Acta Pharm. 66 (2016) 289-295


full paper

Short communication


Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry


1 Quality Assurance, Profit Center Pharmaceuticals, Alkaloid AD, Skopje, Republic of Macedonia

2 Laboratory for Molecular Biology, Institute of Biology, Faculty of Natural Sciences and Mathematics, Ss. Cyril & Methodius University, Skopje, Republic of Macedonia

Accepted October 13, 2015

Published online March 24, 2016


Microbiological control has crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16S rRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in the pharmaceutical industry quality control.

DNA was extracted from overnight incubated colonies from 10 bacterial ATCC strains, which are common contaminants in the pharmaceutical industry. A region of bacterial 16S rRNA gene was analyzed by bidirectional DNA sequencing. Bacterial identification based on partial sequencing of the 16S rRNA gene is the appropriate method that could be used in the pharmaceutical industry after adequate validations. We have successfully identified all tested bacteria with more than 99 % similarity to the already published sequences.


Keywords: 16S rRNA, genotyping, bacterial identification, pharmaceutical industry