Development of methods for quality control test «Total viable aerobic count» for microbiological contamination determination in insoluble in water drugs that possess antimicrobial activity

Abstract

The development of quality control methods of the finished pharmaceutical products (FPP) used for «Microbiological contamination» parameter control is rather long and has intensity of use. Therefore these methods are not usually applicated for control in manufacturing conditions. Time-consuming and material resources optimization for carrying out experimental researches the unified methods for control and determination of «Microbiological contamination» parameter of the finished pharmaceutical products were developed. Represented schemas are used for the development of methods which determine the total amount of the microorganisms. Still these basic principles can be also used for determination of the micro­organisms' specific species. More detailed material concerning development methods of «Microbiological contamination» parameter determination will be published in the methodological recommendations.