Disinfectants used for hand treatment by employees of pharmacies. Hygienic treatment of the hands of medical staff: methods, algorithm and preparations. To disinfect the skin of the hands, use

• subungual space
• periungual ridges
• fingertips

• interdigital spaces
• thumb notch

Hand hygiene of medical personnel - presentation:

Problems

Allergist Alexey Semenovich Dolgin believes that many problems can be avoided. In almost half of the cases, medical staff do not comply with all WHO recommendations.

“The main mistake is that doctors do not wait until their hands are completely dry after washing. The antiseptic is rubbed into damp skin. And this will definitely lead to irritation.”

Constant hand disinfection inevitably leads to rashes, dermatitis and skin irritation. Most often, allergies are caused by substances that are added to ethyl alcohol: iodine, triclosan, and some ammonium compounds. Experienced surgeons claim that when cleansing with pure ethyl alcohol, allergic reactions were many times less, and the disinfection effect remained high.

Medical personnel are advised not to wash their hands vigorously hot water, use alkaline soap and hard brushes to wash your nails. If you have excessive dryness, you should moisturize your skin. protective equipment(usually before bedtime), avoid aggressive substances. This will help minimize allergic skin reactions.

Healthcare-associated infections (HAIs) are a major concern in ensuring patient safety, which is why preventing their occurrence should be a priority for healthcare organizations of all types. According to the World Health Organization, out of 100 hospitalized patients, at least 7 become infected with HAIs. Among seriously ill patients treated in intensive care units, this rate increases to approximately 30 HAIs per 100 people.

HAIs often occur in situations where the source of pathogenic microorganisms for the patient is the hands of healthcare workers. Today, hand washing by medical personnel or treating them with skin antiseptics is the most important events infection control, which can significantly reduce the spread of infections that arise during the diagnostic and treatment process in organizations engaged in medical activities.

Background

The history of hand hygiene for medical personnel dates back to the mid-19th century, when the highest mortality rate due to “puerperal fever” was observed in obstetric clinics in European countries. Septic complications claimed the lives of about 30% of women in labor.
In the medical practice of that time, doctors' passion for dissecting corpses was widespread. Moreover, after visiting the anatomical theater, the doctors went to the patients without treating their hands, but simply wiping them with a handkerchief.
There were many different theories about the origin of puerperal fever, but only the Viennese doctor Ignaz Philipp Semmelweis was able to discover the true reasons for its spread. The 29-year-old doctor suggested that the main cause of postpartum complications is contamination of the hands of medical personnel with cadaveric material. Semmelweis noticed that a solution of bleach eliminates the smell of rotting, which means it can also destroy the infectious principle present in corpses. An observant doctor suggested treating obstetricians' hands with a chlorine solution, which led to a 10-fold reduction in mortality in the clinic. Despite this, Ignaz Semmelweis's discovery was rejected by his contemporaries and received recognition only after his death.

Hand hygiene is a first-line intervention that has proven highly effective in preventing HAIs and the spread of antimicrobial resistance in pathogens. However, even today the problem of cleaning the hands of medical personnel cannot be considered completely resolved. Research conducted by WHO has shown that poor hand hygiene compliance among health care workers occurs in both developed and developing countries.

According to modern concepts, transmission of HAI pathogens occurs in various ways, but the most common transmission factor is the contaminated hands of healthcare workers. Wherein infection through the hands of personnel occurs in the presence of a number of the following: conditions :

1) the presence of microorganisms on the patient’s skin or objects in his immediate environment;

2) contamination of the hands of medical workers with pathogens through direct contact with the patient’s skin or surrounding objects;

3) the ability of microorganisms to survive on the hands of medical personnel for at least several minutes;

4) incorrect implementation of the hand disinfection procedure or ignoring this procedure after contact with the patient or objects in his immediate environment;

5) direct contact of the contaminated hands of a medical worker with another patient or an object that will come into direct contact with this patient.

Microorganisms associated with the provision of medical care can often be found not only on the surface of infected wounds, but also on areas of completely healthy skin. Every day, about 10 6 skin flakes with viable microbes peel off, contaminating patients’ underwear and bed linen, bedside furniture and other objects. After direct contact with a patient or environmental objects, microorganisms can survive on the hands of healthcare workers for quite a long time, most often from 2 to 60 minutes.

The hands of medical personnel can be colonized by representatives of their own, resident microflora, and can also be contaminated with potential pathogens (transient microflora) during various manipulations, which is of great epidemiological significance. In many cases, pathogens of purulent-septic infections released from patients are not found anywhere except on the hands of medical workers.

