A One-Year Environmental and Microbiological Monitoring of Storage Areas and Production Room of a Pharmaceutical Industry from Northern Nigeria

Abstract

The degradation and reduction of the potency of both raw materials and finished pharmaceutical products (FPPs) are of great concern to pharmaceutical industries, making the environmental monitoring of storage areas and production rooms a must. In this study, a one year monthly data for environmental and microbiological monitoring for storage areas (raw materials quarantine room, raw materials approved room, finished product quarantine room and finished product approved room) and production room were collected  and analyzed using IBM SPSS Statistics Version 23. The results revealed that the lowest temperature (21.01oC) was obtained from the raw materials approved room. At the same time, the highest (29.50oC) was recorded from the finished product quarantine room. In contrast, the lowest relative humidity of 11.11% was obtained from raw materials quarantine room while raw materials approved room had the highest relative humidity of 33.33%. The results obtained for microbial loads showed that Escherichia coli, Staphylococcus aureus, Salmonella typhimurium and Pseudomonas aeruginosa recorded 0.00cfu/ml each. In contrast, the value obtained for total viable aerobic mesophilic bacteria plate count ranges from 0.00-28.67 cfu/ml and fungi range from 0.67-5.00 cfu/mL respectively. The significant difference was determined at p<0.05. However, the results obtained for the temperature, relative humidity and microbial loads were within the stated specifications. This shows that the temperature and relative humidity of the storage areas and the production room were controlled and well monitored in line with the current good manufacturing practice which will eventually positively impact the quality, marketability and stability of raw materials and drug products. Environmental monitoring of storage areas and production room should be highly encouraged in pharmaceutical industries to curb the menace of speedy degradation and loss of potency experienced in raw materials and finished pharmaceutical products.