The chemical factor in the enterprises of the pharmaceutical industry. Occupational health in the pharmaceutical industry is a hygienic characteristic. Hazardous and harmful factors in the workplace of pharmaceutical workers
TOPIC 13. HYGIENIC EVALUATION OF CHEMICAL AND BIOLOGICAL FACTORS OF THE WORKING ENVIRONMENT, PRINCIPLES OF THEIR HYGIENIC RATING. PREVENTION OF PROFESSIONAL DISEASES CAUSED BY CHEMICAL AND BIOLOGICAL NATURE FACTORS
TOPIC 13. HYGIENIC EVALUATION OF CHEMICAL AND BIOLOGICAL FACTORS OF THE WORKING ENVIRONMENT, PRINCIPLES OF THEIR HYGIENIC RATING. PREVENTION OF PROFESSIONAL DISEASES CAUSED BY CHEMICAL AND BIOLOGICAL NATURE FACTORS
Objective:to study the main parameters characterizing the degree of toxicity and hazard of chemicals in the production environment, master the methodological methods of toxicological studies carried out during hygienic regulation of harmful substances, methods for assessing working conditions under the influence of industrial factors of a chemical and biological nature in the production of drugs, study the prevention of harmful the effects of these factors and related health-improving measures at the enterprises of the chemical and pharmaceutical industry.
In preparation for the lesson, students should work out the following theory issues.
1. Industrial hazards of a chemical nature, their pathogenic effect. Ways of getting poisons and removing them from the body. Dependence of toxic effects on the chemical structure, physico-chemical properties, concentration and other factors. Local and general resorption effect, acute and chronic intoxication. Allergic condition.
2. Industrial hazards of a biological nature, their pathogenic effect.
3. Measures to combat the chemical and biological factors of the work environment.
After mastering the topic the student must know:
Determination of the degree of toxicity and hazard of chemicals;
be able to:
Use optimal and affordable methods for assessing working conditions of workers under the influence of chemical factors of the working environment;
Use the basic regulatory documents and information sources of a reference nature to create favorable and healthy working conditions for pharmacy personnel under the influence of chemical and biological factors of the working environment.
Training material for the assignment
Hygienic assessment of chemical factors
Many types of professional activities related to the receipt and processing of raw materials, the manufacture and use of industrial products are carried out under the influence of industrial poisons on the body.
Toxic air pollution at the enterprises of the chemical-pharmaceutical industry, it is possible at almost all stages of the technological process for the production of medicines (preparatory operations: transportation of liquid products or gaseous substances; the release of toxic substances from reactors, the use of distillation apparatus and distillation devices, filtration and centrifugation processes, drying, evaporation and crystallization; final operations).
Industrial poisons - chemicals that, as the initial, intermediate, by-products or end products of the production process, enter the human body during his labor activity and have a harmful effect on the worker, leading to a violation of his health or the health of his offspring.
The composition of toxic substances in the air of industrial premises at most chemical pharmaceutical enterprises is complex. This is due to large differences in the volume of production of medicines, characterized by high stability
the presence of many basic chemical ingredients included in the combination in the manufacture of finished dosage forms, as well as auxiliary components (fillers, sweeteners, disintegrants, emulsifiers, etc.) predominantly in the form of finely divided aerosols, vapors and gases. According to the chemical structure of the substance are classified into inorganic, organic and elementary organic.
The degree of toxicity of chemicals is determined by the level of doses or concentrations causing the death of 50% of experimental animals with the main routes of penetration of substances into the body under industrial conditions: inhalation, percutaneous and oral (Table 55).
Table 55.Chemical toxicity classes
Toxic substances can have an effect on the body. local annoyingaction at the point of contact with skin and mucous membranes in the form of skin irritation, inflammation, burns (the biological effect develops before the poison is absorbed into the blood); general toxicaction (acute, subacute, chronic poisoning); sensitizingaction (industrial allergens); cause specific effects, including distant (delayed): mutagenic, gonadotoxic, embryotropic, carcinogenicother. Medicines as a specific factor in air pollution in industrial premises can have a direct effect on the generative function (hormones), cause the development of long-term effects, including effects on the synthesis of DNA and RNA (cytostatics), and entail mental and physical dependence (drugs).
Industrial poisons, depending on their properties and exposure conditions, can cause development acute, subacute and chronic intoxications. Acute poisoningoccur with short-term (7-8 h) intake of relatively large amounts of chemicals in the body and have a short latent period. This most often occurs at high concentrations in the air, mistaken ingestion, and severe contamination of the skin. The first signs of poisoning appear in the form of general weakness, headache, dizziness, nausea, vomiting, then specific changes can develop - pulmonary edema, damage to the organ of vision, paralysis of the nerve centers, etc. Subacute poisoningmore often occur under the same conditions as acute, but develop much more slowly and have a protracted course. Chronic intoxicationdevelop with constant long-term exposure to harmful substances in low concentrations and are characterized by a gradual increase in functional and organic disorders.
Thresholds of acute (Lim ac) and chronic (Lim cn) action of a chemical are considered to be the minimum dose or concentration, a single or prolonged exposure of which causes statistically significant deviations from the norm of a number of functional or biochemical indicators of the state of the body. The degree of danger of the development of acute poisoning by industrial toxic substances is determined by the following indicators: CVI (coefficient of possibility of inhalation poisoning) and Z ac (acute area); To assess the risk of developing chronic poisoning, Z ch (zone of chronic effect) and (cumulation coefficient) are used. Kcum (the ratio of the total average lethal dose ΣDL50 obtained in the experiment with repeated administration of the substance to that with a single injection) is an indicator of the cumulative substance. Cumulation is distinguished between material (accumulation of a substance in the body) and functional (gradual increase in the effect of exposure to repeated influx of a substance into the body). Hazard assessment is shown in table. 56.
The main routes of entry of harmful substances into the body are the respiratory system and skin integument. The ingestion of toxic substances through the gastrointestinal tract under industrial conditions is rare and is usually associated with non-observance of personal hygiene rules, partial ingestion of fumes and dust,
penetrating the respiratory tract, in violation of safety regulations.
When performing physical work or staying in conditions of high air temperature, high humidity, when breathing volume and blood flow velocity increase sharply, the possibility of toxic substances entering the body and, as a result of this, poisoning can occur in a shorter time.
Table 56.Hazard classes for acute and chronic chemical poisoning
Physicochemical properties that determine the toxicity and danger of chemically active substances under industrial conditions include the state of aggregation (solid, liquid, gas, vapors, aerosol), its dispersion, relative solubility in lipoids (the equivalent of lipoids is octanol) and water ( P o / w \u003d S octano (Appendix 1).
For chemicals that have a sharply directed effect (irritating, antienzyme, hemolytic, etc.) during short-term exposure, the leading regulation is the maximum maximum permissible concentration of maximum permissible concentration, which can be measured for any 15-minute period of a shift. There must be no more than four for a change in short-term increases in concentrations not higher than the maximum permissible concentration (MPC) with a break duration of at least 1 hour between them, this should be checked by continuous automatic monitoring with an alarm for exceeding the maximum permissible concentration. For high-cumulative substances (hazard classes 1 and 2 according to the values \u200b\u200bof zones of chronic and biological action), their biological effect is determined mainly by the amount of substance that enters the body during the whole working day, and averaged average (for 8 hours) are used to assess their danger - new working shift), maximum permissible concentrations (MPCss). Medium-shift MPCs have been established for a number of metals (copper, mercury, lead and its inorganic compounds), as well as benzene, boron
hydrochloric acid, etc. In the regulatory and methodological documents, the record of the standard values \u200b\u200bfor the substance is as follows: MPC m / MPC ss. With the simultaneous joint presence in the air of the working zone of harmful substances of unidirectional action with an additive effect, the sum of the ratios of the concentrations of each substance to its maximum concentration limit should not exceed unity, which corresponds to acceptable working conditions. The calculation is carried out according to the formula:
C1 / PDK1 + C2 / PDK2 + ... + Cn / PDKn,<=1,
where: Q, FROM 2, C p- the actual concentration of substances in the air of the working area;
MPC1, MPC2, MPCn - MPC of the same substances in the air of the working area.
As a rule, combinations of substances with the same specific clinical manifestations have the effect of summation: irritating substances (for example, acids and alkalis), allergens (for example, epichlorohydrin and formaldehyde), narcotic substances (combination of alcohols).
