Clean room analysis is the process steps that enable the creation of clean rooms at the desired level and quality.Rooms established for production or research purposes and free from dust and other particles in the air are called “clean rooms”. Since it is installed for special purposes, both the room itself and the equipment used must be easily cleanable.
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. So what is clean room analysis and which steps are used during the analysis?
Clean rooms are created according to the issues specified in the ISO 14644 standard and are generally preferred in medical fields. 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.
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 is created in accordance with the desired qualifications. There are basically three elements of clean room analysis. These are the elements;
Personnel Hand Surface Analysis, which is among the types of clean room analysis, can be defined as performing some tests on the hand surface. In this way, microbial pollution caused by personnel is prevented. Analysis time varies and is usually between 5-7 days.
In order to prevent microbial contamination from equipment, samples are taken from risky points. Equipment surface analysis is performed on the samples taken.
Whether the air in the clean room complies with the determined criteria is determined by the Air Microbiological Measurement, which is one of the clean room analysis types.
Testing the clean room and determining whether it is produced according to the appropriate criteria prevents many problems from occurring during use. In this context, we can say that the following titles are used in clean room tests:
Clean room analyzes are carried out over many aspects to control the cleaning success of the system in systems with HEPA filter leak test installed. Filter failures, bypass leaks and filter leaks are effectively determined by the technology used. The HEPA Filter Leakage Test must be performed in accordance with the “ISO 14644-3:2005 EU Guide lines to GMP:2015” standards.
The specified test is used to determine air flow rates, uniformities and airflow rates in clean rooms. Within the scope of the method, air velocity or air flow is measured. The results of the measurements are recorded as average air flow, total air change or average velocity.
Temperature and Humidity Measurement
In clean rooms, the ideal temperature must remain the same for the specified time. Therefore, it is very important to make and document temperature measurements in clean rooms. Humidity is measured in clean rooms in order to maintain the air humidity level for the specified period of time. Both temperature and humidity measurement are carried out in accordance with certain criteria.
Pressure difference test is performed in order to maintain the pressure difference between the installed system and clean rooms and the surrounding areas.
Nova Test provides the necessary support for the creation of competent, qualified and clean rooms in accordance with the determined criteria. For detailed information, you can contact us and have information about our service.