Research on the Disinfecting Effect and Database of Common Microorganisms in Pharmaceutical Production Environment

OBJECTIVE  To collect and establish a database of common microorganisms in pharmaceutical production environments by researching on literature and pharmaceutical environmental pollution microorganisms. Researching the eliminate virus effect of common disinfectants in the pharmaceutical production environment, to provide a reference for the disinfection of environmental microorganisms in the pharmaceutical industry.

METHODS  The 74 strains of common bacteria in a pharmaceutical production environment were collected, including 36 strains of gram-positive bacteria(including 23 strains of Bacillus), 19 strains of gram-negative bacteria, and 19 strains of fungi. The suspension method was used to study the eliminate virus effect and resistance of compound alcohol disinfectant, hydrogen peroxide, and glutaraldehyde sporicides to the above-mentioned common microorganisms. At the same time, Pseudomonas aeruginosa and 4 strains of Bacillus with strong resistance were selected to conduct research on the disinfecting of microorganisms before and after film formation on 6 common carriers in pharmaceutical environments.

RESULTS  The disinfection effects of 3 disinfectants on 74 strains of microorganisms all reached the standard of decreasing 5 log values, and no strains resistant to disinfectants were found. The eliminated virus effect of hydrogen peroxide sporicide on 8 strains of Bacillus cereus, Bacillus stratosphere, and Bacillus thuringiensis was better than that of glutaraldehyde disinfectant. In the carrier-based disinfecting experiment, the complex alcohol and hydrogen peroxide disinfectants fail to achieve a 3 log reduction in efficacy, regardless of whether 4 strains of Bacillus formed biofilms or not. Conversely, for Pseudomonas aeruginosa, the above-mentioned disinfectants exhibit good effects regardless of biofilm formation.

CONCLUSION  In this test, the three disinfectants meet the requirements for immediate disinfecting of common microorganisms in the pharmaceutical environment. After the compound alcohol disinfectantinteracts with Bacillus that forms biofilm on the carrier, the number of microorganisms has a tendency to proliferate.