With the potentiation effect (synergism) of the combination of harmful substances in the air of the working zone, the sum of the ratios of the measured concentrations to their MPC should not exceed the coefficient established for these concentrations. With the simultaneous maintenance in the air of the working zone of several substances of multidirectional action, the hazard class of working conditions is established by the substance, the concentration of which corresponds to the highest class and degree of toxicity.
The frequency of monitoring the content of harmful substances in the air of the working area is established depending on the nature of the process, the hazard class and the characteristics of the biological effects of chemicals in coordination with the sanitary and epidemiological service.
Depending on the hazard class of harmful substances, the following frequency of control of its content in the air of the working zone is recommended: for substances of the 1st hazard class - at least 1 time in 10 days, 2nd class - 1 time per month, 3rd class - 1 time in 3 months, 4th grade - 1 time in 6 months.
Class of working conditions |
||||||
Harmful | Tolerance | Harmful | Dangerous |
|||
substance | timy | 3.1 | 3.2 | 3.3 | 3.4 |
|
Substances of 1-2 hazard classes | <=ПДК | 1,1-3,0 | 3,1-6,0 | 6,1-10,0 | 10,1-20,0 | |
Substances of 3-4 hazard classes | <=ПДК | 1,1-3,0 | 3,1-10,0 | |||
Substances acute actions | <=ПДК | 1,1-2,0 | 2,1-4,0 | 4,1-6,0 | 6,1-10,0 | |
Carcinogens | <=ПДК | 1,1-3,0 | 3,1-6,0 | 6,1-10,0 | ||
Allergens | <=ПДК | 1,1-3,0 | 3,1-10,0 | |||
The degree of harmfulness of working conditions is established taking into account the hazard class and the concentration of the substance in the air of the working area (Table 57). In this case, the toxicity class and the hazard classes of acute and chronic poisoning are included in the concept of a “hazard class”.
Contact with chemical and biological allergens during their production, packaging and use can lead to the development of allergic reactions. Allergens include antibiotics, sufanilamide preparations, many chlorinated hydrocarbons (dichloroethylene, dichloroethane, methylene chloride, carbon tetrachloride) and some solvents (benzene, aniline), metals (chromium, mercury, lead) and other compounds. Allergic properties are usually enhanced with an increase in the number of active radicals and rings in the molecule, with lengthening of the side chains. The allergy is most often caused not by the substance itself, but by its complex with body proteins.
Employees of the chemical-pharmaceutical industry and pharmacy organizations with constant contact with antibiotics or fungus producers can develop occupational diseases in the form of dysbiosis, candidiasis of the skin and mucous membranes, and visceral candidiasis. With superficial candidiasis, yeast-like fungi of the genus Candida infect mucous membranes
shells, skin and nails, with intestinal form, general weakness, weight loss, subfibril temperature, signs of enterocolitis, impaired carbohydrate metabolism, immunodeficiency states are often noted.
Prolonged professional contact with various medicinal substances can lead to hypersensitivity, i.e. “Allergic background” (90% working with antibiotics), which is accompanied by a more frequent manifestation of highly professional sensitization to certain substances: for novocaine - by surgeons and a small number of therapists; on acrylates - by therapists and orthopedists; on penicillin - with therapists; on plaster - by orthopedists. Skin manifestations are highly polymorphic (dermatitis, eczema, urticaria, etc.). Changes in the internal organs are expressed in asthma bronchitis and bronchial asthma, chronic colitis, myocarditis, etc. The pathology of the nervous system is manifested by vegetative-vascular dystonia and sensory polyneuralgia. Immunity disorders are possible, which contributes to the development of dysbiosis and an increase in infectious diseases.
Prevention of occupational poisoning: toxicological and hygienic assessment of chemicals and their hygienic standardization taking into account biological activity; the degree of toxicity and danger of the main and auxiliary components used in the manufacture of medicines; introduction of continuous technology, eliminating the ingress of toxic substances into the air of the working area; elimination of poison from production or the use of new technologies and rationalization of the technological process aimed at replacing highly toxic substances with non-toxic ones; automation and mechanization of production processes; the use of remote control mechanisms; use of pneumatic transport; local mechanical exhaust ventilation in areas of probable toxic emissions in the form of fume hoods, side exhausts, umbrellas with an air velocity in them ranging from 0.25 to 1.5 m / s or general ventilation with a negative air balance; the use of automatically operating signaling devices for exceeding concentrations of the established MPCs levels for hazardous aerosols, gases and vapors; use of personal protective equipment in the form of gas masks, respirators, protective clothing, goggles, pastes, ointments,
creams and other protective devices; organization of preventive nutrition; conducting preliminary and periodic (2 times a year) medical examinations; regulation (reduction) of the length of the working day, the use of additional holidays; planned and emergency current sanitary monitoring of air pollution of the working area; regular briefing of workers on safety and industrial sanitation.
Hygienic assessment of biological factors
The biological production factor is biological objects, including micro- and microorganisms, products of their metabolism, as well as products of biological synthesis, which are capable of exerting a harmful effect upon exposure to the working body.
MAC of microorganisms is expressed in microbial cells per 1 m 3 (cells / m 3). The maximum permissible concentration of producer microorganisms in the air of the working zone is regulated at the level of 50,000 cells / m 3 [GN 2.2.6.709-98 “Maximum allowable concentrations (MPC) of producer microorganisms, bacterial preparations and their components in the air of the working zone”].
The impact of producer microorganisms, bacterial preparations and their components at the MPC level does not exclude health disorders in people with hypersensitivity.
All microorganisms permitted by the Ministry of Health of the Russian Federation as industrial strains are non-pathogenic or conditionally pathogenic and belong to the 3rd and 4th hazard classes according to GOST 12.1.007-76, which according to the WHO classification corresponds to the 2nd risk group (moderate individual risk and limited risk for the general population). Classes of working conditions when working with substances of biological nature are established, as well as for chemicals, depending on whether they exceed (and how many times) the maximum permissible concentrations of their content in the air of the working zone (Table 58).
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1. Occupational health in the pharmaceutical industry
4. Occupational health in the production of antibiotics
6. Occupational health in the production of galenic preparations and finished dosage forms
9. Hygienic characteristics of working conditions in the manufacture of tablets
10. Genetic characteristics of working conditions in the production of dragees
Conclusion
List of references
1. LABOR HYGIENE IN THE CHEMICAL-PHARMACEUTICAL INDUSTRY
labor protection medicine production
The pharmaceutical industry is one of the leading sectors of the national economy. It includes a production complex in which, along with chemical methods of processing materials, biological synthesis of drugs is widely used.
The modern chemical and pharmaceutical industry has a number of features that determine the specifics of its development, for example, high requirements for the chemical purity of products. In addition, for preparations intended for subcutaneous, intramuscular injection and intravenous infusion, they provide complete sterility. Their quality must strictly comply with the requirements of the State Pharmacopoeia of Russia.
The next feature of the pharmaceutical industry is the small volume of production of most drugs.
This industry is also characterized by a large consumption of raw materials and materials, due to the multi-stage and complexity of the synthesis of drugs.
Finally, the pharmaceutical industry is characterized by a relatively rapid renewal of the range of drugs. This feature, as well as the small volume of production of drugs, caused the widespread use of combined technological schemes that allow the production of 2-3 types of drugs or more during the year. In addition, all substances released by this industry must be processed into finished dosage forms. The indicated features of the chemical-pharmaceutical industry pose a number of new and complex tasks in the field of organizing and conducting recreational activities for hygienic science and practice.
2. Hygienic characteristics of the main technological processes
In the pharmaceutical industry, there are several groups of enterprises. The leading ones are factories for the production of synthetic drugs, factories for the production of antibiotics and enterprises for the production of drugs and finished dosage forms.
The industrial production of synthetic medicines is based on the widespread use of organic synthesis, which brings these enterprises closer to the basic chemistry industry.
Antibiotic enterprises are grouped in a special group. This is due to the fact that the basis of the technological process for obtaining these drugs is biological synthesis.
A characteristic feature of plants for the production of galenic pharmaceutical and finished dosage forms is the release of a large number of various medicines in the form of liquid extracts and tinctures, injection solutions in ampoules, tablets, dragees, plasters, etc.
In the industrial production of chemical and pharmaceutical preparations, various raw materials are widely used, obtained from both plant and animal products, and by chemical synthesis. The most common is chemical raw materials. Mineral raw materials are used for the production of inorganic salts, as well as ingredients for various synthesis of organic compounds. A large number of mineral acids and alkalis are used. The feedstock is supplied by the coke, petrochemical, aniline and paint industries and enterprises of basic organic synthesis.
