Cleanroom Validation Services
Cleanroom validation is the process of testing, calculating and reporting that proves a cleanroom performs at its design class. All tests are carried out in accordance with ISO 14644 and the corresponding TS EN standards.
Calibrated instruments are mandatory for these measurements. Therefore we keep all required test equipment in house through our Sugold Türkiye representation. As a result, the time between measurement and reporting is shortened.
We provide validation services for industrial cleanrooms used in medical and sterile production. In addition, we successfully carry out our measurements in healthcare facilities, including operating theatres, general surgery, cardiovascular intensive care and neonatal intensive care units.
Room Classification
The room is classified between ISO 5 and ISO 8 to ISO 14644-1. The number of sampling points is calculated from the room area.
Particle Counting
Point-by-point measurement is performed with a laser particle counter at 0.5 µm and 5 µm. Results are compared with the class limits.
Airflow Measurements
Supply and extract volumes are measured with a balometer. The air change rate per hour (ACH) is then calculated.
Pressure Control
Differential pressures between adjacent spaces are measured. This verifies that contaminated air cannot enter the clean area.
Where Do We Carry Out Cleanroom Validation?
Pharmaceutical and Sterile Production
Periodic validation of Grade A-D production areas under GMP.
Operating Theatres and Intensive Care
Operating theatres, surgical and cardiovascular ICUs and neonatal units.
Food and Cosmetics
Air quality verification on hygienic filling and packaging lines.
Laboratories and R&D
Analytical laboratories, biosafety cabinets and R&D cleanrooms.
Scope of Our Cleanroom Validation Services
Definition of a Cleanroom
A cleanroom is a hygienic environment in which air quality is kept within defined limits. Products, tools, equipment and people are protected from inanimate particles such as dust, waste anaesthetic gas and odours. In addition, living particles such as germs and microorganisms are kept under control. These conditions are defined by international standards (DIN 1946/4 and/or ISO 14644).
The primary aim in a cleanroom is to achieve a clean air environment that complies with the standards. The temperature, humidity and pressure conditions required by the process are then established. These conditions are continuously monitored.
During the design stage it is determined which of the parameters — temperature, humidity, pressure, noise level and air movement — are critical. This assessment is based on the intended use of the room. Consequently, all factors must be evaluated together during design, construction and operation.
General Scope of Cleanroom Technology
Cleanroom Validation and Filter Testing
Healthcare and food facilities engaged in hygienic production still face significant costs. The main reason is in situ filter test failures caused by inadequate test methods and poor practice. As a result, filter leakage continues without being noticed.
Selecting the correct test method reduces this risk considerably. Furthermore, keeping the complete equipment set available for regular testing lowers the failure rate.
The source of leakage is usually the filter itself or the filter housing. Therefore properly conducted tests identify the root cause and allow a permanent solution to be developed.
TS EN ISO 14644 Standard Definitions
HEPA Filter Testing
HEPA filters capture almost all particles of 5 µm and above. However, the true efficiency of a filter is measured at the most penetrating particle size (MPPS). This size is generally in the range of 0.15-0.25 µm. Depending on the selected filter class, the retention efficiency in this range varies between 95% and 99.9995%.
A filter failure or incorrect installation directly degrades clean air quality. For this reason the HEPA filter is tested in place. This guarantees that the air supplied to the room meets the cleanliness required by the selected filter class.
If no leakage is detected, the clean air supply is confirmed. Nevertheless, filter performance declines over time. Consequently, installed HEPA filters must be retested at regular intervals.
Main Reasons for Testing a Filter
Qualification – Installation Test
It verifies that the installation complies with the order and installation specification. In addition, it confirms the quality of the purchased product.
Periodic Leak Testing
In situ testing shows that the filter maintains its performance over time. This allows early intervention when a problem appears.
Health and Safety Requirements
Regulations require documented evidence that clean air is supplied to the cleanroom. Therefore regular testing and reporting are necessary.
Request Information on Cleanroom Validation Services
If you would like information about our cleanroom validation services and our other solutions, please contact us. You can share the details of your facility by phone on +90 216 606 25 38 or by e-mail to [email protected].
