TS 11605 EN ISO 14644-1 Clean rooms and environments controlled together in these rooms Part 1 - Classification of air cleanliness
A standard for clean rooms and controlled environments with these rooms has been prepared to control airborne particle contamination within the accepted contamination limits in sensitive activities.
Products and processes that benefit from the control of airborne contamination; Products and processes within industries such as aerospace, microelectronics, pharmaceuticals, medical devices, food and medical care are also included.
TS 11605 EN ISO 14644-1 standard; It is divided into ISO classification limits used to define the cleanliness of air in clean rooms and jointly controlled environments. It describes the standard testing method as well as the process for determining the concentration of airborne particles.
In TS 11605 EN ISO 14644-1 standard; for classification purposes; To determine particle concentration limits, a designed size range is given for the particles in question. TS 11605 EN ISO 14644-1 standard, also; It also provides standard protocols for determining and designing cleanliness levels based on the airborne concentration of particles larger or smaller than the values within the particle size range designed in the classification.
TS 11605 EN ISO 14644-1 standard; It is one of the standard series regarding clean rooms and contamination control.
In the design, definition, use and control of clean rooms and other controlled environments, many other factors should be taken into account, 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 on this subject.
In such cases, appropriate adaptations of standard trial procedures may be necessary.
TS 11605 EN ISO 14644-1 standard; It covers the classification of 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 particle populations showing cumulative distribution based on the distribution in the threshold (lower limit) size range from 0.1 µm to 5 µm were taken into account in the classification. TS 11605 EN ISO 14644-1 standard; It does not cover the classification of particle populations outside the specified sizes in the range from 0.1 µm to 5 µm.
Concentrations of ultrafine particles (particles smaller than 0.1 µm) and macroparticles (particles larger than 5 µm) can be used to quantify these populations with the identifiers U and M, respectively.
TS 11605 EN ISO 14644-1 standard; It is not used to indicate the physical, chemical, radiological or permeable nature of airborne particles. Due to the increase in size distribution, the final distribution of particle concentrations is inherently unpredictable and typically variable over time.
Clean room: It is constructed, used, and used in such a way as to minimize the entry of particles into the room, their formation and retention therein, and the concentration of airborne particles and other relevant parameters, for example; It is a room in which temperature, humidity and pressure are properly controlled.
DEMONSTRATION OF CONFORMITY
Customer: It is verified whether the air cleanliness (ISO class) complies with the specifications determined by the customer by performing specified trial procedures agreed upon by the customer and the supplier, and by providing specified documents regarding the results and trial conditions.
Tests: Clean room analyzes must be performed to demonstrate suitability. If no consensus can be reached on any method or no method can be determined, the reference method is used, but an alternative method of comparable clarity can also be used. Tests to demonstrate suitability should be carried out using calibrated instruments.
TS EN ISO 14644-2 CLEAN ROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: TESTING AND MONITORING CONDITIONS FOR TESTING CONTINUOUS COMPLIANCE WITH ISO 14644-1
The TS EN ISO 14644-2 standard provides a process to ensure continuous compliance with ISO 14644-1 and determines the minimum requirements for testing and monitoring. In any test plan, consideration should be given to certain operational conditions, the risk assessment of the installation and their use.
Clean rooms and their associated controlled environments provide control of airborne pollution particles at appropriate levels to identify pollution-sensitive activities. Products and processes that benefit from controlling airborne pollution include aerospace, microelectrics, pharmaceuticals, medical devices, healthcare, food, and others. Many factors besides air particle cleanliness must be considered in design, specification, operation, control of clean rooms and other controlled environments. In some cases, relevant regulatory bodies may impose additional policies and restrictions.
In such cases, appropriate adaptations of standard experimental procedures may be necessary.
TS EN ISO 14644-2 standard covers special conditions for periodic tests that must be carried out to prove the continuous compliance of clean rooms and clean areas with ISO 14644-1 in terms of the airborne particle cleanliness classification. These requirements refer to the tests described for the classification of clean rooms and clean areas in ISO 14644-1.
Additional tests to be carried out in accordance with the requirements of this standard are also specified. Optional experiments that can be performed at the user's discretion are also shown. TS EN ISO 14644-2 standard also specifies the classification of clean rooms and clean areas (hereinafter referred to as facilities) in terms of the airborne particle cleanliness degree classification.
It also covers the conditions for monitoring that must be carried out to provide evidence of continued compliance with ISO 14644-1.
Redetermination of qualification: Depending on the classification of the facility, a specified series of tests must be carried out to demonstrate compliance with ISO 14644-1. This includes verifying conditions before the experiment.
Test: It is a procedure carried out according to a defined method in order to determine the performance of a facility or an element of it. The most likely tests to be performed for the operational clean room are given below.
•Air particle measurement from points determined according to the condition of the clean room
•Air microbiology measurement to be taken from the same points (Total bacteria, Mold-Yeast)
•Samples for microbiological testing to be taken from the hands of the working personnel (Total coliform, E.coli, S.aureus)
•Samples for microbiological testing (Total bacteria, Total coliform, E.coli) to be taken from the floors of points such as clean room entrance, clean room interior, material entrance section.
•Samples for microbiological testing (Total bacteria, Total coliform, E.coli) to be taken from surfaces in the clean room that come into contact with the product (equipment, material box, etc.).
Monitoring: It is an observation activity carried out through measurement and analysis according to a defined method and plan, in order to obtain evidence about the performance of a facility.
Periodic Periods Regarding Clean Room Measurements and Analysis
•Continuous: Update that occurs continuously.
•Frequent: Update that occurs at regular intervals not exceeding 60 minutes during operation.
•6 months: Updates occurring at average intervals not exceeding 183 days during business use.
No interval should exceed 190 days.
•12 months: Updates occurring at average intervals not exceeding 366 days during business use.
No interval should exceed 400 days.
•24 months: Updates occurring at average intervals not exceeding 731 days during business use.
No interval should exceed 800 days.
Demonstration of continued compliance: Continuous compliance with the air cleanliness (ISO class) requirements specified for the facility is verified by carrying out specified tests and documenting the results. Monitoring data is used as an indicator of the condition of the facility and can be used to determine the frequency at which tests are performed.
Tests to be carried out for continued conformity: The maximum time interval between these tests to prove continued conformity to the reference test method and the specified ISO class is given below.
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