Zhassur Taganov

Purified water is one of the most important technological utilities in pharmaceutical manufacturing and is widely used in the synthesis of pharmaceutical substances, preparation of technological solutions, equipment sanitation, and production processes. The stability of its physicochemical and microbiological characteristics directly affects the quality, safety, and reproducibility of pharmaceutical products. Therefore, qualification and validation of water treatment systems are essential requirements of Good Manufacturing Practice (GMP).

Introduction.The growth of antibiotic resistance poses a threat to the global health system and is increasing interest in antimicrobial potentiators. Iodine-based compounds are characterized by low resistance to bacteria and a broad spectrum of action. For their use at the industrial level, it is important to scale up the technology and obtain a stable quality product. Research objective. To conduct the process of scaling up an iodine-based antimicrobial pharmaceutical substance in pilot production conditions, optimize technological parameters and evaluate the quality and stability characteristics of the finished product. Research materials and methods. The study was conducted in the pilot production and laboratories of the JSC « Scientific Center for Anti-Infective Drugs». A substance containing iodine, potassium iodide, starch, polyvinyl alcohol and neutral salts was prepared. Physicochemical analyses (pH, density, quantitative composition), microbiological purity and 12-month stability tests were conducted. Three production batches were prepared and the data were processed. Results. The quality of the finished product met all regulatory requirements: iodine content 8.33–8.39 mg/ml, potassium iodide – 11.73-11.83 mg/ml, pH – 4.24-4.27, density – 1.062-1.063. Microbiological purity indicators fully comply with the requirements. During the study, important technological parameters were analyzed at the main stages of production (raw material measurement, mixing, hydrolysis, obtaining the finished product, quality control, packaging and labeling). Conclusion. The results obtained during the scaling-up of an iodine-based antimicrobial substance are an important scientific and technological base that will allow this substance to be introduced into industrial production. The scaled-up technology allows for the production of high-quality, stable and safe products. As a result of scaling up from the laboratory level to the pilot production site, the critical parameters for the production of an iodine-based antimicrobial potentiator were identified and the technological conditions were optimized. The results obtained will serve as the basis for introducing the pharmaceutical substance into industrial production and will contribute to meeting its growing demand.