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Atmospheric air hygiene, microclimate of pharmacies. Sanitary improvement of pharmacy premises. Characteristics of pharmacy production premises

Maximum and minimum list of jobs industrial pharmacy.

Maximum:

1. public service hall:

Sales of ready-made drugs according to recipes

Sales of ready-made drugs without prescriptions

accepting prescriptions from the population for the production of dosage forms

Dispensing medicines prepared in a pharmacy

information

implementation of optics

sales of parapharmaceutical products

2. assistant:

production of medical forms for internal use

production of medical forms for external use

HP packaging internal use

packaging of drugs for external use

pharmacist-technologist

enlarged production of lek. forms for health care

packaging of medicines for healthcare facilities

3. analytical

quality control of manufactured drugs

4. procurement of concentrates and semi-finished products

production of concentrates and semi-finished products

5. washing and sterilization

processing of prescription dishes

processing of glassware for sterile dosage forms

sterilization of dishes

preparation of closures and auxiliary material

6. distillation

obtaining distilled water (purified)

7. disinfection

processing of returnable dishes from LPU

8. unpacking

unpacking the goods

9. prescription-forwarding

receiving requirements (prescriptions) from healthcare facilities

picking and issuing medical orders

10. assistant-aseptic

production of sterile drugs

packaging of manufactured drugs

11. sterilization

sterilization of dosage forms

sterilization of medical forms

12. control marking

design of manufactured medical forms for healthcare facilities

minimum list of industrial pharmacy jobs:
1.public service hall

sales of drugs and medical products

2. assistant

production of molds according to recipes

3.analytical

quality control of medical forms

4. washing and sterilization

processing of prescription dishes

5. distillation

obtaining distilled water

6. unpacking

unpacking the goods

hygienic requirements for the sanitary improvement of pharmacy premises (insolation, lighting, heating, ventilation, water supply, sewerage.)

insolation-as a factor external environment insolation actively affects human organism. It has been established that even UV rays that penetrate through ordinary glass, have a detrimental effect on the microflora of the room. Besides. Sun rays have a positive effect on mood, well-being, and create a positive emotional background during work. Taking into account 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. violation of 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 room.

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

heating. Pharmacy personnel must perform their complex and responsible work in rooms with optimal microclimatic conditions. the parameters that determine the microclimate of the pharmacy are temperature (18-20), relative humidity(40-60 percent) and air mobility (0.1-0.2ms). The premises of the built-in pharmacies are heated using a centralized water (convection) and radiant (radiation) heating system. The heating system must be carried out in accordance with the current construction code 2.04.05-91 of 1996. In storage rooms, microclimate parameters (temperature, humidity, air speed) must be monitored. 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 body’s heat transfer by radiation is reduced, so a person feels the same thermal comfort at t = 17-18 as at 19-20 in a room with convection heating. in addition, settling and burning of dust on radiators is eliminated; this is especially suitable for heating the aseptic unit, assistant’s room and pharmacist-analyst’s room, where a high level of cleanliness must be maintained. The device is prohibited in pharmacy premises steam heating as the least hygienic. With this type of heating, changes in air temperature occur in the heated rooms. In addition, there is a risk of burns from touching the radiators as the temperature of the supplied steam reaches high level. In pharmacies located in separate buildings in rural areas arrange local water heating, stove heating in rare cases. Dutch ovens are the most suitable. The combustion openings should go into the corridor so as not to pollute the production premises. 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 10.21.97.

lighting. Affects health, visual function, performance, productivity and mood. All production, administrative, auxiliary and sanitary premises must be provided with natural and artificial lighting. Absence is allowed only in storerooms and basements. Sufficient lighting allows you to maintain sanitary conditions and cleanliness. In case of insufficient lighting, incorrect dosage and inaccurate weighing are possible, which leads to a deterioration in the quality of the products being manufactured. To ensure a sufficient level natural light In a pharmacy, it is necessary that the window glass be smooth and the window sills free of various objects that prevent the penetration of light. The window sashes are thin. Mandatory window cleaning at least 2 times a year. In pharmacy premises there should be no protrusions in the path of light flux. With one-sided side lighting, the ratio of the depth of the room (the distance from the light-carrying wall to the opposite wall) to the height of the upper edge of the window should not be more than 2. The intensity of natural lighting in pharmacies is assessed based on indicators such as luminous coefficient (lc) and natural light coefficient (keo). So, in the assistant room of a pharmacist-analyst, aseptic sk should be equal to 1:4, keo 2%. In other premises of the pharmacy, sk is within 1:6, 1:7, keo 1.5-0.6%. Artificial lightingpharmacy premises carried out using fluorescent and incandescent lamps. The main hygienic requirement for artificial lighting of pharmacy premises is to ensure sufficient and uniform illumination of premises and workplaces. For artificial lighting of pharmacy production facilities, it is recommended to use low-pressure fluorescent light sources. The advantage of fluorescent lamps over incandescent lamps comes down to a favorable spectral characteristic, close to the spectrum of daylight. For pharmacies, lampshades are more acceptable; they provide diffused light. Lamps with fluorescent lamps, located localized above workplaces. The sales area is equipped with lamps that meet lighting, hygienic, architectural and artistic requirements. They must create the required level of illumination and satisfy the aesthetic needs of visitors. Besides general lighting Local lighting fixtures with lamps corresponding to the spectrum of lamps used in the general lighting system are installed at the workplaces of pharmacists-technologists and pharmacists. There are fluorescent lamps in the storerooms. In the washing room, distillation and sterilization room, toilet and shower room, waterproof pendant lamps with incandescent lamps are used for damp rooms. The illumination of the manager’s office, staff room, and wardrobes is set in accordance with current standards. The combined use of incandescent and fluorescent lamps in the same pharmacy room is not recommended. Yes and claim Lighting in industrial premises of pharmacies with rational use can improve labor productivity.

Ventilation. It is contaminated as a result of the vital activity of the body of workers, drug production technology, storage, intra-pharmacy transportation, visiting sick visitors, possible microclimatic disturbance of the pharmacy environment. 2 types of ventilation.

Natural ventilation. Aeration through windows, vents, transoms. Most effective due to exhaust through channels. To enhance traction through the channels, special nozzles - deflectors - are installed on the roofs of buildings. 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.

