10 Essential Steps For Setting Up A Pharma Cleanroom – Credihealth Blog

You can’t just wake up one morning and set up a cleanroom. That may not be possible because setting up a cleanroom requires careful consideration when it comes to designing it and how you will use it. Generally, a cleanroom is a crucial part of scientific research, manufacturing processes, as well as quality control.  Before we look at the steps involved in setting up a cleanroom, we need to define what a cleanroom is.

What is a cleanroom? 

A cleanroom is a controlled work area that maintains a specified level of air particles and other contaminants. What makes the cleanroom always clean is that the quality of air is controlled, all the equipment and surfaces are always cleaned to a certain standard, and it is operated in a certain way; for instance, the number of staff who can get access to it is limited.

How to set up a cleanroom

Here are 10 essential steps to setting up a cleanroom:

  • Pay attention to the architectural design of your cleanroom

Cleanrooms are generally designed to achieve and maintain consistent airflow throughout the facility. The airflow shouldn’t be restricted in any way. If that happens, it will lead to turbulence which can cause movement of particles, thus increasing the risk of airborne contaminants.

  • The cleanroom must have HEPA [High-Efficiency Particulate Air] filters

These filters are crucial as they maintain contamination control. These filters can filter as small particles as 0.3 microns. The air in cleanrooms is constantly circulated through these filters to eliminate airborne contaminants and also provide fresh air to the people occupying it.

When setting up a cleanroom, you need to make sure that the design is very flexible so that you won’t struggle so much in case you want to expand it or add new equipment. You can contact cleanroom equipment manufacturer if you want to purchase any cleanroom equipment.

  • Make sure the cleanroom is adequately ventilated

Ventilation is crucial as it helps to maintain air quality and replacing process exhaust. This can be quite energy-intensive, which is why you need additional space for cooling unit components, larger passageways, a backup generator, and noise suppressors. 

  • Pay attention to the temperature and humidity of the cleanroom

Temperature control is vital to provide stable conditions for not only materials and instruments but staff comfort too. On the other hand, humidity control is required to prevent corrosion and condensation on working surfaces and provide a comfortable workspace.  

Remember that your cleanroom ought to have a static pressure to prevent infiltration by the wind. Airlocks can also prevent changes that may compromise the process.

  • Make sure you have measuring equipment

Your cleanroom should be measured constantly to ensure that factors like airflow, particle count, temperature, or humidity are always at the right levels.

Adequate lighting is also vital for a cleanroom. It will help you clean particles properly, hence no buildup. Remember that lighting needs to be consistent.

  • Electronic discharge must be put into place

Both moving people and air can create an electrical charge. That’s why it is important to use electrostatic discharge protective materials to prevent any damage that may occur. 

The last step you ought to do is to validate and certify your cleanroom. This involves doing multiple tests. These tests will depend on your geographic location and what you intend to use the cleanroom for.

Disclaimer: The statements, opinions, and data contained in these publications are solely those of the individual authors and contributors and not of Credihealth and the editor(s). 

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