10 Steps to a Cleaner Cleanroom

The single, greatest challenge to contamination control in a cleanroom is people. A statistic from Cleanroom Technology states that “people can, when walking, produce about 1,000,000 particles ≥0.5 µm and several thousand microbe-carrying particles per minute”. [Ref: Cleanrooms Technology, Author B. Whyte].

The risk of contamination affecting a product increases as operator activities increase within a cleanroom environment.

This is why the correct cleanroom clothing coupled with optimised cleanroom operating procedures can greatly improve the operating state of your controlled environment. This article explores 10 steps you can take to ensure a cleaner cleanroom.

10 steps to a cleaner cleanroom

1) Implement a high standard of personal hygiene and cleanliness

Ensure no jewellery or make-up is worn within your cleanroom and that hands have been washed before entering the change area.

2) Wear appropriate cleanroom clothing

Ensure the clothing and its quality is appropriate for the process and grade of the working area. Set up procedures to ensure that the garments are donned, processed and stored correctly.

3) Move slowly and deliberately

You shed more particles when you move too quickly. Rapid movements can create turbulence and disrupt unidirectional airflow. Careful movement should be followed throughout your cleanroom.

4) Ensure unidirectional airflow is not obstructed  

Unidirectional airflow design is used to protect equipment surfaces and products. Disruption in a critical area can pose a risk to products.

5) Keep your cleanroom validated

A cleanroom validation is akin to a car’s MOT. This annual or bi-annual test confirms to auditors that your cleanroom is operating within the limits set within ISO 14644-1.

6) Monitor particulate levels within your cleanroom

You can’t control what you don’t know is there. Cleanroom particulate monitoring is the only way you can verify that your cleanroom isn’t exceeding the parameters of its ISO 14644-1:2015 class when operational.

7) Clean your cleanroom

It is important to establish cleaning and disinfection policies and procedures that specify which cleaning and disinfection agents to use, as well as areas to be cleaned, and frequency of cleaning.

8) Only introduce what is necessary 

Any time a person or object is introduced into a cleanroom, the risk of contamination increases. Make sure that everything that enters is essential to the process. If it isn’t, don’t introduce it to the classified environment.

9) Create your standard operating procedures (SOPs)

Use industry guidance and your process knowledge to create a set of SOPs that will give workers step-by-step instructions allowing them to work efficiently and comply with governing standards.

10) Train cleanroom personnel

Ensure those who work in cleanrooms understand the risks of introducing or generating contamination. Cleanroom training promotes the responsibility of each operator to make a change to their cleanroom behaviours to prevent contamination entering the cleanroom and risking the reliability of manufacturing processes.

How Can Angstrom Technology Help?

Cleanroom Operator Training

The biggest contamination risk in a cleanroom is people and products. Our CPD-certified ISO and EU GMP cleanroom training courses educate delegates on the correlation between the correct implementation of protocols and contamination control.

Cleanroom Training

Cleanroom Validation

ISO cleanroom validation and GMP cleanroom qualification are achieved through a series of tests that determine if a controlled environment meets process requirements and regulatory guidelines, such as ISO 14644-1:2015 or GMP Annex 1.

Angstrom Technology offers a customised cleanroom qualification testing schedule to certify the class or grade of your cleanroom facilities and localised clean air devices. We provide an immediate interim report followed by a comprehensive full report, ensuring you have the necessary documentation for auditors.

The importance of cleanroom validation

Do You Have The Correct Cleanroom Clothing?

The reliable supply of quality cleanroom consumables, equipment and furniture is paramount to our customers worldwide. Since 2002, our consumables and equipment division, Cleanroomshop, has been the provider of choice for top-tier organisations from every industry.

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