What Are The Requirements for A Clean Room?

Clean Room is a controlled environment specifically developed to minimize contaminants, microorganisms in air, temperature, humidity and pressure differences. The primary goal is to prevent contamination that could compromise sensitive processes, products, or research. Here are the main requirements for establishing and maintaining a Clean Room Design:

• Air Filtration: Supply air entering the cleanroom, should be passed through High-Efficiency Particulate Air filter which efficiently removes at least 99.97% of particles of 0.3µm size. Some of cleanrooms also have the Ultra-Low Particulate Air filters that filter very small particles.
• Pressurization: Cleanrooms normally work under positive pressure compared to zones round them to avoid the ingress of contaminated air. Containment is also necessary in acreting bio-safety labs dealing with hazardous substances where negative pressure may be vital in controlling the spread of the substances.
• Temperature and Humidity Control: It’s important to stabilize environmental conditions, usually temperature fluctuates between 65-75F (18-24°C) and humidity between 30-60%.
• Particulate Control: Facility personnel are required to wear personal protective equipment’ such as gowns, masks, gloves, hairnets to minimize shedding fibers, skin cells, hair etc. Uniforms equates to footwear covers are also mandatory.
• Material Control: Acceptable media that are used in the cleanroom are restricted to those that have been cleared for use and do not leave behind a particulate matter. Any item that is transported into the area is clean and in some cases the objects literally go through a particle wipe down before the area is entered.
• Surface Cleaning Protocols: Particulate and microbial removal require the use of approved chemicals and cleaning frequency and thoroughness.
• Personnel Training: Employees who are serving at cleanrooms are trained so that they can appreciate and follow measures aimed at reducing people-borne contamination.
• HVAC Systems: High-performance HVAC systems are integral, providing filtered air and controlling temperature, humidity, and air pressure within the facility.
• Regular Testing and Certification: Cleanrooms need periodic testing and certification to ensure they meet and maintain industry standards such as ISO classifications (ISO 1 to ISO 9).
• Emergency Preparedness: Modifications that are related to emergency exits, fire and other emergencies suppression mechanisms as well as evacuation procedures are necessary since they handle emergent risks.

The strictly followed norms help to create an environment in cleanrooms free from inherent peculiarities of manufacturing processes or scientific researches contamination.