Artificial ventilation. Necessary in rooms where normalized microclimate parameters, dust content, oxygen and gas flow are not achieved through natural air exchange. impurities. In accordance with SNiP 2.04.05-91 of 1996 and the Instruction on the sanitary regime of pharmaceutical organizations No. 309 of October 21, 1997, pharmacies should provide supply air exhaust ventilation with mechanical impulse, local and exchange. The entire artificial ventilation system must be installed so that air from one room does not penetrate into others. In the assistant's, unpacking, distillation, defector's, storerooms, pharmacist-analyst's room, there is a general supply and exhaust system with a predominance of exhaust over inflow. Also in the pharmacist-analyst’s room there should be a local exhaust ventilation-fume hood. Special attention should be given to washing and distillation-sterilization, because The microclimate of the pharmacy depends on their design. Due to the fact that in these rooms there are sources of heat and moisture release, if ventilation is not efficient enough, hot and wet air may penetrate into other rooms. Supply and exhaust ventilation is installed 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. In the sales area there is a supply and exhaust unit. Ventilation of the aseptic block and aseptic room should ensure the movement of air flows from the aseptic room to the adjacent airlock rooms, and then the corridor. It is necessary to create air pressure from outside. Air exchange should be a multiplicity of +4-2. The air supply should be carried out through the ceiling perforated panel and the side supply slots at a level not lower than 2.5 m from the floor. Exhaust holes are in the anti-fill end of the aseptic tank near the floor. The supplied air must be cleaned by passing it through special filters. The most effective type of ventilation is air conditioning - creating and maintaining an artificially simulated microclimate.

Water supply. Built-in urban pharmacies have central water supply. Pharmacies in rural areas have a separate water supply from a local water source. If there is no local water supply system, water supply is provided from a well. To maintain sanitary and hygienic conditions, it is necessary to provide rational water distribution. Hot water must be supplied to all production and auxiliary sanitary facilities. Water quality must comply with current Sanitary Hygiene requirements (SanPiN)

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.

LPU pharmacies.

Currently, our country has created a wide network of medical and preventive institutions: hospitals, dispensaries, clinics, and maternity hospitals.

The main function of a health care facility pharmacy is to manufacture and dispense according to the requirements of medicines ordered by certain departments of health care facilities, dispensing finished medications to them, dressings, patient care items, medical instruments and other medical products. That. The scope of work of healthcare facility pharmacies is wider than that of pharmacies serving the population, because they supply this institution not only the usual pharmacy assortment, but also reagents, surgical and other instruments, and medical equipment.

Pharmacies of healthcare facilities are divided into categories depending on the number of beds in the hospital.

The technology for manufacturing drugs in health care facilities is no different from pharmacies serving the population, therefore the staffing units in them are the same, with some exceptions. Thus, in health care facility pharmacies there is a position of pharmacist-clinician, pharmaceutical inspector, gas cylinder manager and equipment repair engineer.

In terms of the volume of work in health care pharmacies, 40-50% are requirements for sterile dosage forms (in pharmacies serving the population only 5%). In this regard, the set of premises and their sizes differ slightly from those in self-supporting pharmacies serving the population.

Pharmacies of medical institutions as well as pharmacies, serving the population, have production, auxiliary (storage), administrative and utility premises. They are placed on the 1st floor in compliance with the relevant sanitary and hygienic requirements. These premises should be convenient for reception and storage large quantity medical property, placement of mechanization equipment, equipment and pharmacy furniture.

An important sanitary-hygienic and anti-epidemic requirement is the reliable isolation of the pharmacy premises of health care facilities from the treatment and diagnostic departments intended for the stay of patients, but at the same time the pharmacy must have a convenient, safe connection from the point of view of contamination and infection with the hospital departments. It is most advisable to place a pharmacy in the main building of the hospital or in a separate building. In this case, the pharmacy must have a basement and good access roads. Pharmacies of large clinical hospitals and multidisciplinary health care facilities have a special premises, consisting of 2 rooms with a total area of ​​45 m2, for small-scale production of tablets and ampoule preparations. The hospital pharmacy is responsible for supplying hospitals with oxygen and other gases. In this case, it is planned to build a central oxygen station at the pharmacy.

In healthcare facility pharmacies there is no sales area; instead, there is a waiting area intended for medical staff who come to the pharmacy from the hospital, clinic patients, etc. in order to deliver requests, applications, prescriptions and receive prepared medicines or medical products. Appointments. Unlike pharmacies serving the population, a health care facility pharmacy has a prescription and forwarding department in which a large amount of work is performed on receiving and fulfilling requirements and prescriptions. In addition, healthcare facility pharmacies are distinguished by the presence of a large (from 80-120 m2) well-equipped aseptic unit for the preparation of large quantities of sterile drugs. There is no separate room for a pharmacist-analyst in health care facility pharmacies. The assistant's room has a pharmacist-analyst's desk with the necessary equipment for physical and chemical analyses. These pharmacies are equipped with 2 washing rooms for processing dishes. One of them is for receiving, sorting, processing dishes prepared for eye drops and other sterile injection solutions. The other is for collecting, processing and sorting ordinary pharmaceutical glassware and pharmaceutical equipment. The pharmacy has a large number of special purpose storage areas.

Purpose of the lesson:studying the influence of microclimatic factors on the human body, measuring microclimate parameters, hygienic assessment of individual indicators and the microclimate as a whole.

In preparation for the lesson, students must work through the following theoretical issues.

1. Weather, climate, microclimate.

2. Physical properties of air, their hygienic significance.

3. Complex influence of meteorological environmental factors on the body, its assessment. Heat exchange between the body and the environment. Thermal load index (THI).

4. Hygienic standards for the microclimate of premises for various purposes.

After mastering the topic the student must know:

Methodology for determining and assessing the microclimate of pharmacy premises;

Determination and assessment of the complex influence of meteorological environmental factors on the body of workers;

be able to:

Assess research results for compliance with hygienic standards;

Assess the working conditions of pharmacy staff based on microclimate parameters;

Use basic regulatory documents and reference information sources to develop hygienic recommendations for improving the microclimate of pharmacy premises.

