Cleanroom Measurements are studies performed to ensure that the room and system are performing their function in accordance with predetermined requirements. Especially clean rooms are special rooms where airborne particles are kept under control, built and used in a way to minimize particle entry, particle proliferation and particle accommodation, and also kept under other parameters such as temperature, humidity and pressure. Clean room systems are among the priority requirements in areas such as Human Health Activities, Health Industry, Biomedical Industry, Pharmaceutical Industry, Veterinary Industry, Food Industry, Chemical Industry, Semiconductor Industry, Conductor Industry, Electronics Industry, Optical Manufacturing Industry, Aviation and Defense Industry, and Biotechnology.
Clean Room Measurements are very important. In particular, there are process steps that enable the creation of clean rooms at the desired level and quality. Since it is installed for very specific purposes, both the room itself and the equipment used must be made of materials that can be easily cleaned. Clean rooms are preferred in areas such as agriculture and food, pharmaceutical industry, semiconductor production, health institutions and chemical industry. It should be analyzed whether the clean rooms created within the scope of certain procedures are produced in accordance with their function.
In particular, the clean room measurement is according to the issues specified in the ISO 14644 standard. Temperature, air and humidity are parameters to consider when creating a clean room. Therefore, temperature, humidity and pressure are kept under control. In addition, the number of particles in the room must be within the specified limits. Moreover, the number of particles and microorganisms in the room stands out as two important factors in clean room classification. In this context, clean room analyzes are made and it is determined whether a clean room is created in accordance with the desired qualifications. Cleanroom analyzes basically have three elements.
1-Personnel Hand Surface Analysis: It is defined as performing some tests on the personnel hand surface. In this way, microbial pollution caused by personnel is prevented. Analysis time can vary and is usually between 5-7 days.
2-Equipment Surface Analysis: In order to prevent microbial contamination caused by equipment, samples are taken from risky points. Equipment surface analysis is performed on the samples taken.
3-Air Microbiological Measurement: Whether the air in the clean room complies with the determined criteria is determined by the Air Microbiological Measurement, which is included in the Clean Room Validation processes.
CLEAN ROOM MEASUREMENTS
Temperature and Humidity Measurement:
In particular, the purpose of temperature measurement is to document and verify the success of air conditioning systems installed for clean rooms and clean spaces in maintaining the air temperature level for the required period of time for a given area. In addition, the Temperature Measurement Test is carried out in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions. The purpose of Humidity Measurement is to document and verify the success of air conditioning systems installed for clean rooms and clean areas in maintaining the humidity level of the air for a certain period of time. Humidity Measurement Test is carried out in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions. Temperature and humidity factor are very important for clean room measurements.
Calculation of Air Flow, Air Velocity and Air Change Numbers:
The purpose of these tests is to determine the air flow rates and uniformities in clean rooms and clean areas, the air flow rates provided. With this test, the flow of air provided in Clean rooms without one-way air flow and the distribution of air velocity in Clean rooms with one-way air flow are calculated. Generally, air velocity or air flow is measured and the results of these measurements are recorded in the form of average velocity, average air flow or total air exchange. Total airflow is for calculating the number of air changes (air changes per hour) in Cleanrooms without one-way airflow. Air velocity is calculated by measuring in Clean rooms with unidirectional air flow. Measurement of Air Flow, Air Velocity and Uniformity test is carried out in accordance with ISO 14644-3:2005, EU Guide lines to GMP:2015.
Measuring Pressure Difference:
The purpose of this test is to determine the success of the entire system in maintaining the pressure difference between the Cleanrooms and other surrounding areas. The Test for Measuring Air Pressure Difference only comes after the system installed in Cleanrooms provides Air Flow Rate, Air Flow Flow Rate, Air Flow Uniformity and other applicable tests. This test is in as-built after all devices are connected, after all equipment and goods are completed, at-rest and in operational phases. Pressure Difference Measurement Test is carried out in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions.
HEPA Filter Leak Test (DOP Test):
It detects by-pass leaks, filter failure status, filter leaks (by-pass leaks consisting of filter frame and sealing elements and other leaks consisting of filter surface) that affect the cleaning success of the installed system. These tests do not check the efficiency of the installed filter. These are the tests performed by taking samples from the air outlet of the filter, the connection frame of the filter, or if the duct continues after the filter after the particles (aerosol) are introduced into the air flow direction of the filters. HEPA filter tightness test will be applied in clean rooms and clean areas, after the connection of all devices and the completion of all equipment and items, during unmanned operation (at-rest), in existing systems that are already running and have come to test, or when final stage filters are changed. Hepa Filter Equipment (DOP) Leakage Test is carried out in accordance with ISO 14644-3:2005, EU Guidelines to GMP:2015. Leak tests on clean room measurements directly affect the success of the system.
Clean Room Measurements and Decontamination (Recovery) Test:
The purpose of the Decontamination Recovery Test is to document and record the success of eliminating particles (particles) floating in the air of the setups established for clean rooms and clean areas. The success of recovering cleanliness, especially after the production of particles (particles), is one of the most important abilities of Temizoda. Also, the Decontamination Recovery Test is only important for Cleanrooms without one-way airflow. Because the recovery success is a function of the recirculated air rate, the inlet-outlet airflow pattern, thermal conditions and air distribution characteristics in clean rooms. Whereas, in clean rooms with one-way air flow, pollution can be removed with controlled air flow, so the recovery time is a function of location and distance in these areas with one-way air flow.
The decontamination recovery test should be performed at the at-rest stages after all devices are connected (as-built), after all equipment and items are completed. This test is not recommended for ISO 8 and 9 classes. Decontamination Recovery test is carried out in accordance with ISO 14644-3:2005. Decontamination Recovery Test is carried out in accordance with ISO 14644-3:2005, EU Guidelines to GMP:2015 standards and instructions.
Particle Measurement / Counting:
Particle measurement in particular is applied to determine the air cleanliness class in clean rooms and clean spaces. Moreover, the Particle Measurement test method 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. 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 placement of sampling points, determination of the clean room class and the amount of measurements required are according to the table in the ISO 14644-1:2015 standard.