Active versus Passive Microbiological Air Sampling Risk Assessment: Relation and Comparative Study in Pharmaceutical Industry

Abstract

Microbiological environmental monitoring of pharmaceutical manufacturing area is an essential task for control of the quality during medicinal dosage forms production. However, thorough scientific approach is critical to elucidate the full potential of microbiological test results and its significance. In the present study, 205 passive and 451 active air samples were withdrawn during course of ten months from air in class C production facility, dedicated for manufacturing of liquid and semisolid pharmaceuticals. Microbial counts of samples were enumerated and recorded then the results were trended and analyzed using commercial statistical software package. The outcome of data analysis showed that the general trend lines were shifted towards increasing of bioburden. For convenience, data were grouped into three main categories viz. passive air samples (PAS), active air samples (AAS) of manufacturing rooms and AAS for the main corridor and airlocks (AAS_cal). PAS bioburden counts were significantly lower than both AAS and AAS_cal which were not appreciably different from each other. However, they showed significant correlation between each other. Interestingly, there was significant linear relationship between AAS and both of PAS and AAS_cal which have pooled slope equals 0.72. Risk of failure for microbiological samples was higher for AAS_cal than AAS and AAS than PAS. The former was expected due to nature of the activity and the later because of the difference in the sensitivity. The currently applied analysis provided insight for quality monitoring and evaluation of bioburden in air of clean rooms in addition to rapid spotting of defects for immediate corrections.

Keywords: Environmental monitoring, pharmaceutical manufacturing, passive air, active air, out-of-control

Cite this Article
Eissa ME, Mahmoud AM, Nouby AS. Active versus Passive Microbiological Air Sampling Risk Assessment: Relation and Comparative Study in Pharmaceutical Industry. Research and Reviews: A Journal of Pharmaceutical
Science. 2016; 7(1): 13–27p.