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

Hygiene of Pharmacy Establishments
Sanitary and anti-epidemic regime in pharmacies. Methods for evaluating the effectiveness of antimicrobial measures

Sterilization, disinfection, and antisepsis play a central role in The system of measures aimed at maintaining sanitary and anti-epidemic regimes in pharmacies and pharmaceutical enterprises.

The objects of sterilization include injection solutions, powders, primary packaging and auxiliary Materials, culture media for monitoring the microbiological purity and sterility of drugs, membrane filters, etc. Physical Methods are most commonly used (thermal, radiation, ultrasonic sterilization, high- and ultra-high-frequency currents, laser and electron UV radiation), while chemical (solutions of substances or gases) and mechanical (filtration) methods are employed less frequently.

When disinfecting an object (room surfaces, Processing and sanitary equipment, utilities, cleaning inventory, etc.), chemical agents are most frequently used, whereas physical and mechanical means are less common. Modern requirements for disinfectants include a broad spectrum of antimicrobial activity, a microbicidal effect, good Water solubility, no damaging effect on treated objects, and low toxicity and allergenicity.

Antiseptic agents must ensure the destruction of pathogenic and saprophytic microorganisms on the Skin of personnel hands. For this purpose, 76% ethyl alcohol, a 2.4% solution of C-4 formulation (a mixture of hydrogen peroxide and formic acid solutions), degmin, 1% iodopiron, 0.1% octeniderm, octenisept, and others are used.

To prevent The Emergence of resistant microbial strains and their spread, disinfectants and antiseptics should be alternated every 1–3 months.

The effectiveness of disinfection measures is controlled using bacteriological (swab method), physical, and chemical methods. The latter is based on A change in the color of an indicator substance upon interaction with a disinfectant, or a change in color and state of aggregation under METABOLISM/18.html">The Influence of Temperature.

Objective: to know the methods and regimens of disinfection and sterilization of various objects in pharmacies and pharmaceutical enterprises, to be able to apply them, and to monitor their effectiveness.

QUESTIONS FOR SELF-STUDY

1. Sanitary and anti-epidemic regime in pharmacies, main requirements.

2. Distinctive Features of the concepts of sterilization, disinfection, and antisepsis.

3. Sterilization: objects and methods in pharmacies and pharmaceutical enterprises.

4. Disinfection: objects and methods in pharmacies and pharmaceutical enterprises.

5. Classification of disinfectants, modern requirements for them.

6. Methods for monitoring the effectiveness of disinfection, sterilization, and antisepsis.

Task 1. Determination of the effectiveness of thermal sterilization of pharmacy glassware (biological method)

To prevent secondary contamination, the procedure is performed observing aseptic rules immediately after the sterilization of pharmacy glassware. Using tweezers, a sterile gauze pad (5 x 5 cm) is moistened with sterile water, used to wipe the inner and then outer surface of a vial (or another type of pharmacy glassware) for 1 min, and then transferred into a flask with sterile water. The flask is thoroughly shaken, the wipe is squeezed against the inner surface of the flask using tweezers and removed. Using a pipette, 0.2 ml of the rinse is withdrawn and added to a test tube with Hottinger's broth, and identical volumes are added to test tubes with thioglycolate medium and Sabouraud medium. The inoculations are placed in an incubator: those in Hottinger's broth and thioglycolate medium are kept at 32 °C, and those in Sabouraud medium at 22 °C for 5–8 days.

The absence of Microbial growth on all media indicates the effectiveness of the performed sterilization. If microbial growth is present, it is concluded that the glassware is non-sterile.

Task 2. Determination of the effectiveness of disinfection of working surfaces (tables, equipment, etc.) by the biological method

Samples are taken no later than 30–45 min after the completion of disinfection under conditions that exclude secondary contamination. The swab area should be 100 cm², for which special boundary templates (10 x 10 cm) are used. Swabs are taken with sterile cotton swabs on Glass or metal holders mounted in test tubes containing 10 ml of moisturizer (sterile buffer solution with sodium chloride and peptone, supplemented if necessary with an appropriate disinfectant inactivator, such as a 1% hyposulfite solution for chlorine-containing preparations). Afterwards, nutrient media—meat-peptone Agar (MPA) and Sabouraud agar on Petri dishes—are inoculated by passing the swab over them several times. After taking the swab, the second swab is immersed in Kessler medium (for the subsequent detection of coliform Bacteria). Inoculations on MPA (to determine the bacterial count) are incubated in an incubator at 32.5 ± 2.5 °C, those on Sabouraud medium (to determine the fungal count) at 22.5 ± 2.5 °C for 5 days, and those in Kessler medium at 32.5 ± 2.5 °C for 48 hours.