Training material for completing the assignment

The atmosphere has a multilayer structure. Adjacent to the earth's surface troposphere- the most dense layer of air measuring from 8 to 18 km at different latitudes. The troposphere is characterized by instability of physical properties (fluctuations in temperature, humidity, atmospheric pressure), the presence of water vapor, large amounts of dust, soot, various toxic substances, gases, and microorganisms. There is constant movement of air masses in it. different directions. Above the troposphere is stratosphere- a layer of air up to 40-60 km in size, characterized by rarefied air. Under the influence of cosmic and short-wave ultraviolet radiation from the Sun, as a result of the ionization of molecules of air gases, especially oxygen, ozone molecules are formed in the stratosphere, making up the ozone layer of the atmosphere. The ozone layer traps short-wave UV radiation, which, when reaching the Earth's surface, can cause a variety of negative effects in the biosphere and increase the level of cancer incidence in the human population. An even more rarefied layer of air up to 80 km in size extends above the stratosphere - mesosphere, above follows thermosphere- a layer of the atmosphere up to 300 km high, the temperature in which reaches 1500? C. Behind it is located ionosphere- a layer of ionized air, the dimensions of which, depending on the time of year and day, are 500-1000 km. Even higher are sequentially placed exosphere(up to 3000 km), the density of which is almost no different from the density of airless outer space, and the upper limit of the Earth’s atmosphere - magnetosphere(from 3000 to 50000 km), which includes radiation belts.

In recent decades, biological activity has been established constant geomagnetic field (GMF) of the Earth. Changes (or pulsations) of the geomagnetic field are usually divided into regular, stable, continuous (Pc - pulsations continues), which are recorded in the morning and daytime hours, and irregular, noise-like, impulsive (Pi - pulsations irregular), which are recorded in the evening and night hours . All types of irregular pulsations are signs of geomagnetic disturbances, while regular pulsations are also observed in very calm conditions. The Earth's geomagnetic field is an essential component of the human environment. If the stable wheel mode

banium is “habitual” for biosystems, isolation from it can have negative consequences for the body. As a result of the penetration into the atmosphere of a stream of charged particles flying at enormous speed from the Sun (the so-called solar wind), formed during periods of increased solar activity, GMF disturbances arise, which are expressed in the global excitation of ordinary pulsations of its intensity (geomagnetic storms), recorded throughout the earth. ball for tens of hours. The formation of the natural electromagnetic background of the Earth includes global and local thunderstorm activity. Magnetoreceptors in humans are located in the structures of the brain and in the adrenal glands. Geomagnetic disturbances can have a desynchronizing effect on biological rhythms and other processes in the body, contributing to an increase in the number of myocardial infarctions and strokes, as well as the number of road traffic accidents and aircraft crashes. However, long-term stay of people in shielded rooms under conditions of natural HMF deficiency causes a deterioration in their well-being and health. OAB deficiency entails disorders of the central nervous system: an imbalance of the main nervous processes in the form of a predominance of inhibition, deterioration in coordination of movements and a decrease in the level of attention, a decrease in the speed of motor reaction to light and sound stimuli. Disorders of the cardiovascular system, immune and endocrine systems may occur. A person finds himself in hypogeomagnetic conditions in residential multi-storey buildings built from reinforced concrete structures, in subway cars, passenger car interiors, in airplanes, ships, submarines, and in bank vaults.

From a hygienic point of view, the air environment is not homogeneous. Considering the variety of physical properties and harmful impurities, as well as the conditions of formation and air pollution, several categories are distinguished air environment: atmospheric air, air of residential and public buildings and air of industrial premises.

Characteristics of meteorological factors

Physical properties atmospheric air unstable and related to the climatic characteristics of the geographic region. Weather- this is a set of physical properties of the near-Earth layer

atmosphere (barometric pressure, temperature, humidity, wind speed and direction, solar radiation) over a specific territory for a certain period of time.

A complex weather characteristic is called type of weather. From a hygienic point of view (impact on human health) it is convenient clinical classification of weather types.

1. Clinically optimal type of weather has a favorable, gentle effect on the human body, causes a cheerful mood - this is weather with relatively even meteorological properties: moderately wet or dry, quiet (wind speed no higher than 3 m/s), clear (sunny), day-to-day temperature fluctuations air does not exceed 2? C, atmospheric pressure - 3 mm Hg.

2. Clinically irritating type of weather - weather with a violation of the optimal level of one or more meteorological parameters: the weather is sunny and cloudy, dry and humid (not higher than 90% relative humidity), day-to-day fluctuations in air temperature do not exceed 4? C, atmospheric pressure - 6 mm Hg ., wind speed no more than 9 m/s.

3. Clinically acute type of weather is characterized by sudden changes in meteorological parameters: the weather is damp (above 90% relative humidity), rainy, cloudy and very windy (wind speed more than 9 m/s), day-to-day fluctuations in air temperature exceed 4? C, atmospheric pressure - more than 6 mmHg.

Weather changes can occur gradually (periodically) or abruptly (aperiodically) over a certain period (day, week). Unlike periodic weather changes, sharp fluctuations in meteorological stimuli (movement of air masses, barometric pressure, temperature, etc.) are unexpected for the body. They create an increased load on the regulatory apparatus of the human body, causing overstrain of physiological adaptation mechanisms, which leads to various dysfunctions of the body. (heliometeotropic reactions) in weather-sensitive (or weather-sensitive) people. This often manifests itself in decreased performance, rapid fatigue and deterioration of well-being: sleep disturbance, headaches, dizziness, tinnitus, pain in the heart, legs, arms, painful sensations in closed body cavities (joints,

dental cavities). Heliometeotropic reactions can be considered as a clinical syndrome of maladaptation, i.e. meteoneuroses of maladaptive origin. This reduces sensitivity to drugs, which can lead to overdose. Currently, the negative impact of unfavorable weather on the course of diseases of the cardiovascular, respiratory, digestive and nervous systems, skin and eye diseases, as well as an increase in injuries, car accidents, murders and suicides has been proven. Heliometeotropic reactions are often observed in children infancy, then at 5-6 and 11-14 years, when a physiological restructuring of adaptation mechanisms occurs. Sensitivity increases in women during pregnancy and childbirth, which is expressed in worsening toxicosis of pregnancy, an increase in the number of threatened abortions, and premature births. Prevention of heliometeotropic reactions is carried out using hardening, rational clothing and footwear, improving working and rest conditions, normalizing the indoor microclimate, using specific and non-specific means and medicines.

Climate- statistical long-term weather regime, characteristic of a specific area due to its geographical location. According to average annual temperatures on earth, 7 climatic zones are distinguished: tropical(0?13? geographic latitude; average annual temperature = +20...+24 ?WITH); hot(13-26? northern and southern latitude and +16...+30? C); warm(26-39? latitude and +12...+16? C); moderate(39-52? latitude and +8...+12? C); cold(52-65? latitude and +4...+8? C); severe(65-78? latitude and 0.. -4? C); polar(69-90? latitude and -4? C and below).

