Microbiological evaluation of the environmental quality of a pharmaceutical plant in Lagos, Southwest Nigeria

Abstract

The evaluation of predominant microorganisms distributed in the air of the critical rooms in the production plant of a pharmaceutical company in Agege Local Government area, Lagos-Nigeria was investigated using settle- plate method. A total of seven critical rooms in the production facility that is, Dispensary, Granulation, Blending, Blistering, Tableting, Syrup, and Syrup filling rooms were sampled respectively under aseptic conditions. These samples were processed in duplicates on Sabouraud Dextrose Agar (SDA) and Tryptone Soya Agar (TSA) and incubated at 25ºC and 37 ºC respectively. Thereafter, microorganisms were isolated and identified using standard and conventional methods. The data obtained were analyzed to find the microbial distributions in the environment of the pharmaceutical facility. Eight bacterial species were isolated from different locations in the pharmaceutical facility, they were of the following genera; Staphylococcus (12.5%), Micrococcus (50%) and Bacillus (37.5%). Most of the microorganisms found in this study belong to the genus Micrococcus (four species) and three Bacillus species and one Staphylococcus species. Despite the compliance of this company with international standards, the above mentioned microbial species were still found within the facility. Hence, compliance with the international specified standard alone, that is, Good Manufacturing Practice (GMP) does not guarantee sterile pharmaceutical product from the industry. Therefore, other microbial quality assurance procedures must be strictly adhered to in order to have products that comply with international specifications. The microbial isolates from the pharmaceutical facility include: Bacillus subtilis, Bacillus badius, Staphyloccocus aureus, Proteus mirabilis, Microccocus sp. Pseudomonas aeruginosa, Enterobacter aerogenes, Citrobacter sp. Talaromyces sp. Aspergillus tamari.