Lighting- natural: the windows of the trading floor, assistant's room, aseptic unit are located to the north. The windows of the inventory department, the optics department, the washing department are located to the south. Windows size.

KEO - coefficient representing the percentage of horizontal illumination indoors to the simultaneous horizontal illumination outdoors.

SC is the ratio of the glazed window surface to the floor area.

Incident angle - this indicator characterizes the angle at which light rays fall from the window onto a given horizontal surface in the room, onto the desktop.

Hole angle - characterizes the size of the area of ​​\u200b\u200bthe sky, the light from which falls on workplace and directly illuminates the work surface.

artificial lighting- type of light source: fluorescent lamps low pressure and incandescent lamps, the pharmacy uses two lighting systems, general and local, general system located on the ceiling in all industrial premises, local - mainly localized in the assistant's, aseptic unit, pharmacist-analyst's room above the workplaces.

In the trading floor there are lamps that meet lighting, hygienic, architectural and artistic requirements. For this, artistically designed chandeliers are used, which are combined with decorative trim trading floor. In total, there are six chandeliers in the trading floor, arranged in two rows of three, one after another.

In all other rooms, fluorescent ceiling lamps from the Riga Lighting Engineering Plant were used. Their armature reduces the stroboscopic effect and allows you to get diffused light.

To determine the sufficiency of illumination, a luxmeter is used. The luxmeter consists of a selenium photocell and a pointer galvanometer. When a light flux falls on a photocell, the latter transforms light energy into electrical energy; The resulting current is recorded by a galvanometer. The strength of the current is proportional to the intensity of illumination. According to the deviation of the galvanometer needle, the amount of illumination is judged. The scale of the galvanometer is calibrated in lux.

The intensity of artificial lighting is determined using a luxmeter and, comparing the received illumination with the norms, a conclusion is made about its sufficiency.

Norms of artificial illumination of pharmacies

Of all the existing lamps, LEDs for lighting the trading floor of a pharmacy are the most expedient option today. This lighting solution allows you to harmoniously combine the high quality of light and energy efficiency. LED systems are ideal for pharmacies. They are environmentally friendly, allow you to evenly distribute light in the room, are easy to install and affordable.

Pharmacy LED lighting allows:
significantly save electricity - up to 150%;
increase the illumination of the retail space and equipment - up to 50%;
eliminate the pulsation of the light flux;
positively influence the purchasing activity of visitors;
focus on individual showcases, a group of goods, promotional material.

To replace raster fluorescent lamps previously used for lighting pharmacies, the best way LightLight-Armstrong lamp is suitable. It is adapted to power surges. Depending on the design of the ceiling, it can be installed built-in (in a suspended version) or overhead. LED lights Supplied with diffusers that regulate light transmission. We offer four options to choose from.

Proper pharmacy lighting is not only a requirement of sanitary standards. This is the image component of it. successful work, a guarantee of a comfortable atmosphere for customers and staff, a means of increasing sales.

The photographs show our work on LED lighting premises of the ASNA Pharmacy.

A pharmacy is a specialized establishment where people can buy various medicines. Since medicines are also a commodity, they must be properly presented to buyers so that they can quickly find the required remedy. by the most the best way to demonstrate a wide range of offers, as well as to enable customers to fully consider not only the price, but also the information provided on the packaging is lighting.

Since only pharmacies have the right to sell medicines, then the whole organization of such premises is subject to certain requirements. Our today's article will tell you about what you should pay attention to when creating pharmacy lighting, as well as what requirements exist in this situation.

Pharmacy features

The pharmacy is a hall of a certain area, in which there are stands with medicines, as well as a cash desk. Moreover, the dimensions of the stands depend on the dimensions of the pharmacy itself. In connection with such an organization of the working premises, the lighting system is of great importance. Here, the backlight should perform the following functions:

• sufficiently bright lighting that will allow you to fully view all the shelves of stands and medicines placed on them;

Note! Light coming from lighting fixtures pharmacy, should allow you to see without additional effort the name of the medicine, cost and other information printed on the packaging by the manufacturer.

Medicine rack

• uniform illumination of the entire pharmacy premises. The brightest lighting should cover the entire hall, including the space through which customers and employees move;
• full coverage of the cashier. This will avoid the situation of incorrectly issued change or an error in determining the cost of a particular drug.

A bright and well-lit pharmacy hall has a positive effect on emotional condition visitors. But poorly lit pharmacy rooms, on the contrary, cause discomfort and a feeling of painful despondency.

Existing lighting standards

In order to effectively organize a lighting system in any room, including production and living rooms, there are special regulatory and regulatory documents. They indicate not only the norms of the level of illumination, but also the requirements that apply to each specific room, depending on their purpose. Such documents include SNiP and SanPin.

Note! This documentation defines the minimum level of illumination that must be created in any type of premises. This means that below this level, lighting can begin to cause some discomfort or even harm health.

For a pharmacy, this documentation also has its own rules, as well as requirements.
The requirements and norms that are given in the above documents must be taken into account in the organization of any type of backlight. Otherwise, the lighting system will not be able to efficiently cope with its functions.
To create a comfortable environment for visitors, the light coming from pharmacy lighting fixtures must meet the following requirements:

• the level of lighting in its minimum value should not be lower than the standards prescribed in the regulatory documentation (SanPin and SNiP);

Note! The norms prescribed in the documents are applicable to old light sources (incandescent lamps). Therefore, if they use modern light bulbs (LED, fluorescent, etc.), you need to know the conversion factor for their power in relation to incandescent lamps.

Table of luminous flux of different light bulbs

• on a glass showcase, the light should not create glare that will prevent comfortable viewing of the range of goods presented on the racks;
• the absence of shadows that will fall on the medicines in the showcase;

• when using accent lighting for showcases, the difference in the luminous flux between it and the general lighting should be at least three times. Otherwise, visitors will notice the contrast, which will lead to eye fatigue.

