Microclimate and air condition in a pharmacy. Hygienic requirements for the improvement of pharmacy premises. What SNiP and SanPiN standards are implemented during design

One of the conditions for a pharmacy to operate without justified claims from regulatory authorities is strict adherence to the storage conditions of drugs in accordance with the requirements of drug manufacturers specified on primary and secondary (consumer) packaging. In addition to specific conditions for certain groups medicines, such as storage in cabinets or safes, protection from sunlight, storage in refrigerators, there are parameters that affect almost all products in the pharmacy range. In this regard, during inspections, it is they who are subject to control, or rather, their accounting. We are talking about temperature and humidity parameters in a pharmacy organization.

First of all, let’s outline what current legislation requires of pharmacies. As permissible temperature in the premises of a pharmacy, according to the recommendations of the current State Pharmacopoeia, 13th edition, storage at room temperature implies a temperature range from 15 to 25 ° C or, depending on climatic conditions, up to 30 °C.

Estimated temperatures in the premises of pharmaceutical organizations (pharmacies)

As for humidity, storage of medicinal products is carried out at a relative humidity of no more than 60 ± 5% depending on the relevant climatic zone (I, II, III, IVA, IVB), if special conditions storage not specified in regulatory documentation.

Premises for storing medicines must be equipped with instruments for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). Technological equipment, used in pharmacies, must be registered with the Russian Ministry of Health, permitted for use in in the prescribed manner and have a certificate of conformity.

In addition, monitoring devices must be calibrated and verified in the prescribed manner.

That is, before commissioning, as well as after repair, temperature and humidity control devices in a pharmacy are subject to initial verification and (or) calibration. And during operation - periodic verification and (or) calibration in accordance with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements.

The measuring parts of the devices must be located at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which readings are visually read must be located in a place accessible to personnel at a height of 1.5 - 1.7 m from the floor. However, it is recommended to place them in places where there is highest probability fluctuations in temperature and humidity or most often observed deviations from the required parameters.

Instrument readings must be recorded daily in a special “Log of daily registration of temperature and humidity parameters in premises for storing medicines, medical devices and dietary supplements” on paper or in electronic form with archiving (for electronic hygrometers), which is maintained responsible person.

An example of filling out a journal for daily registration of temperature and humidity parameters in premises for storing medicines, medical devices and dietary supplements (on paper):

Registration records must demonstrate the temperature and humidity conditions established for the premises, and, if they do not comply, corrective actions. That is, the pharmacy management analyzes the temperature or humidity parameters, and, if they do not meet the requirements of regulatory documentation, decides to use, if necessary, additional heating devices or equipment for air dehumidification/humidification.

Such a log is stored for one year, not counting the current one.

Repair, Maintenance, verification and (or) calibration of equipment must be carried out in accordance with the approved schedule, so that the quality of medicinal products is not compromised negative impact. During this time, measures must be taken to ensure the required storage conditions for medicines.

Repair and maintenance must be properly reflected in documents that are archived and stored in accordance with the legislation of the Russian Federation on archival matters.

1 Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 N 706n RULES FOR STORAGE OF MEDICINES 2 MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION ORDER dated October 21, 1997 N 309 ON APPROVAL OF INSTRUCTIONS FOR SANITARY REGIME OF AP PHARMACEUTICAL ORGANIZATIONS (PHARMACIES) 3 Articles 13 and 18 Federal Law dated June 26, 2008 N 102-FZ “On ensuring the uniformity of measurements” (Collected Legislation of the Russian Federation, 2008, N 26, Art. 3021; ​​2014, N 26, Art. 3366; N 30, Art. 4255). 4 Order of the Ministry of Health of the Russian Federation dated August 31, 2016 N 647n RULES OF GOOD PHARMACY PRACTICE FOR MEDICINES FOR MEDICAL USE

Purpose of the lesson:

1. Familiarization with the main types of ventilation.

2. Study of methods for assessing the effectiveness of ventilation.

3. Solving situational problems.

Location of the lesson: educational laboratory of the department of general hygiene.

Equipment: tables and diagrams.

5.1. Terms and Definitions.

1. Ventilation air– air of an appropriate degree of purification, entering the room through a fan or ventilation system and ensuring the appropriate cleanliness of the production room.

2. Room cleanliness class– the status of a “clean” zone or “clean” room, establishing limits for the content of mechanical particles of a certain size and/or viable microorganisms in 1 m3 of air.

