Clean Room Validation is the work 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, pressure. Validation means “VERIFICATION”. It includes the verification of all stages (design, installation, commissioning, functional features, operation, performance, maintenance & operation, personnel training) from the design stage to the final result so that the system to be installed can fulfill the user requests. Especially clean room systems, Human Health Activities, Health Industry, Biomedical Industry, Pharmaceutical Industry, Veterinary Industry, Food Industry, Chemical Industry, Semiconductor Industry, Conductor Industry, Electronics Industry, Optical Production Industry and Aerospace and Defense Industry are among the priority requirements.
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.
HEPA Filter Leakage 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), which 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 given to the air flow direction of the filters. The 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, 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.
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 the 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 the phases of unmanned operation and during manned operation, after the connection of all devices is completed, after the completion of all equipment and goods. Pressure Difference Measurement Test is performed in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions.
Temperature and Humidity Measurement with Clean Room Validation:
In particular, the purpose of Temperature Measurement is to document and verify the success of air conditioning systems installed for clean rooms and clean areas 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.
Particle Measurement / Counting:
Particularly Particle Measurement It is applied to determine the air cleanliness class in clean rooms and clean areas. Moreover, the Particle Measurement test method provides the measurement of particles in the size range of 0.1 μm to 5 μm in clean rooms and clean areas and the 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 location 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.
Decontamination (Recovery) Test:
The purpose of the Decontamination Recovery Test is to document and record the success of the devices installed for clean rooms and clean areas in eliminating floating particles in the air. The success of cleaning, especially after particle production, is one of the most important abilities of cleanrooms. 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, inlet-outlet airflow pattern, thermal conditions and air distribution characteristics in clean rooms. However, in clean rooms with one-way air flow, pollution can be removed with controlled air flow. Therefore, the recovery time is a function of location and distance in these unidirectional airflow areas.
The decontamination recovery test should be performed during unmanned operation phases, after all devices have been connected, after all equipment and items have been 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.
CLEAN ROOM VALIDATION AND ANALYSIS
These are the process steps that enable the creation of clean rooms at the desired level and quality. Clean Room Validation is very important. 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, healthcare 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, clean room validation is based on the issues specified in the ISO 14644 standard. Temperature, air and humidity are parameters to be considered during the creation of 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 factors that have an important place in the classification of clean rooms. In this context, clean room analyzes are made and it is determined whether a clean room has been created in accordance with the desired qualifications. Cleanroom analyzes basically have three elements. These 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 Samples are taken from risky points in order to prevent equipment-induced microbial contamination. 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.