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Clean Rooms; These are special rooms where the concentration of particles flying in the air is kept under constant control by measurements, built and used in a way to minimize particle entry, particle proliferation and particle harboring, and where other variables such as temperature, humidity, pressure, air flow patterns, etc. are kept under control to the extent necessary.

Today, clean room systems are among the priority requirements in many fields such as Human Health Activities, Biomedical Industry, Pharmaceutical Industry, Veterinary Medicine, Food Industry, Chemical Industry, Semiconductor Industry, Conductor Industry, Electronics Industry, Optical Production Industry, Aviation and Defense Industry, Biotechnology etc.

HVAC performance tests alone cannot be considered as Clean Room Validation. HVAC performance tests take place within the framework of PQ (Performance Qualification), which is part of the testing and inspection processes carried out within the scope of Clean Room Validation. In fact, Clean Room Validation has an extremely broad content that includes evaluation studies such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification).

It means “VALIDATION” and includes the validation of all stages (design, installation, start-up, functional characteristics, operation, performance, maintenance & operation, personnel training, etc.) from the design stage to the final result in order for the system to fulfill the user requirements.

During the installation of HVAC systems in qualified areas such as clean rooms and sterile areas, the main mistake made by non-professional teams is that performance tests are considered as clean room validation. Unless the above-mentioned basic verification stages of HVAC systems are performed, the fact that a newly installed ventilation system has successfully passed the performance tests is often repeatable and does not mean that successful results will be obtained consistently throughout the year.

TESTS PERFORMED WITHIN THE SCOPE OF SERVICE

  • Calculation of Air Flow, Air Velocity and Air Change Counts
  • HEPA Filter System Leakage Detection (Dispersed oil particulate (DOP) Test)
  • Content Leakage Testing
  • Measurement of Pressure Difference
  • Measurement of Temperature and Humidity
  • Particle Measurement / Counting
  • Decontamination (Recovery) Test

TS EN ISO/IEC 17020 Conformity assessment — Requirements for the operation of various types of bodies performing inspection

TS EN ISO 14644-1 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

TS EN ISO 14644-2 Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

TS EN ISO 14644-3 Cleanrooms and associated controlled environments — Part 3: Test methods

IEST-RP-CC006.3 Testing Cleanrooms

IEST-RP-CC034.3 Hepa and Ulpa Filter Leak Test

VDI 2083-Part 3 Cleanroom Technology Metrology and Test Methods

Eudralex Volume 4 Medicinal Product for Human and Veterinary Use Annex 1

FDA c GMP Sterile Drug Products Produced by Aseptic Processing

DIN 1946-4 Ventilation and Conditioning-Part 4: VAC Systems in buildings and rooms used in the health care sector