3. Unidirectional air flow (laminar flow)- an air flow with parallel, as a rule, jets (stream lines) passing in the same direction with the same speed in the cross section.

4. "Clean" rooms- production facilities and/or areas for the manufacture of sterile finished medicinal products with air purity standardized for the content of mechanical particles of a certain size and viable microorganisms, designed and used in such a way as to minimize the penetration, spread, formation and retention of mechanical particles and microorganisms inside these premises.

5.2. Hygienic requirements for ventilation and air conditioning.

Ventilation and air conditioning in industrial buildings should be designed in accordance with current building codes and regulations (SNiP), the requirements of the Instructions for construction design medical industry enterprises.

Ventilation is a set of measures and devices used in organizing air exchange to ensure a given state air environment indoors and in workplaces.

Ventilation systems are classified according to the method of creating pressure with natural and artificial (mechanical) stimulation; by purpose: supply and exhaust; by service area: local and general exchange. The basis natural ventilation Air exchange is based on the temperature difference between the outside air and indoor air (thermal pressure) and wind pressure. With unorganized ventilation, carried out using window openings, transoms, etc., the air exchange rate for industrial premises will be insufficient. Only an organized and controlled natural ventilation system (aeration) allows for sufficient air exchange in the premises. For air intake and removal there are special openings in the external fences of the building. In the cold season, the top row of side openings is used, and in the warm season, the bottom row of windows is used. The advantage of aeration is the ability to carry out air exchange of such a large volume, which is practically unattainable with artificial ventilation. It should be noted that in practice, so-called mixed ventilation is often provided, that is, both natural and mechanical

(artificial) ventilation.

Forced ventilation used for supply to ventilated rooms clean air to replace the deleted one. Supply air may be subject to special processing, such as cleaning. This ventilation system is used in rooms where it is undesirable for polluted air to enter (for example, an aseptic block of pharmacies). Exhaust ventilation removes polluted or heated exhaust air from the room. This ventilation system is used in rooms when it is necessary to prevent the spread of harmful emissions into neighboring ones (for example, a washing room and an analytical chemist’s room). As a rule, both supply and exhaust systems are provided in the room. Their performance must be balanced.

Both supply and exhaust ventilation can be installed at the workplace (local) or for the entire room (general). Local exhaust ventilation used when discharge sites harmful substances are localized and can be prevented from spreading throughout the room.

Local supply ventilation used when it is necessary to improve

meteorological conditions in limited areas of the premises (air showers). Their cooling effect is based on increasing heat transfer from the body under the influence of temperature differences and increased speed air movement. However local systems ventilation cannot solve all the problems facing ventilation. Not all harmful emissions can be localized by these systems, for example, when harmful emissions are dispersed over a large area or volume. General ventilation designed for ventilation in the room as a whole. General exhaust systems remove air relatively evenly from the entire room, and general exchange supply systems supply air and distribute it throughout the entire volume of the room. An essential element of exhaust ventilation systems are devices for cleaning the exhaust air from industrial dust, vapors and gases.

Ventilation is assessed based on the volume and frequency of air exchange. Ventilation volume– the amount of fresh air that needs to be supplied to the room per 1 person per hour so that the amount of existing pollutants does not exceed the permissible level. Air exchange rate – a value showing how many times the air in the room is exchanged within an hour. It is defined as the ratio of the amount of air supplied or removed from a room to the volume of the room. For example, from a packaging volume of 60 m3 using exhaust ventilation 180 m3 of air per hour is removed. The air exchange rate is 3. Ventilation rates are preceded by (+) or (–) signs. The sign (+) means air exchange through the inlet, and the sign (–) means air exchange through the exhaust. For example, the air exchange rate in an aseptic room should be +4–2, therefore, four times the amount of air relative to the volume of a given room is supplied to the aseptic room within an hour, and twice the volume of a given room is removed. Thus, knowing the required volume of supplied or removed air, you can calculate the required air exchange rate for inlet and outlet.

5.3. Hygienic requirements for ventilation in pharmacy premises.

For various pharmacy premises, standards for air exchange rates for inlet and outlet have been established in accordance with the Instructions for sanitary regime pharmaceutical organizations (pharmacies) of the Ministry of Health of the Russian Federation 309 dated 10.21.97. (Table 12).

Table 12.

Hygienic requirements to the technological process, decoration of premises, landscaping, personal hygiene of pharmacy workers do not differ from the requirements for those in pharmacies, serving the population. Pharmacies in healthcare facilities and pharmacies serving the population are subject to uniform hygiene standards.

