[Correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test investigated by FTIR].
The FTIR method was used to investigate the correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test. The similarity of bacteria in the contaminated drug and environmental microbes was compared by critical hit value method and cluster analysis method. This constructed the FTIR spectra library of clean room environmental microbe, and determined the criterion to promptly judge if the bacteria isolated from pharmaceuticals were contaminated by environment or not, hence the exactness of "one-off report" of sterile test result can be guaranteed, and can be used for the dynamic monitoring of environmental bacteria of clean room. The method is proven to be simple, accurate and rapid, and can be easily spread to the pharmaceutical microbial control.
Pei
Lin
L
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Hu
Chang-qin
CQ
Ma
Shi-hong
SH
Dai
Hui
H
Hang
Tai-jun
TJ
D001419:Bacteria / Q000302:isolation & purification*; D016000:Cluster Analysis; D004340:Drug Contamination; D004335:Drug and Narcotic Control; D004780:Environment, Controlled; D004783:Environmental Microbiology; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods*