ABSTRACT
Abstract For places where non-sterile drug production occurs, regulatory bodies recommend monitoring of the environmental bioburden. This procedure provides information regarding possible microbiological risks to which the products may be exposed, so that subsequent action measures may be implemented. The aim of the present work was to quantify and characterize the microorganisms present in Grade D (ISO 8) cleanrooms of a Brazilian pharmaceutical industry, identifying any possible seasonal climatic influences on these environments. Sampling was performed by surface and air monitoring, over 12 months during the year 2019, in rooms that were in operation. For both sampling methods, no statistically significant differences in bacteria and fungi counts were found between months or seasonal periods. Microorganisms that presented higher incidence included Staphylococcus epidermidis (15%) and Micrococcus spp. (13%), common to the human microbiota, and the fungi Cladosporium sp. (23%) and Penicillium sp. (21%), typical of the external environment. The results showed that microbial contamination in the Grade D cleanrooms was within the permissible maximum levels and remained similar throughout the year. Microbiological quality control in the clean areas of the pharmaceutical industry investigated was considered effective, with regular maintenance being necessary to keep bioburden levels controlled.
ABSTRACT
@#The effects of children’s exposure on high concentration of airborne pollutants at schools often associated with increased rate of absenteeism, low productivities and learning performances, and development of respiratory problems. Recent studies have found that the presence of occupants in the classroom seems to give major effect towards the elevation of concentration of airborne pollutants in indoors. In order to evaluate and further understand on the significance of occupancy factor on IAQ, this study has been designed to determine and compare the level of selected physical (particulate matter (PM)) and chemical (carbon dioxide (CO2) and temperature) IAQ parameters and biological contaminants via colony forming unit (CFUm-3 ) for bacteria and fungi inside the selected classrooms during occupied and non-occupied period (first objective). The second objective is to describe the possible sources of airborne pollutants inside the classrooms at the selected primary schools around Kuantan, Pahang. Assessments of physical and chemical IAQ were done by using instruments known as DustMate Environmental Dust Detector and VelociCalc® MultiFunction Ventilation Meter 9565.The data were recorded every 30 minutes for 8 hours during schooldays and weekend at the selected sampling point in the classrooms. For microbial sampling, Surface Air System Indoor Air Quality (SAS IAQ) was used to capture the bacteria and fungi. The data obtained were compared with the established standard reference known as the Industrial Code of Practice on Indoor Air Quality (2010) constructed by the Department of Occupational Safety and Health (DOSH), Malaysia. This study has found that some of the IAQ parameters in the selected classrooms were exceeding the established standards during occupied period in schooldays compared to non-occupied period during weekend. Findings of this study provide the insights for future research including the site selection of school, arrangement of the classrooms and numbers of students per class.