Insolation. As a factor external environment Insolation actively affects the human body. It has been established that even those UV rays that penetrate through ordinary glass, have a detrimental effect on the microflora of premises. In addition, the sun's rays have a positive effect on mood, well-being, and create a positive emotional background during work. Considering the beneficial biological and psychophysiological effects of solar radiation, it is necessary to ensure sufficient insolation of pharmacy premises and at the same time prevent them from overheating and disturbing optimal microclimatic conditions. The initial criterion for maintaining these conditions is to provide at least 3 hours per day of continuous direct solar irradiation of the premises.

A significant role in ensuring the insolation regime is played by the correct orientation of the pharmacy premises to the cardinal points. The most favorable orientation for the main production premises of a pharmacy is south and southeast. For rooms where overheating is possible (washing, sterilization, distillation and sterilization), it is recommended to be oriented to the north.

Lighting.Rational lighting of industrial premises and workplaces in pharmacies is of great importance hygienic value, as it affects the health status, visual function, performance, labor productivity and mood of workers. All production, administrative, auxiliary and sanitary premises must be provided with natural and artificial lighting. Absence natural light allowed only in storerooms and basements. Sufficient lighting allows you to maintain a sanitary regime and maintain cleanliness. Poorly lit production areas can create conditions for the accumulation of dust and dirt, which inevitably affects the quality of medicines. If there is insufficient lighting, incorrect dosage and inaccurate weighing are possible, which also leads to a deterioration in the quality of manufactured drugs. Besides, bad light requires strain on the visual analyzer and adversely affects performance and productivity.

To ensure a sufficient level natural light In a pharmacy, it is necessary that the window glass is smooth, clean, and the window sills are free of various objects that prevent the penetration of light. Window sashes should be thin. It is important to emphasize that hygienic standards for natural lighting are established taking into account the mandatory cleaning of windows at least 2 times a year.

A serious factor determining the distribution of luminous flux indoors is interior layout, and painting walls and other (including work) surfaces. There should be no protrusions in the path of spread in pharmacies luminous flux. With one-way side lighting, the ratio of the depth of the room (the distance from the light-carrying wall to the opposite one) to the height of the upper edge of the window should not be more than 2.

The influence of painting walls and other surfaces in pharmacy premises on the level of illumination and the performance of pharmacy staff was studied. It has been established that due to the light coloring of the walls of the premises, multiple reflections of light occur. This increases illumination, promotes uniform dispersion of light, and creates soft diffused lighting. So, for example, walls painted white reflect 80% of the rays falling on them, light yellow - 50%, blue - 25%, brown - only 13 %. Consequently, the choice of color is of great importance for creating an optimal sanitary and hygienic regime in the pharmacy, since it is easier to maintain cleanliness in light rooms than in dark ones. In addition, for successful work of pharmacy staff, one should carefully select color scheme, take into account the spectrum of reflected light and intense lighting. It has been established that the eyes of pharmacy workers involved in the manufacture of medicines are less tired if the color of surrounding objects and equipment is sufficiently diverse. Monotonous and harsh colors have a negative impact on the emotional state of workers. In addition, the choice of color is of great importance for maintaining sanitary and hygienic conditions in pharmacies. Light colors are most favorable in this regard.

The intensity of natural light in pharmacy premises is assessed based on indicators such as luminous coefficient (LC) and natural lighting coefficient (LFC). So, in the assistant's room, pharmacist-analyst's room, aseptic SC should be equal to 1:4, KEO - 2%, in other rooms of the pharmacy - SC within 1:6-1:7, KEO 1.5-0.6%.

Artificial lighting pharmacy premises carried out at the expense of fluorescent lamps and incandescent lamps. The main hygienic requirement for artificial lighting of pharmaceutical production premises is to ensure sufficient and uniform illumination of premises and workplaces. This is especially important, since the illumination of workplaces, in particular the assistant, pharmacist-analyst, packer, pharmacist-technologist, must provide the required visual acuity and speed of discrimination small parts and stability of clear vision. To ensure the required level of artificial lighting in pharmacies, in accordance with the Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) (No. 309 of October 21, 1997) and SNiP 23-05-95, the following standards have been established (Table 5.4).

Table 5.4 - Standards artificial lighting pharmacies

Low-pressure fluorescent light sources are recommended for artificial lighting of pharmacy production facilities. The hygienic advantage of fluorescent lamps over incandescent lamps comes down to a favorable spectral characteristic, close to the spectrum daylight. For pharmacies, lampshades are the most suitable. Their fittings reduce the stroboscopic effect and allow diffused light to be obtained.