Rules for hand treatment of medical personnel

IN Russian Federation the rules for treating the hands of medical personnel are regulated by SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities.” Depending on the nature of the medical procedure being performed and the required level of reduction in microbial contamination of the skin, medical personnel must perform hand hygiene or the so-called surgical hand treatment.

To achieve an effective level of hand skin disinfection healthcare workers must comply with the following requirements :

1. Have short-cut natural nails without varnish.

It should be understood that the use of nail polish itself does not lead to increased contamination of the hands, but cracked polish makes it difficult to remove microorganisms. Varnish dark colors may hide the condition of the subungual space, which leads to insufficient treatment. In addition, the use of nail polish can cause unwanted dermatological reactions, which often result in secondary infection. The procedure for performing a manicure is quite often accompanied by the appearance of microtraumas, which can easily become infected. For the same reasons, medical workers should not wear artificial nails.

2. Do not wear rings, rings or other jewelry on your hands while working. Before surgical treatment It is also necessary to remove wrist watches, bracelets and other accessories.

Jewelry on the hands can lead to increased contamination of the skin and difficulty in removing microorganisms, jewelry and Jewelry complicate the process of putting on gloves and also increase the likelihood of damage.

According to SanPiN 2.1.3.2630-10, there are two types of disinfection of the hands of medical workers - hygienic hand treatment and disinfection of the hands of surgeons.

Hand hygiene must be carried out in the following cases:

Before direct contact with the patient;

After contact with the patient's intact skin (for example, when measuring pulse or blood pressure);

After contact with body secretions or excreta, mucous membranes, dressings;

Before performing various patient care procedures;

After contact with medical equipment and other objects located in close proximity to the patient;

After treating patients with purulent inflammatory processes, as well as after each contact with contaminated surfaces and equipment.

Exist two ways hand hygiene: washing with soap and water to remove contaminants and reduce the number of microorganisms, and using a skin antiseptic to reduce the number of microorganisms to a safe level.

For hand washing, liquid soap is used, dispensed using a dispenser. Avoid using hot water as it may increase the risk of dermatitis. If the faucet is not equipped with an elbow drive, you must use a towel to close it. To dry your hands, use individual clean cloth or paper towels, preferably single-use ones.

Hygienic treatment of hands (without prior washing) with a skin antiseptic is carried out by rubbing it into the skin of the hands in the amount recommended in the instructions for use, focusing Special attention fingertips, skin around nails and between fingers. An important condition effective hand hygiene is to keep them moist for the recommended exposure time. You should not wipe your hands after handling.

For your information

Alcohol-based skin antiseptics show b O greater effectiveness compared to antiseptics on water based, and therefore their use is preferable in the absence of conditions necessary for hand washing, or in conditions of shortage of working time.

Treatment of surgeons' hands performed by all medical workers involved in surgical interventions, childbirth and catheterization of great vessels. Surgical hand antisepsis includes two mandatory stages:

1. Wash hands with soap and water for 2 minutes, then dry with a sterile cloth towel or napkin.

At this stage, it is recommended to use sanitary devices and elbow dispensers, which can be operated without the use of hands. If brushes are used, which is not a requirement, the choice should be either sterile, soft, disposable brushes or brushes that can withstand autoclaving. Brushes should only be used to treat periungual areas when disinfecting hands for the first time during a work shift.

2. Treatment of hands, wrists and forearms with a skin antiseptic.

Hands must be kept moist throughout the recommended treatment time. After exposure to a skin antiseptic, it is prohibited to wipe your hands. The amount of a particular product required for treatment, the time of its exposure and the frequency of application are determined by the recommendations set out in the instructions attached to it. Sterile gloves are put on immediately after the antiseptic has completely dried on the skin of the hands.

For surgical hand treatment, the same preparations can be used as for hygienic treatment. However, it is very important to use skin antiseptics that have a pronounced residual effect.

Fill dispensers for soap or skin antiseptic only after they have been disinfected, washed with water and dried. Preference should be given to elbow dispensers and dispensers powered by photocells.

Skin antiseptics for hand treatment should be readily available at all stages of the diagnostic and treatment process. In departments with a high intensity of patient care and a high workload for staff, dispensers with skin antiseptics should be placed in places convenient for use by medical workers (at the entrance to the ward, at the patient’s bedside, etc.). It should also be possible to provide medical workers with small-volume individual bottles of skin antiseptic (up to 200 ml).