At the same time, street lighting of pharmacy windows should be several times higher than its internal hall.

What you need to do to get a sales license

Being a special institution, a pharmacy must have a license for its work. In order to receive it, all relevant requirements must be taken into account in the premises.

A huge role in obtaining a license to operate a pharmacy is played by its lighting system. The following types of room lighting should be developed here:

• daylight. The pharmacy hall in the daytime should be illuminated by natural lighting, which is achieved through spacious window openings, near which it is worth placing racks and showcases in the room. Since few pharmacies are open around the clock, natural lighting plays a leading role here;

Note! Natural lighting is the most optimal for our eyes. Therefore, it is worth creating such conditions so that the illumination of the pharmacy premises is carried out naturally for as long as possible. To do this, when organizing pharmacies, they choose corner rooms with spacious windows located in two of the four walls.

Pharmacy natural lighting

• artificial lighting. In the evening and at night, any premises, including a pharmacy, are illuminated with the help of artificial lighting, which is organized using various lighting devices. Artificial lighting in this situation is used when natural lighting becomes inadequate (rainy and cloudy day, decrease daylight hours, improper placement of the pharmacy).

Pharmacy artificial lighting

Today, there are a wide variety of artificial lighting options used to ensure that the pharmacy hall is lit evenly and efficiently. Artificial lighting, unlike natural lighting, can be further divided into the following types:

• general. It is organized with the help of ceiling lighting fixtures. It should give a powerful luminous flux sufficient to fully illuminate the entire hall;

Pharmacy general lighting

• accentuating. It is used for full illumination of individual showcases and their shelves. It can also be used to highlight certain products (auction offers or new medicines).

Showcase accent lighting

Both of these types of illumination refer to interior lighting. But the pharmacy must also have street lighting. It is mainly aimed at visual highlighting at night and in the evening of the name. This is done so that customers can quickly find a pharmacy even in a situation where it is not located separately, but, for example, in an apartment building.

Pharmacy street lighting

Only when all the requirements for organizing lighting (natural, artificial, as well as street plan) are taken into account, the pharmacy will receive a license.

What you need to know in organizing the lighting of pharmacy premises

Pharmacy Hall, as well as its utility rooms, have certain requirements, which we partially considered in the previous subparagraphs. Here we will consider in more detail the requirements that exist regarding the organization of natural and artificial type illumination.
The pharmacy hall, in which the showcases and the cash desk are located, must have both types of lighting: natural and artificial. Moreover, much more attention is paid to natural lighting here, since artificial lighting in this room will be of an additional nature (ideally).

Correct lighting of the pharmacy hall

At the same time, for utility rooms, the requirements in this matter are not so categorical. For them, it is allowed to organize lighting only with the help of lighting fixtures.

Note! Warehouses in this case mean rooms that do not have a permanent workplace. This definition includes bathrooms, pantries, dressing rooms, warehouses, showers, etc. But here the requirements of sanitary standards must be met.

Color rendering index

Artificial lighting, which illuminates the hall or any other pharmacy premises, has the following requirements in its organization:

• the luminous flux created by artificial lighting devices should be as close as possible in their technical specifications to natural light;
• no blinding effect;
• the absence of any adverse factors that may adversely affect the performance of the human visual system;

Note! Great importance in this situation, it has such an indicator as the color rendering index. It means how reliably a particular light source is capable of transmitting colors. Such indicators are always indicated by manufacturers on the packaging of light bulbs. The higher the color rendering index, the brighter and closer to reality the colors of drug packages will be. without distortion.

• if possible, the availability of a way to adjust the level of the light flux in order to best adjust the operation of the lamps for specific functions (combining and natural lighting on a cloudy day, hall lighting in the evening, etc.).

Now consider each lighting option in more detail.

Natural type of lighting in a pharmacy room

Ultraviolet radiation

It should be noted that the pharmacy has rather strict requirements for insolation (natural light). It is known that the sun's rays also carry ultraviolet radiation, which is characterized by antimicrobial action. This means that sunlight is able to kill pathogens (viruses, bacteria, fungi and microbes) in a certain amount. And it is often sick people who come to the pharmacy at different stages of the course of the disease, who are potential carriers of the infection. Therefore, in this situation, natural lighting is an element of protecting pharmacy workers, as well as its visitors, from the risk of infection.
Such a positive effect is widely used in medicine today. And to increase the efficiency of ultraviolet radiation, which is minimal in natural light due to the ozone layer of the atmosphere, special ultraviolet lamps are used for these purposes.

A properly organized natural pharmacy lighting option will:

• fully illuminate the hall;
• carry out certain disinfection of the pharmacy premises;
• increase the efficiency of staff;
• improve the mood of employees and visitors;
• support on good level microclimate in the room.

Note! In this situation, you should take care to avoid overheating the room. For these purposes, you can use the conditioner.

To achieve such positive moments, window openings in a pharmacy must meet the following requirements:

• glasses must be clean and even, without distortions and defects. Windows should be washed at least twice a year;
• free from various items window sills. They can reduce the natural light flux that enters the hall through the window opening.

When the window is placed sideways, the light through it is able to penetrate into the interior of the room by no more than two meters.
In addition, a light finish will increase the natural luminous flux. interior spaces, as well as the correct placement of shelving and showcases. A light finish increases the reflective properties of surfaces, resulting in an increase in overall light levels. There are such indicators of the reflectivity of the paint:

• white - 80%;
• light yellow - 50%;
• blue - 25%;
• brown - 13%.

As you can see, when designing natural lighting, many nuances must be taken into account.

Artificial type of illumination of the pharmacy room

Today, various models of light bulbs are used as light sources in a pharmacy:

• fluorescent lamps. They are recommended because they give the closest level of luminous flux to the natural type of lighting. At the same time, it is worth putting on special shades for such lamps, which can reduce the stroboscopic effect, as well as make the light flux diffuse;

Note! Low pressure bulbs should be preferred.