Accounting of results. In the absence of bacterial growth on nutrient media, it is concluded that the disinfection was effective. If bacterial growth is present on Kessler medium, inoculation onto Endo medium is performed, followed by identification of bacteria based on morphological, cultural, and biochemical properties. The presence of smooth, red colonies belonging to gram-negative oxidase-negative rods that ferment lactose with The production of gas and acid indicates the presence of coliform bacteria on the treated surface and, consequently, the ineffectiveness of the disinfection.

An indicator of effective disinfection is the absence of coliform bacteria in the rinses and the presence of no more than 5 colonies of non-spore-forming microorganisms on two Petri dishes from rinses taken during operation.

Task 3. Evaluation of disinfection quality by the chemical method (rapid method)

A sterile cotton swab is moistened first with a 10% potassium iodide solution, then with a freshly prepared 1% starch solution. The surface previously treated with a chlorine-containing disinfectant (e.g., chloramine B) is wiped with it.

Accounting of results. A blue color indicates the presence of active chlorine and, consequently, the reliability of the performed disinfection.

Task 4. Evaluation of the quality of hygienic hand antisepsis by the biological method

The effectiveness of the antiseptic agent is evaluated immediately after hand disinfection. A sterile cotton swab moistened with sterile water is used to thoroughly wipe the palms, backs of the hands, interdigital spaces, and subungual areas. The swab is then streaked several times across The surface of nutrient media in Petri dishes containing nutrient agar and Sabouraud agar. The cultures are incubated in a thermostat at 35 °C and 25 °C, respectively, for 48 hours.

Evaluation of results. The absence of microbial growth on the nutrient media indicates proper hand antisepsis and product efficacy. If bacterial growth is present, further identification is performed. The presence of coliform bacteria in the washings indicates a gross violation of personal hygiene rules and the necessity for urgent preventive measures. During the procedure, no more than 5 non-spore-forming colonies are permitted in hand washings from a single employee across two plates.

PROTOCOL OUTLINE

Topic of the practical session.

1. Determination of the effectiveness of thermal sterilization of pharmacy glassware.

Method ... .

Object of sterilization ... .

Nutrient media ... .

Culture conditions (temperature, time) ... .

Results ... .

Conclusion. Microbial growth was (not) detected on the nutrient media, which indicates the (in)effectiveness of this sterilization method and compliance with (violation of) the sterilization regime.

2. Evaluation of the quality of disinfection of working surfaces.

Method ... .

Object of disinfection ... .

Disinfectant ... .

Time of sampling after Treatment with the disinfectant solution ... .

Area of the treated surface ... .

Moistening agent ... .

Nutrient media ... .

Culture conditions (time, temperature) ... .

Results ... .

Conclusion. Based on Sanitary and hygienic studies carried out in ... , it was established that coliform bacteria were (not) detected in washings from working surfaces, and the total microbial count is ..., which indicates the (in)effectiveness of the disinfection performed.

3. Evaluation of disinfection quality using the chemical (rapid) method.

Principle of the method ... .

Object of disinfection ... .

Result ... .

Conclusion. The rapid chemical method for quality control of the performed disinfection (did not) confirm its efficacy.

4. Evaluation of the quality of hygienic hand antisepsis.

Method ... .

Antiseptic ... .

Time of sampling after hand treatment with the antiseptic ... .

Culture media . .

Cultivation conditions (temperature ... , time ...).

Results ... .

Conclusion. Based on the sanitary and hygienic studies, it was established that microorganisms (were / were not) detected in hand swabs after treatment with the antiseptic, which indicates their (in)effectiveness.