Prevention of occupational dermatitis

Repeated hand cleaning by medical personnel during the performance of work duties can lead to skin irritation, as well as the occurrence of dermatitis - one of the most widespread occupational diseases medical workers. The most common skin reaction is irritative contact dermatitis, which is manifested by symptoms such as dryness, irritation, itching, and in some cases, cracking of the skin. The second type of skin reaction is allergic contact dermatitis, which is much less common and is an allergy to certain ingredients in a hand sanitizer. The manifestations and symptoms of allergic contact dermatitis can be varied and range from mild and localized to severe and generalized. In the most severe cases, allergic contact dermatitis may be accompanied by difficulty breathing and some other symptoms of anaphylaxis.

Irritative contact dermatitis is usually associated with the use of iodophors as skin antiseptics. Other antiseptic components that can cause contact dermatitis, with decreasing incidence, include chlorhexidine, chloroxylenol, triclosan and alcohols.

Allergic contact dermatitis occurs when hand products containing quaternary ammonium compounds, iodine or iodophors, chlorhexidine, triclosan, chloroxylenol and alcohols are used.

There is a large amount of data obtained in various studies on the best skin tolerance of alcohol-containing antiseptics.

Allergic reactions and irritation of the skin of the hands of medical personnel cause a feeling of discomfort, thereby worsening the quality of medical care, and also increase the risk of transmitting HAI pathogens to patients due to the following: reasons:

Due to skin damage, a change in its resident microflora, colonization with staphylococci or gram-negative microorganisms is possible;

When carrying out the procedure for hygienic or surgical treatment of hands, the required level of reduction in the number of microorganisms is not achieved;

As a result of discomfort and other unpleasant subjective sensations, there is a tendency for a healthcare worker who experiences skin reactions to avoid hand treatment.

Adviсe

In order to prevent the development of dermatitis, medical personnel must observe a number of the following additional recommendations:
1) do not resort to frequent washing wash your hands with soap immediately before or after using an alcohol-based product. Washing your hands before using an antiseptic is only necessary if there is visible contamination on the skin;
2) when washing your hands, you should avoid using very hot water, as this can lead to skin injury;
3) when using disposable towels, it is very important to blot the skin rather than rub it to avoid the formation of cracks;
4) you should not wear gloves after treating your hands until they are completely dry in order to reduce the risk of developing skin irritation;
5) it is necessary to regularly use creams, lotions, balms and other hand skin care products.

One of basic preventive measures development of occupational dermatitis in medical workers is to reduce the frequency of exposure of the skin to soap and other irritants detergents through the widespread introduction into practice of alcohol-based antiseptics containing various emollient additives. According to WHO recommendations, use in medical organization alcohol-based hand hygiene products are preferable when available, as this type antiseptics have a number of advantages, such as a wide spectrum of antimicrobial activity, including against viruses, short exposure time, and good skin tolerance.

The problem of medical personnel compliance with hand hygiene rules

Numerous epidemiological studies of the adherence (compliance) of medical personnel to the recommended rules of hand hygiene show unsatisfactory results. On average, medical staff compliance with hand sanitizing requirements is only 40%, and in some cases much lower. Interesting fact is that doctors and junior medical staff are much more likely than nurses to not follow recommendations for hand antiseptics. The highest level of compliance is observed on weekends, which is apparently associated with a significant reduction in workload. Lower levels of hand hygiene are recorded in intensive care units and during busy periods of patient care, while the highest levels are observed in children's wards.

Obvious barriers to proper implementation of recommendations hand treatment by medical personnel are skin allergic reactions, low availability of means for hand antisepsis and conditions for its implementation, priority of measures to care for the patient and provide medical assistance to him, the use of gloves, lack of working time and high professional load, forgetfulness of medical workers, lack of basic knowledge of existing requirements, misunderstanding of the role of hand cleaning in the prevention of HCAI.

Activities to improve hand hygiene practices in a medical organization, there should be extensive educational programs among personnel on hand hygiene issues, monitoring the application of acquired knowledge in professional activity, development of written recommendations on the issues of antiseptic treatment when performing various manipulations, reducing the workload on medical workers, creating appropriate conditions for hand hygiene, providing staff not only with antiseptics, but also skin care products, various administrative measures, sanctions, support and encouragement of employees , performing high-quality hand treatment.

Implementation in organizations carrying out medical activities, modern antiseptics, skin care products and hand hygiene equipment, as well as extensive educational programs for medical personnel, are absolutely worthwhile. Data from numerous studies show that the economic costs associated with treating 4-5 cases of moderate HAI exceed the annual budget required to purchase hand hygiene products for the entire health care organization (HPO).