Animal raw materials are also widely used in the manufacture of medicines, in particular, histidine is obtained from the blood of animals, adrenaline from the adrenal glands, insulin from the pancreas, thyroidin from the thyroid gland, etc.
All types of technological operations upon receipt of drugs can be divided into preparatory, the actual processes for obtaining a drug, final and additional operations.
Preparatory operations - storage, transfer of solid, liquid and gaseous materials, their transformation: grinding and crushing of solid raw materials, separation of solids, removal of liquids and gases from them using the methods of sedimentation, filtration, centrifugation, cooling, crystallization, vacuum, etc.
The processes of obtaining drugs themselves are based on metabolic, thermal, electrochemical, biological processes, electrolysis, etc. At this stage of the technological process, sulfonation, nitration and halogenation reactions, amination and oxidation, reduction and oxidation are widely used, etc.
At the final stage, the drugs are dried, crushed, tabletted, ampouled, packaged and packaged.
Preparatory operations. A significant part of the feedstock for obtaining galenic and synthetic drugs is in the solid state and is subjected to crushing, grinding. The need for this operation often arises when receiving dosage forms (tablets, dragees, etc.). Crushing is carried out on jaw, roll, cone, hammer and other crushers. Grinding is carried out using ball and porcelain mills, disintegrators. Small amounts of the drug product are crushed in mortars on a mechanical drive, mills of Islamgulov, Excelsior, etc.
Occupational hazards during crushing, grinding and separation of the initial products of drugs are dust, intense noise and general vibration. Dust is emitted at the point where the medicinal raw material or finished product enters the crushers and mills and at the exit point of the ground substance.
Hygienically unfavorable operation is the separation of materials into fractions. The air separators and mechanical sieves used are significant sources of dust. In the production of small-tonnage drugs (for example, hormones), manual wiping is often used on sieves, which is associated with the release of dust and contamination of the skin and clothing of workers.
To combat dust emission, proper organization of the technological process and equipment, sheltering places for dust extraction with aspiration of dusty air are necessary. Since noise and vibration at grinding and grinding plants can exceed the permissible values, this equipment must be placed in separate production rooms, and the foundations under them should not be connected with the building structures. In the fight against noise and vibration, it is necessary to use anti-noise and anti-vibration devices and materials. It is advisable to remotely control the grinding and crushing processes.
A significant effect on the level of air pollution of the working area with harmful substances at the preparatory stage is provided by the transportation of the starting components. This is due to the heavy load on communication facilities, the presence of mechanisms and devices designed to move substances that do not have efficient exhaust devices and the necessary tightness.
During transportation, workers can come into contact not only with vapors and gases, but also with liquid and granular harmful substances. In some cases, manual transportation, loading and unloading of medicinal raw materials (for example, plant origin) are still used.
The movement of liquid substances is carried out through pipelines using pumps, air or steam pressure, by gravity and due to vacuum. Gaseous substances are transported by compression and vacuum. The supply of starting products with compressed air is associated with an increase in pressure in communication networks, which can lead to the release of harmful vapors and gases through leaks in pipelines, devices and tanks. It should be noted as imperfect hygienic transportation of liquid products using pumps, which are an additional factor contributing to air pollution by chemicals. From this point of view, the transportation of liquid products by gravity or by vacuum is most favorable. The main hygiene requirements for equipment are the stability of pipelines, gasket and packing material to the action of liquids, the replacement of stuffing box pumps with glandless and submersible.
The supply of solid medicinal raw materials (plant products, organic and mineral substances) from raw materials to preparatory workshops, from one equipment to another, is carried out using conveyor belts, elevators, screws, as well as pneumatic and hydraulic systems. The transportation method is determined by the state of aggregation of substances, their toxicity, nature of production, etc.
Giving a hygienic assessment of these processes, it should be noted that transportation using conveyor belts, screws, etc. is associated with a significant emission of dust. The most advanced hygienic approach is the supply of dry starting products using pneumatic conveying.
Actually the processes of obtaining drugs.
This technological stage of obtaining drugs is characterized by a wide variety of technological processes and operations, equipment and chemicals used. A significant share in the industrial synthesis of intermediates and medicinal substances is occupied by processes associated with the substitution of hydrogen atoms in the nucleus of aromatic compounds by certain groups of atoms, the conversion of substituents already existing in the organic compound molecule into others in order to give it new properties and, finally, change carbon structure of the molecule. These are reactions of nitration, sulfonation, halogenation, reduction, alkylation, etc. These processes are carried out in reactors of various types, which got their name depending on the chemical reactions carried out in them (chlorinator, nitrator, sulfator, etc.).
Reactors can operate under elevated and normal atmospheric pressure or under vacuum. They can be periodic and continuous. These are steel, lead or cast-iron containers with or without agitators, with heating or cooling. Depending on the processes occurring in the reactors, various types of mixers are used: paddle, screw, frame, anchor, etc.
The main harmful factor in the reactor compartment is chemicallyth. The places where toxic substances are emitted from the reactors can be agitator oil seals, hatches through which products are loaded and unloaded, measuring glasses, inspection windows, and flange connections. At the same time, the composition and level of harmful substances in the air of the working area depend on the perfection of the equipment used, the type of medicinal intermediate or finished medicine obtained, the mode of operation and other factors. An unfavorable hygiene situation may be caused by manual operations, for example, when measuring the level of liquids, sampling. The transfer of equipment to the vacuum process, the use of closed reactors with shielded motors of the agitators, as well as automatic control, significantly reduce the emission of harmful substances into the air of working rooms.
A large share at this stage is occupied by the processes of separation of chemical components. The main equipment for such operations are distillation apparatus and distillation plants. Maintenance of this equipment is associated with the possibility of contact with harmful substances that may enter the air through communication systems, hatches, cranes, sampling points, etc.
Filtration and centrifugation processes are widely used to separate suspensions into solid and liquid phases. Filtration is carried out on filters of periodic and continuous action. The first includes nutsche filters, filter presses, sheet filters, and the second includes drum, disk and belt filters. The work of nutsche filters and filter presses is often accompanied by the release of toxic substances into the air of the working area, associated with the use of manual labor and the possibility of intense contamination of the skin and clothing. Hygienically, drum filters are more favorable, which are airtight and equipped with exhaust ventilation.
For the rapid separation of the drug intermediate, batch and continuous centrifuges are used. Batch centrifuges are less perfect and have a number of disadvantages, the main of which are the inconvenience of removing pressed material, the use of manual labor, and the lack of reliable tightness. These shortcomings are the cause of the release of harmful substances into the air of the working area and contamination of the skin.
Hygienically reliable are mechanized and closed filters, self-unloading centrifuges with lower discharge, drum vacuum filters and automatic filter presses.
A significant part of intermediates and finished medicines is dried. This process is necessary when obtaining galenic, synthetic preparations, antibiotics, vitamins, etc. Moisture is removed by mechanical (filtering, pressing, centrifugation), physicochemical (absorption by hygroscopic materials) and thermal (evaporation, evaporation and condensation) methods.
In the production of medicines, chamber, drum, spray, shaft and other dryers are most widely used. The maintenance work of most dryers is accompanied by increased heat directly at the workplace and the release of toxic substances.
A significant drawback of dryers is the insufficient mechanization and sealing of the processes of loading and unloading of substances subjected to drying, which causes air pollution of the working area with dust of the finished product. Significantly less harmful substances are emitted when using continuous dryers (rowing, spraying, drying drums, etc.), provided with complete sealing and mechanization of loading and unloading processes.
The evaporation and crystallization processes are widely used in the production of drugs. The former are used to obtain more concentrated solutions from less concentrated (synthetic and galenic preparations, antibiotics, vitamins, etc.). For this purpose, in most cases, multi-case evaporators are used. Hygienically adverse operations when working with them are the supply of solutions and unloading of the finished product, since they are accompanied by the release of harmful compounds into the air of the working area.
Crystallization processes are used to purify medicinal substances from impurities or to isolate them from a liquid. These processes are carried out in crystallizers of open and closed type. The main disadvantage of this equipment is the lack of sealing and mechanization of the processes of loading and unloading of medicinal substances.
More favorable sanitary conditions at workplaces are created when servicing vacuum crystallizers.
Obtaining finished dosage forms in the form of tablets, dragees, ampoules consists of many preparatory and basic processes and operations carried out in a certain sequence on the appropriate equipment.
Final operations. In the final stage of the technological process, medicinal substances are labeled, packaged and packaged. Packaging of dosage forms is carried out in plastic, paper and glass containers. Most operations at this stage are mechanized.
