Dilai N. Industry optimization and qality control of sterile medicines by the content of bacterial endotoxins

Object – pharmaceuticals and veterinary products for parenteral use produced in terms of pharmaceutical companies, hospital pharmacies and biofactories; aim - to study the concept of optimizing the production and quality control of drugs and veterinary products for parenteral use in pharmaceutical companies, pharmacies and biofactories by the content of bacterial endotoxins; methods - biological methods for determination the bacterial endotoxins (for quality test - a gel-clot test, for semiquantitative test - gel-clot method, for quantitative test - turbidimetrical kinetic method), biological method for determining pyrogens (traditional with the use of laboratory animals - rabbits), depyrogenation methods (filtration by using positively charged filter, heat depyrogenation, ultrafiltration, inactivation of bacterial endotoxins and others) methods of identification and analysis of risks while optimizing technological processes (Ishikawa diagram, matrix comparison, failure mode and effect analysis, the determination of benefits and eligibility); results - proved and developed the main provisions of technology optimization and quality control of medicines and veterinary products for parenteral use in pharmaceutical companies, hospital pharmacies and biofactories, developed and published Guidelines for determination the bacterial endotoxins, research methods of bacterial endotoxins that are included in the regulatory documentation for production: Dyflyuzol, solution for infusion, 2 mg / mL, Volyutan 6% solution for infusion, Neogek 6% solution for infusion, Ornizol, solution for infusion 5 mg / ml, Linezolidyn, 2 mg / ml solution for infusion, Neyrokson, solution for injections, 500 mg / 4 ml and 1000 mg / 4 ml, Reopoliglyukin, solution for infusion, Fluconazole 2 mg / ml solution for infusion, and substance Fluconazole; implemented - in the industrial and educational process; industry - pharmacy