In accordance with the simplified classification on the territory of Russia, taking into account the average temperatures of January and July, 4 climatic region: 1st - cold with January temperatures from -28 to -14? C and July from 4 to 10? C, 2nd - moderate with January temperatures from -14 to -4? C and July from 10 to 22? C, 3rd - warm with January temperatures from -4 to 0? C and July from 22 to 28? C, 4th - hot with January temperatures above -4°C and July temperatures from 28 to 34°C. In addition, local climate varieties are distinguished: marine, continental, steppe, mountain and others.

In medical practice, climate is divided into gentle And annoying. A gentle climate is characterized by slight fluctuations in meteorological factors and minimal

new requirements for the adaptive physiological mechanisms of the human body, annoying The climate is characterized by significant fluctuations in meteorological factors, requiring greater stress on the body's adaptation mechanism. An example of a gentle climate is the forest climate middle zone Russia, climate of the southern coast of Crimea. Irritating is cold climate North, high mountain climate (above 2000 m), hot climate steppes and deserts. This classification is also used for hygienic standardization of certain harmful environmental factors.

Acclimatization- this is the adaptation of the human body to new climatic conditions. Acclimatization is achieved by developing in people a dynamic stereotype that corresponds to changed climatic conditions, through the use of the design features of residential and public buildings, clothing and footwear, nutrition and the rhythm of life. When acclimatizing to low temperatures, there is an increase in metabolism, an increase in heat production, circulating blood volume, a decrease in vitamins C and B1 in the blood, and a disruption in the synthesis of vitamin D. Adaptation to a hot climate is usually more difficult than to a cold one; At the same time, changes are noted in the cardiovascular system (pulse decrease, blood pressure level decreases by 15-25 mm Hg), a decrease in respiratory rate, sweating increases, and a decrease in body temperature and basal metabolism occurs by 10-15%.

There are three phases acclimatization: initial, in which physiological adaptive reactions occur in the body; phase restructuring of the dynamic stereotype, which can develop favorably or unfavorably and then the third phase does not occur; phase sustainable adaptation.

Microclimateis a complex of physical properties of air that influence a person’s heat exchange with the environment, his thermal state in a limited space (in individual rooms, a city, a forest, etc.) and determine his well-being, performance, health and labor productivity. Indicators of microclimate are temperature and humidity, air speed and thermal radiation of surrounding objects and people.

The state of microclimatic factors determines the characteristics of thermoregulation of the human body, which in turn determines the heat balance. It is achieved by the ratio of processes

heat production and heat transfer from the body. Heat production occurs during the oxidation of nutrients, as well as during the contraction of skeletal muscles (Q cont.). In addition, the human body can receive convection and radiation heat from the surrounding air and heated objects if their temperature is higher than the skin temperature of exposed parts of the body (Q ext.). The main mechanisms of heat transfer by the human body: conduction into layers of air adjacent to the skin and less warm objects (Q cond.) and subsequent convection of heated air (Q conv.), radiation towards cooler objects (Q iz.), evaporation of sweat from the skin and moisture from the surface respiratory tract(Q isp.), heating up to 37? C inhaled air Qheat. ). Heat balance in general view can be represented by the equation:

Def. + Qext. - (< >) Qcond. + Qconv. + Qizl. + Oisp. + -load

Normal functioning of the body and high efficiency are possible only if the temperature of the organism remains constant within certain limits (36.1-37.2? C), there is thermal equilibrium with the environment, i.e. correspondence between the processes of heat production and heat transfer.

The unfavorable influence of microclimate is due to the complex influence of physical factors of the air environment: an increase or decrease in temperature, humidity or air speed. At elevated air temperatures, high humidity prevents the evaporation of sweat and moisture and increases the risk of overheating of the body. High humidity at low temperatures increases the risk of hypothermia, since moist air filling the pores of clothing, unlike dry air, is a good conductor of heat. High air speed increases heat transfer through convection and evaporation and contributes to faster cooling of the body if its temperature is lower than skin temperature, and, conversely, increases thermal load on the body at temperatures exceeding skin temperature.

For a pharmacist, information about the microclimate of premises is necessary to assess working conditions in pharmacies, since the microclimate affects the body’s thermoregulation, to assess the effectiveness of ventilation and the characteristics of the production environment in which medicines are stored, manufactured and dispensed. Safety of many drugs and

dosage forms, their biological activity depends on microclimatic conditions and thermoregulation of people.

The hygienic microclimate standard is thermal comfort, which is determined by the combined action of all microclimatic components, ensuring the optimal level of physiological reactions of the body and the least stress on the thermoregulatory system, i.e. optimal thermal state of a person. When normalizing the microclimate, optimal the values ​​of its parameters and acceptable the boundaries of their fluctuations, characterized by insignificant general or local uncomfortable heat sensations and moderate tension in the thermoregulation mechanism, i.e. inclusion of adaptive reactions of the body. Depending on the condition (overheating or hypothermia), these reactions manifest themselves in a moderate dilation (or constriction) of skin vessels, an increase (or decrease) in sweating, and an increase (or decrease) in heart rate. In these conditions, a person can stay for a long time without disruption or danger to health. In conditions close to comfort, indoor microclimate standards can be the same for adults and children; when establishing permissible fluctuations in microclimate indicators, the individual nature of people’s thermoregulation, determined by gender, age, weight, and the degree of physiological adaptive capabilities, must be taken into account. Standardized microclimate parameters must guarantee the preservation of health and performance even for a person with reduced individual tolerance to fluctuations in environmental factors.

The most optimal values ​​of microclimate parameters for residential premises: temperature 18-20? C, relative humidity 40-60%, air speed 0.1-0.2 m/s.

The hygienic parameters of the indoor microclimate are standardized depending on the climate for the warm and cold periods of the year. The optimal temperature for a cold climate region is considered to be 21-22?C, moderate - 18-20?C, warm - 18-19?C, hot - 17-18?C. Calculated temperature standards in rooms are differentiated depending on their functional purpose. Thus, in most pharmacy premises (assistant, aseptic, defective, procurement, packaging, storage rooms for medicinal raw materials and medicinal products)

means) the most favorable air temperature is 18? C; in the premises of medical institutions: in the operating room, preoperative room, resuscitation room, wards for children, burn patients, postoperative wards, intensive care wards, treatment rooms - 22? C, in wards for adults, doctors’ offices and other treatment and auxiliary premises - 20? C, in wards for patients with hypothyroidism - 24? C, in wards for premature and newborns - 25? C, in wards for patients with thyrotoxicosis - 15? 0.15-0.25 m/s; in educational premises: classrooms, auditoriums, offices, laboratories - 18? C, in gyms, training workshops - 15-17? C with relative humidity in the range of 40-60% and air speed 0.1-0.2 m/ With.

