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General characteristics of industrial factors that determine working conditions in the production of drugs.

1. The chemical factor. As studies show, the main unfavorable acting factor of the working environment at the enterprises of the chemical and pharmaceutical industry is the pollution of harmful workplace air, clothing, and skin with harmful organic and inorganic substances.

Air pollution with toxic substances is possible at all stages of the technological process: during preparatory, main and final operations. The main reasons for the content of harmful substances in the air of industrial premises are equipment imperfection, violation of technological regimes, lack or insufficient mechanization of many operations related to the transportation, loading and unloading of materials from apparatuses, the use of leaking equipment, overfilling of chemical products when filling apparatuses, etc.

The composition of the substances that pollute the air in the working zone of the majority of drug manufacturing enterprises is complex, due to the simultaneous presence of many chemical ingredients in the form of aerosols, vapors or gases. Depending on the stage of the technological process, the type of drug received, the air in industrial premises may be polluted by the initial, intermediate and finished products of chemical synthesis. In this case, the entry of harmful substances into the body is carried out mainly through the respiratory tract and to a lesser extent through the skin and gastrointestinal tract.

The effect of a harmful substance on the body is possible at various stages of the technological process: in the preparation of raw materials, the actual processes for obtaining a medicinal product, and final operations. At the same time, the severity and nature of the effect of the chemical factor on the body of workers is determined by the perfection of technology and equipment, the formulation of the drug substance, as well as the construction and planning decisions of the premises and the organization of air exchange in them.

A significant role in the air pollution of industrial premises is played by the nature of the technological process and, above all, its discontinuity. The implementation of the processes on a periodic basis is associated with the repeated loading and unloading of liquids or bulk materials, using various methods of transportation of the processed material. This greatly complicates the organization of effective measures to prevent air pollution. At the same time, the organization of the technological process according to a continuous scheme makes it possible to exclude a number of processes and operations (unloading, transportation, loading of semi-finished products, etc.), which are a source of air pollution of the working area. In addition, favorable conditions are created for the elimination of labor-intensive and dangerous manual operations.

The level of air pollution by vapors and gases of harmful substances is greatly influenced by the pressure in the devices and communication networks. Hygienically, the most favorable conditions are created during the synthesis of drugs carried out under vacuum, since toxic substances cannot be released from the equipment. Vacuum processes take place in the reactor compartment, are widely used in drying and isolation of drugs.

At the same time, many chemical processes for the synthesis of intermediates and finished drugs proceed at elevated and high pressures, for example, the formation of aniline from chlorobenzene occurs at a temperature of about 200 ° C and a pressure of 5.9–9.8 mPa (60–100 atm), and amine hydrolysis to phenol goes at a temperature of 350 ° C and a pressure of 19.6 MPa (200 atm).

In such processes, the tightness of equipment is achieved using flange joints of pipes and apparatuses of a special design using fluoroplastic, asbestos-lead and other gasket materials.

As shown by special timing observations, the apparatchik in the production of sulfa drugs on average 10-12% of working time is in conditions of high levels of harmful substances in the air.
The highest levels of contamination with chemicals are observed at the moment of imperfection of technological equipment, for example, during the hydrolysis of phenylhydrazine sulfate in the production of amidopyrine during the extraction through the open hatch of the apparatus, the concentration of sulfur dioxide can be 4 times higher than the MPC.

2. Dust. Air pollution of workrooms with dust is observed mainly at the preparatory and final stages of obtaining medicinal substances. The main sources of dust extraction at the preparatory stage are the delivery of raw materials from storage facilities to production shops, as well as operations related to crushing, grinding, sieving, transportation, loading, etc.



So, a significant amount of dust is observed at workplaces when grinding plant materials, crushing the initial components of synthetic products. In this case, the dust level may be 3-5 times higher than the permissible level.

In the final stage of drug production, the most often high levels of air pollution with dust of the finished drug, several times higher than permissible, are observed in the process of tabletting, pan-coating, drying, grinding, sieving mixtures, filling and packaging of finished drugs. Under these conditions, drug dust should be considered industrial and considered industrial poison. The dust content in the air of the working area when working on vibrating screens and especially during manual screening can

5 times or more exceed the permissible values. So, during manual packing, the dust concentration in the breathing zone of workers can reach 100 mg / m3 or more.

It is known that the nature of the effect of dust on the body and the severity of biological changes is largely determined by its dispersion. The dust of some drugs is 85–98% composed of particles less than 5 microns in size. This facilitates the penetration of a large number of drugs into the body through the respiratory tract and digestive organs (with saliva).

3. Microclimate. At the enterprises of the chemical-pharmaceutical industry, the microclimate of industrial premises must comply with the requirements established by SanPiN 2.2.4.548-96. However, studies show that with insufficient thermal insulation of the heated surfaces of the apparatus and communication heating networks, it is possible to affect the microclimate working simultaneously with the chemical factor. Elevated air temperatures are mainly found in the drying compartments and in apparatuses in which the reaction proceeds with the release of heat or at high temperature (crystallizers, solvents, hydrolyzers, etc.). So, in the warm season, the air temperature in these areas can reach 34–38 ° С with a relative humidity of 40–60%.

Thus, the thermal microclimate at individual workplaces of the enterprises of the pharmaceutical industry is an additional factor that exacerbates the effect of the chemical factor.

4.Noise. The source of industrial noise in the workplace in the manufacture of drugs are many technological devices. These include compressors, vacuum filters, drum dryers, centrifuges, crushers, vibrating screens, vacuum pumps, etc. The noise level in some cases may exceed the permissible level. So, at workplaces at centrifuges, noise parameters can exceed permissible values ​​by 5 dB, at a vacuum pump - at 5-6 dB, at a compressor - at 14-17 dB.

The most unfavorable areas are engine rooms, where the total level of high-frequency noise often exceeds the permissible values ​​by 20-25 dB. It should be noted that industrial noise, even at the acceptable level, can exacerbate the adverse effects of chemicals.
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