Solution
Cleanroom Testing Solution
2024-03-15 10:31:06
What is Clean Room Testing?
Clean room testing is the process of monitoring the air quality in a clean room to verify it meets test specifications and relevant test standards like ISO14644-1, ISO 144644-2, and ISO 14644-3.
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.
Testing Items?
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.
What equipment is needed for a clean room?
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.
Clean room particle counters like:
| ZR-1620 Handheld Particle Counter | ZR-1630 Particle Counter | ZR-1640 Particle Counter | |
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Photo |
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Flow Rate |
2.83 L/min(0.1CFM) |
28.3 L/min(1CFM) |
100L/min(3.53CFM) |
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Dimension |
L240×W120×H110mm |
L240×W265×H265mm |
L240×W265×H265mm |
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Weight |
About 1kg |
About 6.2kg |
About 6.5kg |
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Sampling volume |
/ |
0.47 L~28300L |
1.67L~100000 L |
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Zero Count Level |
<1 count/5min |
<1 count/5min |
<1 count/10min |
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Particle Size |
6 channels 0.3, 0.5, 1.0, 3.0, 5.0, 10.0μm |
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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.
HEPA Filter Leakage Testers like:
3, Microbial Air Sampler
The content of planktonic bacteria is a key item for clean rooms in pharmaceutical, biological, and medical fields. Collect microorganisms in the air through planktonic bacteria samplers onto agar plates, and count the colonies after cultivation to determine whether the design indicators of the clean room have been met.
4. Airflow Pattern Visualizer（AFPV）
Good airflow organization can ensure rapid purification of pollution. To visualize airflow, the mist needs to occur to flow with the airflow. AFPV as an airflow visualizer for smoke studies to monitor patterns and turbulence in controlled clean room areas.
5. Microbial Limit Tester
Pharmaceutical water has strict requirements on microbial content, which is an important measure to ensure the safety of drugs. By using a filter membrane to suction filtrate water, microorganisms are trapped on the filter membrane and cultured on an agar petri dish to obtain bacterial colonies. By counting the bacterial colonies, the microbial content in the water can be obtained.
Microbial Limit Tester like:
6. Automatic Colony Counter
In clean room testing, colony counting is required for both planktonic bacteria and microorganism detection in water. Colony counting is also a common experimental method in biology majors. Traditional counting requires manual counting by the experimenter, which is time-consuming and prone to errors. Automatic colony counters can realize one-click automatic counting through high-definition imaging and special host computer software to improve efficiency and avoid incorrect counting.
7. Other equipment
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NO. |
product |
Test Item |
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1 |
Thermal anemometer |
Air speed and volume |
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2 |
Air flow hood |
Air speed and volume |
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3 |
lumeter |
Illumination |
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4 |
Sound level meter |
Test Item: Noise |
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5 |
Vibration tester |
Vibration |
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6 |
Digital temperature and humidity meter |
Temperature and humidity |
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7 |
Micromanometer |
Pressure difference |
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8 |
Megger |
Surface electrostatic conductivity |
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9 |
Formaldehyde detector |
Formaldehyde content |
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10 |
CO2 Analyzer |
CO2 concentration |