Assessment of Functional Parameters of Hepa Filters in a Pharmaceutical Industry (Case Study)



Damiri Z¹ ; Yarahmadi R² ; Sharifi J³
Source: Iran Occupational Health Published:2017

Abstract

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