Abstract

The spread of bacterial resistance to antibiotics affects various areas of life. The aim of this study was to assess the occurrence of Pseudomonas aeruginosa, and other bacteria mainly from orders Enterobacterales and Staphylococcus in the pharmaceutical production sites, and to characterize isolated strains in the aspects of antibiotic resistance, biofilm formation, and presence of genes encoding virulence factors. Genes encoding selected virulence factors were detected using PCR techniques. Antimicrobial susceptibility testing was applied in accordance with the EUCAST recommendations. A total of 46 P. aeruginosa strains were isolated and 85% strains showed a strong biofilm-forming ability. The qualitative identification of genes taking part in Quorum Sensing system demonstrated that over 89% of strains contained lasR and rhlI genes. An antimicrobial susceptibility testing revealed nine strains resistant to at least one antibiotic, and two isolates were the metallo-β-lactamase producers. Moreover, the majority of P. aeruginosa strains contained genes encoding various virulence factors. Presence of even low level of pathogenic microorganisms or higher level of opportunistic pathogens and their toxic metabolites might result in the production inefficiency. Therefore, the prevention of microbial contamination, effectiveness of sanitary and hygienic applied protocols, and constant microbiological monitoring of the environment are of great importance.

Highlights

  • Maintaining microbiological purity of the process of manufacturing medicinal products constitute an exceptionally important aspect in pharmaceutical production

  • The aim of this study was to assess the occurrence of P. aeruginosa and other microbiota in the pharmaceutical production environment to characterize isolated strains in the aspects of antibiotic resistance, biofilm formation, and presence of genes encoding virulence factors

  • Medicines and dietary supplements may be contaminated by wide spectrum of microbes

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Summary

Introduction

Maintaining microbiological purity of the process of manufacturing medicinal products constitute an exceptionally important aspect in pharmaceutical production. The occurrence of bioburden on the surface of production equipment is a serious issue, because of the possibility of microbial contamination of the medicinal products. Any element of the pharmaceutical production environment: raw materials, technological media, personnel, air, or usable surfaces may constitute the source of microorganisms. The dominant form of microbial existence, both in natural and industrial ecosystems, is biofilm in which microorganisms carry the ability to cause infections. Bacteria in biofilms are more resistant to disinfectants and antibiotics in comparison to their planktonic counterpart [1,2,3]. In order to obtain a medicinal product of adequate microbiological quality, factories manufacturing medications follow the principles of Good

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