TOPIC No. 1 “Hygiene atmospheric air. Microclimate pharmacy premises».
Air environment and its hygienic value.
Physical properties of air, their hygienic significance and effect on the body.
Weather, climate. Definition of concepts. Hygienic value.
Microclimate of working premises in pharmacies. Definition of the concept. Classification. Complex influence of microclimate factors on the human body.
Chemical composition of atmospheric air and its hygienic significance.
Sources of air pollution. Hygienic standardization of contents harmful substances in the air of working premises.
Bacterial contamination air environment.
Practical skills:
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).
Comprehensive assessment of the microclimate of working premises using the effective temperature method.
Determination of microclimate parameters in classrooms.
Solving situational problems.
Bolshakov A.M. Guide to laboratory exercises on general hygiene. – M., 2004
TOPIC No. 2 “Hygienic principles of lighting, ventilation and heating in pharmacy premises.”
Biological effect of light. Factors influencing the level natural light indoors.
Indicators characterizing the state of natural lighting and their standards for pharmacies of various types.
Hygienic requirements to artificial lighting. Characteristic various types sources of artificial lighting. Types of lamps. Artificial lighting standards for various types of pharmacies.
Ventilation. Definition of the concept. Classification. Hygienic value.
Hygienic requirements for heating.
Practical skills:
Introduction to the structure and operation of a lux meter.
Determination and assessment of natural light indicators in workplaces (luminous coefficient, opening and incidence angle, natural light coefficient).
Determining the sufficiency of artificial lighting in workplaces.
Solving situational problems.
Bolshakov A.M., Novikova I.M. General hygiene. – M., 2002.
TOPIC No. 3 " Hygienic characteristics water. Water supply for pharmacies."
The role of the water factor in human life. Physiological and hygienic importance of water.
The role of the water factor in the occurrence of infectious and non-infectious diseases.
Sources of water supply and their hygienic characteristics.
Sanitary and hygienic characteristics of water supply systems.
Indicators of drinking water quality (organoleptic, chemical, bacteriological). Hygienic standardization of drinking water from centralized and decentralized water supply.
Measures to protect water sources from pollution.
Practical skills:
Determination and assessment of organoleptic properties of water (color, transparency).
Study chemical indicators water quality (dry residue, total hardness, chlorides, oxidation).
Qualitative determination of nitrogen-containing substances (ammonia, nitrites) in water.
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.”
Soil composition and properties.
The importance of the composition and properties of soil (hygienic, epidemiological, geochemical, toxicological). The role of soil in the occurrence and spread of diseases.
Sources of soil pollution.
Hygienic regulation of exogenous chemicals in soil.
The influence of soil on the degree of contamination of medicinal plant materials.
Measures for sanitary soil protection.
Practical skills:
Determination and assessment of organoleptic properties of soil.
Study of soil chemical parameters.
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."
Food and its effect on the body.
Principles of rational and adequate nutrition. Physiological nutritional standards.
The importance of proteins in the life of the body.
The importance of fats in human nutrition.
The importance of carbohydrates in the life of the body.
The importance of vitamins and minerals in human nutrition.
The concept of therapeutic and preventive nutrition and its importance in protecting the health of workers of pharmaceutical enterprises.
Practical skills:
Calculation and analysis of daily menu layouts. Determination of daily nutritional and energy requirements for various groups population.
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.”
Structure of pharmacy network institutions.
Sanitary and hygienic basis for licensing pharmacies.
Types of pharmacies serving the population. Pharmacies of medical and preventive institutions.
Hygienic requirements for the layout, equipment and improvement of pharmacies.
Hygienic and anti-epidemic measures to combat microbial contamination.
Hygienic requirements for the premises of control and analytical laboratories.
Hygienic requirements for pharmaceutical warehouse premises.
Practical skills:
Hygienic assessment of pharmacy projects.
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 production medicines».
Influence labor process on the functional state of the body. Fatigue and overwork. Causes. Prevention.
Characteristic production factors, defining the working conditions of workers in the pharmaceutical industry. Principles of hygienic regulation harmful factors production environment.
The concept of industrial hazards and occupational diseases.
Measures to combat industrial hazards. Prevention of occupational diseases.
Dust as a specific factor in the production of drugs. Definition. Classification. Effect on the body.
Pneumoconiosis. Classification. Pathogenesis.
Prevention of dust diseases.
Classification of harmful substances (poisons) according to their toxicity and danger. Routes of entry, distribution and excretion.
Combined, combined and complex action. Effect on the body.
