Fundamentals of General and Pharmaceutical Hygiene - Dykyi I.L. 2003

Hygiene of Pharmacy Establishments
Hygienic assessment of pharmacies, pharmaceutical warehouses, and drug quality control laboratories

The hygienic inspection of a pharmaceutical establishment (pharmacy, pharmaceutical warehouse, drug quality control laboratory) includes evaluating its Location, layout, utilities (Water supply, ventilation, heating, lighting, sewerage), operating Procedures, compliance with Sanitary and anti-epidemic regimes during drug manufacturing and storage, as well as working conditions. This involves the method of sanitary inspection, supplemented by laboratory and instrumental analyses of air, water, and medicinal products using physical, chemical, microbiological, and other Methods.

The inspection results of the pharmaceutical establishment are compared against the relevant hygienic standards set forth in legislative documents, after which a written report is compiled detailing any identified violations and providing well-founded recommendations for their correction.

This task is facilitated by a specialized sanitary inspection checklist containing questions that must be addressed (see Task 1).

Objective: To acquire the skills in providing a Hygienic assessment of the location and layout of pharmaceutical facilities, their operating regimes, and working conditions; and to be able to compile sanitary inspection reports and develop measures to eliminate identified violations.

QUESTIONS FOR SELF-STUDY

1. Preventive and routine State Sanitary Supervision.

2. Hygienic requirements for the location and equipping of pharmacy premises depending on their type.

3. Hygienic requirements for the location and equipping of pharmaceutical warehouse premises.

4. Hygienic requirements for the location and equipping of drug quality control laboratory premises.

5. Sanitary maintenance and utilities of pharmaceutical establishment premises.

6. Hygienic requirements for the indoor microclimate and methods for its assessment.

7. What are the core principles of medication storage?

8. What are the Specific features of storing herbal medicinal raw Materials?

9. Describe the Temperature regimes for storing medicinal products.

10. Hygienic requirements for premises ventilation.

11. Hygienic requirements for natural and artificial indoor lighting.

12. Sanitary and anti-epidemic regime in pharmacies, and methods for monitoring its Structure/175.html">Implementation.

13. Measures in pharmacies to reduce airborne bacterial contamination.

14. Hygienic requirements for the water supply of pharmacies.

15. Hygienic requirements for the production, transportation, and storage of purified water and water for injections.

16. Potential occupational hazards in pharmaceutical establishments.

17. Hygienic assessment of Chemical factors.

18. Personal hygiene of pharmacy staff.

19. Pre-employment and periodic medical examinations of personnel.

Task 1. Sanitary and hygienic inspection of a pharmaceutical establishment

Conduct a sanitary and hygienic inspection of a pharmacy (pharmaceutical warehouse, drug quality control laboratory) or analyze pre-existing inspection reports (see Situational Tasks). Prepare a written Conclusion answering the questions provided in the sanitary inspection checklist.

Pharmacy Sanitary Inspection Checklist

1. Pharmacy address.

2. Type of pharmacy.

3. Number of employees, their age and gender structure.

4. Operating schedule (number of shifts, breaks).

5. LOCATION OF THE pharmacy (independent building or integrated into another structure).

6. Sanitary condition of the adjacent area (percentage of site development, landscaping percentage, distance to potential pollution sources, waste collection and disposal).

7. CHARACTERISTICS OF THE building housing the pharmacy (number of floors, building materials, year of construction).

8. Whether the pharmacy occupies purpose-built or adapted premises.

9. Availability of a separate customer entrance with a vestibule and a staff entrance.

10. Room equipment, ceiling height, and compliance with regulatory requirements for this type of pharmacy (see Table 16 of the Appendix).

11. Interior decoration and availability of hygiene certificates for finishing materials.

12. Sanitary infrastructure of pharmacy premises:

a) ventilation;

b) heating;

c) lighting;

d) water supply (centralized or local, source and its characteristics, rooms supplied with hot and cold water, drinking water quality).

Assessment of indicators characterizing their efficiency

13. Characteristics of facilities designated for the Production of purified water and water for injections (compliance with pharmacopeial requirements for purified water and water for injections).

14. Assessment of working conditions in the pharmacy (microclimate parameters, air quality—presence of hazardous chemicals, dust, microorganisms).

15. Frequency and methods of premises cleaning.

16. Use of disinfectants, their types, and compliance with regulations regarding their preparation, application, and storage.

17. Use of bactericidal emitters (types, quantity, rooms where they are installed, compliance with Selection and operation guidelines, maintenance log for the emitters).

18. Personal hygiene of the staff.

Conclusion on the sanitary condition of the pharmacy (with justification for specific recommendations aimed at eliminating identified violations and improving working conditions).

Sanitary inspection map of the pharmaceutical warehouse

1. Address, category.

2. Location: characteristics of the land plot, distance from sources of noise and air pollution.

3. Sanitary condition of the area.

4. Equipment, area, and mutual layout of production premises, compliance with regulatory documentation.

5. Interior design and decoration of premises.

6. Ensuring appropriate storage conditions for medicines and medical devices (availability of racks, cabinets, pallets, compliance with placement rules).

7. Sanitary maintenance of premises:

a) heating;

b) lighting: natural (orientation of windows relative to cardinal points, light coefficient, daylight factor) and artificial (light sources, general, local, and combined, illumination level in lux);

c) ventilation: natural, artificial (presence of local ventilation), air exchange rate;

d) water supply (analysis of drinking water quality);

e) removal of liquid and solid waste (garbage collection site, waste receiver, sewage system).

8. Microclimate. Ensuring appropriate temperature regimes for storing various groups of medications. Placement of microclimate monitoring devices, frequency of control.

9. Assessment of working conditions:

a) performance of loading and unloading operations (process mechanization, compliance with maximum permissible load limits when moving goods);

b) Chemical composition of air (presence of harmful substances, their concentration);

c) provision of special clothing, footwear, and availability of personal protective equipment when working with toxic and aggressive substances.

10. Compliance with Sanitary requirements for cleaning storage facilities.

Conclusion on the sanitary condition of the pharmaceutical warehouse (with justification for specific recommendations aimed at eliminating identified violations and improving working conditions).

