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Cleanroom facilities play a vital role in the development and manufacturing of semiconductor products and in pharmaceuticals, biotechnology and other fields that are sensitive to environmental contamination. Designed to maintain extremely low levels of airborne particles, cleanrooms can be classified into nine classes determined by the number of particles per cubic meter.
Take ISO 9 classification as an example. There are about 35,000,000 particles per cubic meter (0.5 μm or larger in size), while ISO 1 classification allows only 12 particles per cubic meter (3μm or smaller).
There are many variables involved in achieving a specific cleanroom certification, but a particle counter is an essential tool used to monitor, classify, and diagnose sources of contaminants in cleanroom operations. Particle counters should be a standard tool used to measure and maintain desired cleanliness levels in all cleanrooms.
KANOMAX 3888 3-Channel Dust Counter
Particle Counter used to monitor and diagnose particulate contamination in specific clean environments, including air, water, and chemicals. Particle counters are used in a variety of applications to support clean manufacturing operations, industries including: electronic components and assemblies, pharmaceutical products and medical devices, and industrial technologies such as oil and gas.
ISO 14644-1 clean room standard
| Maximum particles/ft³ | ||||||
| Class | >0.1 um | >0.2 um | >0.3 um | >0.5 um | >5um | ISO equivalent |
| 1 | 35 | 7 | 3 | 1 | ISO3 | |
| 10 | 350 | 75 | 30 | 10 | ISO4 | |
| 100 | 100 | ISO5 | ||||
| 1000 | 1000 | 7 | ISO6 | |||
| 10.000 | 10.000 | 70 | ISO7 | |||
| 100,00 | 100.000 | 700 | ISO8 | |||
Aerosol particle counters come in two types: optical and condensing.
Optical particle counters are capable of monitoring particles in air and liquids. Using a high-energy light source, particles are measured and counted when the light source is blocked. This particular monitoring device uses the principle of light scattering to measure particles in the air. An optical particle can also detect and measure particles using light blocking, light scattering, and direct imaging methods.
Condensation particle counters use isopropyl alcohol or butanol to increase the size of incoming particles up to 200%, allowing for easier detection by adjusting the saturation level as they fluctuate with temperature. This monitor allows technicians to detect particles as small as 2nm, while particles so small cannot be detected by optical particle counters. Available in handheld form, these models are ideal for cleanrooms as they have lower flow rates for spot testing and certification of smaller air volumes. For round-the-clock monitoring of larger air volumes, large portable condensation particle counters can be installed in cleanrooms.
RION KC-51, KC-52 Air Dust Concentration Meter
Particle counters are used in applications that require contamination control in manufacturing. Examples of these industries include: semiconductor manufacturing; electronic component manufacturing and assembly; optical and photonic manufacturing and assembly; aerospace; pharmaceutical and biotechnology manufacturing; medical device manufacturing; cosmetics manufacturing; and food and beverage manufacturing. They are also used in industrial applications such as oil and gas, hydraulic fluid, and automotive assembly and painting.
The primary use of aerosol particle counters is to determine the level of contamination in a cleanroom or clean containment facility. Cleanrooms and clean containment facilities maintain low levels of particle-free air through the use of filtration and are classified according to the number of particles allowed; the primary standard for cleanrooms or clean air facilities is ISO 14644-1, other local standards may also exist such as FED-STD-209E.
Electronics manufacturing and assembly require stringent environmental controls, especially when processes are performed under reactive conditions. Productivity is reduced when components are contaminated with particles and trace elements. Particle counters demonstrate that these controls are effective and that the manufacturing environment is optimized to achieve the required quality.
Depending on the application and the size of the particles of interest, different measuring equipment is required.
Air particle monitoring is necessary to ensure that the manufacturing environment is free of contamination levels that cause defects. It is performed for the entire cleanroom area (ballrooms, bays and runways), or specific local controlled environments (tools and small environments).
When large areas need to be monitored, manifolds can be used, manifolds are devices used to connect multiple sampling locations through a length of sample tubing, with a central stepper and central particle counter moving sequentially between the tubing locations, taking readings from each location. Smaller spaces can be monitored with point-of-use particle sensors, which are dedicated to sampling at a single location and rely on a central vacuum supply or internal sample pump. The size of the pollutant particle and the frequency of measurement are factors that determine which method is most suitable.
KANOMAX 3443 ENVIRONMENTAL DUST PARTICLE DATA RECORDER
There are two main liquid applications in the electronics manufacturing process, fabrication chemicals and ultrapure water for cleaning and rinsing.
Chemical treatment used in the processing steps of semiconductors and other critical products (chemical etching, mask removal, and chemical mechanical polishing). Monitoring the particles in the process chemicals, from production to the point of use, is critical to controlling these clean processes to ensure quality output and throughput. The use of continuous on-line particle monitoring allows both process engineers and facility engineers to respond quickly to changes in chemical purity throughout the chemical distribution chain.
Ultrapure Water (UPW) / DI Water Used for critical cleaning and rinsing steps, UPW processes must maintain very low particle concentrations, typically measured in the 20 nm range. UPW is also commonly used for chemical dilution and flushing steps in chemical mixing and dispensing systems. The use of continuous on-line particle monitoring, either at the final water purification step or at the wafer point of use, provides process engineers with the critical particle data needed to effectively manage water purification and wafer cleaning processes.
