Cleanroom Testing Solution

A clean room is defined as a room with air filtration, distribution, optimization, construction materials, and devices where specific rules of operating procedures to control the concentration of airborne particles to achieve the appropriate level of particle cleanliness.

Testing clean rooms is essential to achieve contamination-free research and manufacturing as well as efficient operation and financial savings. Manufacturers of semiconductors, flat panel displays, and memory drives have extremely high requirements, and biotech and pharmaceutical companies, medical device manufacturers, healthcare facilities, and other organizations that produce, store and test their products are regulated by law. The sensitive technologies handled in clean rooms require careful vigilance—a single speck of dust, for example, has the potential to destroy a semiconductor’s microscopic electronic components. To maintain a controlled environment, clean rooms are pressurized with filtered air, regulated by ISO, IEST, and GMP standards, and tested annually with the following methods and equipment.

High-efficiency filter leak detection 

Cleanliness 

Floating and settling bacteria

Air speed and volume

Temperature and humidity

Pressure difference

Suspended particles

Noise

Illumination, etc. 

Specific reference can be made to the relevant standards for clean room testing.

1, Particle Counters

Cleanliness is the key indicator for clean rooms, referring to the concentration of dust particles in the air. The measurement of particles in the air is essential to a clean room setting.

Particle counters are the ideal tool; these highly sensitive devices index how many particulates of a specified size are present. Most counters can be adjusted to the allowable threshold of the particle sizes. This practice is essential to maintaining a controlled environment and protecting products or equipment from contamination. The process of how particle counting should be performed is defined in ISO 14644-3.

2, HEPA Filter Leakage Testers

HEPA filter leakage tests are performed to determine if there are leaks in the high-efficiency particulate arrestance (HEPA) filters which remove contaminants and establish a specified level of particles present in the clean room. HEPA filter tests are performed with photometers, which allow the user to scan for pinhole leaks that could transmit contaminant particles. A photometer measures the light intensity of an unknown source in comparison with a standard source. ISO 14644-3 and CGMP both mandate HEPA filter leak tests.