Clean Room ; Airborne particles are controlled, constructed and used to minimize particle ingress, particle growth and particle accommodation, as well as temperature, humidity, pressure, etc. They are special rooms under which other parameters are kept.

• Pharmaceutical Production Facilities
• Laboratories
• Medical Equipment / Medical Device manufacturers
• Cosmetic Production Facilities
• Food Production Facilities
• Micro Electronic Parts Production Areas

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 Manufacturing Industry, Aviation and Defense Industry, Biotechnology etc. are among the priority requirements in many areas.

Validation means “VERIFICATION” and includes the verification of all stages (design, installation, commissioning, functional features, operation, performance, maintenance & operation, personnel training, etc.) from the design stage to the final result so that the system to be installed can fulfill the user requests.

TESTS PERFORMED WITHIN THE SCOPE OF THE SERVICE:

Calculation of Air Flow, Air Velocity and Air Exchange Numbers: The purpose of these tests is to determine the air flow rates and uniformities in clean rooms and clean spaces, and 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 used to calculate 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): By-pass leaks, filter failure status (small holes and other damages that may occur on the filter surface and frame connections), filter leaks (by-pass leaks, which affect the cleaning success of the system where the HEPA filter leak test is installed), -Detects pass leaks and other leaks from the filter surface). 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. HEPA filter tightness test In clean rooms and clean areas, after the connection of all devices (as-built) and after 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 in the final stage will be applied when filters are changed. Hepa Filter Equipment (DOP) Leakage Test is carried out in accordance with ISO 14644-3:2005, EU Guidelines to GMP:2015.

Measurement of 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 Air Pressure Difference Measurement Test can only be applied after the system installed in Cleanrooms provides Air Flow Rate, Air Flow Rate, Air Flow Uniformity (Uniformity) and other applicable tests. This test can be applied in at-rest and in operational phases after all devices are connected (as-built), after all equipment and goods are completed.

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:

Temperature Measurement:
The purpose of temperature measurement is to document and verify whether you can sustain the required time from the air for a given space with air conditioning for clean rooms and clean spaces. 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. .

Humidity Measurement:
Purpose of Humidity Measurement The Cleanroom can maintain the humidity profile of the air (referred to as the relative humidity or dew target) for the time required for a given area, with proper air conditioning for clean areas. 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: Particle Measurement Clean rooms are made for and for clean air cleaning class. With the particle measurement test method, they can clean their cleaners. The Particle Count Test and the completion of the installation of all clean systems (built), can be applied in the enterprise and clean enterprise, which is installed independently of all equipment and equipment. in Cleanroom and clean-friendly ISO14644-1: 2015 using ISO 1464 class to document and verify tests are carried out in accordance with required periods (periods) in 2015.

The room class at the location of the sampling points required for particle measurement and the amount of the required ones are made according to the ISO 14644-1:2015 standard.

Decontamination (Recovery) Testing: The purpose of the Decontamination Recovery Test is to maintain and record the remaining floats (batch documentation) of the setups to be considered for cleanrooms and areas. Recovery (healing) after the application of particles is one of the most important uses of Cleanrooms. The Decontamination Recovery Test is important only for ‘cleanrooms without one-way air’, because the recovery recoveries in cleanrooms are re-sirle air, inlet-outlet air pattern, thermal air and weather forecast, only in cleanroom to life worldwide Being removed with air targets related to deaths in the ‘s is a target from these travel and living spaces whose heat recovery is one-way air.

Completed in-house installation of all equipment and equipment not fully completed after the completion of the installation of all decontamination recovery facilities. This test is not recommended for ISO 8 and 9 classes. Decontamination Recovery test is performed 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.