Particular attention should be paid to the lighting of the assistant's room - the main functional unit of the pharmacy. Here it is advisable to use lamps with fluorescent lamps located locally above the workplaces. Similar principles of artificial lighting are used in the aseptic room, the pharmacist-analyst room, the packaging room and the defect room.

The sales area should be equipped with lamps that meet lighting, hygienic, architectural and artistic requirements. Lamps must not only create the required level of illumination, but also satisfy the aesthetic needs of visitors. For this purpose, artistically designed chandeliers and shades are used, harmoniously combined with decorative finishing trading floor. Besides general lighting, at the workplaces of pharmacists-technologists and pharmacists, local lighting lamps with lamps corresponding to the spectrum of lamps used in the general lighting system are installed. Otherwise, colored shadows may appear, which makes work difficult, causes rapid eye fatigue, and reduces labor productivity.

In storerooms, fluorescent lamps are used, installed at the workplaces of the pharmacist-technologist and packer. The same lamps are used as in the assistant's room.

In the washing and distillation-sterilization rooms, toilets and showers, waterproof pendant lamps with incandescent lamps are used, intended for damp rooms. In the washing room above each bathroom, a local lamp is installed on a bracket, which has a protective angle of the fittings (more than 30") to protect the eyes from the glare of light.

The illumination of the pharmacy manager's office, staff room, wardrobes, and corridors is established in accordance with current standards. The combined use of fluorescent lamps and incandescent lamps in the same pharmacy room is not recommended.

Natural and artificial lighting in the production premises of pharmacies with rational use may improve the productivity of pharmacy workers. Thus, hygienic studies in a number of pharmacies showed that as a result of improving the illumination of the workplace of packers, their labor productivity increases by 12%, that of assistants by 11%, and that of pharmacist-technologists by 8%. %.

Heating. Pharmacy personnel must perform their complex and responsible work in rooms with optimal microclimatic conditions. The parameters that determine the microclimate of pharmacy premises are temperature (18-20 ° C), relative humidity (40-60%) and air mobility (0.1-0.2 m/s). The premises of the built-in pharmacies are heated using a centralized water (convection) and radiant (radiation) heating system. The heating system must be designed in accordance with current SNiP 2.04.05-91 of 1996. Microclimate parameters (temperature, humidity, air speed) must be monitored in storage rooms. The most optimal and hygienically justified is radiant heating. In pharmacies, it is advisable to use panel heating (one of the types of radiant). The advantage of panel heating compared to water heating is that the heat transfer from the body by radiation is reduced, so a person feels the same thermal comfort at a temperature of 17-18 ° C as at 19-20 ° C in a room with convection heating. In addition, , dust does not settle and burn on radiators. This is especially suitable for heating aseptic block, assistant and pharmacist-analyst's room, where a high level of cleanliness must be maintained.

Steam heating is prohibited in pharmacy premises as it is the least hygienic. With this type of heating, dust burns on the radiators, which is accompanied by the appearance of an unpleasant odor; Heats up unevenly throughout the day heating devices, resulting in changes in air temperature in heated rooms. In addition, there is a risk of burns from touching the radiators as the temperature of the supplied steam reaches a high level.

In pharmacies located in separate buildings in rural areas, it is advisable to organize a local water heating. Stove heating allowed in extreme cases. Dutch ovens are the most acceptable. The combustion openings for the ovens should go into the corridor so as not to pollute the production premises. It is necessary to ensure that the chimney is closed in a timely manner to avoid carbon monoxide poisoning.

The air temperature in pharmacy premises must be within the requirements set out in the Instructions for the sanitary regime of pharmacy organizations (pharmacies) No. 309 dated October 21, 1997 (Table 5.5).

Table 5.5 - Estimated temperatures, air exchange rates of pharmacy organizations (pharmacies)

Ventilation. In a pharmacy setting, ventilation is especially important for maintaining sanitary and hygienic conditions. The air in the premises of a pharmacy, like other premises, is polluted as a result of the vital activity of the body of the people working there. A major role in air pollution in pharmacies is played by the technology of drug production, their storage, packaging, intra-pharmacy transportation, as a result of which dust of medicinal substances, plant raw materials, and gaseous chemicals enters the air. toxic substances and substances with various, often unpleasant odors. Due to the fact that not only healthy but also sick people visit the pharmacy, there may be microorganisms in the air, including pathogenic ones. In a pharmacy, microclimatic conditions may be disrupted due to the accumulation of humid and hot air in rooms such as washing, sterilization and distillation.