The main hygienically unfavorable factor in this stage of drug production is dust. Workers, as a rule, are exposed to dust of complex composition, since several types of drugs can be packed and packaged at the same time.
Work with the semi-mechanized and especially manual method of packaging and packing of tablets, ampoules, dragees, as well as gluing boxes and convoy with cellophane strips and a number of other operations are associated with the forced position of the body.
3. General characteristics of industrial factors determining 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-pharmaceutical industry is the pollution of harmful working air and 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 imperfect equipment, violation of technological conditions, lack or insufficient mechanization of many operations related to the transportation, loading and unloading of materials from apparatus, the use of leaky equipment, overflow of chemical products when filling apparatus, etc.
The composition of the substances that pollute the air in the working zone of the majority of pharmaceutical 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 of industrial premises may be contaminated with 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 implementation of the processes for obtaining the drug, and final operations. At the same time, the severity and nature of the effect of the chemical factor on the workers' bodies 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 transporting 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, and are widely used in the 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 proceeds at a temperature of about 200 ° C and a pressure of 5.9-9.8 MPa (60-100 atm), hydrolysis of the amine to phenol occurs at a temperature of 350 ° C and a pressure of 19.6 MPa (200 atm).
In such processes, the tightness of the equipment is achieved by 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 the working time is in conditions of high levels of harmful substances in the air. The highest levels of chemical contamination 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 facilities, 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. At the same time, the dust level can 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 vibration screens and especially during manual screening can
5 times or more exceed the permissible values. So, during
manual filling 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, which helps to penetrate 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 devices and communication heating networks, it is possible to affect the microclimate working simultaneously with the chemical factor. Elevated air temperature is 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 aggravates 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 the workplaces of centrifuges, noise parameters can exceed permissible values \u200b\u200bby 5 dB, by a vacuum pump - by 5-6 dB, by a compressor - by 14-17 dB.
The most unfavorable areas are engine rooms, where the total level of high-frequency noise often exceeds the permissible values \u200b\u200bby 20--25 dB. It should be noted that industrial noise, even at the acceptable level, can exacerbate the adverse effects of chemicals.
4. LABOR HYGIENE IN THE PRODUCTION OF ANTIBIOTICS
Antibiotics - substances produced by microorganisms, higher plants and animal tissues in the process of life and having a bactericidal or bacteriostatic effect. Now there are about 400 antibiotics belonging to various classes of chemical compounds. The antibacterial properties of antibiotics served as the basis for their widespread use in medicine, in particular in the treatment and prevention of infectious diseases and inflammatory processes.
In addition to use in medicine, antibiotics have been used in the food and meat and dairy industries for canning products.
The technological process for producing antibiotics consists of several stages carried out in a certain sequence and on the appropriate equipment:
a) growing seed and biosynthesis of antibiotics (fermentation);
b) pre-treatment of the culture fluid;
c) filtration;
d) isolation and chemical purification (extraction method, ion exchange method, precipitation method);
d) the manufacture of finished dosage forms;
e) packing and packaging
The initial technological processes are based on growing seed (producer) in flasks and fermenters. The grown production strain of the producer is transferred to special inoculators in order to further enrich it. The process of growing fungi, bacteria in inoculators is carried out under strictly defined conditions, which are provided by heating and cooling systems, air supply, devices for mixing the production mass. Then the producer goes to fermentation. By fermentation is understood the cultivation (cultivation) of the producer and the formation of the maximum amount of antibiotic. Antibiotics are synthesized in the cells of microorganisms or released during biosynthesis into the culture fluid.
Pure antibiotic The basic technological scheme for injecting and cleaning antibiotics.
The main equipment for the fermentation process is fermenters, which are huge containers up to 100,000 liters. They are equipped with heating and cooling systems, sterile air mixture supply, mixers, as well as devices for loading and unloading the nutrient medium, culture fluid. This stage of the technological process is characterized by the tightness of the equipment used, and therefore the possibility of air pollution with substances used for the biosynthesis of antibiotics, as well as the biomass itself, which is formed at the end of the fermentation process, is practically eliminated.
Due to the fact that antibiotics form insoluble compounds with many substances present in the culture fluid, in order to increase the concentration and more complete precipitation of impurities, the culture fluid is acidified to pH 1.5--2.0 with oxalic acid or with a mixture of oxalic and hydrochloric acids . The treated culture fluid is filtered from mycelium and precipitated ballast substances to obtain a clear filtrate, called native solution. Filtration of the treated culture fluid is carried out on open-type frame filter presses, as a result of which spraying of the native solution may occur. Manual unloading of filter presses causes workers to come in contact with a culture fluid containing antibiotic.
The next step in obtaining an antibiotic is the isolation and chemical purification. At this stage, the antibiotic solution is concentrated and purified to such a purity that a finished drug can be obtained from it. The content of the antibiotic in the native solution is very low, therefore, its isolation in pure form, purification and completion of the finished dosage form is a very complex and time-consuming process: for example, to obtain 1 kg of the antibiotic, about 600 l of culture fluid must be processed.
For isolation and chemical purification of antibiotics use one of the following methods: extraction method using various solvents; precipitation method; ion exchange method. The most widely used in the biosynthesis of antibiotics have found extraction and ion-exchange methods, and in recent years, the ion-exchange method for the isolation and purification of antibiotics has been used in the preparation of other drugs. Its main advantage is that it eliminates the need for toxic and explosive solvents. The method is economically advantageous, since its technology is simple and does not require expensive equipment and raw materials.
The extraction of antibiotics from the native solution is carried out in separator extractors, the main disadvantage of which is the need for manual unloading, as a result of which the workshop air can be contaminated with solvents, for example, isooctanol in the production of tetracycline and oxytetracycline.
Along with solvents, oleic acid, caustic soda, oxalic acid, butyl and ethyl alcohols, butyl acetate, and others can enter the air at the stage of separation and chemical purification of antibiotics due to imperfections in the equipment used.
The ion sorption method consists in the fact that the native solution is fed by means of centrifugal pumps to a battery of ion-exchange columns loaded with SBS-3 sulfocathionite. As a result of ion exchange, the antibiotic is adsorbed on the ion exchanger, after which it is desorbed (eluted) with an ammonia-borate buffer solution.
This method has certain hygienic advantages compared to precipitation and extraction methods. It does not require manual labor when working with precipitation, which eliminates the contact of antibiotics working with concentrated solutions and precipitates. No toxic organic solvents are used with this method.
The pasty products obtained during the chemical cleaning process are subsequently dried and sieved. The drying process in the production of antibiotics plays an extremely important role, since the quality of products depends on its organization. Thermostable antibiotics, obtained in crystalline form with a low moisture content, are usually dried in vacuum ovens. Antibiotics obtained after chemical cleaning in the form of aqueous concentrates are dried in evaporative-drying units and vacuum freeze dryers. These processes must be carried out under sterile conditions.
The main disadvantage of working in the drying departments is the use of manual labor when loading and unloading products. The performance of these operations, as well as the need to mix the powdered mass and control the technological mode of operation of the drying units, is associated with the possibility of contact of antibiotics working with dust. Insufficient sealing of drying units contributes to the release of some toxic substances into the air of industrial premises, the residual amounts of which may be contained in antibiotics. For example, the finished chlortetracycline may contain an admixture of methanol, tetracycline — isooctyl alcohol, tetracycline and hydroxy-tetracycline hydrochlorides — n-butanol and hydrochloric acid.
5. Hygienic characteristics of working conditions and the health status of workers in the production of antibiotics
Working conditions in the production of antibiotics are characterized by the possible entry into the air of fine dust of antibiotics, vapors and gases used in the technological process of chemicals and the release of excess heat. At the fermentation stages, workers can be exposed to phenol and formaldehyde vapors used to sterilize rooms and equipment, as well as producer dust.
At the stages of pre-treatment and filtration, workers are in contact with oxalic and acetic acid vapors. Manual operations often lead to contamination of the skin and clothing with a culture fluid and a native antibiotic solution.
The processes of isolation and chemical purification of an antibiotic carried out by extraction and precipitation are associated with the possibility of exposure to the body of working vapors and gases of butyl, isopropyl and methyl alcohols, butyl acetate, oxalic, acetic, sulfuric and hydrochloric acids and other substances used in this stage. The concentration of these substances in the air in some cases may exceed the maximum permissible. The main causes of air pollution of the working area with harmful substances are insufficient tightness of equipment, the presence of manual operations, low efficiency of ventilation devices, etc.