Sanitary inspection map of the drug quality control laboratory

1. Address, category.

2. Laboratory location: integrated into a building or housed in a separate dedicated facility.

3. Sanitary condition of the area: percentage of landscaping, site improvement.

4. Equipment and layout of premises, compliance with regulatory documentation.

5. Characteristics of Specific rooms: analytical room, balance room, instrument rooms, rooms for bacteriological and biological analyses, and washing room (area, height, wall, ceiling, and floor finishes).

6. Sanitary maintenance of premises:

a) heating;

b) lighting: natural — window orientation relative to cardinal points, lighting coefficient, daylight factor; artificial — general, local, combined, light sources (incandescent lamps, fluorescent lamps);

c) ventilation: natural, artificial, air exchange rate; presence of local ventilation;

d) water supply (drinking water quality analysis);

e) disposal of liquid and solid waste (sewerage system, waste collection site).

7. Working conditions assessment:

a) indoor microclimate: temperature, humidity, air velocity;

b) air quality: presence of hazardous chemicals, their physical state, concentration per 1 m³ of indoor air;

c) illumination level at workstations.

8. Maintenance of premises: frequency and nature of cleaning, use of disinfectants, compliance with hygienic requirements for them, and control of disinfection efficiency.

9. Personal hygiene of laboratory personnel.

Conclusion on the sanitary state of the laboratory with specific, substantiated recommendations aimed at eliminating identified violations and improving working conditions.

PROTOCOL OUTLINE

Topic of the practical session.

1. Sanitary inspection card of a pharmacy (pharmaceutical warehouse, drug quality control laboratory).

2. Answers to the questions outlined in the inspection card.

Conclusion. During the sanitary and hygienic inspection of the pharmacy (pharmaceutical warehouse, drug quality control laboratory), the following violations were identified ... .

Recommendations for eliminating the identified violations ... .

Assignments FOR INDEPENDENT WORK

1. Test control of knowledge.

2. Solving situational tasks.

TESTS

1. When planning pharmacies, pedestrian and transport accessibility is taken into account, which in urban areas should not exceed:

A. 10-15 minutes.

Б. 20-25 minutes.

B. 30-40 minutes.

Г. 45-50 minutes.

2. When planning pharmacies, pedestrian and transport accessibility is taken into account, which in rural areas should not exceed:

A. 10-15 minutes.

Б. 20-25 minutes.

B. 30-40 minutes.

Г. 45-50 minutes.

3. A rural pharmacy is located on a land plot of 0.15 ha. The groundwater level is 1.6 m, the building footprint is 30%, and the landscaped area is 60%. Evaluate the data. Which parameter does not comply with the standards:

A. Area of the land plot.

Б. Percentage of landscaping.

B. Building footprint.

Г. Groundwater level.

4. A pharmacy is located on a land plot of 0.2 ha. The groundwater level is 1.2 m, the building footprint of the plot is 15%, and the landscaped area is 50%. Evaluate the data. Which parameter does not comply with the standards:

A. Area of the land plot.

Б. Percentage of landscaping.

B. Building footprint.

Г. Groundwater level.

5. The production premises of a pharmacy include:

A. Customer service area.

Б. Dispensary room (Assistent's room).

B. Washing room.

Г. Unpacking room.

D. Staff room.

E. Aseptic room.

6 The ceiling height of pharmacy premises must be at least:

A. 2.3 m.

Б. 2 m.

B. 3.3 m.

Г. 3.8 m.

7. What rooms should be included in the aseptic unit of a pharmacy?

A. Aseptic room.

Б. Quality control and compounding preparation room.

B. Dispensing and compounding room.

Г. Washing room.

Д. Sterilization room.

Е. Water-for-injection preparation room.

8. Which pharmacy premises must be equipped with an airlock?

A. Sterilization room.

Б. Dispensing and compounding room.

B. Aseptic room.

Г. Quality control and compounding preparation room.

Д. Washing room.

9. Which pharmacy premises should be adjacent to each other?

A. Dispensing and compounding room and prescription department.

Б. Dispensing and compounding room and customer service hall.

B. Dispensing and compounding room and washing room.

Г. Dispensing and compounding room and quality control and compounding preparation room.

D. Dispensing room and analytical provisor's office.

10. According to current regulatory documents, non-manufacturing pharmacies (which only sell medications and medical devices) must have the following mandatory premises:

A. Customer service area.

B. Dispensing room.

C. Washing room.

D. Storage rooms.

E. Manager's office.

F. Staff room.

G. Sanitary and utility facilities.

11. Rational layout of laboratories for drug quality control involves adhering to THE PRINCIPLE OF adjacency between functionally related rooms. Which rooms should be adjacent to the analytical laboratory?

A. Reagent storage room.

B. Balance room.

C. Bacteriological department.

D. Optical room.

E. Washing room.

12. During the Hygienic evaluation of a drug quality control laboratory project, an error in the internal layout was identified. Indicate it. The adjacent rooms are:

A. Washing room and optical room.

B. Analytical laboratory and balance room.

C. Optical room and analytical laboratory.

D. Methodological office and manager's office.

13. According to the requirements of current regulatory documents, the production area of a pharmaceutical warehouse must be at least:

A. 50 m².

B. 100 m².

C. 150 m².

D. 200 m².

14. Mechanical ventilation is installed in the production areas of a pharmaceutical warehouse to maintain air purity. Which room requires a local ventilation system?

A. Packaging room.

Б. Storage room.

B. Wrapping room.

Г. Dispatch room.

15. Periodic medical examinations of pharmacy staff must be carried out:

A. Annually.

Б. Once a quarter.

B. Once every six months.

Г. When health Complaints arise.

16. What is the purpose of preventive medical examinations?

A. Detection of occupational pathology.

Б. Identification of diseases that are contraindications for employment.

B. Treatment of identified occupational diseases.

Г. Identification of individuals subject to follow-up medical supervision.

17. In the production areas of a pharmaceutical warehouse, the walls are painted with water-resistant paint up to a height of 1.8 m, the floor is covered with linoleum, the light coefficient is 1:4, the supply and exhaust ventilation has a predominance of exhaust over supply, and the heating is steam-based. Which of the following does not meet hygienic requirements?

A. Lighting.

Б. Interior decoration.

B. Ventilation.

Г. Heating.