Gas system . High purity gases are critical to advanced component manufacturing. Products such as integrated circuits require a variety of process gases for: etching, deposition, oxidation, doping, and inert coating applications. Impurities in these gas streams can cause defects in critical processes and impact productivity and throughput. Explosive or hazardous gases are tested at pressure using particle counters contained in pressurized, inert gas jackets. Non-reactive gases can be depressurized using clean-path gas diffusion equipment and tested using portable particle counters.
Life Science applications include industries such as pharmaceutical manufacturing, biotechnology manufacturing, compounding facilities, medical devices, functional medicine and food processing; these are industries that create products to improve the lives of living organisms. The production environment must eliminate or minimize contaminants to minimize the risk of contamination of the finished product, which can lead to chemical reactions in the product or undesirable product quality.
The industry is regulated through government oversight of the formulation, production and release of all products, and controls are established and monitored to ensure that production is maintained to agreed quality standards. Good Manufacturing Practices (GMPs) ensure that products are manufactured to national and international standards set by organizations such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the World Health Organization (WHO), other national government agencies also regulate the production of products for their countries.
The environment for the manufacture of medicinal products must be controlled to ensure that the total amount of particulate matter and microbial aerosols is maintained at an appropriate level to reduce the risk of product contamination. Environmental design considers contamination at various process steps, including: raw material purification, product formulation, final filling and packaging. Depending on the type of product being manufactured, the initial level of cleanliness of the controlled space is determined using cleanroom classification standards, the higher the risk of contamination the cleaner the environment, for example, aseptic filling is performed in an ISO 5 controlled environment, while final sterilised product is completed in an ISO 7 area (prior to final sterilisation).
Risk classification also contributes to the type of instrumentation used. Routine general monitoring uses mobile equipment, which is moved from location to location as determined by the risk assessment. For more critical risk production, these operations are carried out in a machine that isolates the general environment from the process environment, removing personnel from the immediate area using an isolator or RABS increases the reliability of control, these machines are continuously monitored using point sampling instruments that provide continuous feedback on the quality of the environment and any contamination events in real time. The primary concern with contamination is the potential for adverse effects on the end user, a demonstration of control resulting in increased throughput. The general environment is also monitored for any microbial contaminants using traditional techniques such as settling plates and volumetric air samplers.
Liquid systems are primarily used in the laboratory to demonstrate the absence of particles in finished liquid products. Any particles present may be contaminants or unwanted agglomerates of the insoluble product. Liquids for injection have specified limits for maximum particle concentrations, standards contained in the United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) define these limits.
Compressed air used in the preparation, transport and coating processes must meet the same GMP standards as all ambient air quality and must be tested at the point of use. The particle counter is equipped with a gas pressure diffuser that reduces the line pressure to atmospheric without affecting the path of the particles in the air stream, and the gas is then tested at atmospheric pressure.
Other industries also use particle counters to demonstrate the cleanliness of a manufacturing environment or the quality of a finished product. Together, they reduce any additional cleaning procedures.
Automotive painting in a clean environment reduces the need for rework on defects in the finish. Particle counters located in the clean area provide continuous feedback to quality engineers, ensuring that clean conditions are maintained. Engines built to exacting tolerances are cleaned and assembled in the clean area, using cleaning agents verified by the particle counter.
Hydraulic fluids and oils must meet specific ISO 4406 standards. Hydraulic fluid applications range from aerospace and turbine cooling and lubrication to heavy machinery. The accumulation and presence of particulates can cause bearing, pump and seal failure.
Water is a ubiquitous product with an unlimited number of applications and can become contaminated through intentional interactions with processes or unintentional and seasonal variations. Monitoring water quality with particle counters, either by spot testing at sampling locations or by continuous monitoring of the distribution system, allows quality engineers to respond to changes in water-using processes.
Particle counters are used to determine filtration rates, chemical replenishment requirements, flush intervals, settling information, cooling flow rates and other process variables allowing continuous feedback, ensuring consistent water quality for a process.
Particles that exist in the atmosphere at concentrations that can be harmful to health and have been shown to be a factor in many airborne diseases such as asthma. Types of particles in the atmosphere include suspended particulate matter; inhalable and respirable particles; respirable coarse particles, known as PM10, which are coarse particles 10 micrometers (μm) in diameter or smaller; fine particles, known as PM2.5, which are 2.5 μm in diameter or smaller; ultrafine particles; and soot.
Particle counters are used to monitor the level of airborne pollution from these particles, allowing for reductions in particles associated with a specific source (e.g. combustion) or technology (e.g. power generation). Modeling of particle data from globally distributed particle counters provides trend information on air quality status and its movement.
The choice clean room particle counter can be a daunting process, but we hope this article can provide enough information to help you purchase the right particle monitoring equipment for your cleanroom.
SEMIKI is a leading company in the market providing solutions for dust measurement systems, particle analysis in clean rooms in the electronics and pharmaceutical industries... Semiki products can support many requirements of famous manufacturing plants.
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Phone: +84 9797 61016