Medical gloves

Another aspect related to hand hygiene for medical personnel is use of medical gloves. Gloves significantly reduce the likelihood occupational infection upon contact with patients or their secretions, reduce the risk of contamination of the hands of medical personnel with transient microflora and its subsequent transmission to patients, and prevent infection of patients with microorganisms that are part of the resident flora of the hands of medical workers. By creating an additional barrier to potentially pathogenic agents, gloves simultaneously protect both the healthcare worker and the patient.

The use of gloves is an important component of universal precautions and infection control in healthcare facilities. However, medical personnel often neglect to use or change gloves even in cases where there are clear indications for this, which significantly increases the risk of transmission of infection both to the medical worker himself and from one patient to another through the hands of staff.

According to existing requirements of sanitary legislation gloves must be worn in all of the following situations :

There is a possibility of contact with blood or other biological substrates potentially or obviously contaminated with microorganisms;

There is a possibility of contact with mucous membranes or damaged skin of the patient.

If gloves are contaminated with blood or other biological fluids, in order to avoid contamination of hands during the process of removing gloves, remove visible contamination with a swab or napkin moistened with a solution of a disinfectant or skin antiseptic. Used gloves are disinfected and disposed of along with other medical waste of the appropriate class.

The significant effectiveness of gloves in preventing contamination of the hands of medical personnel and reducing the risk of transmission of microorganisms during the provision of medical care has been confirmed in clinical studies. However, healthcare workers must be aware that gloves cannot provide complete protection against microbial contamination of the hands. Microorganisms are able to penetrate through the smallest defects, pores and holes in the material, and also get onto the hands of personnel during the procedure for removing gloves. Penetration of liquids into gloves is most often observed in the area of ​​the fingertips, especially the thumb. However, only 30% of medical personnel notice such situations. In connection with these circumstances, before putting on gloves and immediately after removing them, it is necessary to carry out antiseptic treatment of hands.

Gloves are single-use medical devices and therefore decontamination and reprocessing are not recommended. This practice should be avoided, including in organizations engaged in medical activities, where the level of material resources is low and the supply of gloves is limited.

The following main ones are distinguished types of medical gloves:

Examination (diagnostic) gloves;

Surgical gloves with an anatomical shape, providing high-quality wrist girth;

Special purpose (for use in various branches of medicine): orthopedic, ophthalmological, etc.

To make putting on gloves easier, manufacturers use various substances. Most often, talc, starch-containing powder, magnesium oxide, etc. are used. It should not be forgotten that the use of powdered gloves can lead to a decrease in tactile sensitivity. It is undesirable for glove powder to get into the wound area, since cases of postoperative complications due to hypersensitivity reactions in patients have been described. The use of powdered gloves in dental practice is not recommended, as this can cause discomfort in the patient’s oral cavity.

The following requirements apply to medical gloves: :

Should fit snugly to the hand throughout the entire time of use;

Should not cause hand fatigue and correspond to the size of the healthcare worker’s hand;

Must maintain good tactile sensitivity;

The material from which the gloves are made, as well as the substances used to powder them, must be hypoallergenic.

Compliance modern requirements to hand hygiene of medical personnel can significantly improve the quality of medical care in healthcare facilities by significantly reducing the risk of patients becoming infected with HAIs.

Literature

1. Afinogenov G. E., Afinogenova A. G. Modern approaches to hand hygiene of medical personnel // Clinical microbiology and antimicrobial chemotherapy. 2004. T. 6. No. 1. P. 65−91.
2. Hand hygiene and the use of gloves in health care facilities / Ed. Academician of the Russian Academy of Natural SciencesL. P. Zuevoy. St. Petersburg, 2006. 33 p.
2. Opimakh I. V.The history of antiseptics is a struggle of ideas, ambitions... // Medical technologies. Evaluation and selection. 2010. No. 2. P. 74−80.
3. WHO guidelines on hand hygiene in health care: summary, 2013. Access mode:http:// www. who. int/ gpsc/5 may/ tools/9789241597906/ ru/ . Date of access: 11/01/2014.
4. SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities.”

