ABSTRACT
@#Objective To establish CNC(controlled not classified)area microbial database of pharmaceutical enterprises,conduct correlation analysis with microbial distribution in clean area to achieve good microbial control in the clean area,especially in the core aseptic operation area,and improve the sterility assurance level of pharmaceutical enterprises.MethodsThe CNC area of a manufacturing workshop from pharmaceutical enterprise was selected as the research object,the airborne microbe,settling microbe,personal and environmental surface microorganisms were sampled one by one in the CNC area according to the route of personnel and materials entering the clean area. After the microorganisms were cultured and purified,the 16S rRNA sequencing method was used to identify the strains. Microbiomeanalyst online analysis software was used for data analysis.ResultsThe number of microorganisms in the CNC area of pharmaceutical enterprises was large and the species were rich. A total of 4 080 microorganisms were collected,which distributed in 47 genera. Gram-positive bacteria accounted for 84. 4%,mainly belonging to Staphylococcus,Micrococcus,Microbacterium. Gram-negative bacteria accounted for 15. 6%,and the distribution of Acinetobacter was much higher than other gram-negative bacteria. The Alpha diversity index was used to characterize the richness of microbial populations. The richness of microbial populations of airborne microbe and settling microbe was the highest,followed by environmental surface microorganisms,and the microbial population richness of personnel surface microorganism was the lowest. The number of microorganisms in the personnel's hood and chest was relatively small,and the number of microorganisms in the personnel's soles of feet and hands was relatively large. There were relatively few types of microorganisms on the surface of personnel,and staphylococcus showed an absolute advantage. The microbial distribution in CNC area was correlated with the microbial distribution in Class B and C clean areas of the same production workshop. Most of the microorganisms collected in Class B and C clean areas were included in the microbial population in CNC area. Class B and C clean areas were similar to CNC area,both of which were dominated by Staphylococcus and Micrococcus. The distribution proportion of Acinetobacter in Class B and C clean areas decreased compared with that in CNC area.ConclusionThe CNC area microbial database of the pharmaceutical enterprises has been established and the microbial population that is easy to enter the clean area has been determined,providing reliable technical support for the good microorganism control in the clean area
ABSTRACT
In this study, we focussed on the isolation, enumeration, distribution and occurrence of rhizomicroflora of Musa sapientum var parasidiaca and Senna occidentalis. The population, occurrence and distribution of culturable bacteria, fungi and actinomycetes in 5, 10, 15, and 20 cm depths rhizosphere samples of Musa sapientum var parasidiaca and Senna occidentalis growing in the botanical garden of the University of Lagos, Akoka, Nigeria, were investigated using standard plate count and biochemical techniques. Bacteria were the most predominant in the rhizosphere of both plants, followed by fungi, then actinomycetes. The culturable microbial population was at its maximum for depths 10 and 15 cm in M. sapientum var parasidiaca. In S. occidentalis, bacterial population was highest at 5cm, fungi at 10cm and actinomycetes at 15cm depth of the rhizosphere. Bacillus cereus had 100% distribution in the rhizosphere of both plants and Staphylococcus aureus, Pseudomonas aeruginosa, Proteus mirabilis each had 75% distribution in both rhizospheres. Rhizosphere depth of 10 cm had 100% distribution of bacteria, and the least bacterial distribution was found at 20cm. Fungi were most distributed at 15cm rhizosphere of M. sapientum var parasidiaca and at 10 and 15 cm rhizosphere of S. occidentalis. Rhizopus stolonifer had 100% distribution and the highest % occurrence in the rhizosphere of both plants with Aspergillus niger having 100 and 75% distribution in the rhizosphere of M. sapientum and S. occidentalis respectively. Actinomycetes were most distributed at 10 cm (60 and 80% in rhizosphere of M. sapientum and S. occidentalis respectively). Streptomyces sp had the highest distribution in the rhizosphere of both plants and 58.33 and 55.17% occurrences in rhizosphere of M. sapientum and S. occidentalis respectively. Streptomyces alanosinicus and S. gancidicus were absent among the rhizosphere isolates of M. sapientum. Similarly, S. globosus and S. sampsonii were not found in the rhizosphere of S. occidentalis. The abundance of the microorganisms in these rhizospheres is typical of an environment with high species richness and functional diversity.