Pharmacy fluorescent lighting

• LED lamp. These light sources have appeared on the lighting market relatively recently. Therefore, they are not included in normative documents just like other types of light bulbs. As a result, before installing them, it is necessary to consult with authorized authorities regarding the appropriateness of their use in pharmacy premises.

Note! Among all the light bulbs that exist at the moment, LED light sources are considered the most optimal. They consume a minimum of electricity, and are also able to provide high-quality luminous flux for long period time without failure. In addition, they do not have negative impact on the human body.

Pharmacy LED Lighting

Separately, it should be noted that for street lighting Pharmacies are currently actively using LED strips. Also, LED strips can be used to create accent lighting on showcases and racks.

Placement of lighting fixtures in a pharmacy

One of the most important points in organizing the lighting of pharmacies is the competent placement of lighting devices. Luminaires must be placed in accordance with their purpose:

• for general lighting - it is recommended to use built-in luminaires (Armstrong type), which are evenly distributed over the entire surface of the ceiling. At the same time, one lamp must be placed above the cash register, as well as above all workplaces of the attendants. All ceiling lighting fixtures must be equipped with diffusers to create a diffused and full-fledged light flux covering the entire hall;

Note! This principle applies to all pharmacy premises, including the hall.

Placement of lamps in a pharmacy

• accent lighting can be organized as spotlights built into shelves, or led strip, launched around the perimeter of the showcase.

AT warehouses wall lights can be used. But here you should also choose an installation location where their luminous flux will be optimal.
Separately, it is worth noting that in rooms with high humidity (for example, a toilet), it is necessary to install lighting devices that have an increased moisture resistance class. It will help to avoid negative consequences for lamps as a result of moisture penetration into their electronic parts. lamps with higher class moisture-proof capable long time withstand contact with water, without reducing the efficiency of its work.
The lamps themselves can be of two varieties:

• invoices;
• embedded.

Their choice is based on the option of ceiling finishes. Yes, for hanging ceiling structures built-in lamps should be used. And in all other situations, you can use overhead varieties of lighting fixtures.

The most common mistakes in organizing pharmacy lighting

The most common mistakes that are often found in pharmacies when organizing their coverage include:

• insufficient illumination of the trading floor. This error can be easily determined by subjective feelings. In such a room, a long stay will cause discomfort, as well as eye strain. Such a situation can be caused by improper placement of showcases and racks that block natural or artificial light flux, low power of light sources, incorrectly correlated dimensions of the room with standards regarding the level of illumination, malfunction of a part of lighting equipment, etc.;

Incorrect room lighting

• Incorrectly used shop window lighting. When creating accent lighting on the shelves, it must be remembered that the light flux should evenly illuminate all medicinal products, without glare and dark areas. So, very often, setting one Spotlights, it turns out uneven illumination of the underlying shelves.

Note! The best way to qualitatively and fully evaluate the whole showcase, including all its shelves, is to use an LED strip.

Incorrect window lighting

In addition, you can make a mistake with street lighting. For example, if part of the lighting equipment is out of order, the name of the establishment may glow incorrectly. For example, only part of the letters may be illuminated or the entire inscription may flicker. In any situation, the enticing function of such a backlight should be forgotten, as it will rather scare away customers than attract. After all, the facade is the face of any institution. If there are problems outside, then even worse can be expected inside.

Conclusion

The lighting system in a pharmacy, in all its premises and corners, must always meet the standards and requirements specified in the relevant regulated documentation. A pharmacy is a narrowly focused space that should not only be attractive to customers, but also provide them with a comfortable, safe stay in its hall. Therefore, when organizing lighting, it is necessary to take into account not only the location of the lighting fixtures, but also other nuances: the number of windows, interior decoration etc. Only in this way the pharmacy premises will correspond to their purpose.

We select lamps for mirrors, possible options Choice of lighting in the children's room, possible options We equip the lighting of working areas of the kitchen: simple rules for comfortable cooking

Ventilation- natural, there are 5 windows in the pharmacy, the size of the windows is 1.5x2.0m. (s = 3m2) in each window there is one window, the size of the windows is: 0.4x0.5m. (s=0.2m. The area of ​​the vent from the area of ​​the window is 7 parts. Ventilation mode: 2 times during the working day.

Pharmacy lighting

Natural lighting of the premises is provided by direct sunlight (insolation), diffused light from the sky and reflected light from the opposing building and the surface of the coating. The lack of natural light causes the phenomenon of "light starvation", i.e. a state of the body caused by a deficiency of ultraviolet radiation and manifested in metabolic disorders and a decrease in the body's resistance. Premises with permanent residence of people should have natural lighting. Natural lighting of premises is determined by the light climate, i.e. conditions of outdoor natural lighting, which depend on the general climatic conditions terrain, the degree of transparency of the atmosphere, as well as the reflectivity of surrounding objects. The level of natural lighting in the premises is also influenced by the geographic latitude of the area, the orientation of the building to the cardinal points, the presence of window shading by the opposing building, which in turn depends on the distance between them, the height and color of the walls, as well as the proximity of green spaces. Of great importance is the size of window openings, their shape and location. All these factors determine the duration and intensity of illumination of the room with direct sunlight, i.e. insolation mode of the premises. The hygienic classification of the duration of indoor insolation takes into account the general health-improving, bactericidal and psychophysiological effects of direct sunlight, as well as the optimal combination of all factors, subject to minimum values each of them.

