Analysis of microbial communities in clean areas of five pharmaceutical companies

Objective: To study the composition and distribution of microbial communities in clean areas of pharmaceutical companies, and to provide a basis for good microbial control in pharmaceutical companies. At the same time, it also provides data support for investigation and analysis of exceeding standards, traceability analysis of drug detected bacteria, and establishment and analysis of a clean environment bacteria database.

Methods: Settlement bacteria were collected at the production cleanrooms, clean laboratories, operators, and other monitoring points of five pharmaceutical companies : A, B, C, D, and E. Using 16S rRNA sequence analysis, ITS sequence analysis, and housekeeping gene sequence analysis, The collected bacteria and fungi were identified to the genus or species.

Results: A total of 139 bacteria and 5 fungi were collected in this study. 16S rRNA sequence analysis results identified 40 strains of Staphylococcus, accounting for 27.8%; 27 strains of Micrococcus, accounting for 18.8%; 16 strains of Bacillus, accounting for 11.1%; 9 strains of Microbacteria, accounting for 6.3%; 8 strains of Acinetobacter, accounting for 5.6%; 6 strains of Pseudomonas, accounting for 4.2%; 5 strains of fungi, accounting for 3.5%; 33 strains belonging to 10 genera, 22.9%.

Conclusion: The composition of pharmaceutical clean environment microorganisms is mainly Gram-positive cocci including staphylococcus and micrococcus; Gram-positive bacilli include bacillus and microbacteria; a small number of gram-negative bacilli such as Pseudomonas and Acinetobacter ; Also includes small amounts of fungi. It is suggested that pharmaceutical companies should control the number of personnel in the clean zone, regulate the procedures for changing clothes and entering the field and clean zone behavior, develop effective cleaning and disinfection procedures, strengthen environmental monitoring, analyze the monitoring data regularly, study the trend of data changes, and abnormal data should be taken in time. To keep the clean area in a well-controlled state.

prepGEM Bacteria was used in this study to extract bacteria DNA.