Particle Measurement The concentration of particles in the air in clean rooms and controlled areas is a critical parameter for the risk of infection. This test evaluates the air cleanliness in the measurement environments. Particle density should be monitored regularly and continuously in such critical areas. It is of critical importance to determine the number of measurements and measurement points in accordance with the TS ISO EN 14644 standard in order to be an acceptable data. Novatest offers this measurement service in accordance with the relevant standards with its advanced technology products with calibration certificates.

The result of the particle measurement test allows to determine the air quality of the space and to which cleanliness class it belongs. This result also enlightens the user about how suitable the area is for its intended use. All of the performance test procedures carried out to prove whether the hygienic ventilation systems installed in sterile and clean areas meet the required minimum technical hygienic conditions are considered as HVAC validation. Particle measurements made within the scope of HVAC Validation and analysis of the results are carried out with reference to the TS EN ISO 14644-1 standard. According to this standard, the Particle Counting and Classification of the Clean Room test is the last test to be performed in the Clean area. Before the measurement is made, these operations are performed in order;

1. Air flow rate measurement
2. Hepa-Ulpa filter tightness test
3. Measurement of pressure differences
4. Temperature and humidity measurement

Particle measurement analyzes are based on certain standards. Binding particulate matter to a standard is one of the most important issues in air quality analysis. Particles of a certain size are analyzed, and then the level of air quality of the space is determined by using analysis methods. Clean room particle measurements are made by Taksim Consulting. Particle amounts determined as a result of the measurement are evaluated according to the ISO 14644-1 standard. Particle Diameters of 0.3 µm, 0.5 µm, 1 µm, 3 µm, 5 µm and 10 µm in the Clean Room Air are detected.

PARTICLE MEASUREMENT

Especially, this test is applied to determine the air cleanliness class in clean rooms and clean areas. It consists of three parts as outlined below;

• Classification Test
• Very Fine Particle Test (Optional)
• Large Particle Test (Optional)

In order for the Particle Measurement Test to be APPROPRIATE AND COMPATIBLE WITH STANDARDS, the following pre-tests must be completed successfully.

1. Air flow measurement or air velocity measurement tests
2. Differential pressure measurement test between spaces
3. Media leak test
4. Assembled hepa filter tightness (DOP) test

Particle Measurement Test Method

It provides particle measurement (measurement of particle concentration) in clean rooms and clean areas with a size range of 0.1 μm to 5 μm and classification of these areas according to the number of particles obtained. Particle Count Testing and Classification of the Clean Room can be applied in the at-rest and in-operation phases after all devices are connected (as-built), after all equipment and items are completed. The particle count tests to be performed are carried out in accordance with the required periods (periods) specified in ISO 14644-2:2015 in order to document and verify the cleanliness classification of the relevant Cleanroom and clean areas according to ISO14644-1:2015.

Determination of the number of sampling points required for Particle Measurement, determination of the location of sampling points, determination of the clean room class and the amount of measurements required must comply with the ISO 14644-1:2015 standard. If a different particle counting method was not agreed upon directly or if there is any disagreement (ambiguity), it would be appropriate for the particle count test methods to be applied in accordance with ISO 14644-3:2005.

Particle Measurement Standards

In order to control airborne particle contamination to remain within the contamination limits accepted in sensitive activities, a standard for clean rooms and controlled environments with these rooms has been prepared. Products and processes that benefit from airborne contamination control include products and processes within industries such as aerospace, microelectronics, pharmaceuticals, medical devices, food and medical care.

The TS 11605 EN ISO 14644-1 standard is reserved for the ISO classification limits used to define the cleanliness of the air in clean rooms and controlled environments. It describes the standard test method as well as the process of determining the concentration of airborne particles. In TS 11605 EN ISO 14644-1 standard; For classification purposes, there is a size range for such particles to set particle concentration limits. The TS 11605 EN ISO 14644-1 standard also provides standard protocols for the determination and design of cleanliness levels based on the airborne concentration of particles larger or smaller than the values in the particle size range designed in the classification.

TS 11605 EN ISO 14644-1 standard is one of the standard series related to clean rooms and contamination control. In the design, definition, use, and control of clean rooms and other controlled environments, many other factors should be considered, besides being free from airborne particles. These are detailed in other parts of the international standards prepared by ISO/TC 209.

In some cases, there are additional methods and limitations on the subject. In such cases, appropriate adaptations of standard trial procedures are required. The TS 11605 EN ISO 14644-1 standard covers the classification of the air cleanliness of clean rooms and the environments controlled together in clean rooms, especially according to the concentration of airborne particles. In the classification, only the particle populations showing a cumulative distribution based on the dispersion in the threshold (lowest limit) size range from 0.1 μm to 5 μm, the classification has been considered. TS 11605 EN ISO 14644-1 standard does not cover the classification of particle populations outside the specified dimensions within the range from 0.1 μm to 5 μm. The concentrations of very small particles (particles smaller than 0.1 µm) and macro particles (particles larger than 5 µm) play a role in quantifying these populations with the identifiers U and M, respectively.

TS 11605 EN ISO 14644-1 standard does not specify the physical, chemical and radiological structures of airborne particles. Due to the increase in size distribution, the final distribution in particle concentrations is inherently unpredictable and typically variable over time.

Particle Effects

Particularly, it causes the concentration of the particulate product in the environment to deteriorate, its purity to change, its safety to decrease, its stability to deteriorate, and accordingly, “Loss of Money” and, above all, “Loss of Time”. Particle in the environment is very important in the field of health, space science, electronic circuits and causes irreversible errors. Working Principle of Particle Counting Systems is particle counting by light scattering method. First, luminescent sensors detect particles by scattering or reflecting light from the particle’s surface. It also uses an advanced optical system to collect B scatter and focus it on the detector. Finally, when the particle passes through the light, it reflects the light onto a curved reflector, the light scattered from this reflector is converted from photonic energy to electrical energy.

Novatest

Our company was established in 2014. It has set out especially not to compromise on QUALITY and TRUST. Moreover, its own YOUNG, its team YOUNG, its equipment YOUTH, but it has set out with academic career people who have a say in the sector. In addition, it proceeds with the motto of continuous innovation. As can be understood from the meaning of its name, our company has set out to become a ‘shining star’ in the sector. In addition, NOVA TEST provides HVAC Validation tests, Duct Leak Tests, Biosafety Cabinets Performance Tests and Air Flow Measurement (Air Balance) services. In principle, we are in control of what we do. We work very meticulously. We also provide high quality services for our customers in all industries. However, NOVATEST undertakes to fulfill all the requirements of its quality policy.