The pharmacy has the best orientation, providing sufficient illumination and insolation of the premises without overheating, is south I and southeast, east sides. It contributes to the sanitation of the air, which occurs due to the penetration and impact sun rays, the bactericidal energy of which is sufficient to improve the internal environment of the premises in normal conditions. North, northwest, northeast rooms are located in which high insolation is not required or it is necessary to prevent the action of direct sunlight. These are auxiliary premises of pharmacies. ( material premises, washing.) This orientation provides uniform natural light to the space and prevents overheating. Western orientation causes overheating of the premises in summer and lack of solar insolation in winter. The illumination of the premises depends on the degree of light reflection, which is determined by the color of the ceiling, walls, floor and equipment in the room itself. dark colors absorb a large number of light, and light coloring increases illumination due to reflected light. White color and bright hues provide reflection of light rays by 70-90%, light yellow color - by 60%, light green - by 46%, color natural wood- by 40%, blue - by 25%, dark yellow - by 20%, light brown - by 15%, dark green - by 10%, blue and purple - by 6-10%. In our pharmacy, the color is light green.

The level of natural light is affected by the quality and cleanliness of glass, walls, ceiling, the shading of windows with curtains, the presence of high flowers on the windowsills. So, dirty walls reflect light 2 times less than newly painted ones. A sooty ceiling reduces the illumination of the room by one third. Depending on the location of the light openings, natural lighting is divided into side (through windows), upper (through skylights) and combined (top and side). In our pharmacy side. Natural illumination is normalized in relative terms, depending on the arrival of the solar luminous flux (natural illumination coefficient, light coefficient, incidence angle and opening angle). For hygienic assessment of natural lighting, lighting equipment is used. and G geometric (graphic ) research methods. Using the lighting method, the coefficient of natural light is determined (KEO). Daylight ratio shows what percentage is the natural illumination at the workplace indoors, created by skylight (direct or after reflection), to the simultaneous value of natural illumination at horizontal surface outside the building in the open air.

KEO at natural light for various premises pharmacies depending on their functional purpose is installed with the optimal orientation of the premises and the minimum duration of insolation of their facades with direct sunlight. This takes into account the nature of visual work and the light climate. Using the geometric method, the light coefficient is determined (SK), penetration factor ( KZ) . Light coefficient expresses the ratio of the area of ​​the light (glazed) surface of the windows, taken as a unit, to the floor area of ​​the room. To calculate the light coefficient, the area of ​​​​the glazing of the windows and the floor area (in m 2) are measured, and then their ratio is calculated. The light coefficient in residential and preschool institutions is recommended at the level 1:5-1:6, in classrooms 1:4-1:5. When designing pharmacies, it is necessary to take into account that the SC is not lower than the indicated values.

The value of the light coefficient in pharmacy premises: Material, washing, shopping room, recreation room, 1:6

Depth factor expresses the ratio of the distance from the floor to the top edge of the window to the depth of the room. KZ should not exceed 2,5, which is ensured by the depth of the room up to 6 m.

APPROVED by the Deputy Chief State Sanitary Doctor of the USSR A.I. Zaichenko N 4079-86, March 14, 1986

1. General Provisions

1. General Provisions

1.1. The rules apply to operating, projected, newly built and reconstructed enterprises for the production of medicinal products.

1.2. When developing technological processes and equipment, designing, building, reconstructing and operating enterprises, along with these Rules, one should be guided by the requirements of the relevant sections of sanitary and building codes and rules, labor safety system standards (SSBT), industry standard "Industrial regulations for the production of a chemical and pharmaceutical preparation. Content, procedure for development, approval and changes", OST 64-2-72, and other regulatory documents.

1.3. In the production of medicines, workers can be exposed to a number of harmful factors, the leading of which is chemical, and in enterprises using microbiological synthesis, in addition, a biological harmful factor. As a rule, there is a combined effect of various adverse factors.

2. Requirements for industrial buildings and premises

2.1. space-planning and Constructive decisions industrial buildings and premises must meet the requirements Sanitary standards design of industrial enterprises SN 245-71, building codes and regulations, etc.

2.2. In rooms where dust release of raw materials, semi-finished products and target products is expected, structural elements that contribute to the accumulation of dust and make it difficult to clean should not be designed.

2.3. Floors in working rooms should be made of materials that do not absorb harmful substances and are easy to remove.

2.4. For walls, ceilings and other surfaces, including internal building structures, where areas with the use of harmful and aggressive substances are located, a finish should be provided that prevents sorption and allows systematic cleaning, wet and vacuum cleaning, and, if necessary, disinfection.

3. Requirements for production processes and equipment

3.1. General requirements

3.1.1. Organization of technological processes and technological equipment must comply with the requirements of the "Sanitary rules for the organization of technological processes and hygienic requirements for production equipment", N 1042-73, "Intersectoral requirements and normative materials on the scientific organization of labor, which should be taken into account when designing new and reconstructing existing enterprises, developing technological processes and equipment", M., 1978, "Sanitary standards for the design of industrial enterprises", SN 245-71, state and industry standards of the labor safety system .

3.1.2. In isolated rooms, technological processes should be carried out:

- production of injection solutions;

- production using microbiological synthesis;

- production of children's dosage forms and other sterile products;

- operations with the release of significant amounts of dust, vapors and gases (unloading, grinding, screening, etc.);

- production with the use or formation of coloring and foul-smelling substances.

3.1.3. Cleaning of premises, equipment and ventilation ducts should be carried out using centralized vacuum units or using a wet method.

3.1.5. Do not use organic solvents to clean floors in work areas. Washing of working surfaces should be carried out using aqueous solutions of surfactants.

3.1.6. In case of bacterial contamination, cleaning should be carried out with preliminary disinfection of the surfaces of rooms and equipment.

3.1.7. Multi-storey production workshops are recommended to be equipped with garbage chutes.

3.1.8. Waste after cleaning should be removed to specially designated areas and stored in closed boxes, which should be cleaned at least once a day.

3.1.9. It is forbidden to use used cotton materials (filter sheets, etc.) for household needs.

3.1.10. Hygienic assessment of new technological processes and new drugs should be carried out before they are introduced into production.

3.1.11. When choosing technological processes, preference should be given to those that are characterized by the least severity of harmful factors.

