Database establishment and analysis of environmental monitoring microorganism in vaccine production workshop

Objective To establish a database and analyze distribution of environmental monitoring microorganism in vaccine production workshop. Methods From 2012 to 2016, dynamic environmental monitoring was performed for clean workshops of live attenuated Japanese encephalitis vaccine at certain frequency. The collected microorganisms were identified and classified. A microbial database was established. Statistical analysis of the 5 year data was performed. Results The positive rates of microorganisms in grade A clean zone during 2012-2016 were 0.00%. The 5-year positive rates of microorganisms were 2.89%, 1.32%, 1.27%, 1.03% and 1.04% in grade B clean zone, 12.96%, 10.14%, 7.63%, 4.43% and 4.56% in grade C clean zone, and 31.20%, 33.41%, 28.04%, 19.58% and 22.02% in grade D clean zone, respectively. The positive rates of surface bacteria (1.21%-2.62%) were lower than those of sedimentation bacteria (2.29%-4.02%) and planktonic bacteria (2.09%-3.67%). The positive rates of sedimentation bacteria and planktonic bacteria were similar. Micrococcus luteus/lylae, Staphylococcus, and Bacillus cereus appeared more often in clean workshops. Conclusion The establishment of environmental monitoring microbial database and analysis of microbial distribution play an important role for aseptic control during vaccine production. Key words: Environment, controlled; Environmental microorganisms; Database; Japanese encephalitis vaccines