Properly organized ventilation helps remove contaminated air from the premises of the pharmacy and maintain a sanitary and hygienic regime. The pharmacy uses both natural and artificial ventilation.

Natural ventilation is carried out through aeration through windows, vents, transoms. The most effective ventilation is carried out by extracting air through channels enclosed in the walls of the building. To enhance draft in the channels on the roofs of buildings (on the hood), special deflector attachments are installed. All pharmacies have natural ventilation, but the frequency of air exchange does not always ensure the removal of industrial hazards, so it is sufficient only for administrative and sanitary premises.

An artificial ventilation device is necessary in rooms where the normalized microclimate parameters, dust content, microorganisms and gaseous impurities are not achieved through natural air exchange. In accordance with SNiP 2.04.05-91* of 1996 and Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) No. 309 of October 21, 1997, pharmacies should provide supply and exhaust ventilation with mechanical impulse, local and general. The entire artificial ventilation system of pharmacy premises must be installed in such a way that air from one room does not penetrate into others. Different nature of work in various rooms pharmacy requires a particularly careful approach to choosing a ventilation system and type ventilation devices. So, in the assistant's room - mainly production premises where release of medicinal dust, gaseous medicinal and chemical substances, a general exchange is arranged supply and exhaust ventilation with a predominance of exhaust over inflow (+2-3). Exhaust and supply openings are located in the upper zone of the room. The same ventilation should be provided in the unpacking, distillation, defector's, packaging, storerooms, and in the pharmacist-analyst's room. In the latter, in addition to general supply and exhaust ventilation, there must be local exhaust ventilation - a fume hood.

The ventilation of the washing and distillation-sterilization rooms should be Special attention, since the microclimatic conditions of the entire pharmacy depend on its correct design and operation. Due to the fact that in these rooms, especially in the washing room, there are sources of heat and moisture release, with insufficient efficient work ventilation hot and wet air can penetrate into other rooms of the pharmacy, therefore, in the washing and distillation-sterilization rooms there should be supply and exhaust ventilation with an air exchange rate of +3-4. In the washing room, in addition, it is necessary to install local exhaust ventilation above the washing baths in the form of an umbrella.

The sales area also requires general supply and exhaust ventilation with a predominance of exhaust over inflow (+3-4).

Ventilation of the aseptic unit and especially the aseptic room (where injection solutions and eye drops are prepared, which requires complete sterility) must ensure movement air flow from the aseptic room into the adjacent rooms - a gateway, and then into the corridor. It is necessary to create an air supply from the aseptic room, preventing the penetration of untreated air from outside. Aseptic ventilation should provide air exchange with a multiplicity of +4-2. The air supply should be carried out through the ceiling perforated panel and side supply slots at a level not lower than 2.5 m from the floor. Exhaust openings should be located at the opposite end of the aseptic tank at the bottom of the floor. The supplied air must be cleaned by passing it through special filters.

Most effective look ventilation of pharmacy premises is air conditioning - the creation and automatic maintenance of an artificially simulated microclimate.

Ventilation units that create noise and vibration during operation must be placed in basements on a vibration-damping foundation with a noise-damping shelter.

Water supply. Built-in urban pharmacies have a central water supply by connecting to the city water supply network. Pharmacies located in rural areas, have a separate water supply from a local water source. If it is not possible to install a local water supply system, the pharmacy’s water supply is provided from a well located on the territory land plot pharmacies.

To maintain optimal sanitary and hygienic conditions, it is necessary to provide rational water distribution. Hot water must be supplied to all production, auxiliary and sanitary premises.

The quality of water supplied to pharmacies, both with centralized and non-centralized water supply, must comply with current sanitary and hygienic requirements (SanPiN, etc.).

Sewerage. Wastewater from city pharmacies is disposed of through the sewer system. In rural areas, a liquid sewage removal system is used. Solid waste is collected in metal, hermetically sealed garbage containers installed in the yard on cemented areas.

TOPIC No. 1 “Hygiene of atmospheric air. Microclimate of pharmacy premises."

1. 
   Air environment and its hygienic significance.
2. 
   Physical properties of air, their hygienic significance and effect on the body.
3. 
   Weather, climate. Definition of concepts. Hygienic value.
4. 
   Microclimate of working premises in pharmacies. Definition of the concept. Classification. Complex influence of microclimate factors on the human body.
5. 
   Chemical composition of atmospheric air and its hygienic significance.
6. 
   Sources of air pollution. Hygienic regulation of the content of harmful substances in the air of working premises.
7. 
   Bacterial air pollution.