3.1.12. Making changes to the technology for obtaining a medicinal product is allowed only after the development and implementation of measures that ensure harmless and safe conditions labor and protection environment.

3.1.13. The organization of production facilities that are similar in technology is allowed to be carried out according to a combined scheme.

When switching from one type of product to another industrial premises, equipment and containers must be checked for the absence of harmful substances.

3.1.14. Detachable connections - flanges, fittings, valves, taps must be tight.

3.1.15. Dosing devices (merniki, collectors, etc.) for liquid harmful substances should be equipped with devices that prevent their overflow. All dosing devices must be airtight.

3.1.16. Do not use benzene as a solvent. The use of benzene is permitted in cases where it is included in the chemical formula of the resulting medicinal product (intermediate).

3.1.17. The use of methanol should be carried out in accordance with the "General Sanitary Rules for the Storage and Use of Methanol", N 549-65.

3.1.18. Conducting technological processes using mercury should be carried out in accordance with " Sanitary regulations design, equipment, operation and maintenance of industrial and laboratory premises intended for work with mercury, its compounds and mercury-filled devices", N 780-69.

3.1.19. Sanitary air control working area carried out by sanitary laboratories of industrial enterprises in accordance with the "Regulations on the sanitary laboratory at an industrial enterprise" N 822-69 and GOST 12.1.005-76 "SSBT. Work area air. General sanitary and hygienic requirements."

3.1.20. In all cases of possible entry into the air of the working area of ​​harmful substances of hazard class I, as well as those substances of hazard class II, which, due to their high volatility, can cause severe or fatal acute poisoning, continuous, preferably automatic, sanitary control should be provided.

When other harmful substances of hazard class II enter the air of the working area, sanitary control must be carried out at least once a month.

Monitoring the content of toxic substances that have a sensitizing effect and the ability to penetrate the skin should be carried out once a week.

3.1.21. When harmful substances of III and IV hazard classes enter the air of the working area, sanitary control is carried out at least 1 time per quarter. With insufficient stability of the regime technological process or a change in the technical condition of the equipment during operation, which can have a significant impact on air pollution in the working area, as well as in the event of possible seasonal fluctuations in the concentration of harmful substances, the frequency of control should be increased.

3.1.22. Cases of exceeding the maximum permissible concentrations of harmful substances in the air of industrial premises should be investigated and taken into account in accordance with the "Regulation on the procedure for investigating and recording cases of exceeding the maximum permissible concentrations (MPC) of harmful substances in the air of the working area at enterprises and organizations of the Ministry of Medical Industry" (Order of the Minister medical industry N 247 dated 3.06.85).

3.2. Requirements for chemical synthesis processes

3.2.1. When developing new systems for the synthesis of drugs, preference should be given to the use of the least toxic substances.

3.2.2. When developing new and improving existing synthesis processes, preference should be given to conducting processes with minimal losses to the working area and the environment.

3.2.3. Processes using bromine, chlorine, iodine, phosgene, methanol, hydrocyanic acid salts must be organized in a closed circuit.

3.2.4. When carrying out reactions of chlorination, bromination, iodination, cyanidation, methylation, nitration, phosgenation, etc. the addition of substances must be strictly controlled in speed in order to avoid foaming of the reaction mass and its ejection.

3.2.5. To eliminate the release of harmful substances into the air of industrial premises, reactors and mixers must be equipped with samplers, sight glasses, and measuring instruments that exclude, where possible, the need to open hatches for sampling and monitoring the process.

3.3. Requirements for biosynthetic processes

3.3.1. The organization of the technological process for biological methods of obtaining drugs must comply with the requirements of GOST 12.1.008-76 "SSBT. Biological safety. General requirements".

3.3.2. When taking samples from seeding machines and fermenters in the production of antibiotics, measures must be taken to prevent the cultural liquid from getting on the skin of workers.

3.4. Requirements for loading, unloading processes

3.4.1. Loading and unloading of bulk materials should be carried out in a manner that excludes dust emission.

3.4.2. Loading and unloading of liquid raw materials and semi-finished products should be carried out through closed communications using pumps, gravity, vacuum. The supply of solutions of toxic substances by open jets is not allowed. The use of gutters is prohibited.

3.4.3. Reagents should be loaded into the apparatuses in such a way as to exclude the possibility of overheating, ejection, sudden boiling, gumming of the reaction mass and exceeding the permissible pressure inside the apparatuses.

3.4.4. All drugs belonging to hazard classes I or II, including narcotic and synthetic hormonal drugs, must be unloaded in a closed way.

3.4.5. Processes associated with loading, mixing and unloading of dried medicinal products, as well as ion exchange resins, should be predominantly mechanized.

3.4.6. It is forbidden to unload filtered intermediates and medicines without first turning on the local exhaust ventilation system.

3.5. Requirements for purification processes of intermediates and medicinal products

3.5.1. For filtration of solutions, suspensions and reaction masses containing harmful substances of hazard classes I and II, as well as substances that are dangerous when they enter through the skin and sensitizing, sealed filtering equipment with local suction should be used.

3.5.2. The use of open suction filters for filtering substances of hazard classes I and II is not allowed.

3.5.3. For filtration of volatile substances of hazard classes I and II, it is not allowed to use installations operating under pressure (druk filters and filter presses).

3.5.4. Crystallization of solutions of intermediates and drugs should be carried out in a closed apparatus equipped with local exhaust ventilation.

3.6. Requirements for drying, grinding, screening and packaging processes

3.6.1. For large-scale production, drying, screening and packaging of powdered products should be carried out on flow-mechanized lines.

The entire system must be hermetically sealed and equipped with aspiration units.

3.6.2. When choosing the instrumentation for the final stages of technological processes, preference should be given to multifunctional devices that allow a number of sequential operations (crystallization, filtration, sediment washing and drying) to be performed in a closed hermetic system.

3.6.3. Application of rack dryers periodical action with the use of trays is allowed only in the production of small-tonnage drugs.

