О. О. Saliy, H. H. Kuryshko, A. S. Momotenko, T. A. Palchevska


The purpose of the work is to carry out validation researches of the technological process of production of glucose solution for infusions using the bracketing approach for batches of different volumes and  fullness the filling of containers. The object of the research is the manufacturing process for the manufacture of glucose infusion solution 50 mg / ml.  Data collection was carried out on the basis of series production protocols, protocols for analysis of of raw materials and supplies, intermediate and finished products, series packaging protocols, other protocol and registration documentation of the drug production process.  Validation studies were carried out at all stages of the technological process with the determination of critical parameters, confirming the quality of the product under the investigated parameters and the reproducibility of the results when the initial parameters were changed, such asy: preparation of raw materials, solution preparation, filtration of solution, filling and capping of vials, sterilization, inspection, packaging. The technological scheme for the production of the drug Glucose solution for infusion of 50 mg / ml was determined. Validation studies and data collection were carried out on 3 industrial series, determined by the bracketing method: 2000 l with a dosage of 200 ml of medicine per bottle (min. series size, min. dosage), 5000 l and a filling volume of 400 ml (min. series size for bottles of 400 ml), 10000 l with packaging in bottles of 500 ml (max. series size, max. dosage). The obtained research results indicate the reproducibility and normativity of the quality indicators of intermediate and finished products in accordance with the regulatory documentation and declared acceptance criteria for all investigated release forms of 200 ml, 400 ml and 500 ml in glass bottles. The results of validation examinations of the technological process for preparing a solution for glucose infusion solution of 50 mg / ml is representative of the intermediate parameters of drug production and are determined to be satisfactory to ensure stable quality indicators. The results of validation researches were obtained using a scientifically based approach to the selection of limit values, risk analysis and determination of critical parameters. The results of the study are of practical importance for organizing the validation of the technological process for the production of medicines with several dosages, volumes of production series, various sizes of container filling, in order to reduce the number of tests to save resources and time.


technological process; validation; bracketing approach; acceptance criteria

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