Dubel E.V., head epidemiological department, epidemiologist of the Vologda City Hospital No. 1; Gulakova L. Yu., chief nurse of the Vologda City Hospital No. 1

STAFF HANDS TREATMENT

1. Hand treatment is carried out in specially designated places. It is forbidden to wash your hands over a sink to wash pharmaceutical glassware.
2. To mechanically remove contaminants and microflora, wash hands with warm running water and soap for 1-2 minutes, paying attention to the periungual spaces. It is optimal to use varieties of soap with high foaming ability (bath, children's, laundry). Then the hands are rinsed with water to remove soap and treated with disinfectants.
3. In the aseptic block (in the airlock), after rinsing, hands are wiped dry, sterile clothes are put on, then hands are washed off with water and treated with disinfectants. The treatment is repeated if the work lasts more than 4 hours.
4. To disinfect the skin of the hands, use ethyl alcohol 70% or other alcohol-containing preparations (AHD-2000, octoniderm, octonisept), a solution of chlorhexidine bigluconate 0.5% (in 70% ethyl alcohol), a solution of iodopirone and other iodophors (iodonate, iodovidone) 1%, chloramine B solution 0.5% (in the absence of other drugs) or other means approved by the Ministry of Health of the Russian Federation for these purposes.
5. When disinfecting hands with alcohol-containing preparations, wipe them gauze pad, moistened with solution. At the same time tanning of the leather is achieved; when using solutions of chlorhexidine or iodophors, the drug is applied to the palms in an amount of 5-8 ml and rubbed into the skin of the hands; When treating hands with a chloramine solution, immerse them in the solution and wash for 2 minutes, then allow the hands to dry.
6. When finishing work, wash your hands with warm water and treat them with emollients, for example, a mixture of equal parts of glycerin, alcohol, 10% ammonia solution and water, which is shaken thoroughly before use. It is possible to use other emollients and ready-made creams that provide elasticity and strength to the skin of the hands.