The microclimate of the premises is assessed by temperature conditions, i.e. differences in air temperature horizontally and vertically in various places premises. To ensure thermal comfort, the air temperature in the rooms must be relatively uniform. The horizontal temperature change from the outer wall to the inner wall should not exceed 2? C, and vertically - 2.5? C for each meter of height. The temperature fluctuation in the room during the day should not exceed 3? C.

For an integral assessment of the microclimate, it is used index of thermal load of the environment (TNS-index), characterizing the combined effect on the human body of temperature, humidity, air speed and thermal radiation from surrounding surfaces. This indicator is recommended to be used when the air speed is less than 0.6 m/s and the intensity of thermal radiation is less than 1000 W/m2.

Normalization of microclimatic conditions in production premises is carried out in relation to the warm and cold periods of the year, taking into account the category of work and the corresponding energy expenditure of the body (Table 1).

For employees pharmacies, belonging to category 1a in terms of energy consumption (up to 139 W), the optimal values ​​of microclimate indicators are regulated: in the cold season of the year, the temperature is 22-24? C, relative humidity 40-60%, air speed 0.1 m/s; in the warm period of the year, the temperature is 23-25? C, relative humidity 40-60%, air speed 0.1 m/s.

Table 1.Optimal values ​​of microclimate parameters for industrial premises (SanPiN 2.2.4.548-96)

Period of the year

(based on energy consumption level), W

Air temperature, ?С

Surface temperature, ? C

Relative humidity,%

Air speed, m/s

1a (< 139)

22-24

21-25

40-60

16 (140-174)

21-23

20-24

40-60

Cold

11a (175-232)

19-21

18-22

40-60

116 (233-290)

17-19

16-20

40-60

111 (> 290)

16-18

15-19

40-60

1a (< 139)

23-25

22-26

40-60

16 (140-174)

22-24

21-25

40-60

Warm

11a (175-232)

20-22

19-23

40-60

116 (233-290)

19-21

18-22

40-60

111 (> 290)

18-20

17-21

40-60

Laboratory work “Definition and hygienic assessment room microclimate"

Student assignments

1. Familiarize yourself with the design and principle of operation of devices for determining microclimate parameters and assessing them.

2. Determine atmospheric pressure using an aneroid barometer.

3. Determine the air temperature at 4 points in the room, calculate the average temperature of the room, horizontal and vertical temperature differences at 1 m height, evaluate the temperature regime.

4. Using an aspiration psychrometer, determine and calculate the absolute air humidity in the classroom, and use the table of maximum air humidity to calculate the relative humidity.

5. Using a catathermometer, determine the cooling capacity of the air and calculate the speed of air movement in the classroom.

6. Examine the skin temperature of 2-3 students with an electric thermometer and do a sweat test. Subjectively evaluate your own feeling of heat.

7. Assess the parameters of the microclimate of the room, comparing them with hygienic standards, and give a comprehensive hygienic assessment of the microclimate of the classroom, taking into account the objective and subjective reactions of the body to microclimatic factors.

Working method

1. Determination of atmospheric pressure produced using aneroid barometer. Atmospheric pressure is measured in hectopascals (hPa) or mmHg. 1 hPa = 1 g/cm2 = 0.75 mmHg. Normal atmospheric pressure on average fluctuates between 1013 + 26.5 hPa (760 + 20 mm Hg).

For continuous recording of atmospheric pressure fluctuations, a recording device is used - barograph(Fig. 1). It consists of a set of aneroid boxes that respond to changes in air pressure, a transmission mechanism, a hand with a feather and a drum with a clock mechanism. Vibrations of the walls of the box are transmitted using a system of levers to the recorder pen. Pressure fluctuations are recorded on a paper tape mounted on a rotating drum.

Rice. 1. Barograph

2. Air temperature determination

Isolated determination of air temperature can be carried out mercury thermometers type TM-6 (measurement range from -30 to +50? C) or laboratory alcohol thermometers with a scale from 0 to +100?C. To fix the maximum or minimum temperature apply maximum and minimum thermometers. Measuring air temperature in industrial premises is usually combined with determining its humidity and is carried out using a psychrometer. If there are sources of infrared radiation, temperature measurement is carried out using a dry thermometer of an aspiration psychrometer, since the thermometer reservoirs are reliably protected from the influence of thermal radiation by double polished and nickel-plated screens.

Using alcohol thermometers mounted on a portable stand at a height of 1.5 m and 0.5 m from the floor, measure the air temperature at each point for 7-10 minutes at the following 4 points:

In the center of the room at a height of 0.5 m (T1) and 1.5 m from the floor (T2);

At a height of 1.5 m at a distance of 5-10 cm from the outer wall ( window glass in room) (T3) and from the opposite inner wall (T4);

To study temperature dynamics, when there is a need to determine temperature fluctuations in a room, recording instruments are used - thermographs (daily or weekly) type M-16 (measurement range from -20 to +50? C) (Fig. 2).

Rice. 2. Thermograph

The thermograph sensor is a bimetallic curved plate, the inner surface of which consists of an invar alloy, which practically does not expand when heated, and the outer surface of constantan, which has a relatively large coefficient of thermal expansion. As the temperature increases or decreases, the curvature of the bimetallic strip changes. Vibrations of the plate through a system of levers are transmitted to a pen with ink, which records the temperature curve on a tape mounted on a drum rotating at a certain speed.

3. Determination of thermal radiation carried out if there is heating devices or heated equipment. Thermal radiation is infrared radiation with a wavelength from 760 to 15000 nm. To measure thermal radiation it is used actinometer. The actinometer sensor (Fig. 3) is a thermopile and consists of alternating black and silver-white metal plates connected to different ends of the electrical

chains. When there is a temperature difference at the ends of the electrical circuit, due to the heating of the black plates as a result of the absorption of infrared rays, a thermoelectric current arises, which is recorded by a galvanometer calibrated in units of thermal radiation - cal/cm 2. min or W/m 2 . Maximum permissible level of thermal radiation in the workplace = 20 cal/cm 2. min.

Rice. 3. Actinometer

Before starting the measurement, the pointer on the galvanometer scale must be set to the zero position, then open the cover on the back surface of the actinometer. The galvanometer readings are taken 3 seconds after the actinometer thermal receiver (sensor) is installed towards the source of thermal radiation.

4. Determination of air humidity.

Air humidity depends on the content of water vapor in it. To characterize humidity, the following concepts are distinguished: absolute, maximum, relative humidity, saturation deficit, physiological saturation deficit, dew point.

