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ECPB 2018, 82(2): 15–20
Research articles

System Approach to Regulation of the Harmful Influence of Medicines in the Manufacturing Process and Environment


The manufacturing of medicines is considered as the ecologically dangerous process what dictates the necessity to prevent the negative influence of its active components on the working conditions and air of the inhabited places.

A system approach has included the development of the sanitary regulations for allowable active components of some medicines. Simultaneously the following hygiene standards have been elaborated - in the working area air: bismuth citrate (citric acid bismuth) - MAK 1.0 mg/m3, L-lysine aescinat - MAK 2.0 mg/m3, diphenhydramine hydrochloride - ASLI 0.2 mg/m3, procaine hydrochloride - MAK 0.5 mg/m3, сyanocobalamin - MAK 0.05 mg/m3; in the atmospheric air: bismuth citrate - MAK 0.02 mg/m3, L-lysine aescinat - MAK 0.04 mg/m3, diphenhydramine hydrochloride - ASLI 0.006 mg/m3, procaine hydrochloride - MAK 0.01 mg/m3, сyanocobalamin - MAK 0.002 mg/m3. As a result of the sanitary-chemical researches the effect of the mentioned compounds in the working area and air of the inhabited places has been confirmed.

Article recieved: 29.05.2018

Keywords: medicines, working area air, atmospheric air, regulation of the harmful influence

Full text: PDF (Eng) 261K

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