Establishment Of Contaminated Bacteria Bank In Every System Of Biological Drug Production Process

Since microorganisms are widely distributed in nature,In recent years,a series of incidents about drugs endangering people’s health due to microbial pollution have reminded pharmaceutical companies that microbial pollution has become one of the main factors affecting the quality of drug production.Prevent substandard quality medicines from entering the market.The most important thing is to reduce the risk from the source of the drug,that is,to pay attention to the quality control management in the pharmaceutical production process and establish a microbial monitoring system、establish a complete database of contaminated strains.Enhance the traceability and analysis capabilities of microbial contamination.Avoid microbial contamination of the drug at the root cause and thus ensure the quality of the drugAccording to regulations and to provide data support for future investigations,this study established a contamination strain library at each production stage to provide data support for daily microbial investigations and continuous optimization and improvement of pollution control strategies.At the same time,it provides data reference for other pharmaceutical companies.Collect microorganisms in the entire production process of biological drug(including material system,water system,environment and intermediate product library),Through plate streaking and bacterial 16 S r DNA gene sequencing,a total of 242 strains were identified,belonging to 30 genus and 50 species,all of which were strains that had not appeared in various production stages before.The identified strains were frozen.Among them,the species with a higher proportion in the material system are Bacillus,Kocuria and Enterococcus,accounting for54.24%,6.78% and 5.08% respectively.Process water The higher proportions in the system are Sphingomonas and Methylobacter,accounting for 40.00%and 30.00% respectively,and the higher proportion in the environmental system is Staphylococcus,Bacillus and Micrococcus,accounting for 48.84%,16.28%,and 6.98% respectively.Pseudomonas and Bacillus accounted for14.29%,26.65% and 27.27%.The bacterial species isolation and identification data showed that,Microbial contamination occurs at many points in the production of sterile pharmaceuticals.Recommendations are made on the control measures of contaminated microorganisms in enterprises through the strain categories contaminated by each system...