18. In rooms designated for drug storage, an objective Assessment of the microclimate is essential, which depends on the correct placement of monitoring instruments. Indicate their correct placement:

A. Distance of 1 m from the door, height of 1.4-1.6 m from the floor.

Б. Distance of 2 m from the door, height of 1.8-1.9 m from the floor.

B. Distance of 3 m from the door, height of 1.5-1.7 m from the floor.

SITUATIONAL PROBLEMS

1. Analyze the sanitary and hygienic inspection materials of the pharmacy establishment by answering the questions set out in the sanitary inspection chart.

2. Provide a written conclusion based on the inspection findings.

3. Propose measures aimed at eliminating the identified violations.

Problem 1.

The pharmacy is located in a rural area. It manufactures non-sterile dosage forms and medicinal products under aseptic conditions, and sells medicines and medical devices. A poultry farm is located 100 m to the west of the pharmacy. The prevailing wind direction in this area is westerly. The relief of the land plot is flat, with a slight slope to the south. The groundwater table is at 1.2 m. The area of the land plot allocated for the pharmacy construction is 0.1 ha. The built-up and landscaped areas are 365 and 799 m², respectively.

In addition to the pharmacy building, the site houses a garage, an icehouse, a well, and a waste collector. The distance between the well and the waste collector is 29 m.

The pharmacy building is single-story, purpose-built for a pharmacy. The visitor entrance is equipped with a vestibule with a depth of 1.2 m. The doors in the vestibule are aligned opposite each other. An air-thermal curtain is installed in the vestibule, supplying air heated to 25 °C during the cold season.

Composition and area of premises: customer service hall 20 m², dispensing room adjacent to the packaging room and the office of the analyst pharmacist with a total area of 22 m², washing room 6 m², purified water production room 10 m², pharmacy glassware sterilization room 4 m². The aseptic block includes an aseptic room with an airlock 10 + 2 m², a preparation room for compounding with an airlock 11 + 2 m², a drug sterilization room 12 m², a control and labeling room 13 m², a water-for-injection production room 10 m². Medicinal product storage room 15 m², flammable and combustible liquids storage room 6 m², sanitary, hygienic and medical supplies storage room 10 m², auxiliary materials and packaging storage room 8 m², Medicinal plant raw materials storage room 8 m², manager's office 12 m², accounting office 8 m², staff room 10 m², locker room 8 m², cleaning equipment storage room 3 m², restroom 3 m². Ceiling height is 3.5 m.

Interior decoration of premises. The walls in the customer service hall, dispensing room, and aseptic block are painted from floor to ceiling with light-colored oil paint; in the washing room and restroom, wall panels are tiled with glazed tiles to a height of 1.8 m, and painted with water-emulsion paint from above the panels to the ceiling. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The floors in the customer service hall, restroom, and washing room are covered with ceramic tiles, and with linoleum in the other rooms.

The pharmacy building has no centralized sewerage system. Liquid and industrial wastewater is discharged into a cesspool, while solid waste is collected in a metal waste collector installed on a clay-rammed platform. The waste collector is hermetically sealed.

The pharmacy is equipped with a water heating system. Water with a temperature of 80 °C is used as a heat carrier. The air temperature during the cold season is 15 °C, air humidity in the main production rooms is 65 %, in the washing room 76 %, and air velocity is 0.03 m/s.

All pharmacy premises have natural ventilation provided via window vents. Mechanical ventilation is absent.

Air composition. The following were detected in the dispensing room: validol 6 mg/m³, lincomycin 8 mg/m³, carbon dioxide 0.4 %. Microbial air contamination in the dispensing room after work is 1100 CFU in 1 m³ of air, and 500 in 1 m³ in the aseptic room.

Lighting. The windows of the pharmacy production rooms are rectangular and oriented to the west, except for the washing room and the aseptic block (windows oriented to the east). The upper edge of the windows is located 25 cm from the ceiling. Window height is 1.8 m. The light coefficient is 1:7 in the customer service hall, 1:6 in the dispensing room, 1:4 in the aseptic room, and 1:4 in the washing room. The natural light factor (NLF) in these rooms ranges from 1.5 to 2.5 %, the angle of incidence is 38°, and the aperture angle is 10°.

Artificial lighting is provided in all rooms. The light sources are 60 W fluorescent lamps. The illumination level is 200 lx in the customer service hall, 300 lx in the dispensing room, 400 lx in the aseptic room, 100 lx in the washing room, and 100 lx in the preparation room.

Water supply is local, from a bored well. Water quality analysis results: odor 3 points, aftertaste 3 points, chromaticity 30°, transparency 28 cm, hardness 6.5 mEq/L, chlorides 29 mg/L, nitrates 37 mg/L, fluorine 2.4 mg/L, microbial count 280, coli index 8.

Purified water from the burette above the assistant's table contains 75 saprophytic Bacteria. Swabs from pipettes revealed 105 saprophytic bacteria. Swabs from the hands of personnel engaged in drug manufacturing showed no Escherichia coli, while Staphylococcus aureus was detected in one employee.

An open-type BUV-25 W bactericidal lamp is installed only in the aseptic room.

Premises cleaning. Production premises undergo wet cleaning using detergents and Chloramine B. Floors are washed once per shift, and walls and doors once a month. Medication storage cabinets are cleaned as they become soiled.

Personnel workwear and towels are replaced 2 times a week. Cleaning equipment is labeled, but the markings are indistinct. A sanitary day is held once a quarter.

Problem 2.

The pharmacy is located on the ground floor of a multi-story residential building. It manufactures non-sterile medicines and sells medicines and medical devices.

The distance to the opposite building is equal to twice its height. The visitor entrance is equipped with a vestibule with a depth of 1.5 m. The doors in the vestibule are aligned opposite each other. An air-thermal curtain is installed in the vestibule, supplying air heated to 35 °C during the cold season.

Composition and area of premises: customer service hall 22 m², dispensing room adjacent to the packaging room and the office of the analyst pharmacist with a total area of 22 m², washing room 6 m², purified water production room 10 m², pharmacy glassware sterilization room 6 m², medicinal product storage room 15 m², flammable and combustible liquids storage room 6 m², auxiliary materials and packaging storage room 8 m², medicinal plant raw materials storage room 6 m², manager's office 12 m², accounting office 8 m², staff room 10 m², locker room 8 m², cleaning equipment storage room 3 m², restroom 3 m². Ceiling height is 3.3 m.