Practical skills:

1. 
   Familiarity with the design and operation of instruments for measuring microclimate parameters (dry and wet thermometers, psychrometer, temperature, humidity and air velocity meter - TKA-1).
2. 
   Comprehensive assessment of the microclimate of working premises using the effective temperature method.
3. 
   Determination of microclimate parameters in classrooms.
4. 
   Solving situational problems.

Bolshakov A.M. Guide to laboratory classes on general hygiene. – M., 2004

TOPIC No. 2 “Hygienic principles of lighting, ventilation and heating in pharmacy premises.”

1. 
   Biological effect of light. Factors influencing the level of natural light in rooms.
2. 
   Indicators characterizing the state of natural lighting and their standards for pharmacies of various types.
3. 
   Hygienic requirements for artificial lighting. Characteristics of various types of artificial lighting sources. Types of lamps. Artificial lighting standards for various types of pharmacies.
4. 
   Ventilation. Definition of the concept. Classification. Hygienic value.
5. 
   Hygienic requirements for heating.

Practical skills:

1. 
   Introduction to the structure and operation of a lux meter.
2. 
   Determination and assessment of natural light indicators in workplaces (luminous coefficient, opening and incidence angle, natural light coefficient).
3. 
   Determining the sufficiency of artificial lighting in workplaces.
4. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

TOPIC No. 3 " Hygienic characteristics water. Water supply for pharmacies."

1. 
   The role of the water factor in human life. Physiological and hygienic significance of water.
2. 
   The role of the water factor in the occurrence of infectious and non-infectious diseases.
3. 
   Sources of water supply and their hygienic characteristics.
4. 
   Sanitary and hygienic characteristics of water supply systems.
5. 
   Quality indicators drinking water(organoleptic, chemical, bacteriological). Hygienic standardization of drinking water from centralized and decentralized water supply.
6. 
   Measures to protect water sources from pollution.

Practical skills:

1. 
   Determination and assessment of organoleptic properties of water (color, transparency).
2. 
   Study of chemical indicators of water quality (dry residue, total hardness, chlorides, oxidability).
3. 
   Qualitative determination of nitrogen-containing substances (ammonia, nitrites) in water.
4. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.
TOPIC No. 4 “Soil and its hygienic importance.”

1. 
   Soil composition and properties.
2. 
   The importance of the composition and properties of soil (hygienic, epidemiological, geochemical, toxicological). The role of soil in the occurrence and spread of diseases.
3. 
   Sources of soil pollution.
4. 
   Hygienic regulation of exogenous chemicals in soil.
5. 
   The influence of soil on the degree of contamination of medicinal plant materials.
6. 
   Measures for sanitary soil protection.

Practical skills:

1. 
   Determination and assessment of organoleptic properties of soil.
2. 
   Study of soil chemical parameters.
3. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.
TOPIC No. 5 “Hygienic fundamentals of nutrition. Principles of rational and adequate nutrition."

1. 
   Food and its effect on the body.
2. 
   Principles of rational and adequate nutrition. Physiological nutritional standards.
3. 
   The importance of proteins in the life of the body.
4. 
   The importance of fats in human nutrition.
5. 
   The importance of carbohydrates in the life of the body.
6. 
   The importance of vitamins and minerals in human nutrition.
7. 
   The concept of therapeutic and preventive nutrition and its importance in protecting the health of employees of pharmaceutical enterprises.

Practical skills:

1. 
   Calculation and analysis of daily menu layouts. Definition daily requirement in nutrients and energy for various groups population.
2. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.

TOPIC No. 6 “Hygiene of pharmacies. Hygiene assessment planning, development and mode of operation of pharmaceutical warehouses and control and analytical laboratories.”

1. 
   Structure of pharmacy network institutions.
2. 
   Sanitary and hygienic basis for licensing pharmacies.
3. 
   Types of pharmacies serving the population. Pharmacies of medical and preventive institutions.
4. 
   Hygienic requirements for the layout, equipment and improvement of pharmacies.
5. 
   Hygienic and anti-epidemic measures to combat microbial contamination.
6. 
   Hygienic requirements for the premises of control and analytical laboratories.
7. 
   Hygienic requirements for pharmaceutical warehouse premises.

