兽用生物制品无菌检验行业比对及培养基质量分析OA

To investigate the testing capabilities of domestic biological product manufacturers and regional biological product testing centers,as well as variations in sterility testing media,and to standardize sterility testing procedures and media quality control,this industry-wide sterility testing proficiency testing program involved 66 participating institutions.The organizing body provided reference standards for microbial growth-promoting tests of sterility testing media and supplied three test samples.Testing was conducted according to the proficiency testing protocol.Results showed that 97.0%(64/66)of the sterility testing media used by the 66 institutions met specified requirements for microbial growth promotion tests..The initial testing satisfaction rate based on the Chinese Pharmacopoeia for Veterinary Drugs,Volume Ⅲ,Appendix 3306 was 84.8%(56/66).For unsatisfactory results,samples were reissued for retesting.Correct results were considered satisfactory,yielding an overall satisfaction rate of 97.0%(64/66).The primary cause of unsatisfactory results was Sample 2(Pasteurella multocida),mainly attributed to variations in the growth-promoting capacity of the media.These results provide a reference basis for quality control of sterility testing media and optimization of sterility testing for special products.