Interior decoration of premises. The walls in the customer service hall and dispensing room are painted with white oil paint from floor to ceiling; in the washing room and restroom, wall panels are faced with glazed tiles to a height of 1.3 m, and painted with water-emulsion paint from above the panels to the ceiling. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The floor in the customer service hall, restroom, and washing room is covered with ceramic tiles, and with linoleum in the other rooms.

The pharmacy's production facilities are equipped with standard Processing machinery, ventilation, gas supply, hot and cold running water, and sewage systems. Central water heating is installed throughout the pharmacy. During the cold season, the air temperature in the main production areas is 19 °C, relative humidity is 60 %, and air velocity is 0.3 m/s.

Natural ventilation is provided in all pharmacy rooms through the inflow of air via windows and transoms. Mechanical ventilation is also installed, with the air exchange rates as follows: 3–4 air changes per hour in the customer service area, 2–3 in the dispensing room, and 2–3 in the washing room. A fume hood is installed in the dispensing room with an air extraction velocity of 0.9 m/s.

Air composition. An assessment of the indoor air environment revealed that the concentration of ammonia vapors in the dispensing room is 6 mg/m³, iodine is 0.4 mg/m³, and Carbon dioxide is 0.08 %. Post-operation microbial contamination of the air is 1,100 CFU per 1 m³ in the dispensing room and 2,500 CFU per 1 m³ in the customer service area.

Lighting. The windows in the pharmacy's production areas are rectangular and east-facing, except for the glassware washing and sterilization room (which has west-facing windows). The upper edge of the windows is located 25 cm from the ceiling, and the window height is 2.8 m. The daylight factor is 1:5 in the customer service area, 1:4 in the dispensing room, and 1:7 in the washing room. The daylight factor (DF) in these areas ranges from 1.5 to 2.5 %, with an angle of incidence of 38° and an aperture angle of 10°. Artificial lighting is provided in all rooms using 60 W fluorescent lamps. Illuminance levels are 200 lx in the customer service area, 250 lx in the dispensing room, 100 lx in the washing room, and 50 lx in the storage rooms.

Water supply is centralized, sourced from the municipal water grid. Results of tap water quality analysis: odor 1.5 points, aftertaste 2 points, color 16°, transparency 28 cm, hardness 6.5 mEq/L, chlorides 45 mg/L, sulfates 98 mg/L, nitrates 37 mg/L, fluorine 0.4 mg/L, iron 0.2 mg/L, total dissolved solids 490 mg/L, microbial count 28, coliform index 2. Wastewater is discharged via a sewage piping system connected to the municipal sewer network.

Purified water from the burette above the assistant's desk contains 25 saprophytic bacteria. Washings from pipettes revealed 105 saprophytic bacteria. Washings from the hands of personnel involved in drug preparation showed no presence of Escherichia coli or Staphylococcus aureus.

Closed-type BUV-30 W germicidal lamps are installed in the dispensing room and the customer service area, with a specific power rating of 2 W per 1 m³ of room volume.

Premises cleaning. Production areas undergo wet cleaning using detergents and Chloramine B. Floors are washed once per shift, and walls and doors once a week. Medicament storage cabinets in the drug storage areas are cleaned as needed.

Staff workwear and towels are replaced twice a week. Clearly labeled equipment is used for cleaning purposes. A sanitary day is held once a month.

Pharmacy staff undergo routine medical examinations once a year. These checks screen for Skin and venereal diseases, carriage of intestinal infection pathogens, and tuberculosis.

Problem 3.

The pharmacy is located in a city on the ground floor of a residential building. It engages in the retail of medicinal products and medical devices. The distance from the pharmacy building to the opposite building equals twice the height of the latter.

The visitor entrance features an airlock vestibule with a depth of 1.3 m, where the doors are positioned directly opposite each other. An air thermal curtain is installed in the vestibule, supplying air heated to 15 °C during the cold season.

Composition and area of premises: customer service area 16 m², drug storage room 12 m², flammable and combustible liquids storage room 3 m², sanitation, hygiene and medical devices storage room 4 m², manager's office 12 m², accounting office 5 m², staff room combined with a cloakroom with a total area of 6 m², and a cleaning supply closet combined with a restroom with a total area of 3 m². Ceiling height is 3.3 m.

Interior decoration. Walls and ceilings in the customer service area are finished with water-emulsion paint, in the manager's office, accounting office, and staff room with wallpaper, and in the storage rooms and restroom with oil paint. Linoleum flooring is installed throughout all rooms.

The pharmacy is equipped with water heating. During the cold season, the indoor air temperature is 15 °C, air humidity in the main production areas is 65 %, and air velocity is 0.03 m/s.

Natural ventilation via transoms is provided in all pharmacy rooms. Mechanical ventilation is absent.

Air composition. In the customer service area, the carbon dioxide concentration is 0.6 %, and microbial air contamination reaches 12,100 CFU per 1 m³ of air.

Lighting. The windows in the customer service area are rectangular and north-facing, except for those in the manager's and accounting offices (which are east-facing). The upper window edge is located 25 cm from the ceiling, and the window height is 1.8 m. The daylight factor in the customer service area is 1:8, angle of incidence is 20°, aperture angle is 10°, and daylight factor (DF) is 1.3 %.

Artificial lighting is provided in all rooms via 60 W fluorescent lamps. Illuminance is 300 lx in the customer service area and ranges from 40 to 60 lx in other rooms.

Water supply is centralized, sourced from the municipal water mains. Tap water quality analysis results: odor 2 points, aftertaste 1.5 points, color 10°, transparency 30 cm, hardness 6.5 mEq/L, chlorides 129 mg/L, sulfates 350 mg/L, nitrates 37 mg/L, fluorine 2.9 mg/L, iron 0.2 mg/L, total dissolved solids 580 mg/L, microbial count 80, coliform index 1.

A closed-type BUV-25 W germicidal lamp is installed exclusively in the customer service area, with a specific power of 1 W per 1 m³ of room volume.

Premises cleaning. Rooms undergo wet cleaning using detergents and Chloramine B. Floors are washed once per shift, and walls and doors once a month. Medicament storage cabinets are cleaned as needed.

Staff workwear is replaced once a week. A sanitary day is conducted once a quarter.