| | sterilization-autoclave, | | | | | | distillation | | | | |_________|______________________________|______|________|_____________| |18 C |Control and analytical, | 2 | 3 | 1 | | |sterilization solutions, | | | | |unpacking | | | | |_________|______________________________|______|________|_____________| |18 C |Premises for preparation | 4 | 2 |not | | |medicines under aseptic conditions | | |allowed | | |__________________________________________|______|________|_____________| | |Stock storage premises: | | | | |_________|______________________________|______|________|_____________| |18 C |a) medicinal substances, | 2 | 3 | 1 | | | dressings, heat-labile | | | | | |drugs and medical supplies| | | | | |appointments | | | | |_________|______________________________|______|________|_____________| |18 C |b) medicinal plant | 3 | 4 | 3 | | |raw materials | | | | |_________|______________________________|______|________|_____________| |18 C |c) poisonous drugs and drugs| - | 3 | 3 | |_________|______________________________|______|________|_____________| | 18 C | d) flammable and combustible | - | 10 | 5 | | |liquids | | | | |_________|______________________________|______|________|_____________| |18 C |e) disinfectants, acids, | - | 5 | 3 | | |disinfection | | | | |_________|______________________________|______|________|_____________| Appendix 5 to the Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) Preparation of personnel for work in the aseptic unit. Rules of conduct 1. Trained personnel of the aseptic unit must have a special set of sanitary technical clothing: a robe or trouser suit or overalls (optimally a stand-up collar, tied at the waist, tight-fitting cuffs); safety shoes and shoe covers; a cap or helmet with a mask or hood covering the mouth and nose, and, if necessary, rubber gloves without talc. The set must be made from materials or mixed fabrics that meet hygienic requirements and have minimal lint. 2. A set of clothing is sterilized in containers in steam sterilizers at 120 C for 45 minutes or at 132 C for 20 minutes and stored in closed containers for no more than 3 days. If possible, use a set of disposable sterile clothing. 3. Before starting and after finishing work, personnel’s shoes are disinfected and stored in closed cabinets or in boxes in the airlock. Disinfection is carried out by wiping the outside twice with a chloramine solution of 1% or 0.75% with the addition of 0.5% detergent, or a solution of hydrogen peroxide 3% with 0.5% detergent. In addition, shoes are disinfected in a bag of cotton wool moistened with a 40% formaldehyde solution or acetic acid 40%, neutralized with ammonia or alkali. 4. Entry and exit in aseptic rooms, transfer of necessary items and materials must be carried out only through an airlock. Every time you enter aseptic room a set of sterile clothing should be changed. 5. When entering the airlock, put on shoes. It is advisable to provide a double-sided bench with cells for shoes in the lower part. Sitting on a bench, the employee takes off his slippers and places them in an individual compartment. Then, throwing his legs over the bench, he turns 180 degrees. and takes a bag or bag with sterile technical clothing from an individual shelf or rack. The bench is designed to conditionally separate the stages of preparation. After washing and drying your hands, put on a set of sterile clothing, except gloves), then clean your hands and, if necessary, put on sterile gloves. 6. During work, the minimum required number of workers must be present in the aseptic unit. Personnel movements should be slow, smooth, and rational. Sudden movements should be avoided, conversations and movements should be limited. If oral communication is necessary with a staff member located outside the aseptic unit, a telephone or other intercom device should be used. 7. For notes, use pre-cut sheets of parchment and ballpoint pens or felt-tip pens, which should be wiped with a lint-free cloth moistened with ethyl alcohol. 8. When working under aseptic conditions, it is prohibited to: - enter the aseptic room in non-sterile clothing and leave the aseptic unit in sterile clothing; - have bulky fleecy clothing under sterile sanitary clothing or in which the employee is on the street; - use cosmetics and aerosol deodorants; - wear watches and jewelry; - bring in personal items (keys, combs, handkerchiefs, etc.); - clean your nose, to do this you should go out into the airlock, use a sterile scarf or napkin; then wash and disinfect your hands; - pick up and reuse objects that fall on the floor during work; - rubbing your hands or face, scratching your head, bending over bottles or other containers with medicines; - use pencils, erasers, fountain pens. Appendix 6 to the Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) Hand treatment of personnel 1. Hand treatment is carried out in specially designated places. It is forbidden to wash your hands over a sink to wash pharmaceutical glassware. 2. To mechanically remove contaminants and microflora, wash hands with warm running water and soap for 1-2 minutes, paying attention to the periungual spaces. It is optimal to use varieties of soap with high foaming ability (bath, children's, laundry). Then the hands are rinsed with water to remove soap and treated with disinfectants. 3. In the aseptic block (in the airlock), after rinsing, hands are wiped dry, sterile clothes are put on, then hands are washed off with water and treated with disinfectants. The treatment is repeated if the work lasts more than 4 hours. 4. To disinfect the skin of the hands, use ethyl alcohol 70% or other alcohol-containing preparations (AHD-2000, octoniderm, octonisept), a solution of chlorhexidine bigluconate 0.5% (in 73% ethyl alcohol), a solution of iodopirone and other iodophors (iodonate, iodovidone) 1%, chloramine B solution 0.5% (in the absence of other drugs) or other means approved by the Ministry of Health of the Russian Federation for these purposes. 