期刊文献+

Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit 被引量:3

Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit
在线阅读 下载PDF
导出
摘要 Aims: To screen for the predominant bacteria strains distributed in clean rooms and to analyze their phylogenetic relationships. Methods and Results: The bacteria distributed in air, surfaces and personnel in clean rooms were routinely moni-tored using agar plates. Five isolates frequently isolated from the clean rooms of an aseptic pharmaceutical production workshop were selected based on their colony and cell morphology characteristics. Their physiological and biochemical properties, as well as partial 16S rDNA sequences, were analyzed. Results showed that all the five isolates belong to Gram positive bacteria, of which three were Staphylococcus, one Microbacterium and one Bacillus species. Sensitivity tests for these bacteria isolates to 3 disin-fectants showed that isolate F03 was obtuse, and had low susceptivity to UV irradiation, while isolates F02, F01 and F04 were not sensitive to phenol treatment. Isolates F04, F01 and F05 were resistant to chlorhexidine gluconate. Conclusion: Bacteria widely distributed in clean rooms are mainly a group of Gram positive strains, showing high resistance to selected disinfectants. Sig-nificance and impact of the study: Clean rooms are essential in aseptic pharmaceutical and food production. Screening bacteria isolates and identifying them is part of good manufacturing practices, and will aid in finding a more effective disinfection method. Aims: To screen for the predominant bacteria strains distributed in clean rooms and to analyze their phylogenetic relationships. Methods and Results: The bacteria distributed in air, surfaces and personnel in clean rooms were routinely monitored using agar plates. Five isolates frequently isolated from the clean rooms of an aseptic pharmaceutical production workshop were selected based on their colony and cell morphology characteristics. Their physiological and biochemical properties, as well as partial 16S rDNA sequences, were analyzed. Results showed that all the five isolates belong to Gram positive bacteria, of which three were Staphylococcus, one Microbacterium and one Bacillus species. Sensitivity tests for these bacteria isolates to 3 disinfectants showed that isolate F03 was obtuse, and had low susceptivity to UV irradiation, while isolates F02, F01 and F04 were not sensitive to phenol treatment. Isolates F04, F01 and F05 were resistant to chlorhexidine gluconate. Conclusion: Bacteria widely distributed in clean rooms are mainly a group of Gram positive strains, showing high resistance to selected disinfectants. Significance and impact of the study: Clean rooms are essential in aseptic pharmaceutical and food production. Screening bacteria isolates and identifying them is part of good manufacturing practices, and will aid in finding a more effective disinfection method.
出处 《Journal of Zhejiang University-Science B(Biomedicine & Biotechnology)》 SCIE CAS CSCD 2007年第9期666-672,共7页 浙江大学学报(英文版)B辑(生物医学与生物技术)
基金 Project (No. 30371703) supported by the National Natural ScienceFoundation of China
关键词 Clean room BACTERIA 16S rDNA Phylogenetic tree DISINFECTANT Resistant abilities 药品生产 细菌 系统树 消毒剂 抗菌活性
  • 相关文献

参考文献10

  • 1Akers,J.E.Environmental monitoring and control: proposed standards, current practices, and future direc-tions[].J Pharm Sci Technol.1997
  • 2Akers,M.J.Parenteral Quality Control[]..1994
  • 3Ajaz, M,Noor, N.,Rasool, S.A.,Khan, S.A.Phenol resistant-bacteria from soil: identification-characterization and genetic studies[].Pakistan J Botany.2004
  • 4Wu, G.F,Zhou, X.P.Characterization of phospho-rus-releasing bacteria in a small eutrophic shallow lake, Eastern China[].Water Research.2005
  • 5USGSA (US General Services Administration).Federal Standards 209E: Airborne Particulate Cleanliness Classes in Clean Rooms and Clean Zones[]..1992
  • 6Schicht,H.H.New European GMP rules for manufac-turing sterile medicinal products[].Cleanrooms Int.1998
  • 7Rosch, P.,Harz, M.,Schmitt, M.,Peschke, K.D.,Ronneberger, O.,Burkhardt, H.,Motzkus, H.W.,Lankers, M.,Hofer, S.,Thiele, H.,Popp, J.Chemotaxonomic identifica-tion of single bacteria by micro-Raman spectroscopy: application to clean-room-relevant biological contamina-tions[].Appl Environ Microbiol.2005
  • 8Park, H.D.,Noguera, D.R.Characterization of two ammonia-oxidizing bacteria isolated from reactors oper-ated with low dissolved oxygen concentrations[].J Appl Microbiol.2007
  • 9Onaolapo,J.A.Contamination of hospital disinfectants and antiseptics[].Int Biodeter Biodegr.1995
  • 10Ogunniyi, T.A.B.,Oni, P.O.,Juba, A.,Asaolu, S.O.,Kolawole, D.O.Disinfectants/antiseptics in the management of guinea worm ulcers in the rural areas[].Acta Tropica.2000

同被引文献10

引证文献3

二级引证文献28

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部