Absolute humidity - elasticity (partial pressure) of water vapor in the air at the time of measurement (in g/m 3 or mm Hg). Maximum humidity- the elasticity of water vapor when the air is completely saturated with moisture at a certain temperature (in g/m 3 or mm Hg). Relative humidity- the ratio of absolute humidity to maximum, expressed as a percentage. Saturation deficit- difference between maximum and absolute humidity

ity (in mmHg). Dew point- the temperature at which the air is maximally saturated with water vapor. Only relative humidity is standardized, which is considered normal in the range of 40-60%.

Air humidity can be measured using various instruments. Absolute humidity can be determined using psychrometers. There are 2 types of it: the Assmann aspiration psychrometer and the August station psychrometer (Fig. 4). The psychrometer consists of two identical thermometers, the reservoir of one of which is wrapped in a light hygroscopic cloth, moistened with distilled water before measurement, and the second remains dry.

Rice. 4.Psychrometers: a) aspiration; b) station

Station psychrometer Augusta used in stationary conditions, excluding exposure to wind and radiant heat. It consists of two alcohol thermometers. Based on their readings, absolute humidity is determined using tables or the formula:

K= f- a (tс--tв) B,

where: K - absolute air humidity at a given temperature, mm Hg;

f- maximum air humidity at wet-bulb temperature, mmHg. (see Table 2);

a - psychrometric coefficient, equal to 0.001 with gentle air movement;

tc and tB - temperature of dry and wet thermometers, ? C; IN- atmospheric pressure at the time of measurement, mm Hg.

Most widely in hygienic practice, portable devices are used to measure absolute humidity both indoors and outdoors. Assmann aspiration psychrometers, having protection from wind and thermal radiation. The psychrometer consists of two mercury thermometers (having a scale from -30 to +50? C), which are enclosed in a common frame, and their reservoirs are in double nickel-plated metal tubes for protection against radiant heat. A fan with a clock mechanism built into the head of the device sucks air along the thermometers with constant speed 2 m/s.

Before starting measurements using a pipette, you need to moisten the fabric on the reservoir of the wet thermometer, turn the device mechanism to full with a key and hang it vertically on the bracket at the point under study, usually in the center of the room, and then after 3-5 minutes record the readings of the dry and wet thermometers .

Absolute air humidity in this case is calculated by the formula:

K= / 755.

Relative air humidity (in%) is calculated using the formula:

P= K. 100/F

Where: P- relative humidity, %,

F- maximum air humidity at dry thermometer temperature, mm Hg. (see Table 2).

Table 2.Maximum air humidity at different temperatures

Air temperature, +? C

Air temperature, +? C

Maximum humidity, mm Hg.

10,5

30,04

11,23

31,84

11,99

33,69

12,73

35,66

13,63

37,73

14,53

39,90

15,48

42,17

16,48

44,16

17,73

46,65

18,65

49,26

19,83

52,00

21,07

55,32

22,38

58,34

23,76

61,50

25,20

64,80

26,74

68,26

28,34

71,88

Directly relative humidity can be measured hygrometer(Fig. 5). Fat-free human hair in the hygrometer is stretched along the frame of the device and attached to the needle. The property of hair to change its length depending on humidity is used. When the degree of its tension changes, the arrow moves along a scale graduated in percentage. Relative humidity is usually measured in the center of the room.

For continuous graphical recording of relative air humidity over a certain period of time, recorders - hygrographs(daily or weekly) type M-21 (measurement range from 30 to 100% at temperatures from -30 to +45? C), in which the sensor is a bundle of fat-free human hair stretched in a frame (Fig. 6).

Rice. 5. Hygrometer

Rice. 6. Hygrograph

5. Determination of air speed

The movement of air in the atmosphere is characterized by direction of movement and speed. Direction determined by side

light, where the wind blows from, and speed - the distance traveled by the air mass per unit time (m/s). The prevailing wind direction in a particular area must be taken into account when planning and constructing populated areas, placing residential buildings, pharmacies, kindergartens, schools, hospitals and other institutions on their territory, which should be located on the windward side in relation to sources of air pollution and other environmental objects (industrial enterprises, thermal power plants, etc.).

The prevailing wind direction for a given location is determined by the wind rose. Rose of Wind is a graphical representation of the frequency (recurrence) of winds by bearings (directions) observed in a given area throughout the year. To designate rhumbs, the initial letters of the names of the cardinal directions are used. To construct a wind rose from the center of the graph, on the main (N, S, O, W) and intermediate (N-O, N-W, S-O, S-W) points of reference, segments are laid out on a certain scale, corresponding to the number of days in a year with a given wind direction. Then the ends of the segments along the directions are connected by straight lines. Calm (lack of wind) is indicated by a circle from the center of the graph with a radius corresponding to the number of days of calm.

Rice. 7. Rose of Wind

In Fig. 7, the wind rose indicates the prevailing north-eastern direction of winds in the study area throughout the year, therefore residential buildings, pharmacies, hospitals and child care institutions should be located on the windward side (in the north-eastern direction), and industrial enterprises and other sources of pollution - on the leeward side (in the southwest direction). Industrial enterprises and other sources of negative impact on the environment and human health must be separated from residential buildings sanitary protection zones (SPZ). The width of the sanitary protection zone is established in accordance with the sanitary classification of industrial enterprises, buildings and other objects, depending on the degree of harmfulness of production, its capacity, the nature and amount of emissions released into environment pollutants, noise, vibration and other harmful physical factors (Sanitary protection zones and sanitary classification of enterprises, structures and other objects. SanPiN2.2.1/2.1.1.1200-03). Based on these criteria, industrial enterprises are divided into 5 classes, for each a SPZ size is established: for 1st class enterprises - 1000 m with at least 40% landscaping, for 2nd - 500 m, 3rd - 300 m with at least 50 % landscaping, for the 4th - 100 m and 5th - 50 m with at least 60% landscaping.

Rice. 8.Anemometers (on the left - cup, on the right - vane)

Relatively high air velocities are measured anemometers various designs. The choice of anemometer type is determined by the measured air velocity. Cup anemometer MS-13 measures speeds from 1 to 30 m/s. It is most often used in meteorological practice. The ASO-3 vane anemometer is used in industrial premises to measure air speeds in the range of 0.3-5.0 m/s (Fig. 8).

The operating principle of the devices is based on transmitting the rotation of the blades mounted on an axis to a counting mechanism that records the number of revolutions. To determine the speed of the air environment, the difference between the anemometer readings after being in the air stream for 3 minutes and the initial readings of the device is divided by the number of seconds of measurement. The number of revolutions per chest corresponds to the speed of air movement in m/s.