Practical skills:

1. 
   Hygienic assessment of pharmacy projects.
2. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.
Topic No. 7 “Fundamentals of occupational hygiene and health-improving measures in the production of medicinal products.”

1. 
   The influence of the labor process on the functional state of the body. Fatigue and overwork. Causes. Prevention.
2. 
   Characteristics of production factors that determine the working conditions of workers in the pharmaceutical industry. Principles of hygienic regulation of harmful factors in the production environment.
3. 
   The concept of industrial hazards and occupational diseases.
4. 
   Measures to combat industrial hazards. Prevention of occupational diseases.

1. 
   Dust as a specific factor in the production of drugs. Definition. Classification. Effect on the body.
2. 
   Pneumoconiosis. Classification. Pathogenesis.
3. 
   Prevention of dust diseases.
4. 
   Classification of harmful substances (poisons) according to their toxicity and danger. Routes of entry, distribution and excretion.
5. 
   Combined, combined and complex action. Effect on the body.
6. 
   Toxicological and hygienic characteristics of the main groups of harmful substances. Prevention measures.

Practical skills:

1. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.
TOPIC No. 9 “Noise and vibration as specific factors in the production of drugs.”

1. 
   Noise. Definition. Classification. Main sources.
2. 
   Features of the biological influence of noise on the body of workers of pharmaceutical enterprises.
3. 
   Measures to prevent noise pathology.
4. 
   Vibration. Definition. Classification. Main sources.
5. 
   Features of the biological effect of vibration on workers of pharmaceutical enterprises.
6. 
   Measures to prevent vibration pathology.

Practical skills:

1. 
   Solving situational problems.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.

TOPIC No. 10 “Sanitary and hygienic inspection of the pharmacy.”

The lesson is held at a pharmacy
Practical skills:

1. 
   Conducting a sanitary and hygienic inspection of the pharmacy.
2. 
   Writing an inspection report.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.

TOPIC No. 11 “Occupational hygiene in the production of various

medicines."

1. 
   Hygienic characteristics of the main technological processes at enterprises of the chemical and pharmaceutical industry.
2. 
   Occupational hygiene in the production of synthetic drugs.
3. 
   Hygienic characteristics of working conditions and health status of workers in the production of antibiotics.
4. 
   General characteristics of industrial factors that determine working conditions in the production of herbal preparations.
5. 
   Occupational hygiene in the production of finished dosage forms.

Practical skills:

1. 
   Solving situational problems.
2. 
   Final testing.

Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.

Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004.

TOPIC No. 12 TEST.

Thousands of assortment items on the computer, tens of thousands of packages on pharmacy shelves, and all of them bring health to our customers! True, only if we store them correctly. The abundance of goods in the pharmacy and the multitude of storage modes will confuse the average person, but for us, professionals in the pharmaceutical market, it is not difficult to comply with the requirements of the pharmacopoeia.

Temperature and humidity in a pharmacy

Storage of medicines for medical use carried out in accordance with the requirements of the state pharmacopoeia and regulatory documentation, as well as taking into account the properties of the substances included in their composition. In addition to the pharmacopoeia, the microclimate of a pharmacy is regulated by three main documents: Order of the Ministry of Health of the Russian Federation No. 377 of November 13, 1996 “On approval of requirements for the organization of storage in pharmacies of various groups of medicines and medical products”, Order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 No. 706n “On approval of the Rules for the storage of medicines” and Order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. 309 “On approval of instructions on the sanitary regime of pharmacy organizations.”

The State Pharmacopoeia of the Russian Federation (12th edition, put into effect in 2009) contains detailed information about temperature conditions x storage of medicines and substances for their manufacture:

• in the refrigerator: 2-8⁰C
• cold or cool place: 8-15⁰C
• room temperature: 15-25⁰C
• warm storage mode: 40-50⁰C
• hot storage mode: 80-90⁰C
• water bath temperature: 98-100⁰C
• ice bath temperature: 0⁰С
• deep cooling: below – 15⁰C

In a pharmacy that offers visitors only finished dosage forms, usually the first three temperature modes are used, and constant monitoring of air humidity is carried out. Used to measure relative humidity electronic hygrometer or psychrometer. There may be only one hygrometer in a small pharmacy, but a thermometer should be available not only near the pharmacy shelves, but also in refrigerators. All instruments must be properly certified and calibrated. The thermometer is placed on the interior walls of the room away from heating devices at a height of 1.5 -1.7 m from the floor and at a distance of at least 3 m from the doors. The recommended air temperature in the pharmacy premises is 16-20⁰С, relative air humidity is up to 60% (in some areas up to 70%). It is in this interval that it is ensured proper storage most dosage forms that have a “room temperature” storage mode (for example, most manufacturers recommend storing aerosols at a temperature of 3-20⁰C).

