Various microorganisms in the inhaled air move towards the particles and thus form a living space. Microorganism and particle numbers vary depending on the size of the area, the excess of the movements in the environment, the climatic conditions and the number of people in the environment. For example, in a static environment, 100 is spread over a particle of one thousand particles per minute, while a human has to sit up and the 2,5 million particles are spread over the 10 million particles.
There are generally four clean area classes for clean and sterile areas. Essentially, the factors that determine the quality of clean air are the number of particles and microorganisms.
Although the number of particles and microorganisms seem to be linked to each other, it is necessary to control separately and classify accordingly.
Class A: Areas requiring the highest degree of sterility. For example, aseptically filled areas. Class A class areas require air to be routed as 0,45 m / s (+/-% 20) laminar.
Class B: Class A is the sterile field surrounding the area A.
Class C and D: Less critical are clean areas. For example, equipment washing, solution preparation areas.
The particle in question and the microorganisms carried therein cause fungal infections, bacterial infections, viral infections and similar infections. In addition, these particles cause allergies in the human body, cause poisoning and cause various reactions. is a method of measurement made by counting the particle level as described in the standard. In this method, 14644, 1, 0.3 and 0.5 micrometer sized particles in one cubic meter are counted.
Particle counting is performed in places with hygienic ventilation system. These places are provided with adequate isolation of the external environment, regular airflow is provided from the clean area and the working inputs and outputs are controlled. There is no point in making this count in places where control is not provided. In addition, before the particle counting according to the standard, it is necessary to carry out a leak test, to measure the air flow and to determine the ambient differential pressures and air flow rates. Because the particle and microorganism density can only be reduced to the desired levels in these environments.
Clean rooms for controlling airborne particulate contamination and contamination limits accepted for sensitive activities and standard controlled environments with these rooms have been prepared. products and processes within industries such as space, microelectronics, pharmaceuticals, medical devices, food and medical care.
TS 11605 EN ISO 14644-1 standard; It is divided into ISO classification limits used to define the cleanliness of air in cleanrooms and co-controlled environments. It describes the standard trial method as well as the determination of the concentration of airborne particles. In the TS 11605 EN ISO 14644-1 standard; for classification purposes; In order to determine the particle concentration limits, a size range designed for the particular particles is given. TS 11605 EN ISO 14644-1 standard, at the same time; It also provides standard protocols for the determination and design of cleanliness levels based on airborne concentration of particles larger or smaller than the designed particle size range in the classification. TS 11605 EN ISO 14644-1 standard; It is one of the series of standards for clean rooms and contamination control. In the design, identification, use and control of clean rooms and other controlled environments, many other factors should be considered in addition to the factor of being clean from airborne particles. These are detailed in other parts of the international standards prepared by ISO / TC 209.
In some cases; additional methods and limitations may be given by the competent regulators. In such cases, appropriate adaptations of standard testing procedures may be necessary.
TS 11605 EN ISO 14644-1 standard; It covers the classification of the air cleanliness of clean rooms and environments controlled together, especially according to the concentration of airborne particles. In the classification, only the particle populations showing cumulative distribution based on the threshold (lower limit) size range from 0,1 μm to 5 μm are considered. TS 11605 EN ISO 14644-1 standard; It does not cover the classification of particle populations outside the specified sizes within the range from 0,1 μm to 5 μm. Concentrations of very small particles (particles smaller than 0,1 μm) and macroparticles (particles larger than 5 μm) can be used to quantify these populations with the U and M identifiers, respectively.
TS 11605 EN ISO 14644-1 standard; it is not used to indicate the physical, chemical, radiological or permeable structures of airborne particles.
Our company also performs particle measurements within the scope of gas measurements. These studies comply with the relevant legal regulations, standards and test methods published by local and foreign institutions. Here are a few standards that are taken into account in these studies:
- Clean rooms and their controlled environments - Part 14644: Classification of air purity by particle concentration
- TS EN ISO 14644-8 ... Section 8: Classification of airborne molecular contamination