TASKS FOR INDEPENDENT WORK

1. Test control of knowledge.

2. Solving situational tasks.

TESTS

1. According to GMP requirements in the manufacture of medicinal products, it is necessary to adhere to a set of measures aimed at preventing their microbial contamination. What is this set of measures called?

A. Disinfection.

Б. Antisepsis.

B. Asepsis.

Г. Sterilization.

Д. Deratization.

2. According to modern concepts, the most complete elimination of microorganisms from an object is achieved by:

A. Sterilization.

Б. Antisepsis.

B. Disinfection.

3. Objects of sterilization are:

A. Primary packaging materials.

B. Injection solutions.

B. Personnel hands.

G. Working garments.

D. Culture media.

4. Objects of disinfection include:

A. Equipment surfaces.

B. Pharmacy glassware.

B. Personnel hands.

G. Room air.

D. Working garments.

5. Objects of hygienic antisepsis include:

A. Room air.

B. Pharmacy glassware.

B. Medicinal products.

G. Personnel hands.

6. Chemical disinfectants must meet the following requirements:

A. Selective antimicrobial activity.

B. Broad-spectrum antimicrobial activity.

B. Storage stability.

G. Low toxicity.

D. Microbicidal mode of action.

E. Microbiostatic mode of action.

7. Sterilization aims to free an object from microorganisms that are:

A. Pathogenic.

B. Opportunistic.

C. Saprophytic.

D. All types.

8. Violations of the sanitary and anti-epidemic regime in the production of injection solutions may cause their pyrogenicity. Indicate the sign of a pyrogenic reaction:

A. Hypertension.

B. Hypothermia.

C. Hyperthermia.

D. Hypotension.

9. Following drug administration, the patient developed signs of a pyrogenic reaction. Indicate the cause taking into account the route of administration:

A. Intranasal.

B. Sublingual.

C. Parenteral.

D. Oral.

10. To prevent The Development of microorganism resistance to disinfectants, it is necessary to:

A. Rotate disinfectants.

B. Regularly use a single disinfectant.

C. Concurrently use a disinfectant and a detergent.

D. Decrease the concentration of the disinfectant.

11. Choose the method of sterilization for the workwear of pharmacy personnel.

A. Steam under pressure.

B. Dry heat.

C. Flowing steam.

D. Tyndallization.

E. Membrane filtration.

SITUATIONAL PROBLEMS

Problem 1.

It is necessary to carry out preventive disinfection of the pharmacy's production premises. Specify the disinfectants, disinfection regimens (solution concentration, exposure time), and the method of application.

Problem 2.

It is necessary to disinfect rubber and plastic medical devices in a pharmacy Setting. Specify the disinfectants, disinfection regimen (solution concentration, exposure time), and the method of application.

Problem 3.

It is necessary to disinfect cleaning equipment in a pharmacy setting. Specify the disinfectants, disinfection regimens (solution concentration, exposure time), and the method of application.

Problem 4.

It is necessary to disinfect metal and glass articles in a pharmacy setting. Specify the disinfectants, disinfection regimens (solution concentration, exposure time), and the method of application.

Problem 5.

It is necessary to disinfect sanitary and technical equipment (sinks, toilets, etc.) in a pharmacy setting. Specify the disinfectants, disinfection regimens (solution concentration, exposure time), and the method of application.

Problem 6.

It is necessary to disinfect the work footwear of pharmacy personnel. Specify the disinfectants, disinfection regimens (solution concentration, exposure time), and the method of application.

Problem 7.

It is necessary to sterilize pharmacy glassware. Propose the methods, operating regimens, equipment, and conditions for sterilization, as well as methods for monitoring its effectiveness.

Problem 8.

It is necessary to sterilize filter paper and parchment in a pharmacy setting. Propose the method, regimen, equipment, and conditions for sterilization, as well as methods for monitoring its effectiveness.

Problem 9.

Polymeric material items must be sterilized in a pharmacy setting. Propose the methods, regimens, and conditions for sterilization, as well as methods for monitoring its effectiveness.

Problem 10.

It is necessary to perform preventive antiseptic hand treatment for pharmacy personnel. Propose the antiseptic agents, their concentration, and the method of application.