At the final stages, studies show that drying, sieving, tabletting, filling and packaging of antibiotics can be accompanied by significant environmental pollution with fine dust of the finished product. In addition, the workers of the preparatory workshops, drying department, fermentation, in addition to the chemical factor, can be simultaneously exposed to excess heat, the main source of which are inoculators, fermenters, drying units, as well as the surfaces of communication networks in case of insufficient thermal insulation.
A study of the state of health of antibiotic workers working in the production shows that under the influence of occupational hazards, functional impairment of the body, and in some cases the development of occupational diseases, are possible.
One of the characteristic manifestations of the toxic effect of antibiotics is complaints of persistent itching of the skin, frequent headaches, pain in the eyes, fatigue, pain and dry throat. In some cases (for example, when exposed to streptomycin), workers also note hearing loss and pain in the heart.
The most common and characteristic symptoms when exposed to antibiotics are complications of the gastrointestinal tract: lack of appetite, nausea, flatulence, abdominal pain. A significant group of complications are liver damage, impaired renal function, cardiovascular and nervous systems.
At present, considerable material has been accumulated on the effect of antibiotics on the blood system: the development of anemia, agranulocytosis, leukopenia, impaired vitamin metabolism.
Antibiotics should be attributed to the group of so-called allergens, the sensitizing effect of which is manifested mainly in damage to the skin and respiratory system. Allergy occurs both with the inhalation route of entry into the body, and in contact with the skin. The development of skin sensitization contributes to a violation of the integrity of the skin. Positive allergenic tests, for example, on penicillin, were detected in 18% of those working with an antibiotic, on streptomycin - in 18.5%, on both antibiotics with a combined effect - in 47%. Persons who are constantly in contact with antibiotics most often (50%) develop dermatitis, eczema, urticaria, localized mainly on the hands, forearms, face. These changes are most often recorded in workers with experience of more than 5 years in the production of biomycin, chloramphenicol, tetracycline, penicillin. In this case, skin lesions begin with diffuse hyperemia and swelling of the face (especially in the eyelids), hands and forearms. With further contact with antibiotics, the development of acute or subacute recurrent dermatitis, passing into eczema, is possible.
Changes in the upper respiratory tract are expressed in the development of hyperemia and atrophy of the mucous membranes, mainly of the nose and larynx. With the progression of the disease can be complicated by asthma bronchitis and bronchial asthma. One of the manifestations of the side effect of antibiotics is dysbiosis - a violation of the normal microflora of the body. Secondary mycoses (most often candidiasis), changes in the gastrointestinal tract and upper respiratory tract, which developed against the background of dysbiosis of the mucous membranes, as well as inhibition of factors of natural immunity, are detected in antibiotics working in the production of antibiotics. Workers observed constipation, diarrhea, flatulence, erosion and ulcers of the rectal mucosa. The detected changes in the state of health to some extent resemble the manifestations of the side effects of antibiotics in the conditions of their clinical use.
Along with this, workers have an increased incidence of influenza, acute respiratory viral infections and diseases of the female genital area.
Preventive measures in the production of antibiotics should be aimed primarily at combating the release of harmful substances into the air of the working area. For this purpose, it is necessary to provide for automation and mechanization of technological processes in the complex of recreational activities, the effective operation of general and local ventilation, and compliance with the technological regime. This not only eliminates the effect on the working emissions of harmful substances, but also eliminates the adverse effects of meteorological factors.
Particular attention in the fight against harmful air pollution should be given to sealing technological equipment and communications, mechanization of processes and operations for loading, unloading and transportation of raw materials, semi-finished products and finished products.
An important place in the prevention of the harmful effects of chemical factors should take laboratory control over the content of harmful substances in the air of the working area, the amount of which should not exceed the established norms. Currently, MPCs have been established for the following antibiotics: streptomycin - 0.1 mg / m, oxacillin - 0.05 mg / m3, florimycin - 0.1 mg / m3, hygromycin B - 0.001 mg / m3, oxytetracycline - 0 , 1 mg / m3, ampicillin - 0.1 mg / m3, biovita (according to the content of chlortetracycline in the air) - 0.1 mg / m3, oleandomycin - 0.4 mg / m, phytobacterin - 0.1 mg / m3.
To a large extent, the improvement of the air environment in the production of antibiotics will be facilitated by the replacement in the technological formulation of harmful ingredients with new, less toxic compounds.
In the production of antibiotics, treatment and preventive measures are also important. These primarily include the organization and conduct of preliminary and periodic medical examinations. Admission to work in the preparatory, reactor, drying and other departments should be made taking into account the contraindications provided for working in contact with the hazards existing in these departments. Periodic medical examinations are aimed at the timely identification of possible occupational diseases.
In order to prevent allergization of the body and the skin-irritating effect of chemicals, prophylactic desensitization, the use of protective ointments (for example, 2% salicylic), detergents, etc. are recommended.
Important in the prevention of diseases and strengthening the state of health is the organization of a proper diet and rest. The delivery of lactic acid colibacterin is recommended for the prevention of dyspeptic disorders in workers, as well as the enrichment of food rations with vitamins A, B, PP, C. It is necessary to strictly observe the rules of personal hygiene - wash hands after each manipulation with antibiotics, wash in the shower and change clothes after work. In addition, those working in the production of antibiotics should be provided with rational work clothes, underwear, shoes, gloves and mittens, dust masks such as Petal-5, Petal-40, and goggles.
6. LABOR HYGIENE IN THE PRODUCTION OF GALENE DRUGS AND PREPARED MEDICINAL FORMS
The pharmaceutical industry unites enterprises for the production of galenic, newgalenic drugs, as well as finished dosage forms (pelleting, ampouling, tabletting, etc.). At the enterprises of this industry, galenic and newgalenic preparations are manufactured, such dosage forms as tinctures, liquid and dry extracts, syrups, solutions, drops, tablets, plasters. A large amount of work is carried out by weighting, mixing, grinding and packaging of pharmaceutical preparations, completing first-aid kits, etc. The technological process is built on the guild principle and includes such main workshops as galenical, ampoule, tablet, packing, pan-coating, etc.
A variety of substances of plant, animal and mineral origin are used as the initial medicinal raw material for obtaining galenic and newgalen preparations. The features of this production are a wide range of products, a variety of feedstock, the release of numerous drugs in small quantities (low tonnage), a variety of equipment used for basic technological and auxiliary operations. These manufactures often work according to a combined technological scheme, that is, the equipment is arranged and placed in such a way that it would be possible to obtain various medicines on it that are similar in accordance with the technological regulations for manufacturing.
7. Hygienic characteristics of working conditions in the manufacture of herbal remedies
Herbal preparations are obtained from medicinal plant materials. They are divided into two groups: preparations from fresh plants and preparations from dried plant materials. When they are manufactured, in the event of equipment leakage and poor ventilation performance, working pairs may be affected by extractant pairs (dichloroethane, ethers, alcohols, etc.). Hygienically unfavorable operations should be considered to grind fresh medicinal herbs, since at this moment droplets of their juice and small particles can enter the respiratory system, the skin from the covered parts of the body (hands, face), while causing skin-irritating and sensitizing effect.
Preparations from dried plant materials include tinctures and extracts.
Tinctures are alcohol or alcohol ether extracts from dry plant materials obtained without heating and removing the extractant. Tinctures are obtained by infusion, percolation (continuous filtering through a filter) and dissolving the extracts.
Extracts - galenic preparations, concentrated extracts from dry plant materials, purified from ballast substances. The concentration distinguish between liquid, thick and dry extracts. The main operations in the technological scheme of extracts are:
a) the extraction of dry plant materials;
b) separation of the liquid phase from the solid by settling, filtering, centrifuging and pressing;
c) distillation of extractants - water, ether, alcohol, chloroform, etc. by evaporation (thick extracts) or drying under vacuum (dry extracts).
There are many methods of extraction. In general, they can be classified into static and dynamic.
In terms of hygiene, the most progressive methods are dynamic extraction, which is based on a constant change of extractant or extractant and raw materials.
Thick extracts are obtained by evaporation (thickening) of liquid extracts in vacuum evaporators at a temperature of 50-60 ° C.
Dry extracts are extracts from dry plant materials. They are obtained by further drying the thick extract in a vacuum roll dryer or by drying the non-concentrated extract in a spray dryer.
Working conditions in the manufacture of galenic and newgalenic preparations are characterized by the possibility of exposure to working dust of medicinal plants released during the crushing of plant materials, sifting, transportation, loading, unloading, etc. Thus, the loading of medicinal plants in percolators is accompanied by air pollution of the working area with medicinal dust herbs. Its concentration depends on the type of plant material, the degree of its grinding, mass, etc.: for example, the concentration of dust of Eleutherococcus when loading it into percolators was 2-4 times higher than the levels of pollution when loading valerian root.