3.6.4. It is forbidden to screen and average batches of drugs that have an irritating, sensitizing effect, dangerous when they enter through the skin, on open sieves and in open containers.

3.6.5. Packing of solid bulk drugs, ointments and pastes should be carried out on automatic lines, using reliable shelters, local exhaust ventilation.

3.6.6. Packing of finished dosage forms belonging to hazard classes I and II must be carried out on specially dedicated equipment, isolated in boxes or installed in a separate room.

3.6.7. Work at the stages of drying and packaging of synthetic male hormonal preparations should be carried out by male personnel, female hormones- female.

3.6.8. Production facilities for drying, sifting and packaging of drugs should be equipped with vacuum lines for collecting and returning spilled drugs for recycling.

3.7. Requirements for the preparation of injection solutions in ampoules and vials

3.7.1. The processes for the production of injection solutions in ampoules must comply with the requirements of OST 64-7-472-83 "SSBT. Technological processes for the production of finished medicinal products. Production of injection solutions in ampoules. Safety requirements."

3.7.2. The extraction of defective products from vials and ampoules must be mechanized and taken to a separate room.

3.7.4. The technological process should include mechanized methods cleaning the outer surface of ampoules and vials after their capping before transferring for viewing.

3.8. Requirements for tableting and drageeing processes

3.8.1. Antibiotic tableting must meet the requirements of OST-64-3-417-80 "SSBT. Antibiotic tableting processes. Biological safety requirements".

3.8.2. Obtaining drugs in the form of tablets and dragees in large-scale production should be carried out on technological lines, mechanized and automated, with dust aspiration from the equipment and its capture before being released into the atmospheric air. Dedusting of finished tablets should be carried out on special installations equipped with aspiration devices, followed by dust capture.

3.8.3. In the production of solid dosage forms, sealed equipment should be used, the processes of loading powders and granulates should be mechanized; the equipment must be equipped with effective local ventilation, taking into account the main sources of dust release (bunker, carriage, descent).

3.8.4. Dragee tablets should be carried out mainly by the suspension method.

4. Requirements for the transportation and storage of raw materials and materials

4.1. Loading and unloading areas should be provided with mechanization means (conveyors, self-stackers, forklifts, narrow gauge railways, winches, launching trays, etc.), which eliminate the need to carry goods manually, regardless of the type of cargo (in containers or in bulk).

4.2. Temporary storage of waste should be carried out in special rooms equipped with a ventilation system.

4.3. Transportation of raw materials, intermediate products, finished products and production waste (bottom residues, cake, biomass, vegetable raw meal, etc.) should be produced in a way that excludes the possibility of harmful substances entering the production and environment, using pipelines, containers, lifts and other types of mechanized transport.

4.4. Unloading of acids and alkalis from containers must be mechanized. Acids and alkalis should be transported through pipelines by gravity, pumps or vacuum.

4.5. Transportation of reagents from apparatus to apparatus must be carried out through pipelines by gravity, pumps, overpressure (inert gas) or vacuum.

4.6. Pneumatic conveying systems for dry products must be sealed and under vacuum.

4.7. Transportation of flammable liquids and liquefied gases must be carried out by pumps with mechanical seals. In the case of use of stuffing box pumps for flammable liquids and liquefied gases, the latter must be equipped with seals of increased reliability.

4.8. The placement of production equipment for crushing, grinding, screening and mixing dusty materials should be carried out taking into account the maximum reduction in the length of their transportation routes.

4.9. Transportation of solid medicinal substances for packaging and processing must be carried out in a special container, with tight-fitting lids, having a device for unloading and labeled with the name of the substances.

5. Requirements for heating, ventilation and air conditioning

5.1. Production premises must be equipped with heating and supply and exhaust ventilation systems in accordance with the requirements of SNiP II-33-75 "Heating, ventilation and air conditioning", with the exception of premises where the process conditions require special meteorological parameters and increased purity of the air (sterile premises, production of bacterial and viral preparations, premises of vivariums and nurseries of small laboratory animals, etc.).

5.2. Places for storage of replaceable stocks of initial products, semi-finished products, emitting harmful substances of hazard classes I and II or foul-smelling substances into the indoor air, located inside the production premises, must be equipped with special ventilated shelters, the vacuum in which must be at least 2.0 kgf/m.

5.3. Places for draining intermediates and reagents and finished products into portable containers (bottles, flasks, etc.) should be equipped with local suctions: stationary or mobile.

5.4. The air flow rate in the open working openings of shelters for the removal of harmful substances of I and II hazard classes must be at least 1.5 m/s, for the removal of other harmful substances - at least 1.0 m/s.

5.5. To supply fresh air in rooms with dust emissions (final stages, areas and production of finished dosage forms, etc.), air diffusers with a rapid attenuation of the jet velocity should be provided.

6. Lighting Requirements

6.1. The device of natural and artificial lighting in the production and auxiliary premises of enterprises in the pharmaceutical industry should be carried out in accordance with the requirements of these Rules, SNiP II-4-79 "Natural and artificial lighting", "Instructions for the design of power and lighting electrical equipment of industrial enterprises" SN 365- 77, Rules for the installation of electrical installations (PUE-85), Rules for the technical operation of electrical installations of consumers (approved by the State Energy Supervision Authority in 1969).

6.2. The choice of system and lighting levels should be carried out in accordance with Appendix 1. General lighting should be diffused.

6.3. Localized placement of general lighting fixtures, regardless of the lighting system used, should be provided for:

- with an uneven arrangement of equipment in the premises;

- in the premises where it is installed large equipment and ventilation ducts that create shading of work surfaces or make it difficult to locate fixtures;

- for illumination of workplaces on mechanized production lines;

- to illuminate workplaces in order to reduce glare and eliminate glare of greater brightness (for example, control panels, scales of individual instruments, instrumentation panels and other areas where there are surfaces with directional and directional-scattered reflections).

