental monitoring systems), lighting and pressure cascade (either positive or negative).

This article is based on the text from the article A Cleanroom Approach published in 2024 by the Construction Quality Improvement Collaborative (CQIC)

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