Aspects of the industrial manufacture of concentrates for haemodialysis

Abstract

The import dependence of the pharmaceutical market of Ukraine on concentrates for hemodialysis determines the relevance of their manufacture. Elaboration of the transfer of drug development to industrial manufacture and, accordingly, the development of industrial technology of liquid acid concentrates for hemodialysis involves scaling the process, organization of production control, establishing critical points of the production and determining cleanliness classes for concentrates and risks, including ecological ones.
 The aim of the work is to develop approaches to the development of technology for industrial manufacture of acid concentrates for hemodialysis, identification of risks in the technological process and quality control, as well as analysis of major ecological risks and development of methods for their reduction.
 The object of the study was the regulatory and technical documentation regarding the requirements for hemodialysis concentrates, characterization of the hazard profile of acid concentrates as a source of pharmaceutical wastes and generalization of the information about them in the manufacture of acid concentrates. We used the results of our own experimental research on the development of concentrates. The system-survey method of research and content analysis were used in the analysis.
 On the basis of researches, it was to work up the approaches to the development of technology of industrial manufacture of acid concentrates. Requirements of various normative and technical documents for water for the manufacture were generalized, classes of cleanliness of industrial premises for the preparation of containers, preparation, filtering, and packing of solutions are offered. The scheme of pharmaceutical wastes of acid concentrates, which are formed during pharmaceutical development, industrial manufacture, and medical administration, is presented. The profile of their unsafety is given. Potential and real ecological risks in the manufacture of acid concentrates for hemodialysis and ways to minimize them are presented. The proposed stages of risk management for pharmaceutical waste during the manufacture of acid concentrates of hemodialysis include: determining the hazard profile of acid concentrates for the environment; identification of risks, as well as replenishment of knowledge about the hazard profile; planning and implementation of risk minimization measures as well as evaluation of the effectiveness of these risk reduction measures. Methods for eliminating the safety of pharmaceutical wastes of acid hemodialysis concentrates (dilution with water or electrolysis to obtain by-products) have been developed.