Establishing a Validated Cleanroom Procedure

Cleanrooms are expensive to create and important to maintain. Establishing a cleanroom procedure is vital to maintaining cleanliness and control within these rooms. Without the correct procedure, you run the risk of adversely influencing your projects or products inside the cleanroom.

Cleanroom validation is only achieved if there is a controlled environment that meets certain requirements and prescribed guidelines. While each cleanroom has a different purpose, here is a general guide for setting up a validated cleanroom procedure.

How To Validate A Cleanroom Procedure

Keeping your cleanroom free from contamination is not as simple as it sounds. You need to follow certain guidelines to make sure you still maintain the status of a ‘cleanroom’. There are several steps that need to go into your procedure.


In order to maintain good practice in your cleanroom, you need to clean the room with a detergent and two or more disinfectants in rotation. Deep cleaning is essential in these rooms to rid them of unwanted impurities and organisms.

Rotating your disinfectants is important to ensure organisms do not get used to the disinfectants and become resistant to them.

Cleaning is, of course, the most fundamental part of maintaining your cleanroom validation status. However, it should not be the sole focus of your procedure. There are other things you need to do to ensure your cleaning is actually effective.


Sampling the air and contact plates is an important way to monitor the environment in your cleanroom. Since these organisms are invisible to the eye, you need to rely on tests to tell you what is going on.

You should sample the air and surfaces before and after cleaning. This will give you an idea of what contamination enters your room so that you can set the right cleaning procedures and use the right supplies.

Air sampling involves drawing in an amount of air that is incubated and tested. This will show the testers what microorganisms generally float around in the cleanroom.

Surface sampling is also important to do in order to be thorough. This involves testing the various surfaces you have in your cleanroom to see what organisms are present.

Testing the surfaces generally involves using swabs on the surfaces and then testing these swabs. This is more commonly used in areas that would be otherwise difficult to test.


You need to actually identify the microorganisms that you come across in your sampling in order for this data to be useful. Not only do you need to know whether the organisms are bacteria, yeast, or mold, you also need to know what they are specifically.

If you keep coming across the same isolates in your monitoring, then you know you have a problem with the protocols in your cleanroom.


Once you know which microorganisms are present in your cleanroom, you can test your cleaning products against them. Your testing should involve using the cleaning products in the same way as you would use them generally in the cleanroom.

You also need to test these products on the same surfaces you need to clean inside your cleanroom. The test must mimic your exact cleaning procedure in order to see if the product and how you use it works on the relevant surfaces. This enables you to determine whether certain supplies are effective against the unwanted microorganisms or not.


If you experience a problem or keep encountering the same harmful microorganisms, you know it is time to adjust your procedure. Your cleanroom procedure should be flexible to be able to respond to any problems you may encounter.

Once you see something is not working or is not effective, change it immediately. Make sure all staff in the cleanroom know how to clean properly with the correct products. If the way the products are administered is not consistent, this can mean your procedure will be more difficult to adjust to future problems.


Establishing and following a procedure is how you stick to the standards required for a validated cleanroom. Your procedure needs to include the guidelines we explained above in order to be thorough and consistent.

If you follow these points and ensure your staff is properly trained on how to conduct the procedure, your cleanroom will remain up to regulatory standards.

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