To measure low air velocities in a room, glass ball or cylindrical catathermometers, which allow you to measure speed in the range of 0.05-2.0 m/s (Fig. 9).

Rice. 9.Ball catathermometer

The scale of the ball catathermometer consists of 7? (from 33 to 40?), cylindrical scale - from 3? (from 35 to 38?). The definition is based on assessing the cooling intensity of a heated device due to the cooling capacity of the air. Air cooling capacity "N" determined by the catathermometer factor (F) and cooling time of its tank (t) in sunds with 38? up to 35? C or from 40? up to 33? From the instrument scale. The F value is indicated at the top of the catathermometer; it corresponds to the amount of heat in millicalories lost from 1 cm 2 of the surface of the device when it is cooled from 40? up to 33? C or from 38? up to 35? C. The device is heated in a glass with hot water with a temperature of 66-75? C in order for the alcohol to rise slightly above the upper mark of the device scale, wipe the device dry and, hanging it in the center of the room, note the time required for cooling the alcohol from 40? up to 33? C or from 38? up to 35? C. Air cooling capacity "N" found by the formula:

H= [(F/3) (40-33)] / t, μcal / cm 2.

To take into account the cooling effect of ambient air, it is necessary to calculate the factor Q, equal to the difference between the average temperature of the catathermometer (36.5? C) and the air temperature in the room. Having calculated H/Q, The speed of air movement at the measurement point is found from the table. 3.

The speed of air movement can also be calculated using the empirical formula: V= [(H/Q- 0.20)/0.40] 2 m/s. In summer, atmospheric air speeds within the range of 1-4 m/s are favorable, and indoors - 0.2-0.4 m/s.

Special instruments are currently used to measure and control air parameters meteorometers type MES-200, designed to measure atmospheric pressure, relative humidity, temperature and air flow speed indoors. The device uses thermistors and a humidity sensor with an amplifier unit as sensors for measuring parameters.

6. Study of the body's reactions to microclimate

* Human thermal sensation depends on the complex action of microclimatic factors, as well as on the intensity of the work performed, the degree of fatigue, the nature of nutrition, clothing, emotional state, and a person’s fitness for cold

Table 3.Air movement speed is less than 1 m/sec at different air temperature ranges in the room

and other factors. A person’s assessment of thermal well-being is as “cold”, “cool”, “normal” (or “comfortable”), “warm”, “hot”. More indicative are objective methods for studying the thermal state of the body.

Skin temperature detection made with an electric thermometer at symmetrical points (3-4 cm from midline) on the forehead, on the chest, in the middle of the shoulder, on the back of the hand (between the bases of the thumb and index finger). The temperature of the skin of the forehead and chest with normal human thermal sensation = 31? - 34?, hand temperature - not lower than 27?.

"Sweating Research" produced in hot microclimates or intense physical work and is

one of the indicators of tension in thermoregulation processes. Minor's iodine-starch method is based on the color reaction of starch with iodine when the skin is wetted with sweat. A piece of filter paper treated with a dried mixture of 10% iodine tincture is applied to the area of ​​forehead skin powdered with starch. ethyl alcohol and castor oil. When sweat is secreted, the paper turns dark blue. In a comfortable microclimate, there may be only isolated small dots on it; large spots indicate increased sweating.

Sanitary and hygienic conclusion is based on a comparison of the results of measuring microclimatic parameters with their hygienic standards, as well as with subjective and objective indicators of thermoregulation of people present in the room. The microclimate can be assessed as optimal (comfortable); acceptable cool or warm; unacceptably cold or hot.

Sample protocol for completing the laboratory task “Determination and hygienic assessment of the microclimate of the room”

H/Q

17,5?

20,0?

22,5?

25,0?

0,27

0,035

0,041

0,047

0,051

0,28

0,049

0,051

0,061

0,070

0,29

0,060

0,067

0,076

0,085

0,30

0,073

0,082

0,091

0,101

0,31

0,088

0,098

0,107

0,116

0,32

0,104

0,113

0,124

0,136

0,33

0,119

0,128

0,140

0,153

0,34

0,139

0,148

0,160

0,174

0,35

0,154

0,167

0,180

0,196

0,36

0,179

0,192

0,206

0,220

0,37

0,198

0,212

Vertical, m

Horizontally,?C

At the outer wall

In the center

At the inner wall

Drop

1.5 m from the floor

T s

T 2

T 4

T 3 -T 4

0.5 m from the floor

Drop,?C

T 2 -T 1

Calculation of average indoor air temperature:

T?av =(T1 + T 2 + T h + T4) / 4 ... 3. Determination of air humidity:

Determination of absolute humidity using an Assmann aspiration psychrometer:

Dry bulb readings. Wet bulb readings. Calculation of absolute humidity using the formula: Calculation of relative humidity using the formula: 4. Determination of the speed of air movement in the room using a ball catathermometer: Cooling time of the device (t)... Instrument factor (F) ...

Air cooling capacity: H= [(F/3) (40-33)] / t...

Q(36,5? - T?sr) =..., H/ Q= ..., V = ... Conclusion(sample)

The microclimate of a given room provides comfortable conditions (or unacceptably hot and causes significant thermoregulation stress; slightly above the comfort zone - acceptable warm and causes some thermoregulation stress; below the comfort zone - unacceptably cold and causes a feeling of cold, etc.). To improve the microclimate, it is recommended...

Central heating of pharmacy premises is recommended - water. Pharmacies located in residential or public buildings, are usually connected to the building's heating system. Heating devices placed in special niches under windows and recesses in external walls. The most appropriate are smooth-walled radiators that are easily accessible for cleaning from dust. The laying of pipelines to them in the public service, aseptic, assistant and packaging rooms must be hidden. IN aseptic block It is advisable to install panel heating. In category V-VI pharmacies located in a separate building, it is advisable to install local water heating (see page 138), but stove heating is also allowed. The heating system must ensure the air temperature in the pharmacy premises indicated in Table 14.

Importance in creating comfortable hygienic conditions the pharmacy has the organization of correct and sufficient air exchange, which can be achieved with the help of natural and artificial (mechanical) ventilation. Its goal is to maintain normal microclimatic conditions in all premises of the pharmacy and ensure the maximum permissible concentrations of toxic vapors, gases and dust in the air established by our sanitary legislation. Air exchange also plays a very significant role in the fight against air pollution by microflora.

