DRUG CONTAMINATION WITH THE BACTERIA BURKHOLDERIA CEPACIA

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DOI: https://doi.org/None
Issue: 
7
Year: 
2017

L.V. Kolosova, PhD; M.V. Roshchina; O.V. Gunar, PhD Research Center for Examination of Medical Products, Ministry of Health of Russia; 6, Shchukinskaya St., Build. 1, Moscow 123182, Russian Federation

Introduction. Burkholderia cepacia (B. cepacia) is one of the leading pathogens of human opportunistic, nosocomial, and postoperative wound infections. There is information in the foreign literature on the contamination of ready-made drugs and excipients with these microorganisms. Objective: to identify and investigate B. cepacia in the drugs available on the Russian pharmaceutical market. Material and methods. 4935 samples of different dosage forms were analyzed. The samples were selected, prepared, and tested in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, Editions XII and XIII (the general pharmacopoeial articles «Microbiological purity» and «Sterility»). Direct inoculation and membrane filtration methods were applied. Microorganisms were identified using a Vitek 2 Compact analyzer. Results. Microbial contaminants were isolated from the drugs not meeting the requirements of the normative documents and identified. B. cepacia was found in 10.34% of the samples. Whether the viability of these bacteria could be preserved in the contaminated drugs was investigated. Conclusion. Both nonsterile drug (nasal spray) samples and sterile solutions for injection were ascertained to contain B. cepacia during a long shelf-life (for 6–24 months). According to the data available in the literature on an extreme danger of these bacteria and the obtained results from this investigation, their presence in some drugs, particularly in nasal sprays, can be considered unacceptable.
Keywords: 
drugs
quality control
microbiological methods
microbial contaminants
Burkholderia cepacia
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