Medicinal dust, depending on the physical properties, chemical structure, can have a very different effect on the body: general toxic, skin irritant, allergenic, etc. For example, when loaded, belladonna grass containing atropine alkaloids, getting on the skin, causes its irritation. With prolonged exposure, especially when this grass gets dust through the respiratory tract, the toxic effect manifests itself in the form of dizziness, general excitement, increased heart rate and respiration. Dust of red pepper, sage, wormwood, etc. has a skin-irritating effect. Cases of allergic lesions upon contact with dust of magnolia vine, lycopodia, and other herbs are described.
Obtaining galenic and newgalenic preparations is associated with air pollution of the working area with vapors of extractants and solvents (alcohol, ether, chloroform, dichloroethane, etc.). For example, high concentrations of ethyl alcohol vapors were found at a number of enterprises in the premises for the manufacture of alcohol solutions, where in 20-30% of the samples taken, the vapor content in the air of the working zone exceeded the MPC.
In combination with the chemical factor in certain areas, workers are exposed to the simultaneous influence of a microclimate determined by excess heat and noise.
The nature and severity of the effect of the chemical factor on workers in galenical workshops is determined by the perfection of the technological equipment used, the composition of the medicinal product, as well as the construction and planning decisions of the premises and the organization of air exchange in them.
Studies show that in those enterprises where sealed equipment is widely used to obtain galenical and newgalen preparations, and the processes of loading, unloading and transporting semi-finished products and finished dosage forms are mechanized, the concentration of vapors and aerosols of extractants and drugs in the air does not exceed acceptable levels. At the same time, the violation of the tightness of equipment and communications, the use of manual labor, the presence of open surfaces, the discontinuity of technological processes, and the imperfection of ventilation devices are one of the reasons for the high content of harmful substances in the air of the working zone, 2--5 times or more exceeding the maximum permissible concentration.
The most important health-improving measure in the galenic preparation workshops is the rationalization of technological processes with the widespread introduction of automation and mechanization. Sealing equipment, communications, conveyors, etc. is an important condition in the system of preventive measures. Supply and exhaust ventilation is essential in improving working conditions. First of all, it is necessary to equip local exhaust devices at crushers, vibrosieve, places of loading and unloading of raw materials, auxiliary ingredients, etc.
An extremely important role in ensuring normal working conditions is played by the planning decisions of galenical workshops, taking into account the emission of harmful substances and noise sources. Of great importance in preventing the harmful effects of production factors are personal protective equipment. Workers serving crushers, mills, sieves, screw and belt conveyors and other technological equipment should be provided with protective clothing, goggles of the 03-N, 03-K type, gloves, and respirators of the ШБ-1 type. In addition, apparatchiks in contact with organic extractants must have gas masks with a filter box of grade A.
8. Hygienic characteristics of working conditions in the production of drugs in ampoules
The technological process for the production of drugs in ampoules is carried out in the ampoule shop of a pharmaceutical plant. The production cycle for the manufacture of ampoules consists of the following basic operations: manufacturing of ampoules, preparation of an injection solution and filling of ampoules (ampoules), sealing of ampoules, sterilization, control, labeling and packaging.
Making ampoules. It is produced in the department of the ampoule shop using special devices (automatic machines or semi-automatic machines). Ampoules are made of long chemically resistant glass tubes - drots. At first, the drone is washed, and then strengthened on rotary semiautomatic devices or automatic machines, where ampoules are obtained from it using gas burners. At subsequent stages, ampoules with open capillaries are washed in vacuum semiautomatic devices. For more effective washing in recent years, the treatment of ampoules with ultrasound has been widely used. Washed ampoules are dried with hot air in ovens and then transported to ampoule filling compartments.
As studies have shown, in this area, workers are exposed to carbon monoxide and high temperatures (up to 28 ° C). The main source of hazardous emissions is the process of burning natural gas in gas burners of ampoule machines.
In case of violation of the rules for cleaning premises, in particular when removing dust mechanically and by blowing off the surface of ampoule machines, the concentration of glass dust during this period may exceed the MPC by 2 times or more. Along with the specified occupational hazards, workers are exposed to noise emitted from ampoule machines. In addition, it must be borne in mind that when washing drills and ampoules, as well as when servicing ampoule machines, there is a risk of injury from glass fragments.
Solution preparation and ampoules. Preparation of the injection solution begins with the processing of the solvent, which is used as water, various oils (peach, almond, peanut, etc.), synthetic and semi-synthetic compounds. Water treatment for injection is carried out on high-performance distillers, ensuring its appropriate quality, including pyrogen-free.
Ampulation is carried out by the syringe or vacuum method: at the first, the ampoules are filled with a solution automatically using a syringe, at the second, a vacuum is created in them of a certain depth, after which the ampoule immersed in the injection solution is filled with a certain volume.
Filling ampoules with a medicinal substance requires perfect cleanliness, therefore, particularly strict sanitary and hygienic requirements are imposed on technological operations, planning, decoration and maintenance of premises. Walls must be tiled or oiled. The floor material must be resistant to water, disinfectants, organic solvents and other chemicals. These requirements are more consistent with its coating with a polymeric material (polyvinyl chloride tiles, relin, etc.). An important point is air purification (filtration) and its disinfection using bactericidal lamps. In the room it is necessary to systematically produce wet cleaning.
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As studies show, the main unfavorable acting factor of the working environment at the enterprises of the chemical-pharmaceutical industry is the pollution of harmful working air and 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 imperfect equipment, violation of technological conditions, lack or insufficient mechanization of many operations related to the transportation, loading and unloading of materials from apparatus, the use of leaky equipment, overflow of chemical products when filling apparatus, etc.
The composition of the substances that pollute the air in the working zone of the majority of pharmaceutical 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 of industrial premises may be contaminated with 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 implementation of the processes for obtaining the drug, and final operations. At the same time, the severity and nature of the effect of the chemical factor on the workers' bodies 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 transporting 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, and are widely used in the 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 proceeds at a temperature of about 200 ° C and a pressure of 5.9-9.8 MPa (60-100 atm), hydrolysis of the amine to phenol occurs at a temperature of 350 ° C and a pressure of 19.6 MPa (200 atm).
In such processes, the tightness of the equipment is achieved by 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 the working time is in conditions of high levels of harmful substances in the air. The highest levels of chemical contamination 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.
Multicomponent pollution of the air is distinguished by the production of the pharmaceutical industry, where dozens of chemical compounds are detected in the air of the working area (chemical factor), microbial sensitization of the working organism (biological factor), adverse physical factors (noise, vibration, ultrasound, microclimatic conditions) are present, psychophysiological factors (monotony of the production process, tension of the visual analyzer, etc.).
In cases of a disease directly related to production, we are talking about occupational diseases: for example, pneumoconiosis caused by sclerogenic dust, silicosis, which is accompanied by pulmonary tuberculosis.
At present, the final definition of the concept of a biological factor has not yet been formulated. However, based on available materials, it can be said that under biological factor means the totality of biological objects, the impact of which on a person or the environment is related to their ability to reproduce in natural or artificial conditions or to produce biologically active substances. The main components of a biological factor that have a direct or indirect effect on humans are:
micro- and macroorganisms, products of the metabolic activity of microorganisms and microbiological synthesis, as well as some organic substances of natural origin.The existence of life on Earth is inextricably linked with the diverse world of microorganisms, but only a few decades ago their widespread, targeted use began.
The 40s of the 20th century are characterized by the rapid development of the production of a number of valuable products based on microbiological synthesis, i.e., using the ability of microorganisms to synthesize new structural elements (substances) or to excess accumulation of metabolic products due to enzyme systems inherent in the microbial cell. Among such industries is the production of antibiotics, amino acids, proteins, enzymes, etc.
To date, biologically active substances (antibiotics, enzymes, vitamins, IOO, fodder yeast) have acquired social significance.
Bacteriological study of the microflora of the mucous membrane of the oral cavity, pharynx, nose of workers revealed a violation of microbial biocenosis, which, as shown by clinical studies, contributes to the development of subatrophic rhinitis, hyperplastic and catarrhal processes of the mucous membranes of the upper respiratory tract.
The professional nature of these changes is confirmed by the presence of pathological changes in the mucous membranes of the respiratory tract from professions; the greatest number of cases of diseases is observed among workers employed in those operations where there is the greatest contact with antibiotics.