In pharmacies located in residential buildings, natural air exchange is ensured using exhaust ventilation ducts in the internal walls of the premises. Air enters these channels through grilles located in the upper zone of the premises. The amount of air removed depends mainly on the difference between the external and internal temperatures: the greater the difference between them, the greater the air exchange. However, the efficiency of ventilation in such conditions is insufficient even if deflectors are installed at the outlet openings of the channels to enhance air exchange.

From the above it follows that in pharmacies it is necessary to use additional devices for natural ventilation of premises in the form of transoms or windows, the area of ​​which in each room must be at least 1/50 of the floor area.

However, if we take into account the purpose separate rooms, natural air exchange can be limited only to the manager’s office, office, staff room, toilet and shower. All other rooms must have artificial ventilation, providing the most stable air conditions. When installing ventilation, one should be guided by design standards internal temperatures and the frequency of air exchange separately in the exhaust and in the supply.

Bearing in mind the nature of the operations performed and the characteristics of the air environment, the design temperature and the frequency of exchange in various rooms should be provided in accordance with Table 14.

The choice of mechanical ventilation system and type of ventilation devices depends on the operating conditions. To maintain a normal microclimate in the prescription department and in the manual sales department in the vestibule entrance doors must be provided air curtain with supply air temperature at winter time 30-35°; the amount of heated air is determined by the volume of the vestibule.

In the hall for visitors, an exhaust ventilation device is needed with air intake from the upper zone, and in order to prevent it from flowing from here into neighboring rooms (primarily into the assistant's room), the exhaust should be slightly larger than the inflow.

For assistant room ventilation, the most appropriate is a supply and exhaust system with exhaust and supply ventilation openings located in the upper zone. A similar system should be implemented in material room. Workplace It is advisable to install the analyst in the assistant's room in a shelter with an incentive thrust. In the work room of the analytical chemist, local exhaust ventilation should be provided - a fume hood, as well as an inflow into the upper zone. Very great importance To create normal microclimatic conditions, the pharmacy has ventilation for the washing and still-sterilization rooms. In these premises, along with the installation exhaust hoods General ventilation is required above the washing baths and stove, and in order to prevent the spread of overheated and over-humidified air into adjacent rooms, the inflow volume must be less than the exhaust volume. Warehouses In basements, general ventilation should also be provided.

Question:
Our pharmacy has an indefinite sanitary and epidemiological certificate for the premises. Is it legal for the licensing authority to provide additional microclimate measurement inspection reports, if in our production control program the measurement period is specified once every 5 years? How often do you need to examine the microclimate of the pharmacy premises (take measurements of light and humidity, etc.) and what document regulates this?

Answer:

Attention, you are using open access to outdated consultations. Current consultations for the last 5 years are available only to registered clients who have paid for access to the site.

According to paragraph 3.7 of the Order of the Ministry of Health of the Russian Federation of October 21, 1997 N 309 “Instructions for the sanitary regime of pharmacy organizations (pharmacies)” (as amended on April 24, 2003), microclimate parameters (temperature, humidity) must be monitored in the pharmacy premises , air exchange). The procedure for carrying out such control is not established by regulatory legal acts.
In accordance with clause 1.5. Sanitary rules SP 1.1.1058-01 “Organization and conduct of production control over compliance with sanitary rules and implementation of sanitary and anti-epidemic (preventive) measures”, approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation dated July 13, 2001 N 18 (as amended on March 27 .2007), legal entities, in accordance with the activities they carry out, are obliged to exercise production control over compliance with sanitary rules and the implementation of sanitary and anti-epidemic (preventive) measures when performing work and providing services.
In accordance with clause 2.6. of these Rules, a production control program is drawn up by a legal entity before the start of activities, then agreed upon by the chief physician (deputy chief physician) of the center for state sanitary and epidemiological supervision (territorial body of Rospotrebnadzor), which carries out state sanitary and epidemiological supervision over the activities of the legal entity, and approved by the head of the organization.
According to paragraph 3.3 of the Rules, the production control program must contain, inter alia, a list of chemical substances, biological, physical and other factors, as well as production control objects that pose a potential danger to humans and their environment (critical control points), for which it is necessary organization of laboratory research and testing, indicating the points at which sampling is carried out (carried out laboratory research and testing), and frequency of sampling (laboratory research and testing).
The basis for determining the list of chemical substances, biological, physical and other factors, the selection of points at which sampling, laboratory studies and tests and determinations are carried out, the frequency of sampling and research, including in the sanitary protection zone and in the zone of influence of the enterprise are sanitary rules, hygienic standards and sanitary-epidemiological assessment data.
Moreover, according to clause 6.2. sanitary rules SP 1.1.1058-01, when preparing a production control program, bodies and institutions of the state sanitary and epidemiological service have the right to send legal entities a list of factors for which the organization of sampling is necessary, indicating their frequency.
An approximate production control program for all pharmacies, regardless of their organizational and legal forms and departmental subordination, including pharmacies serving inpatients (hospital pharmacies, interhospital pharmacies, pharmacies of psychiatric and drug treatment hospitals), and pharmacy distribution points, was introduced by the Decree of the Chief State Sanitary Doctor RF dated July 30, 2002 N 26 “On the introduction of production control programs.”
It must be emphasized that not a single regulatory legal act establishes the frequency of sampling in pharmacy organizations. Thus, periodic sampling as part of production control is carried out in accordance with the production control plan (program) agreed upon by these Rospotrebnadzor bodies.
In accordance with paragraph 4a of the approved Decree of the Government of the Russian Federation of July 6, 2006 N 416 “Regulations on licensing of pharmaceutical activities” (as amended on November 13, 2010), the licensing requirements and conditions for carrying out pharmaceutical activities are, in particular, the presence of the license applicant (licensee) of premises and equipment belonging to him by right of ownership or on another legal basis, necessary for the implementation of pharmaceutical activities and meeting the requirements established for them (with the exception of medical organizations and separate divisions of medical organizations).
According to subparagraph 5 of paragraph 3.3.3 approved by Order of the Ministry of Health and Social Development of the Russian Federation dated December 31, 2006 N 897 “ Administrative regulations federal service for supervision in the field of healthcare and social development for execution state function on licensing of pharmaceutical activities" (as amended on August 20, 2009) to confirm compliance of the pharmacy premises with the requirements established by law when obtaining a license to carry out pharmaceutical activities, the license applicant sends or submits it to the Roszdravnadzor department for the subject Russian Federation a copy of the in the prescribed manner sanitary and epidemiological conclusion on the compliance of the premises with the requirements of sanitary rules.
The provision of other documents confirming the compliance of premises with established requirements is not provided for by current legislation.

17.03.11