Environmental monitoring and quality control analysis of vaccine filling area

Objective To construct a clean area environmental monitoring microorganism database, and statistically analyze changes in the dynamic monitoring of airborne particulates, in order to confirm that the cleanliness of vaccine filling area meets vaccine production requirements. Methods The heating, ventilating and air conditioning system performance re-validation environment monitoring was carried out on the vaccine filling area. The online environment monitoring of the medium filling test in the area was performed. All bacteria obtained from environmental monitoring were subjected to bacterial type analysis to establish an environmental monitoring microorganism database. Results The concentration of airborne particulates varied significantly during pre-filling preparation, product entering into cabinet, troubleshooting and post-filling clearing, reaching peak values (maximum concentration of particles ≥0.5 μm at 1 624 /m3), though overall level was still low. The main bacterial types detected included lira/Micrococcus luteus, Bacillus cereus, Staphylococcus hominis, Staphylococcus cohnii subsp. cohnii and Staphylococcus warneri. Conclusions The cleanliness of the vaccine filling area meets the requirements for the production of sterile drugs. The establishment of the environmental monitoring microorganism database and the statistical analysis of the results from suspended particle monitoring help to trace the source of contamination in sterile drugs, and provide the necessary and highly targeted basis to establish effective quality control for sterile pharmaceutical production. Key words: Environmental monitoring; Particulate matter; Microorganism database; Microbial consortia