Full Text:   <3401>

CLC number: Q93

On-line Access: 

Received: 2007-03-19

Revision Accepted: 2007-06-18

Crosschecked: 0000-00-00

Cited: 7

Clicked: 5815

Citations:  Bibtex RefMan EndNote GB/T7714

-   Go to

Article info.
1. Reference List
Open peer comments

Journal of Zhejiang University SCIENCE B 2007 Vol.8 No.9 P.666-672


Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit

Author(s):  WU Gen-fu, LIU Xiao-hua

Affiliation(s):  Institute of Microbiology, School of Life Sciences, Zhejiang University, Hangzhou 310058, China

Corresponding email(s):   wugenfu@zju.edu.cn, liuxh221@163.com

Key Words:  Clean room, Bacteria, 16S rDNA, Phylogenetic tree, Disinfectant, Resistant abilities

WU Gen-fu, LIU Xiao-hua. Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit[J]. Journal of Zhejiang University Science B, 2007, 8(9): 666-672.

@article{title="Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit",
author="WU Gen-fu, LIU Xiao-hua",
journal="Journal of Zhejiang University Science B",
publisher="Zhejiang University Press & Springer",

%0 Journal Article
%T Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit
%A WU Gen-fu
%A LIU Xiao-hua
%J Journal of Zhejiang University SCIENCE B
%V 8
%N 9
%P 666-672
%@ 1673-1581
%D 2007
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.2007.B0666

T1 - Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit
A1 - WU Gen-fu
A1 - LIU Xiao-hua
J0 - Journal of Zhejiang University Science B
VL - 8
IS - 9
SP - 666
EP - 672
%@ 1673-1581
Y1 - 2007
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.2007.B0666

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.

Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article


[1] Ajaz, M., Noor, N., Rasool, S.A., Khan, S.A., 2004. Phenol resistant-bacteria from soil: identification-characterization and genetic studies. Pakistan J. Botany, 36(2):415-424.

[2] Akers, M.J., 1994. Parenteral Quality Control, 2nd Ed. Marcel Dekker Inc., New York.

[3] Akers, J.E., 1997. Environmental monitoring and control: proposed standards, current practices, and future directions. J. Pharm. Sci. Technol., 51(1):36-47.

[4] Chapman, J.S., 2003. Disinfectant resistance mechanisms, cross-resistance and co-resistance. Int. Biodeter. Biodegr., 51(4):271-276.

[5] Cloete, T.E., 2003. Resistance mechanisms of bacteria to antimicrobial compounds. Int. Biodeter. Biodegr., 51(4):277-282.

[6] Dukan, S., Touati, D., 1996. Hypochlorous acid stress in Escherichia coli: resistance, DNA damage, and comparison with hydrogen peroxide stress. J. Bacteriol., 178(21):6145-6150.

[7] John, G.H., Noel, R.K., Peter, H.A.S., Bergy, D., 1994. Bergey’s Manual of Determinative Bacteriology, 9th Ed. Williams & Wilkins, Lippincott.

[8] MHPRC (Ministry of Health of People’s Republic of China), 2002. Technical Standard for Disinfection. Ministry of Health of People’s Republic of China, Beijing (in Chinese).

[9] Nagarkar, P.P., Ravetkar, S.D., Watve, M.G., 2001. Oligophilic bacteria as tools to monitor aseptic pharmaceutical production units. Appl. Environ. Microbiol., 67(3):1371-1374.

[10] Newcombe, D.A., Schuerger, A.C., Benardini, J.N., Dickinson, D., Tanner, R., Venkateswaran, K., 2005. Survival of spacecraft-associated microorganisms under simulated martian UV irradiation. Appl. Environ. Microbiol., 71(12):8147-8156.

[11] Ogunniyi, T.A.B., Oni, P.O., Juba, A., Asaolu, S.O., Kolawole, D.O., 2000. Disinfectants/antiseptics in the management of guinea worm ulcers in the rural areas. Acta Tropica, 74(1):33-38.

[12] Onaolapo, J.A., 1995. Contamination of hospital disinfectants and antiseptics. Int. Biodeter. Biodegr., 36(3-4):471-472.

[13] Park, H.D., Noguera, D.R., 2007. Characterization of two ammonia-oxidizing bacteria isolated from reactors operated with low dissolved oxygen concentrations. J. Appl. Microbiol., 102(5):1401-1417.

[14] Rosch, P., Harz, M., Schmitt, M., Peschke, K.D., Ronneberger, O., Burkhardt, H., Motzkus, H.W., Lankers, M., Hofer, S., Thiele, H., Popp, J., 2005. Chemotaxonomic identification of single bacteria by micro-Raman spectroscopy: application to clean-room-relevant biological contaminations. Appl. Environ. Microbiol., 71(3):1626-1637.

[15] Schicht, H.H., 1998. New European GMP rules for manufacturing sterile medicinal products. Cleanrooms Int., 2:17-28.

[16] Shaban, A.M., El-Taweel, G.E., Ali, G.H., 1997. UV ability to inactivate microorganisms combined with factors affecting radiation. Wat. Sci. Technol., 35(11-12):107-112.

[17] Teske, A., Sigalevich, P., Cohen, Y., Muyzer, G., 1996. Molecular identification of bacteria from a coculture by denaturing gradient gel electrophoresis of 16S ribosomal DNA fragments as a tool for isolation in pure cultures. Appl. Environ. Microbiol., 62(11):4210-4215.

[18] USGSA (US General Services Administration), 1992. Federal Standards 209E: Airborne Particulate Cleanliness Classes in Clean Rooms and Clean Zones. General Services Administration, Washington DC.

[19] Wu, G.F., Zhou, X.P., 2005. Characterization of phosphorus-releasing bacteria in a small eutrophic shallow lake, Eastern China. Wat. Res., 39(19):4623-4632.

Open peer comments: Debate/Discuss/Question/Opinion


Please provide your name, email address and a comment

Journal of Zhejiang University-SCIENCE, 38 Zheda Road, Hangzhou 310027, China
Tel: +86-571-87952783; E-mail: cjzhang@zju.edu.cn
Copyright © 2000 - 2024 Journal of Zhejiang University-SCIENCE