A decrease in the antimicrobial resistance of the body (bactericidal activity of the skin, phagocytic activity of neutrophils), i.e., the effect of antibiotics on factors of natural immunity, was also revealed.
Data on the specific effect of antibiotics on the normal intestinal microflora, as well as their effect on factors of natural immunity and the development of allergic diseases, were taken when normalizing antibiotics in the air of the working area as the basis for the specific effect. So, along with tests for general toxicity, studies are carried out with the aim of:
Identification of sensitizing properties;
- determining the danger of sensitization when an allergen enters through the skin and respiratory organs, as well as bacteriological studies of feces to determine the degree of change in the normal intestinal microflora.
At present, the final definition of the concept of a biological factor has not yet been formulated. However, based on the available materials, it can be said that the biological factor is understood as the totality of biological objects, the impact of which on a person or the environment is related to their ability to reproduce in natural or artificial conditions or to produce biologically active substances. The main components of a biological factor that have a direct or indirect effect on humans are:
micro- and macroorganisms, products of the metabolic activity of microorganisms and microbiological synthesis, as well as some organic substances of natural origin.
In the production of the chemical-pharmaceutical industry, the air environment is polluted by a complex of various chemicals. Their quantity is especially large in those synthesis processes in which the final product is obtained from a large number of various raw materials, additives, and catalysts.
Impact example chemicalfactors on the human body are diseases caused by beryllium, phosphorus, chromium, arsenic, mercury, lead, manganese, carbon disulfide or their toxic compounds, halogenated hydrocarbons of the fat series (dichloroethane, etc.), benzene and its toxic compounds, toxic nitro and groups, nitrogen oxides, fluorine-containing compounds, etc. Primary skin cancer is caused by tar, tar, mineral oils, or their compounds.
Chemically dangerous and harmful production factors by the nature of their effects on the human body are divided into: general toxic, irritating, sensitizing, carcinogenic, mutagenic (see lecture No. 4).
TO physically hazardous and harmful production factors include: non-hygienic conditions of the industrial microclimate (see lecture No. 2), increased noise and vibration, non-ionizing electromagnetic fields and radiation, ionizing radiation, ultrasound, infrasound, dust and aerosols of fibrogenic effect.
Psychological harmful production factors by the nature of the impact on the human body are divided into: physical overload (static and dynamic), affecting the musculoskeletal system, cardiovascular, respiratory systems and neuro-psychological (mental overstrain, monotony of labor, stereotyped movements, overstrain of analyzers , emotional, sensory loads), causing an overstrain of the functional systems of the body, fatigue and overwork, which leads to a decrease in human performance.
HYGIENIC CHARACTERISTICS OF THE BASIC TECHNOLOGICAL PROCESSES In the pharmaceutical industry there are several groups of enterprises. The leading ones are factories for the production of synthetic drugs, factories for the production of antibiotics and enterprises for the production of drugs and finished dosage forms. The industrial production of synthetic medicines is based on the widespread use of organic synthesis, which brings these enterprises closer to the basic chemistry industry.
HYGIENIC CHARACTERISTICS OF BASIC TECHNOLOGICAL PROCESSES The antibiotic enterprises are united in a special group. This is due to the fact that the basis of the technological process for obtaining these drugs is biological synthesis. A characteristic feature of plants for the production of galenic pharmaceutical and finished dosage forms is the release of a large number of various medicines in the form of liquid extracts and tinctures, injection solutions in ampoules, tablets, dragees, plasters, etc.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES In the industrial production of chemical pharmaceutical preparations, various raw materials are widely used, obtained both from plant and animal products, and by chemical synthesis. The most common is chemical raw materials. Mineral raw materials are used for the production of inorganic salts, as well as ingredients for various synthesis of organic compounds. A large number of mineral acids and alkalis are used. The initial organic raw materials are supplied by the coke, petrochemical, aniline-paint industry and enterprises of basic organic synthesis.
HYGIENIC CHARACTERISTICS OF BASIC TECHNOLOGICAL PROCESSES In the production of pharmaceuticals, animal raw materials are also widely used, in particular, histidine is obtained from animal blood, adrenaline from the adrenal glands, insulin from the pancreas, thyroidin from the thyroid gland, etc.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES All types of technological operations upon receipt of drugs can be divided into Preparatory operations - storage, transfer of solid, liquid and gaseous materials, their transformation: grinding and crushing of solid raw materials, separation of solids, removal of liquids and gases from them using methods of sedimentation, filtration, centrifugation, cooling crystallization, evacuation, etc. Actually, the processes of obtaining drugs - exchange, thermal, electrochemical, biological processes, electrolysis, etc. At this stage of the technological process, sulphation, nitration and halogenation, amination and oxidation of reduction and oxidation, etc. The final stage is that the drugs are dried, crushed, tabletted, ampouled, packaged and packaged. Additional operations
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS A significant part of the feedstock for obtaining galenic and synthetic drugs is in the solid state and is subjected to crushing, grinding. The need for this operation often arises when receiving dosage forms (tablets, dragees, etc.). Crushing is carried out on jaw, roll, cone, hammer and other crushers. Grinding is carried out using ball and porcelain mills, disintegrators. Small amounts of the drug product are crushed in mortars on a mechanical drive, mills of Islamgulov, Excelsior, etc.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS Professional hazards during crushing, grinding and separation of the initial products of drugs are dust, intense noise and general vibration. Dust is emitted at the point where the medicinal raw material or finished product arrives at the crushers and mills and at the exit points of the ground substance. Hygienically unfavorable operation is the separation of materials into fractions. The air separators and mechanical sieves used are significant sources of dust. In the production of small-tonnage drugs (for example, hormones), manual wiping is often used on sieves, which is associated with the release of dust and contamination of the skin and clothing of workers.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS To combat dust emission, § proper organization of the technological process and equipment, § shelter of dust extraction sites with aspiration of dusty air is necessary.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS Since noise and vibration at grinding and grinding plants can exceed the permissible values, this equipment must be placed in separate production rooms, and the foundations under them should not be connected with the building structures. In the fight against noise and vibration, it is necessary to use anti-noise and anti-vibration devices and materials. It is advisable to remotely control the grinding and crushing processes.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS A significant impact on the level of air pollution of the working area with harmful substances at the preparatory stage is provided by the transportation of the starting components. This is due to the heavy load on communication facilities, the presence of mechanisms and devices designed to move substances that do not have efficient exhaust devices and the necessary tightness. During transportation, workers can come into contact not only with vapors and gases, but also with liquid and granular harmful substances. In some cases, manual transportation, loading and unloading of medicinal raw materials (for example, plant origin) are still used.
HYGIENIC CHARACTERISTICS OF MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS Liquid substances are transported through pipelines using pumps, air or steam pressure, gravity flow and vacuum. Gaseous substances are transported by compression and vacuum. The supply of starting products with compressed air is associated with an increase in pressure in communication networks, which can lead to the release of harmful vapors and gases through leaks in pipelines, devices and tanks.
HYGIENIC CHARACTERISTICS OF THE BASIC TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS It should be noted as imperfect hygienic transportation of liquid products using pumps, which are an additional factor contributing to air pollution by chemicals. From this point of view, the transportation of liquid products by gravity or by vacuum is most favorable. The main hygiene requirements for equipment are the stability of pipelines, gasket and packing material to the action of liquids, the replacement of stuffing box pumps with glandless and submersible.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES PREPARATORY OPERATIONS The supply of solid medicinal raw materials (plant products, organic and mineral substances) from raw materials to preparatory workshops, from one equipment to another, is carried out using conveyor belts, elevators, pneumatic systems, and also hydraulic systems. The method of transportation is determined by the state of aggregation of substances, their toxicity, nature of production, etc. Transportation with belt conveyors, augers, etc. is associated with significant dust emission. The most advanced hygienic approach is the supply of dry starting products using pneumatic conveying.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. This technological stage of obtaining drugs is characterized by a wide variety of technological processes and operations, equipment and chemicals used. A significant share in the industrial synthesis of intermediates and medicinal substances is occupied by processes associated with the substitution of hydrogen atoms in the nucleus of aromatic compounds by certain groups of atoms, the conversion of substituents already existing in the organic compound molecule into others in order to give it new properties and, finally, change carbon structure of the molecule. These are reactions of nitration, sulfonation, halogenation, reduction, alkylation, etc. These processes are carried out in reactors of various types, which got their name depending on the chemical reactions carried out in them (chlorinator, nitrator, sulfator, etc.).
