The substantiation for introduction of the innovative technological process for industrial production of parenteral dosage forms by the example of torasem?de, solution for injection

SUMMARY

The introduction of the innovative technological process for industrial production of parenteral dosage forms by the example of Torasemide, solution for injection has been substantiated in the article. The experimental studies for improving the manufacturing technology of Torasemide, solution for injection, 5 mg/ml, the choice of the filter material, the scientific substantiation of the innovative technological process are presented. In particular, the aseptic conditions of production have been selected using sterile filtration and thermal sterilization (stabilization), the algorithm of monitoring of the critical parameters has been developed using the elements of risk management design of pharmaceutical production.