Pharmacy employees undergo routine medical examinations once a year, which include screening for skin and venereal diseases, intestinal infection pathogen carriage, and tuberculosis.

Problem 4.

The pharmacy is located in a rural area. It is engaged in the compounding of non-sterile dosage forms and drugs under aseptic conditions, as well as the retail of finished medicinal products and medical devices. A poultry farm is situated 150 m west of the pharmacy. The prevailing wind direction in this area is easterly. The terrain is flat with a slight southern slope. The groundwater table is at a depth of 1.9 m. The land plot allocated for the pharmacy building is 0.1 ha. The footprint (building area) and landscaped areas account for 15% and 65% of the total pharmacy plot, respectively.

In addition to the pharmacy building, the site houses a garage, an icehouse, a well, a waste bin enclosure, and a refuse pit. The distance between the well and the waste bin enclosure is 12 m.

The pharmacy building is a single-story structure specially designed for pharmacy operations. The visitor entrance features an airlock vestibule with a depth of 1.2 m, where the outer and inner doors are aligned directly opposite each other. The vestibule is equipped with an air thermal curtain that supplies air heated to 35 °C during the cold season.

Composition and floor area of the premises: customer service area 20 m²; compounding room combined with the packaging room and the analytical pharmacist's office, with a total area of 22 m²; washing room 8 m²; purified water production room 12 m²; pharmacy glassware sterilization room 6 m². The aseptic block includes an aseptic room with an airlock (12 + 2 m²), a quality control (defecting) room with an airlock (10 + 3 m²), a drug sterilization room 10 m², a labeling and quality inspection room 10 m², and a water-for-injection production room 10 m². Herbal storage room 18 m²; flammable and combustible liquids storage room 6 m²; auxiliary materials and packaging storage room 9 m²; manager's office 12 m²; accounting office 8 m²; staff room 10 m²; locker room 8 m²; cleaning equipment storage closet 3 m²; restroom 3 m². Ceiling height is 3.5 m.

Interior decoration. The walls in the customer service area, compounding room, and aseptic block are painted with light-toned oil paint from floor to ceiling. In the washing room and restroom, the wall panels are tiled with glazed tiles up to a height of 1.6 m, while the walls above the panels and the ceiling are coated with water-based emulsion paint. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The flooring in the customer service area, restroom, and washing room is ceramic tile, while linoleum is used in the other rooms.

The pharmacy building lacks a sewerage system. Liquid and production wastewater are discharged into the refuse pit, whereas solid waste is collected in a sealed metal waste bin installed on a clay-rammed platform.

The pharmacy is equipped with a water heating system. During the cold season, the indoor air temperature is 20 °C, air humidity is 55% in the main production areas and 89% in the washing room, and the air velocity is 0.2 m/s.

Natural ventilation is available in all rooms through doors and transom windows (ventilators). The production facilities are equipped with mechanical general exchange ventilation, with air change rates (air exchanges per hour) as follows: customer service area +3–4, compounding room +1.5–2, washing room +2–2.5, and aseptic room +2–3.5.

Air quality. In the compounding room, the concentrations are 0.09 mg/m³ for mercury vapor, 2 mg/m³ for iodine, and 0.3% for carbon dioxide. Microbial contamination of the air (per 1 m³) after working hours is 2,400 CFU in the compounding room, 1,500 CFU in the aseptic room, and 9,000 CFU in the customer service area.

Lighting. The windows in the pharmacy production areas are rectangular and oriented to the southeast, except for the washing room and glassware sterilization room (which have north-facing windows). The top edge of the windows is located 20 cm from the ceiling, and the window height is 2.8 m. The light coefficient is 1:5 in the customer service area, 1:3 in the compounding room, 1:4 in the aseptic room, and 1:6 in the washing room. The daylight factor (KPO) in these rooms ranges from 1.5 to 2.5%, the angle of incidence is 48°, and the aperture angle is 19°.

Artificial lighting is provided in all rooms using 60 W incandescent lamps. The illumination level is 250 lx in the customer service area, 300 lx in the compounding room, 350 lx in the aseptic room, 150 lx in the washing room, and 100 lx in the quality control room.

Water supply is local, sourced from a driven shaft well. Water quality analysis results: odor 3 points, taste/flavor 3 points, color intensity 30 °, transparency 28 cm, hardness 6.5 mEq/L, chlorides 29 mg/L, nitrates 37 mg/L, fluorine 0.2 mg/L, total bacterial count 280, coli index 8.

Purified water sampled from the burette above the compounding desk contains 15 saprophytic bacteria. Swabs taken from pipettes revealed 5 saprophytic bacteria. Swabs from the hands of personnel engaged in drug compounding showed no presence of *Escherichia coli* or *Staphylococcus aureus*.

Closed-type BUV-30W germicidal lamps with a specific power of 2.5 W per 1 m³ of room volume are installed in the compounding and aseptic rooms. An open-type BUV-25W germicidal lamp is installed exclusively in the aseptic room.

Premises cleaning and sanitation. Production areas undergo wet cleaning using detergents. Floors are washed once per shift, and walls and doors once a week. Cabinets used for medication storage are cleaned as needed. Staff workwear and towels are replaced twice a week. Color-coded cleaning equipment is used; however, the color coding is worn and not clearly visible. A sanitary (deep cleaning) day is held once a quarter.

Pharmacy staff undergo routine medical examinations once a year. These screenings include checks for skin and venereal diseases, carrier states of intestinal infections, and tuberculosis.

Problem 5.

The pharmacy is located on the ground floor of a multi-story residential building. It engages in the compounding of non-sterile preparations and preparations under aseptic conditions, as well as the retail of medicinal products and medical devices. An enterprise manufacturing synthetic drugs is located 600 m west of the building housing the pharmacy.

The visitor entrance features an airlock vestibule with a depth of 1.2 m, where the outer and inner doors are aligned directly opposite each other. The vestibule is equipped with an air thermal curtain that supplies air heated to 35 °C during the cold season.

Composition and floor area of the premises: customer service area 20 m²; compounding room combined with the packaging room and the analytical pharmacist's office, with a total area of 28 m²; washing room 6 m²; purified water production room 10 m²; pharmacy glassware sterilization room 6 m².