Toxicological and hygienic characteristics of the main groups of harmful substances. Prevention measures.
Practical skills:
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.”
Noise. Definition. Classification. Main sources.
Features of the biological influence of noise on the body of workers of pharmaceutical enterprises.
Measures to prevent noise pathology.
Vibration. Definition. Classification. Main sources.
Features of the biological effect of vibration on workers of pharmaceutical enterprises.
Measures to prevent vibration pathology.
Practical skills:
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:
Conducting a sanitary and hygienic inspection of the pharmacy.
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
Hygienic characteristics of the main technological processes at enterprises of the chemical and pharmaceutical industry.
Occupational hygiene in the production of synthetic drugs.
Hygienic characteristics of working conditions and health status of workers in the production of antibiotics.
General characteristics of industrial factors that determine working conditions in the production of herbal preparations.
Occupational hygiene in the production of finished dosage forms.
Practical skills:
Solving situational problems.
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.
Hygienic requirements for technological process, decoration of premises, landscaping, and personal hygiene of pharmacy workers do not differ from the requirements for those in pharmacies serving the public. 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. 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, disrupting optimal micro climatic 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 hygienic importance, as it affects the health, visual function, performance, productivity and mood of workers. All production, administrative, auxiliary and sanitary premises must be provided with natural and artificial lighting. The absence of natural light is 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. In addition, poor lighting requires strain on the visual analyzer and adversely affects performance and productivity.
To ensure a sufficient level of natural light in a pharmacy, it is necessary that window glass were smooth, clean, the window sills were free of various objects that would block 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. In pharmacy premises there should be no protrusions in the path of light 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. For example, walls painted in White color, reflect 80% of the rays incident on them, in light yellow - 50%, in blue - 25%, in 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 Pharmacy staff should be carefully selected 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 of pharmacy premises is provided by 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 artificial light in pharmacies in accordance with the instructions for sanitary regime pharmaceutical organizations (pharmacies) (No. 309 of October 21, 1997) and SNiP 23-05-95 established the following standards (Table 5.4).
Table 5.4 – Standards for artificial lighting of pharmacies
| No. | Room | Illumination of working surfaces | Light source | Acceptable level of discomfort | Allowable ripple factor | Characteristics of premises according to environmental conditions | Lamp type |
| 1. | Area for visitors in the service hall | LL | Normal | LB LE | |||
| 2. | Prescription department, prepared medicines department, hand selling, opticians, pharmacy kiosk | LL | Normal | LB LE | |||
| 3. | Assistant, aseptic, analytical, control and marking, packaging | LL | Normal | LEC LHE | |||
| 4. | Distillation, sterilization, washing | LL | - | Moist | LB | ||
| 5. | Storage of medicinal substances, utensils, hygiene items, parapharmaceutical products | LL | - | Class II-IIa | LB | ||
| 6. | Storage room for flammable liquids, acids and flammable liquids | LL | - | - | Chemically active II-IIa | LB | |
| 7. | Container storage room | LN | - | - | Class II-IIa | LN |
Fluorescent light sources are recommended for artificial lighting of pharmacy production facilities. low pressure. 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 should not only create required level illumination, but also to 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, corridors is set 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 at 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). Advantage panel heating Compared to water, 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, subsidence is eliminated and burning of dust on radiators. This is especially appropriate for heating the aseptic unit, assistant’s room and pharmacist-analyst’s room, where it must be observed. high level cleanliness.
The device is prohibited in pharmacy premises steam heating as the least hygienic. With this type of heating, dust burns on the radiators, which is accompanied by the appearance of an unpleasant odor; Heating devices heat up unevenly throughout the day, 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 arrange local water heating. Stove heating permitted 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)
| Name of departments | Air temperature, not lower | Air exchange rate, mechanical ventilation | Exhaust ratio of natural air exchange | |
| influx | hood | |||
| Public service halls | 16°C | |||
| Placement of orders from attached pharmacies, for receiving and processing orders, prescription | 18°C | |||
| Assistant, aseptic, defector, blanking, packaging, sterilization-autoclave, distillation | 18°C | |||
| Control and analytical, sterilization solutions, unpacking | 18°C | |||
| Premises for the preparation of medicines under aseptic conditions | 18°C | Not allowed | ||
| Stock storage premises: | ||||
| A) medicinal substances, dressings, thermolabile drugs and items medical purposes | 18°C | |||
| b) medicinal plant materials | 18°C | |||
| c) poisonous drugs and drugs | 18°C | - | ||
| d) flammable and combustible liquids | 18°C | - | ||
| e) disinfectants, acids, disinfectant | 18°C | - |
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, gaseous chemical 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.