6.4. It is forbidden to install general lighting fixtures in such a way that their outlets are located on a vertical or inclined plane if they can get into the worker's field of vision. The use of open fluorescent lamps is not permitted.

6.5. To protect production facilities from direct sunlight, sun protection devices (blinds, visors, etc.) should be provided.

6.6. The arrangement of equipment in relation to the light openings should be carried out so that natural light falls on the workplace from behind or to the side of the worker.

6.7. Visual control of drugs should be carried out with combined lighting (general - natural, local - artificial). Light openings should be filled with light-diffusing material (frosted glass, fiberglass, etc.).

6.8. General lighting in the combined system, at the places of control of finished products, should be performed by lamps with solid smooth diffusers and it should be possible to turn on individual lamps to create an illumination level of about 50 lux in the room during operation.

6.9. Control over the state of lighting installations during operation, as well as after reconstruction, the timing of cleaning fixtures, replacing burned-out lamps should be carried out at least once a year in accordance with the requirements of the Guidelines for Preventive and Current Sanitary Supervision of Artificial Lighting at industrial enterprises", N 1322-75 and appendix 2.

6.10. When organizing air disinfection with bactericidal lamps in rooms where powders are not circulated, the installed power should not exceed 1 W of power consumed from the network per 1 m 2 of the room.

Disinfection of indoor air using bactericidal lamps, as a rule, should be carried out in the absence of people for 1 hour.

6.11. When disinfecting air in the presence of people, germicidal lamps should be placed only in special fittings (shielded lamps) at a height of at least 2 m from the floor. Every 2-3 hours of burning, it is necessary to turn off the lamps for 1-1.5 hours to reduce the concentration of ozone formed during the burning of bactericidal lamps.

7. Requirements for the organization and performance of repair work

7.1. Carrying out repair work should be carried out in accordance with the "Regulations on the conduct of preventive maintenance of equipment at the enterprises of the medical industry". Approved by the USSR Ministry of Medical Industry on February 5, 1977.

7.2. Gas-hazardous work, including inside tanks, should be carried out in accordance with the "Standard Instructions for the Organization of Safe Gas-Hazardous Work" . Order of the Minister of Medical Industry N 219 of 05/20/85

8. Requirements for environmental protection

8.1. Requirements for the sanitary protection of atmospheric air

8.1.1. When designing enterprises for the production of medicinal products, materials containing:

- characteristics of the main physical and chemical parameters of the soil of the built-up areas (soil background ) : soil type, pH, content organic matter and expected specific chemical and biological components of production emissions and wastes;

- data on the quantity and quality (by hazard class) of the expected industrial waste in accordance with the projected volume of production development;

- characteristic possible consequences the impact of industrial waste and waste on the soil;

- measures for the sanitary protection of the soil.

8.1.2. In the absence of the technical possibility of introducing a waste-free technology, which is preferred, the project should provide for the entire necessary complex for the treatment of industrial waste, ensuring their maximum use in production.

8.1.3. In construction projects for newly built, reconstructed and expanded enterprises for the production of medicinal products, materials must be submitted to substantiate the MPE of harmful substances in atmospheric air for each source and pollutant in accordance with GOST 17.2.3.02-78 "Nature protection. Atmosphere. Rules for establishing permissible emissions of harmful substances by industrial enterprises." When calculating the amount of biological emissions, one should be guided by the fact that the content of the corresponding type of microorganism-producers in the atmospheric air should not exceed the natural background.

8.1.4. At the enterprises for the production of medicinal products, environmental measures should be provided:

- for capturing with recovery or neutralization of emissions containing organic solvents, reagents, synthesis intermediates and other harmful chemicals;

- for the neutralization of technological emissions into the atmosphere containing producer microorganisms at enterprises using microbiological synthesis (production of antibiotics, enzyme preparations, vitamins, etc.), providing for measures to inactivate or capture spores, fungi, yeasts and other producer microorganisms;

- to capture biologically active substances with their disposal and neutralization;

- for deodorization of emissions with bad smell biosynthetic and other industries using animal and vegetable raw materials (production of antibiotics, enzyme preparations, vitamins, synthetic drugs, organ preparations, hormones, etc.);

- on equipping with dust and gas cleaning facilities for the departments of drying and packaging of finished medicines.

8.2. Requirements for the sanitary protection of water bodies

8.2.1. Enterprises for the production of medicinal products are obliged to reduce water consumption and wastewater disposal by maximizing the use of wastewater treatment plants. Wastewater in systems of reverse and repeated water supply of industrial water pipelines.

8.2.2. Wastewater from enterprises characterized by constant microbial contamination is subject to mandatory disinfection.

8.2.3. In the case of treatment of household wastewater together with industrial wastewater intended for feeding circulating industrial water supply systems, preventive and current sanitary supervision should be carried out in accordance with the requirements of the "Guidelines for the hygienic assessment of the use of treated urban wastewater in industrial water supply", N 3224 -85 (Ministry of Health of the USSR).

8.2.4. The preparation and use of treated wastewater in circulating industrial water supply systems should exclude the possibility of exceeding the standards (MPC and MPV) of environmental pollution (reservoirs) from blowdown water, and atmospheric air from hydroaerosols carried out from cooling towers.

8.2.5. The release of wastewater from enterprises for the production of medicinal products into a reservoir should be carried out in accordance with the requirements of the "Rules for the Protection of Surface Water from Pollution by Sewage" N 1166 and " Guidelines on the establishment of maximum allowable discharges (MPD) of substances entering water bodies with wastewater", 1982, Ministry of Water Resources of the USSR.

8.2.6. The use of wastewater from enterprises for the production of medicinal products for irrigation of agricultural lands is carried out in accordance with the "Sanitary Rules for the Arrangement and Operation of Agricultural Irrigation Fields", N 1370-75 and "Methodological Guidelines for the Implementation of State Sanitary Supervision over the Arrangement and Operation of Agricultural Irrigation Fields", N 1369-75.