The aseptic block includes an aseptic room with an airlock (10 + 2 m²), a quality control room with an airlock (11 + 2 m²), a drug sterilization room 12 m², a labeling and quality inspection room 10 m², and a water-for-injection production room 10 m². Medicinal supplies storage room 18 m²; flammable and combustible liquids storage room 6 m²; auxiliary materials and packaging storage room 8 m²; manager's office 12 m²; accounting office 8 m²; staff room 8 m²; locker room 4 m²; cleaning equipment storage closet 3 m²; restroom 3 m². Ceiling height is 3.5 m.

Interior decoration. The walls in the customer service area, compounding room, and aseptic block are painted with bright green oil paint from floor to ceiling. In the washing room, the wall panels are tiled with glazed tiles up to a height of 1.8 m, while the walls above the panels up to the ceiling are coated with water-based emulsion paint. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The flooring in the customer service area, restroom, and washing room is ceramic tile, while linoleum is used in the other rooms. The floor level in rooms subject to wet processing is 3 cm lower than in the other rooms.

The pharmacy's production facilities are equipped with standard technological equipment and a sewerage system, and feature hot and cold running water, heating, ventilation, and gas supply.

The pharmacy is equipped with a water heating system. During the cold season, the indoor air temperature is 18 °C, air humidity is 55% in the main production areas, and air velocity is 0.1 m/s.

All pharmacy premises feature natural ventilation provided by air inflow through doors and fanlights. Mechanical ventilation is provided in all production areas. The air exchange rate is as follows: customer service area +3 – 4, compounding room +2 – 3, washing room +3 – 4, and aseptic room +4 – 2. A fume hood is installed in the compounding room to exhaust contaminated air at a velocity of 0.9 m/s.

Air composition. In the compounding room, the concentration of validol is 2 mg/m³, lincomycin is 1 mg/m³, and carbon dioxide is 0.09%. Microbial air contamination after work is 100 CFU in the compounding room, 20 in the aseptic room, and 1500 in the customer service area per 1 m³ of air.

Lighting. The windows in the pharmacy's production areas are rectangular and south-facing, except for the washing room, glassware sterilization room, and storage rooms (which are north-facing). The upper edge of the windows is located 25 cm from the ceiling. The window height is 2.8 m. The daylight factor is 1:5 in the customer service area, 1:4 in the compounding room, 1:3 in the aseptic room, and 1:6 in the washing room. The daylight factor (DF) in these areas ranges from 1.5 to 3.5%, the angle of incidence is 48°, and the aperture angle is 20°.

Artificial lighting is provided in all rooms. The light sources are 60 W fluorescent lamps. The illumination level is 400 lx in the customer service area, 500 lx in the compounding room, 400 lx in the aseptic room, 100 lx in the washing room, 100 lx in the analytical/defector room, and 45 lx in the storage rooms.

Water supply is centralized from the municipal water grid. Results of tap water quality analysis: odor 4 points, taste 4 points, color 30°, transparency 20 cm, hardness 6.5 mEq/L, chlorides 129 mg/L, sulfates 290 mg/L, nitrates 47 mg/L, fluorine 2.9 mg/L, iron 1.8 mg/L, microbial count 108, and coli index 3.

Purified water from the burette above the pharmacist's desk contains 5 saprophytic bacteria. Washings from pipettes revealed 10 saprophytic bacteria. Washings from the hands of personnel engaged in drug manufacturing tested positive for Escherichia coli.

Closed-type BUV-60 W bactericidal lamps are installed in the aseptic room, compounding room, and customer service area. Their specific power is 2 W per 1 m³ of room volume. An open-type bactericidal irradiator with a specific power of 1.5 W/m³ is additionally installed in the aseptic room.

Premises cleaning. Production areas undergo wet cleaning using detergents and disinfectants: Chloramine B, hydrogen peroxide, chlorhexidine bigluconate in ethyl alcohol, and chlorcin. Floors are washed once per shift, walls and doors once a week, and medication storage cabinets are wiped daily with clean, damp, boiled cloths. Clearly labeled equipment is used for cleaning. A general sanitary day is conducted once a quarter.

Replacement of staff workwear and towels is carried out twice a week. Employees directly involved in drug manufacturing use 96% ethyl alcohol as an antiseptic.

Pharmacy staff undergo routine medical examinations once a year. These include screenings for skin and venereal diseases, carriage of intestinal infection pathogens, and tuberculosis.

Problem 6.

The pharmacy sells medicinal products and medical devices. It is located on the ground floor of a multi-story residential building.

Composition and area of premises. Customer service area 15 m², medication storage room 12 m², herbal raw materials storage room 4 m², sanitary, hygiene, and medical devices storage room 4 m², manager's office combined with the accounting department with a total area of 6 m², staff room 5 m², cloakroom 4 m², cleaning supplies closet 2 m², and restroom 3 m².

The visitor entrance is equipped with a vestibule having a depth of 1 m. The vestibule doors are angled relative to each other. An air curtain is absent.

Interior decoration. Walls in all rooms are covered with moisture-resistant wallpaper, ceilings are whitewashed, and floors are covered with linoleum.

The pharmacy is equipped with water heating. Indoor air temperature during the cold season is 15 °C, relative humidity is 75%, and air velocity is 0.03 m/s.

All pharmacy premises feature natural ventilation provided through transoms (hopper windows). Mechanical ventilation is absent.

Air composition. In the customer service area air, the carbon dioxide concentration is 0.8%, and post-operation microbial air contamination is 9100 per 1 m³ of air.

Lighting. The windows of the pharmacy premises are rectangular and north-facing. The upper edge of the windows is 25 cm from the ceiling. Window height is 1.8 m. The daylight factor in the customer service area is 1:9, and 1:7 – 1:8 in other rooms. The daylight factor ranges from 0.5 to 1%, the angle of incidence is 18°, and the aperture angle is 3°. Artificial lighting is provided in all rooms. The light sources are 60 W incandescent lamps. The illumination level is 100 lx in the customer service area and 75 lx in other rooms.

Water supply is centralized from the municipal water grid. Results of water quality analysis: odor 4 points, taste 4 points, color 25°, transparency 20 cm, hardness 6.5 mEq/L, chlorides 129 mg/L, sulfates 670 mg/L, nitrates 47 mg/L, fluorine 1.4 mg/L, iron 0.4 mg/L, microbial count 80, and coli index 2.