Device artificial ventilation necessary in rooms where 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. The different nature of work in different areas of the pharmacy requires a particularly careful approach to the choice of ventilation system and type ventilation devices. So, in the assistant's room - the main production room, where you can expect the 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 the general exchange supply exhaust ventilation, there must be local exhaust ventilation - a fume hood.
Particular attention should be paid to the ventilation of washing and distillation-sterilization rooms, since the microclimatic conditions of the entire pharmacy depend on its proper 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.
The most effective type of 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 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.
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 the desired state of the air environment in rooms and 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 cold period During the summer, the top row of side openings is used, and in the warm season, the bottom row of windows is also 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. The supply air can be subjected to special treatment, for example, 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, the premises are provided with both supply and exhaust systems. 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 the places where harmful substances are released are localized and their spread throughout the room can be prevented.
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 increased heat transfer from the body under the influence of temperature differences and increased air speed. 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 hoods 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- quantity fresh air, which must be supplied to the room for 1 person per hour, so that the amount of harmful substances present 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, 180 m3 of air per hour is removed using exhaust ventilation. 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 rooms pharmacies have established standards for the frequency of air exchange for inflow and exhaust in accordance with the Instructions for the sanitary regime of pharmacy organizations (pharmacies) of the Ministry of Health of the Russian Federation 309 dated 10.21.97. (Table 12).
Table 12.
Multiplicity |
|||||||
air exchange, |
|||||||
Name of departments |
mechanical |
||||||
ventilation |
|||||||
16 0 C |
Public service halls |
||||||
18 0 C |
Placing orders attached to app- |
||||||
tech, for receiving and processing orders, |
|||||||
prescription |
|||||||
Assistant, aseptic, defector- |
|||||||
skaya, procurement, packaging, sterile |
|||||||
lization-autoclave, distillation- |
|||||||
Control and analytical, sterilization |
|||||||
tion solutions, unpacking |
|||||||
Premises for the preparation of medicines |
|||||||
under aseptic conditions |
|||||||
Stock storage premises: |
|||||||
a) medicinal substances, dressings |
|||||||
agents, thermolabile drugs |
|||||||
goods and medical supplies |
|||||||
18 0 C |
b) medicinal plant materials |
||||||
18 0 C |
c) poisonous drugs and drugs |
||||||
d) flammable and combustible |
|||||||
liquids |
|||||||
18 0 C |
e) disinfectants, acids, disinfectant |
||||||
Question:
Our pharmacy has an indefinite sanitary and epidemiological certificate for the premises. Is it legal for the licensing authority to provide additional certificates for examining microclimate measurements if our program includes production control Is the measurement period indicated 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 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 required to exercise production control for compliance with sanitary rules and carrying out 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 license applicant (licensee) of premises and equipment belonging to him by right of ownership or on another legal basis, necessary for carrying out 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 of the Federal Service for Surveillance in the Sphere of Healthcare and Social Development for the Execution of the State Function of Licensing 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 department of Roszdravnadzor for the subject Russian Federation a copy of the sanitary and epidemiological report issued in accordance with the established procedure 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
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. Besides specific conditions for certain groups of medicines, such as storage in cabinets or safes, protection from sun rays, storage in refrigerators, there are parameters that affect almost all products pharmacy assortment. 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 us outline what is required from pharmacies current legislature. 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 temperature regime from 15 to 25 °C or, depending on climatic conditions, up to 30 °C.
Estimated temperatures in the premises of pharmaceutical organizations (pharmacies)
| Name of departments | Air temperature not lower than ˚С |
| Public service halls | 16 |
|
Placement of orders from attached pharmacies, for receiving and processing orders, prescription |
18 |
| Assistant, aseptic, defector, blanking, packaging, sterilization - autoclave, distillation | 18 |
| Control and analytical, sterilization solutions, unpacking | 18 |
| Premises for the preparation of medicines under aseptic conditions | 18 |
| Stock storage premises | 18 |
As for humidity, storage of medicines is carried out at relative humidity no more than 60 ± 5% depending on the relevant climate 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, approved for use 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. At the same time, they are recommended to be placed in places where there is the greatest likelihood of temperature and humidity fluctuations or deviations from the required parameters are most often observed.
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 biological active additives» on paper or in in electronic format 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 THE SANITARY REGIME OF PHARMACEUTICAL PRODUCTS PRIVATE 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).
