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].
Cleanroom clothing can reduce 0.5µm particles by up to 50%, as long as they are donned, processed and stored correctly. However, the use of cleanroom clothing alone is not sufficient.
The risk of contamination affecting a product increases as operator activities increase within a cleanroom environment.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Train cleanroom personnel
Ensure those who work in cleanrooms understand the risks of introducing or generating contamination. 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.
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