Checking the temperature and humidity in a pharmacy rests with the pharmacist: at least once a day, instrument readings are entered into a card (log) for recording temperature and relative humidity, which must be kept in each department of the pharmacy. There should be separate accounting cards not only in sales departments, but also in storage areas - the material room, the goods acceptance area. A log of air temperature and humidity can be kept in electronic form with data archiving for the last year. Handwritten journals and accounting cards are stored for one year, not counting the current one (Order No. 706n).

If the air temperature in the pharmacy does not meet the required one, it is worth taking care of air conditioning or additional heating. Heating and ventilation systems must be located so as to exclude sharp changes temperatures and excessive heating of the drug storage area. When you turn on the air conditioner, do not forget to control the humidity: even the most modern climate systems have the ability to “dehydrate” the environment.

It is advisable to have at least two refrigerators or a two-chamber refrigerated display case with the ability to separately set temperatures. The storage temperature for ATP is 3-5⁰С, many suppositories are stored at a temperature of 8-15⁰С - it is impossible to store them in the same refrigerator compartment.

Where to identify the product?

A common mistake when receiving goods at a pharmacy is placing boxes brought by the warehouse forwarder on the floor. This is unacceptable: both in the storage area and in the receiving area there must be pallets and racks on which boxes of goods can be placed.

Information about the storage mode of the drug is always present in the annotation to it and on the secondary (consumer) packaging, if available, therefore, in the process of accepting goods from the distributor’s warehouse, you can not rely on memory, but follow the manufacturer’s instructions (Order No. 377). Described temperature requirements and in the accompanying delivery documents: many pharmaceutical warehouses mark with a special icon drugs that must be stored in the refrigerator; The necessary information is also contained in documents confirming the quality of the product (certificate, hygiene certificate, etc.).

Often in the annotation there is a recommendation to store the drug in a dry place. Pharmacopoeia considers dry a place with a relative humidity of not more than 40% at room temperature. During inspections of pharmacies by Roszdravnadzor, violations of this storage regime are often encountered - not all pharmacy organizations can identify separate room and provide there such low humidity for placing herbs and a number of other drugs that should be stored in a dry place. The pharmacy is recommended to allocate a separate room for such drugs and dry the air in it to the required humidity.

Excellent knowledge comes to the aid of the pharmacist regulatory documents. Order No. 706n, issued many years after Order No. 377, states: “Bulk medicinal plant materials must be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container. Packaged medicinal plant materials are stored on shelves or in cabinets.” Despite the fact that this provision somewhat contradicts the pharmacopoeia, one should be guided by it: medicinal raw materials in the manufacturer’s packaging are pre-packaged and can be stored in display cabinets in the sales area. Yes, sometimes a pharmacy manager has to be a bit of a lawyer to defend his point of view during an inspection!

Some pharmacy products require additional protection from light (herbal medicinal raw materials, antibiotics, tinctures and extracts, vitamin complexes, essential oils, nitrates and many others). They arrive at the pharmacy in packaging made from light-protective materials, but they should be stored in a dark room or in tightly closed cabinets or on racks, provided that measures are taken to prevent these medications from being exposed to direct sunlight or other bright directional light (use of reflective film, blinds , visors, etc.).

Narcotic, psychotropic, potent and poisonous drugs have their own special storage rules, but their compliance is more related to ensuring safety than maintaining the quality of the drug in the pharmacy. The rules for storing narcotic drugs and psychotropic substances are established by Decree of the Government of the Russian Federation of December 31, 2009 N 1148.

Requires special attention placement of flammable drugs in a pharmacy– alcohol, alcohol solutions, tinctures, extracts, organic oils and a number of other products. For their storage, a separate cabinet should be allocated away from heating devices (at least 1 meter), in which bottles can only be placed in one row in height.

In a pharmacy, the rules for storing drugs are usually followed, but what happens after the drug is sold? Many of our customers place a first aid kit in the bathroom or kitchen, which negatively affects the quality of medicines and can significantly reduce their effectiveness, because it gets hotter in the kitchen while cooking, and hot drinks drinkers in the bathroom water procedures they can “raise” the temperature to 50⁰С and even higher, and the air humidity does not meet the required level. When completing the sale, be sure to remind the client of the need to follow the rules for storing the drug at home!