ارزیابی پارامترهای عملکردی در فیلترهای هپا در یک صنعت دارویی(مطالعه موردی1394)

Abstract: Background and aims: Nowadays, cleanrooms have become impartible parts of an industry with sensitive products. Sources of contamination in cleanrooms are impaired performance and quality sensitive products in the cleanrooms .The aim of this study was to evaluate the efficiency of HEPA filter and check the concentration and number of airborne particles in cleanrooms for pharmaceutical industry.  Methods: This study an experimental study that was conducted at 2015  in the pharmaceutical industry. The method of this study investigated the HEPA filter leakage test and number concentration of particles in the cleanroom according to the ISO 14644 – 3 standards .17 HEPA filters were studied for cleanroom with cleanliness class B, C and D.  The leakage filters using aerosol photometer, aerosol generator and Positive injection pump and the Particle Counter was used to measure the concentration of particles. Results: In HEPA filter leakage test, 17 filters have been tested and only 3) 18 %( filters indicate leakage and had an efficiency lower than standard limits. Other filters had a no leakage and show acceptable results (99.99%). The results show that with increasing velocity, permeability and pressure drop in the range of particle size increased and decreased quality factor. In addition, the measurement results show that the concentration of particles in the cleanroom the average density of particles pollution in the cleanliness class B, C and D of the ISO-14644 standard limits was lower. Conclusion: the study showed that the airborne particles concentration are lower than the permissible limits which determined by ISO 14644 standards. Interestingly in this study, the impact of high air quality cleanroom was a good performance HEPA filters.