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Reactors can operate under elevated and normal atmospheric pressure or under vacuum. They can be periodic and continuous. These are steel, lead or cast-iron containers with or without agitators, with heating or cooling. Depending on the processes occurring in the reactors, various types of mixers are used: paddle, screw, frame, anchor, etc.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. The main harmful factor in the reactor compartment is a chemical. The places where toxic substances are emitted from the reactors can be agitator oil seals, hatches through which products are loaded and unloaded, measuring glasses, inspection windows, and flange connections. At the same time, the composition and level of harmful substances in the air of the working area depend on the perfection of the equipment used, the type of medicinal intermediate or finished medicine obtained, the mode of operation and other factors. An unfavorable hygiene situation may be caused by manual operations, for example, when measuring the level of liquids, sampling.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Significantly reduce the emission of harmful substances into the air of working rooms, the transfer of equipment to the vacuum process, the use of closed reactors with shielded mixer motors, the use of automatic control
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. A large share at this stage is occupied by the processes of separation of chemical components. The main equipment for such operations are distillation apparatus and distillation plants. Maintenance of this equipment is associated with the possibility of contact with harmful substances that may enter the air through communication systems, hatches, cranes, sampling points, etc.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Filtration and centrifugation processes are widely used to separate suspensions into solid and liquid phases. Filtration is carried out on filters of periodic and continuous action. The first includes nutsche filters, filter presses, sheet filters, and the second includes drum, disk and belt filters. The work of nutsche filters and filter presses is often accompanied by the release of toxic substances into the air of the working area, associated with the use of manual labor, the possibility of intense contamination of the skin and overalls. Hygienically, drum filters are more favorable, which are airtight and equipped with exhaust ventilation.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. For the rapid separation of the drug intermediate, batch and continuous centrifuges are used. Batch centrifuges are less perfect and have a number of disadvantages, the main of which are the inconvenience of removing pressed material, the use of manual labor, and the lack of reliable tightness. These shortcomings are the cause of the release of harmful substances into the air of the working area and contamination of the skin.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Hygienically reliable are mechanized and closed filters, self-unloading centrifuges with lower discharge, drum vacuum filters, automatic filter presses.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. A significant part of intermediates and finished medicines is dried. This process is necessary when obtaining galenic, synthetic preparations, antibiotics, vitamins, etc. Moisture is removed by mechanical (filtering, pressing, centrifugation), physicochemical (absorption by hygroscopic materials), thermal (evaporation, evaporation and condensation) methods. In the production of medicines, chamber, drum, spray, shaft and other dryers are most widely used.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. The maintenance work of most dryers is accompanied by increased heat directly at the workplace and the release of toxic substances. A significant drawback of dryers is the insufficient mechanization and sealing of the processes of loading and unloading of substances subjected to drying, which causes air pollution of the working area with dust of the finished product. Significantly less harmful substances are emitted when using continuous dryers (rowing, spraying, drying drums, etc.), provided with complete sealing and mechanization of loading and unloading processes.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. The evaporation and crystallization processes are widely used in the production of drugs. The former are used to obtain more concentrated solutions from less concentrated (synthetic and galenic preparations, antibiotics, vitamins, etc.). For this purpose, in most cases, multi-case evaporators are used. Hygienically adverse operations when working with them are the supply of solutions and unloading of the finished product, since they are accompanied by the release of harmful compounds into the air of the working area.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Crystallization processes are used to purify medicinal substances from impurities or to isolate them from a liquid. These processes are carried out in crystallizers of open and closed type. The main disadvantage of this equipment is the lack of sealing and mechanization of the processes of loading and unloading of medicinal substances. More favorable sanitary conditions at workplaces are created when servicing vacuum crystallizers.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES THE PROCESSES OF OBTAINING MEDICINES. Obtaining finished dosage forms in the form of tablets, dragees, ampoules consists of many preparatory and basic processes and operations carried out in a certain sequence on the appropriate equipment
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES FINAL OPERATIONS At the final stage of the technological process, medicinal substances are labeled, packaged and packaged. Packaging of dosage forms is carried out in plastic, paper and glass containers. Most operations at this stage are mechanized. At the same time, manual operations at individual enterprises make up a significant part.
HYGIENIC CHARACTERISTICS OF THE MAIN TECHNOLOGICAL PROCESSES FINAL OPERATIONS The main adverse factor in hygiene in this stage of drug production is dust. Workers, as a rule, are exposed to dust of complex composition, since several types of drugs can be packed and packaged at the same time. Work with the semi-mechanized and especially manual method of packaging and packing of tablets, ampoules, dragees, as well as gluing boxes and convoy with cellophane strips and a number of other operations are associated with the forced position of the body.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN PRODUCTION OF MEDICINES Chemical factor. The main unfavorable factor of the working environment at the enterprises of the pharmaceutical industry is pollution by harmful organic and inorganic substances from the air of the working area, clothing and skin.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN PRODUCTION OF MEDICINES Dust. Air pollution of workrooms with dust is observed mainly at the preparatory and final stages of obtaining medicinal substances. The main sources at the preparatory stage are the delivery of raw materials from storage facilities to production workshops, as well as operations related to crushing, grinding, sieving, transportation, loading, etc. Thus, a significant amount of dust is observed at workplaces when grinding vegetable raw materials, crushing the original components of synthetic products. At the same time, the dust level can be 3-5 times higher than the permissible level.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN THE PRODUCTION OF MEDICINES Dust. In the final stage of obtaining drugs, the processes 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 vibration screens and especially when manually sifting can be 5 times or more higher than the permissible values. So, during manual packaging, the dust concentration in the breathing zone of workers can reach 100 mg / m 3 or more.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN PRODUCTION OF MEDICINES Dust. It is known that the nature of the effect of dust on the body and the degree of severity of biological changes are largely determined by its dispersion. The dust of some drugs is 85-98% composed of particles less than 5 microns in size (table. 1. 1). This facilitates the penetration of a large amount of medicinal substances into the body through the respiratory tract and digestive organs (with saliva).
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN PRODUCTION OF MEDICINES Microclimate. 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 temperature is 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 ° C with a relative humidity of 40-60%. Thus, the thermal microclimate at individual workplaces of the enterprises of the chemical pharmaceutical industry is an additional factor aggravating the effect of the chemical factor.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN THE PRODUCTION OF NOISE MEDICINES. 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.
GENERAL CHARACTERISTICS OF INDUSTRIAL FACTORS DETERMINING LABOR CONDITIONS IN THE PRODUCTION OF NOISE MEDICINES. The noise level in some cases may exceed the permissible level. So, in the workplace, the noise parameters can exceed the permissible values \u200b\u200bof üу centrifuges by 5 d. B, üу vacuum of the pump by 5-6 d. B, üy of the compressor by 14-17 d. B. The most unfavorable sections are engine rooms, where the total high-frequency noise level often exceeds the permissible values \u200b\u200bby 20–25 days. B. It should be noted that production noise even at the acceptable level can aggravate the adverse effects of chemicals.
MEASURES TO IMPROVE LABOR CONDITIONS IMPROVEMENT OF TECHNOLOGICAL PROCESSES IN PRODUCTION OF MEDICINES AND EQUIPMENT § § § replacement of harmful substances in the formulation with less harmful ones, replacement of an open process with a closed one, transfer of the process from high pressure to low heat, and mechanization. § transition to pressurized continuous technological processes with remote control and monitoring § automation
MEASURES TO IMPROVE LABOR CONDITIONS VENTILATION To ensure high ventilation efficiency, the correct layout and layout of the premises, the decoration of the inner surfaces of the fences that impede the sorption of toxic substances, etc. are required. Local ventilation in accordance with features of working equipment and the nature of the operations performed.
MEASURES TO IMPROVE WORKING CONDITIONS VENTILATION Over the hatches of reactors and other equipment that periodically open, an exhaust system is arranged in the form of an umbrella with a soft movable sleeve. When sampling, opening the hatches of devices, unloading components and other operations, significant release of harmful substances can occur, therefore, when performing such operations, PPE should be used.
MEASURES TO IMPROVE THE WORKING CONDITIONS OF NOISE Measures to combat noise ü Improvement of technological equipment, ü Proper layout of production facilities, ü Use of sound-absorbing building materials (foam, felt, wood fiber boards, etc.). Also, timely preventive inspection and repair of equipment and systems that are a source of noise. In some cases, when it is impossible to reduce noise to acceptable values, the use of PPE (antiphons) is recommended.
MEASURES TO IMPROVE LABOR CONDITIONS HEALING AND PREVENTIVE MEASURES ü conducting preliminary and periodic medical examinations ü observing the established regime of work and rest, ü organizing a balanced diet, ü doing sports.
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