Objective: To quickly detect contaminating microorganisms in the production process of pharmaceutical companies by using molecular biology methods, and establish contaminating drug-contaminated microorganism resource bank and database at the same time, so as to provide corresponding technical guidance for drug manufacturers to trace pollution sources. Methods: Oral solid preparations, pharmaceutical water, staff and production environment for a pharmaceutical company were monitored microbiological for six months. The traditional morphological method and molecular biology method with 16S rDNA sequence comparison were used to identify contaminated microorganisms, and the results were analyzed and sorted to establish a drugcontaminated microorganism resource bank and database. Results: A total of 294 strains of microorganisms were collected, of which the production environment had the highest microbial contamination rate, accounting for 92. 5% of all pollution sources;followed by oral solid preparations（3. 7%）, pharmaceutical water（2. 0%）, and staff（1. 7%）. The contaminating microorganisms were mainly distributed in 20 genera and 35 species, of which the Staphylococcus contamination rate reached 56. 3%, followed by Bacillus（17. 6%）, Micrococcus （15. 8%）, and Microbacteria（4. 0%）. According to the identification results, the four aspects of pollution source, culture characteristics, morphological staining and bacterial Genebank number were summarized, and the contaminated microbial resource bank and database were established with Excel and Word electronic documents. Conclusion: In this study, a variety of contaminating microorganisms ware detected in multiple drug production processes. Therefore, the establishment of a contaminated microbial resource bank and database for pharmacy companies can provide a technical platform for future risk assessment and adverse event investigation of pollution levels.
LI Nan, SUN Li-yuan, GUAN Yi-ze, ZHAO Yuan, WANG Xin-ying, LIU Yue, ZHAO Yun-dong
. Rapid identification of contaminated microorganisms in drug production work area and establishment of contaminated microorganism resource bank and database*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(3)
: 474
-483
.
DOI: 10.16155/j.0254-1793.2021.03.13
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