8.2.7. The choice of treatment facilities and installations should be made differentially, depending on the type of production, the stage of the technological process and the physical and chemical composition of wastewater in accordance with industry standards for industrial regulations for the production of a chemical and pharmaceutical preparation, and in each case requires coordination with the local authorities of the state sanitary supervision.

8.2.8. Production control over the operating conditions and the efficiency of the facilities for cleaning, disinfection and the conditions for the disposal of wastewater is the responsibility of the enterprises operating these facilities.

8.3. Requirements for the sanitary protection of the soil

8.3.1. Industrial waste, as a rule, should be used (recycled) in the production itself or in related industries as secondary raw materials. In the event of the formation of non-utilizable toxic waste, they must be buried at specialized landfills (substances of I, II, III hazard classes) or taken to landfills (landfills) for household waste(waste containing substances of hazard class IV and some substances of hazard class III).

8.3.2. The burial of non-utilizable toxic waste should be carried out at special landfills in accordance with the document: "The procedure for the accumulation, transportation, neutralization and disposal of toxic industrial waste (sanitary rules)", N 3183-84. Storage of toxic waste of hazard class IV and some substances of hazard class III should be carried out at landfills for municipal solid waste in accordance with the document: "The maximum amount of toxic industrial waste allowed for storage in storage facilities (at landfills) of municipal solid waste (regulatory document)", approved by the USSR Ministry of Health May 30, 1985 N 3897-85 and the Ministry of Housing and Communal Services of the RSFSR, 85-191-1 dated 05/30/85

8.3.3. Methods for collecting, storing and transporting waste and waste should exclude the possibility of pollution of the surrounding area, the soil of populated areas and ensure the safety of personnel involved in all stages of cleaning and neutralization of industrial waste and waste.

8.3.4. Laboratory control over the sanitary condition of the soil in the areas where pharmaceutical enterprises are located should be carried out for leading pollutants, including biological components.

8.3.5. The assessment of the level of soil pollution in the absence of MPC is carried out by comparison with the background data of uncontaminated soils in the same area.

9. Sanitary facilities

9.1. Sanitary provision of workers should be carried out in accordance with SNiP II-92-76 "Auxiliary buildings and premises of industrial enterprises", taking into account the sanitary characteristics of production processes (Appendix 3).

9.2. The number of places for storing clothes in dressing rooms should be taken equal to the number of workers in all shifts. The method of storing clothes in dressing rooms can be closed, combined.

9.3. Access to the sanitary premises of workers in areas where harmful substances of hazard classes I and II are used or dyes are used should not be carried out through production facilities that are not related to the use of these substances.

9.4. The set of sanitary premises for the production of medicines should include specialized laundries for inactivation, neutralization, if necessary, of overalls, safety shoes, equipped in accordance with the "Sanitary rules for industrial and city specialized laundries for the decontamination of overalls and additional personal protective equipment" N 1298-75 .

________________

*Document not cited. Per additional information refer to the link. - Database manufacturer's note.

9.5. Drinking fountains or saturator installations should be located not in working rooms, but in adjacent rooms (corridor, canteen).

10. Requirements for personal protective equipment

10.1. Workers in contact with raw materials, semi-products, producers, biologically active products of their vital activity and finished medicinal preparations must be provided with personal protective equipment in accordance with the norms and within the established time limits in accordance with the "Model industry standards for the free issuance of overalls, safety shoes and safety equipment", approved The State Committee of the Council of Ministers of the USSR on Labor and Social Affairs and the All-Union Central Council of Trade Unions N 43 / II of February 20, 1980 and GOST 12.4.011-75 "SSBT. Means of protection for workers. Classification", and for the production of finished medicines - in accordance with OST 64-7-473-83 "SSBT. Funds personal protection in the manufacture of finished pharmaceutical products. Classification. Application area".

When organizing new production facilities, prior to making changes to the "Model Industry Standards for the Free Issue of Workwear, Safety Shoes and Protective Equipment", the administration of enterprises is obliged to provide employees with personal protective equipment, coordinating their range and protective properties with state sanitary supervision bodies and trade union bodies.

10.2. Working areas of sterile products are provided with technological clothing in accordance with RDP 64-3-80 "Requirements for premises for the production of medicines in antiseptic conditions".

10.3. When choosing personal protective equipment, the whole complex of harmful factors of the production environment should be taken into account.

10.4. Operations associated with dust formation should be carried out in respirators of the "Lepestok" type, and, if necessary, in a pneumohelmet LIZ-4, pneumomask LIZ-5.

10.5. Overalls of persons exposed to the dust of drugs and their intermediates should be dedusted daily.

10.6. Overalls should be washed at the enterprise at least once a week. Overalls contaminated with substances of hazard classes I and II must be neutralized before washing. When working with mercury, overalls are decontaminated in accordance with the requirements (Appendix 4 to the "Sanitary rules for the design, equipment, operation and maintenance of industrial and laboratory premises intended for work with mercury, its compounds and mercury-filled devices" N 780-69) .

10.7. To protect the skin of the hands of workers from exposure to harmful substances of an irritating nature and penetrating the skin, gloves, protective ointments, pastes should be used in accordance with the "Directory of Personal Protective Equipment for Workers in the Medical Industry".

10.8. When washing in the shower to prevent fungal diseases, workers must be provided with individual open safety shoes.

10.9. Workers and employees engaged in work with harmful or hazardous conditions labor, undergo mandatory preliminary examinations upon admission to work and periodic medical examinations in accordance with the order of the Ministry of Health of the USSR N 700 of June 19, 1984 "On the conduct of mandatory preliminary upon admission to work and periodic medical examinations of workers exposed to harmful and unfavorable working conditions" .

Appendix 1. Lighting standards and lighting quality indicators

Attachment 1