Premises cleaning. Pharmacy premises undergo wet cleaning using detergents. Floors are washed once per shift, and walls and doors once a month. Medication storage cabinets are cleaned as needed.

Replacement of staff workwear is carried out once a week. A sanitary day is conducted once a quarter.

Pharmacy staff undergo routine medical examinations once a year. These include screenings for skin and venereal diseases, and tuberculosis.

Problem 7.

The pharmacy is located in a detached, specially constructed single-story building. The land plot area is 0.2 hectares. The pharmacy manufactures non-sterile dosage forms and drugs under aseptic conditions, and sells medicinal products and medical devices. To the west of the pharmacy, at a distance of 1000 m, there is an antibiotic manufacturing plant. The prevailing wind direction in this area is westerly. The relief of the site is flat with a slight southward slope. The groundwater level is 1.9 m. The building footprint and landscaping areas of the plot account for 15% and 65%, respectively.

On the site grounds, alongside the pharmacy building, There is a garage, a waste container, and a refuse bin. The distance between the pharmacy building and the waste container is 29 m.

The visitor entrance is equipped with a vestibule 1.2 m deep. The doors within the vestibule are aligned opposite each other. The vestibule features an air-thermal curtain that supplies air heated to 38 °C during the cold season.

Composition and floor area of the premises: customer service hall 40 m², compounding room 20 m², packaging room 10 m², analytical pharmacist's office 15 m², washing room 10 m², purified water production room 10 m², pharmacy glassware sterilization room 14 m². The aseptic unit includes an aseptic room with an airlock 10 + 2 m², a quality control and pre-dispensing room with an airlock 11 + 2 m², a drug sterilization room 12 m², a labeling and control room 13 m², and a water-for-injection production room 10 m². Herbal storage room 15 m², flammable and combustible liquids storage room 8 m², auxiliary materials and packaging storage room 10 m², manager's office 16 m², accounting office 10 m², staff room 15 m², locker room 10 m², cleaning supply closet 3 m², restroom 3 m². Ceiling height is 3.8 m.

Interior decoration. The walls in the customer service hall, compounding room, and aseptic unit are painted with light blue oil-based paint from floor to ceiling; in the washing room, wall panels are tiled with glazed tiles up to a height of 1.8 m, while the area above the panels to the ceiling is coated with water-emulsion paint. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The floors in the customer service hall, restroom, and washing room are finished with ceramic tiles, and with linoleum in the other rooms.

The pharmacy building lacks a sewage system. Liquid waste is poured into the refuse bin, and solid waste is collected in a metal waste container installed on a clay-rammed platform. The waste container is airtight.

The pharmacy is equipped with water heating. The indoor air temperature during the cold season is 20 °C, air humidity in the main production areas is 75 %, in the washing room 86 %, and air velocity is 0.08 m/s.

Natural ventilation is provided in all pharmacy rooms through doors and transom windows. Mechanical ventilation is absent.

Air composition. In the compounding room, the concentration of validol is 16 mg/m³, mercury vapor 0.12 mg/m³, and carbon dioxide 0.5 %. Microbial air contamination in the compounding room after operation is 2100, and in the aseptic room 500 per 1 m³ of air.

Lighting. The windows of the pharmacy production rooms are rectangular, facing east, except for the washing room and glassware sterilization room (where windows face west). The upper edge of the windows is located 25 cm from the ceiling. Window height is 2.8 m. The daylight factor is 1:6 in the customer service hall, 1:3 in the compounding room, 1:4 in the aseptic room, and 1:4 in the washing room. The natural light factor in these rooms ranges from 1.5 to 2.5 %, the angle of incidence is 48°, and the aperture angle is 10°.

Artificial lighting is provided in all rooms. The light sources are 90 W fluorescent lamps. The illumination level is 300 lx in the customer service hall, 500 lx in the compounding room, 500 lx in the aseptic room, 75 lx in the washing room, 100 lx in the quality control room, and 60 lx in the other rooms.

Centralized water supply is available. Water quality analysis results: odor 3 points, taste 3 points, color 30 °, transparency 28 cm, hardness 6.5 mg-eq/L, chlorides 29 mg/L, nitrates 7 mg/L, fluorine 1 mg/L, iron 0.7 mg/L, microbial count 28, coliform index 1, residual chlorine 0.3 mg/L.

Purified water from the burette above the pharmacist's desk contains 55 saprophytic bacteria. Pipette rinses revealed 5 saprophytic bacteria. Rinses from the hands of personnel engaged in drug preparation showed no Escherichia coli.

Premises maintenance. Production areas undergo wet cleaning using detergents and Chloramine B. Floors are washed once per shift, and walls and doors once a month. Medication storage cabinets are cleaned as needed.

Replacement of staff workwear and towels is carried out twice a week. Color-coded equipment is used for cleaning the premises, although the markings are poorly visible. A general cleaning and sanitation day is held once a quarter.

Pharmacy staff undergo routine medical examinations once a year. These include screening for skin and Sexually Transmitted Diseases as well as testing for intestinal infection carriers.

Problem 8.

The pharmacy warehouse is housed in a separate, purpose-built building. The groundwater table at the site is 1.2 m below the ground surface.

Room layout: operational department (dry medications room, liquid medications room, liquid drugs room), receiving department, dispatch department, washing and packaging room. The liquid medications room stores drugs in ampoules, bacterial preparations, and disinfectants. The total floor area of the warehouse production facilities is 76 m².

In the production areas, the walls are painted with water-emulsion paint from floor to ceiling, and the floors are covered with ceramic tiles.

Natural lighting is available in all rooms. Windows in the production areas face north, while the others face south and southwest. The daylight factor in the production areas is 0.3 %. Artificial lighting is provided by incandescent lamps, which ensure a general illumination level of 200 lx. In the drug storage rooms, the illumination level is 35 lx.

In the main production, sanitary, domestic, and utility rooms, the air temperature is 24–26 °C, relative air humidity is 30–40 %, and air velocity is 0.2 m/s.

In the room intended for storing bacterial preparations, the air temperature is 18–20 °C, organo-preparations are stored at 12–15 °C, and ointments, liniments, and extracts at 20 °C.

Devices for measuring temperature and relative air humidity (thermometers and psychrometers) are located at a height of 1.7 m from the floor and 4 m from the doors. Temperature and humidity control is carried out twice a week.

