Microbial quality evaluation of two pharmaceutical companies in Kano State, Nigeria

Abstract

Environmental monitoring is one of the systems that helps determine the quality of product in the manufacture of pharmaceuticals in a pharmaceutical industry. This research was therefore carried out to evaluate the microbial quality of air, equipment and personnel in two pharmaceutical plants coded as Plant A and Plant B in Kano state, Nigeria. Parameters such as aerobic mesophilic bacterial and fungal count, and identification, were carried out. Data obtained from the study showed that some of the sampled air exceeds the limit of European Union (EU) and World Health Organization Good Manufacturing Practice (WHO GMP) with <100cfu/4hrs especially for Plant B. Meanwhile, the most prominent organism isolated from air was Micrococcus luteus . Similarly, some swab samples from personnel and equipment did exceed the permissible microbial limit with 198 CFU/25 cm 2 and 156 CFU/ cm 2 being the highest respectively. Organism isolated from these samples includes M. luteus , Klebsiella sp, Citobacter sp, Providencia sp and Erwinea ( Pectobacterium ). The Citobacter sp was isolated from the hands of personnel who manually fill methylated spirit and from the jug used in the course. Isolated fungi from this research were Aspergillus niger , A. amstelodami , Penicillium spinulosum and Saccharomyces cerevisiae . The results show that while the microbial limit for equipment are still within permissible levels, there is a need to improve on personnel hygiene and air quality in the plant. Keywords: Environmental monitoring, Pharmaceuticals, Microbial quality, EU, WHO GMP, Swab sample