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What is Validation?
Validation is the process of proving that any procedure, process, equipment, material, system or activity produces the expected results according to the principles of quality manufacturing practices. With validation;
Quality is assured, variability is minimized,
The accuracy, precision and repeatability of the process are proven,
Efficiency is increased, energy is saved,
Well-controlled, reliable protected areas are created,
Training and information of the working personnel are provided on this subject.
All tests related to receiving must be performed by an individual or group independent of the planner, supplier, system installer and the hygiene expert responsible for evaluating the systems.
Regarding the controls to be carried out in hygienic areas, first of all, qualification requirements,
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (PQ) must be provided.
It must be checked whether the design and installation qualifications are suitable according to the relevant standards.
In the control of the operation qualification, physical and microbiological controls must be carried out. Physical controls include temperature, humidity, differential pressure, air flow, particle determination. Microbiological tests must be carried out by an expert microbiologist.
In the performance qualification control, whether the operating rooms and hygiene rooms work correctly must be checked by making measurements and tests.
Each of the measurement devices must be calibrated at certain periods, by certified and documented companies, with systems that can definitely be monitored in a national standard. Calibration of measurement devices at certain periods is mandatory.
We can list the points to be considered in the measurements and controls made in hygienic areas as follows.
Determining whether they comply with the relevant standards (installation, design, operation),
Classification and grading of system filters,
Selection of suitable filters,
Air flow rate tests,
Amount of fresh air,
Air differential pressure difference tests,
Room comfort parameters (room temperature, fresh air inlet temperature, air inlet amount, turbulence degree, noise pressure level and relative humidity measurement),
Determining the clean room class,
Determining the air flow direction at the doors,
Air particle count,
Determining air change rates,
Hepa filter leakage test,
Hepa filter particle count,
Visual monitoring of air flow (smoke test),
Performing air flow tests and arranging air flows,
Determining the time for cleaning rooms from particles,
Measurement of light and noise levels,
Clean area improvement tests,
Performing microbial controls,
Determining filter efficiencies.
Particle count and air microorganism concentration should be measured after each change of the HEPA filter.
Within the scope of validation, which confirms that the system consisting of the ventilation system tests mentioned above works correctly;
A full-fledged assessment result report indicating the current status of your clean rooms, including the main scheme and sampling plan of the validated clean rooms, measurement results, calibration dates of the measurement devices, general deficiencies and outputs from the measurement devices, should be prepared.
We can collect the qualification conditions to be considered regarding the ventilation system tests performed in clean rooms under 4 main headings.
Design Qualification (DQ, Design Qualification)
Installation Qualification (IQ, Installation Qualification)
Operation Qualification (OQ, Performance Qualification)
Performance Qualification (PQ, Performance Qualification) should be provided.
Documentation and installation studies of the type and brand of the fan used in a clean room design, pulley diameter, motor power and brand conformity to the design and specifications are defined as installation qualification and IQ.
The measurement of the speed, flow rate, static pressure and ampere drawn by this fan and the documentation of the conformity of these values to the design values are called operating qualification and are defined as OQ.
While the installation qualification checks the conformity with the design and technical specifications, the operating qualification documents that each equipment in the air conditioning system fulfills the functions defined in its design.
Performance qualification studies are measurement studies directly related to the clean room and control its performance.
The following should be taken into consideration in the physical tests to be carried out in the ventilation system.
Fan operating test including fan speed measurement,
Filter operating test including filter surface speed and pressure loss,
Operating test including the performance of the battery,
Pressure loss test including the performance of the fans,
Sealing test protecting the air capacity in the ducts,
In the physical tests to be carried out in clean rooms, the following should be taken into account attention should be paid.
Hepa Filter Efficiency Test
Hepa Filter Air Velocity Measurement
Room Air Change Number Measurement
Room Classification
Re-Cleaning Time Measurement
Pressure, Temperature, Humidity Measurement
Critical Area Curves Measurement
Air Flow Direction Determination
In microbiological controls, the conformity of microbiological quality is determined by measuring the amount of microorganisms in the air, on the surface, in the equipment, on the personnel, in the system. All physical and microbiological conformity tests constitute ventilation validation.
İlker KURAN
Alperen Ltd Şti