Drug storage racks are positioned at a distance of 0.3 m from the exterior wall, 0.2 m from the ceiling, and 0.2 m from the floor.

Air exchange in the rooms is provided by natural ventilation; mechanical ventilation is absent.

During a sanitary and chemical assessment of the air in the emergency department, the following concentrations were detected: norsulfazole dust 2 mg/m³, phenol vapor 0.6 mg/m³, and acetylsalicylic acid 0.8 mg/m³.

The pharmacy warehouse is equipped with central heating, water supply, and sewage systems. Laboratory Analysis of the water revealed the following parameters: total microbial count 50, coliform index 1, odor 4 points, aftertaste 3 points, color 29°, turbidity 2.5 mg/L, total hardness 7 mEq/L, sulfates 450 mg/L, chlorides 240 mg/L, copper 0.8 mg/L, iron 0.8 mg/L, chlorophenols 0.0001 mg/L, total mineralization 980 mg/L, total alkalinity 5.8 mg/L, magnesium 21 mg/L, fluorine 0.3 mg/L, aluminum 0.2 mg/L, arsenic 0.005 mg/L, nitrates 41 mg/L, pesticides 0.00009 mg/L, oxidizability 3 mg/L, total alpha-radiation activity 0.1 Bq/L, residual free chlorine 0.1 mg/L.

Problem 9.

The pharmacy manufactures non-sterile dosage forms and medications under aseptic conditions, as well as dispenses medicines and medical devices. It is located in a standalone building. An expanded clay (dunstone) plant is situated 150 meters to the west of the pharmacy. The prevailing wind direction in this area is westerly.

The Topography of the land plot is flat with a slight southern slope. The groundwater table is at a depth of 1.9 m. The total area of the land plot allocated for the pharmacy construction is 0.1 ha. The built-up area and landscaping account for 20% and 25% respectively.

In addition to the pharmacy building, the site accommodates a garage, an icehouse, a well, and a waste collection bin. The distance between the well and the waste collection bin is 29 m.

The pharmacy building is single-story, purpose-built. The visitor entrance is equipped with a vestibule 1.2 m deep. The doors of the vestibule are aligned opposite each other. An air-thermal curtain is installed in the vestibule, supplying air heated to 25 °C during the cold season.

Composition and area of premises: customer service hall 40 m², dispensing room combined with the packaging room and the analyst-provisor's office with a total area of 32 m², washing room 8 m², purified water production room 10 m², pharmacy glassware sterilization room 9 m². The aseptic unit includes an aseptic room with an airlock 12 + 2 m², a quality control (defector) room with an airlock 14 + 2 m², a drug sterilization room 12 m², a labeling and control room 13 m², and a water-for-injection production room 10 m². Medicinal herbs storage room 15 m², flammable and combustible liquids storage room 8 m², auxiliary materials and packaging storage room 8 m², manager's office 12 m², accounting office 8 m², staff room 10 m², cloakroom 8 m², cleaning gear storage room 3 m², restroom 3 m². Ceiling height is 3.5 m.

Interior decoration. The walls in the customer service hall, dispensing room, and aseptic unit are painted with light-toned oil paint from floor to ceiling; in the washing room and restroom, the wall panels are tiled up to a height of 1.8 m, while the upper section up to the ceiling is finished with water-emulsion paint. In the corridors, manager's office, and accounting office, the walls are covered with moisture-resistant wallpaper. The flooring is finished with ceramic tiles in the customer service hall, restroom, and washing room, and with linoleum in all other rooms.

There is no sewage system in the pharmacy building. Liquid and production wastes are discharged into a cesspool, while solid wastes are collected in a metal waste bin installed on a clay-rammed platform. The waste bin is hermetically sealed.

The pharmacy is provided with water heating. Water at a temperature of 80 °C is used as the Heat transfer fluid. During the cold season, the indoor air temperature is 15 °C, air humidity is 75% in the main production areas and 86% in the washing room, and the air velocity is 0.02 m/s.

All pharmacy premises feature natural ventilation provided via window transoms. Mechanical ventilation is absent.

Air composition. The dispensing room air contains validol concentration of 26 mg/m³, lincomycin 18 mg/m³, and carbon dioxide 0.5%. Microbial air contamination in the dispensing room after working hours is 11,100 per 1 m³ of air, and 1,500 per 1 m³ in the aseptic room.

Lighting. The windows of the pharmacy production areas are rectangular and oriented westward, except for the washing room and aseptic unit (which have east-facing windows). The upper edge of the windows is located 25 cm from the ceiling. Window height is 1.8 m. The daylight factor is 1:7 in the customer service hall, 1:6 in the dispensing room, 1:4 in the aseptic room, and 1:4 in the washing room. The natural light factor (KPO) in these rooms ranges from 1.5 to 2.5%, the angle of incidence is 38°, and the aperture angle is 10°. Artificial lighting is provided in all rooms. The light sources are 60 W fluorescent lamps. The illumination level is 300 lx in the customer service hall, 500 lx in the dispensing room, 500 lx in the aseptic room, 75 lx in the washing room, and 100 lx in the quality control room.

Local water supply from a shaft well. Results of water quality analysis: odor 3 points, aftertaste 3 points, color 30°, transparency 28 cm, hardness 6.5 mEq/L, chlorides 29 mg/L, nitrates 37 mg/L, fluorine 2.4 mg/L, microbial count 280, coliform index 8.

Purified water from the burette above the assistant's table contains 75 saprophytic bacteria per 1 mL. Pipette rinses revealed 105 saprophytic bacteria. Rinses from the hands of personnel engaged in drug manufacturing showed no Escherichia coli, while Staphylococcus aureus was detected in one employee.

An open-type BUV-25 W germicidal lamp is installed exclusively in the aseptic room.

Premises cleaning. Production areas undergo wet cleaning using detergents and Chloramine B. Floors are washed once per shift, and walls and doors once a month. Medication storage cabinets are cleaned as needed.

Replacement of staff workwear and towels is carried out twice a week. Cleaning tools are color-coded, though the markings are faintly visible. A sanitary day is held once a quarter.

Pharmacy staff undergo routine medical examinations once a year. These include screenings for skin, venereal, and tuberculosis diseases.