5. When disinfecting hands with alcohol-containing preparations, wipe them with a gauze cloth moistened with a solution. At the same time tanning of the leather is achieved; when using solutions of chlorhexidine or iodine, the drug is applied to the palms in an amount of 5-8 ml and rubbed into the skin of the hands; When treating hands with a chloramine solution, immerse them in the solution and wash for 2 minutes, then allow the hands to dry. 6. When finishing work, wash your hands with warm water and treat them with emollients, for example, a mixture of equal parts of glycerin, alcohol, 10% ammonia solution and water, which is shaken thoroughly before use. It is possible to use other emollients and ready-made creams that provide elasticity and strength to the skin of the hands. Head of the Department for the Organization of Provision of Medicines and Medical Equipment T.G. Kirsanova Appendix 7 to the Instructions on the sanitary regime of pharmaceutical organizations (pharmacies) Rules for the operation of bactericidal lamps (irradiators) * Germicidal irradiators are low-pressure gas-discharge lamps emitting ultra-violet rays with a wavelength of 254 nm, corresponding to the region of greatest bactericidal action of radiant energy. Irradiators have open lamps for rapid disinfection of air and surfaces in the absence of people and shielded lamps for irradiating the upper layers of air in the presence of people (while the lower layers of air are disinfected due to convection). 1. Use of open lamps. 1.1. Open bactericidal lamps are used in the absence of people, during breaks between work, at night, or at specially designated times - before starting work for 1-2 hours. 1.2. Switches for open lamps should be placed in front of the entrance to the production room and equipped with a warning sign: “Bactericidal lamps are on” or “Do not enter, the bactericidal irradiator is on.” It is prohibited for people to be in rooms where unshielded lamps are operating. 1.3. Entry into the room is permitted only after the unshielded bactericidal lamp is turned off, and a long stay in the specified room is allowed only 15 minutes after the turn off. 1.4. The installed power of open lamps should not exceed (2-2.5) W of power consumed from the network per 1 m@ of room. 2. Use of shielded lamps. 2.1. Air disinfection in the presence of people can be carried out by placing shielded bactericidal lamps in special fittings at a height of at least 2 m from the floor. The fittings should direct the flux of lamp rays upward at an angle ranging from 5 to 80 C above the horizontal surface. 2.2. Shielded germicidal lamps can operate up to 8 hours a day. If, after 1.5-2 hours of continuous operation of the lamps in the absence of sufficient ventilation, a characteristic ozone odor is felt in the air, it is recommended to turn off the lamps for 30-60 minutes. 2.3. When using a tripod irradiation unit for special irradiation of any surfaces, it must be brought as close as possible to carry out irradiation for at least 15 minutes. 2.4. The installed power of shielded lamps should not exceed 1 W of power consumed from the network per 1 cubic meter. m of premises. 3. The optimal climatic parameters for the operation of bactericidal irradiators are - ambient air temperature 18-25 C and relative humidity no more than 65%. 4. The average service life of the germicidal lamp is 1500 hours. It is necessary to take into account the operating time of each irradiator in a special journal, recording the time the lamp is turned on and off. Do not use germicidal lamps with expired suitability. 5. Exterior finishing bactericidal irradiators allows wet sanitary treatment of external surfaces. Head of the Department for the Organization of Supply of Medicines and Medical Equipment T.G. Kirsanova * - Premises where bactericidal lamps are installed: distillation, washing-sterilization, assistant-aseptic, sterilization of dosage forms. Appendix 8 to the Instructions on the sanitary regime of pharmacy organizations (pharmacies) Table 1. Means and modes of disinfection of various objects (thermal) Table 2. Means and modes of disinfection of various objects (chemical) Table 1 Means and modes of disinfection of various objects (thermal) __________________________________________________________________________________________________________ | Name of object |Disinfectant|Disinfection mode using thermal methods |Conditions | | |agent | |carrying out | | | |_______________________________________________|disinfection | | | |temperature C |holding time | | | | |_______________________|______________________| | | | |nominal|ultimate|nominal|ultimate| | | | |value |deviation|value |deviation| | |__________________________|_______________|___________|__________|___________|__________|________________| |Glass, metal products,|Purified water | | _ | | |Boiling | |heat-resistant polymer | | 96 | + 1 | 30 | +5 |at full | |__________________________|_______________|___________|__________|___________|__________|________________| | materials, rubber | or water | | | | |immersion | | (spatulas, scissors, | cleaned | | | | | products in | | tweezers, tubes, brushes for | with 2% sodium | | | | | water | | hand washing, brushes) | bicarbonate | | | 15 | |disinfecting | | | | | | | | boiler | |__________________________|_______________|___________|__________|___________|__________|________________| | | | | _ | | | | |Glass products, |Water | 110 | +2 | 20 | +5 |In steam | |metal, rubber, latex |saturated | | | | |sterilizer, | | and heat-resistant polymers | steam under | | | | |packed in | | |redundant | | | | |sterilization| | |pressure | | | | |boxes | | | P=0.05 | | | | | | | |MPA | | | | | | | |(0.5 kgf/ | | | | | | | |cm2) | | | | | | |__________________________|_______________|___________|__________|___________|__________|________________| |Brushes for washing hands | | 120 | | 20 | | | |__________________________|_______________|___________|__________|___________|__________|________________| | | | | _ | | | | |Glass products, |Dry hot | 120 | +4 | 45 | +5 |In the air | |metal |air | | | | | sterilizer | | | | | | | |without packaging | | | | | | | |(in trays) | |__________________________|_______________|___________|__________|___________|__________|________________| | | | | _ | | | | |Rags, rags for |Water | 96 | +1 | 30 | +5 |After washing | |cleaning | | | | | |boiling | | | | | | | |at full | | | | | | | |immersion | | | | | | | |into the water | |__________________________|_______________|___________|__________|___________|__________|________________| Table 2 Means and modes of disinfection of various objects (chemical) _____________________________________________________________________________________________________ | Name|Disinfectant agent |Disinfection mode |Processing method |Methodological *| | object | | | |instructions, N | | | |_________________________| | | | | |concentration,|exposure,| | | | | |in% |in min | | | |___________||_______________________|___________|___________|_____________________|______________| | 1 | 2 | 3 | 4 | 5 | 6 | |___________||_______________________|___________|___________|_____________________|______________| | Premises, | 1) chloramine B | 1 |30-60 |2 times wiping |N 1359-75 | |items | | | |or irrigation | | | conditions, | | | |surfaces from | | |equipment | | | |calculation 300 ml/m2 | | |(walls, |_______________________|___________|___________|_____________________|______________| |doors, floor, |2) chloramine B with |0.75 | | | | |hard |0.5% detergent | | | | | | furniture) | facilities | | | | | | |_______________________|___________|___________|_____________________|______________| | |3) hypochlorite | | | | | | |sodium | 1 | 60 |irrigation |N 9429-71 | | |_______________________|___________|___________|_____________________|______________| | |4) hypochlorite |0.5 | |wiping twice|N 15-6/15 | | | sodium obtained in | | |with an interval of 15 minutes |15. 02.1989 | | |electrochemical | | |200 ml/m2 | | | |installation ELMA-1 | | | | | | |_______________________|___________|___________|_____________________|______________| | |5) peroxide | 3 | 60 |followed by |N 858-70 | | |hydrogen with 0.5% | | |wiping dry |08/29/1970 | | | detergent | | | clean rags | | |____________________|________________________|____________________|___________|_____________________| | | Rugs from | 1) chloramine B with | 0.75 | 30 |Immersion in solution | | | porous | 0.5% detergent | | | | | | rubber | means | | | | | | |_______________________|___________|___________|____________________| | | |2) peroxide | 3 | 30 | Same | | | |hydrogen with 0.5% | | | | | | | detergent | | | | | |____________________|________________________|____________________|___________|_____________________| | |Rugs from | Peroxide | 3 | 30 | " | | | foam | hydrogen with 0.5% | | | | | | | detergent | | | | | |_____________|________________________|_____________|___________|_____________________ | | | Cleaning |1) chloramine B | 1 | 60 | Immerse in the solution, | | |equipment |___________________________|_____________|___________|washed and dried | | |rags | | | | | | | |2) dichlor 1 | 2 | 60 | | | | |________________________|_____________|___________| | | |3) chlordesine | 1 | 60 | | | | |________________________|_____________|___________|_____________________|______________| | |4) hypochlorite | 1 | 60 |Immersion based on|N 942a-71 | | |sodium | | | 4-5 liters per 1 kg of dry | | | | | | |weight of things | | | |___________________________|_____________|___________|_____________________|______________| | |5) hydrochlorite |0.25 | 60 |Soaking, |N 15-6 /15 | | |sodium obtained in | | |washing with |15.02.89 | | |electrochemical | | |subsequent washing and | | | |installation ELMA-1 | | |drying | | | |________________________|_____________|___________| _____________________| | | |6) peroxide | 3 | 120 |Soaking | | | |hydrogen with 0.5% | | | | | | | detergent | | | | | |____________________|________________________|____________________|___________|_____________________| | |Hands |1) ethyl | 20 | |After washing with soap | | |personnel ** |alcohol | | | wipe with gauze | | | | | | | with a napkin moistened | | | | | | | solution | | | |_______________________|___________|___________|____________________| | | |2) solution |0.5 | | | | | |chlorhexidine | | | | | | | bigluconate at 70 | | | | | | |% ethyl alcohol | | | | | | |_______________________|___________|___________|____________________| | | |3) solution | 1 | |(2 and 3) drug | | | |iodopirone | | | applied to the palms | | | | (iodonate, | | | in the amount of 5-8 ml and | | | | iodovidone) | | | rubbed into the skin of the hands | | | |_______________________|___________|___________|____________________| | | |4) chloramine B | 0.5 | |Hands are immersed in | | | | (apply | | | solution and wash in | | | | in the absence of | | | for 2 minutes, then | | | | other drugs) | | |allow to dry | | |____________________|________________________|____________________|___________|_____________________| | |Footwear |1) chloramine B | 1 | |2 times wiping | | | |_______________________|___________|___________|____________________| | | |2) chloramine B with |0.75 | | | | | |0.5% detergent | | | | | | | means | | | | | | |_______________________|___________|___________|____________________| | | |3) peroxide | 3 | | | | | |hydrogen with 0.5% | | | | | | | detergent | | | | | | |_______________________|___________|___________|____________________| | | |4) solution | 40 | |In a packer with fleece, | | | |farmaldehyde | | | moistened with solution, | | | | | | |neutralized | | | | | | | ammonia solution or | | | | | | |alkali | | | |_______________________|___________|___________|____________________| | | |5) solution | 40 | | | | | |acetic acid | | | | | |____________________|________________________|____________________|___________|_____________________| | |Sanitary - |1) detergent-disinfectant|0.5g per | 5 |Wipe with dampener| | |technical |products: "Dichlor-1", |100 cm2 | |rags | | | equipment | "Belka", etc. ; | | | | | |(sinks, |cleaning and disinfecting | | | | | |toilets, etc.)|preparations: "Desus", | | | | | | |"Sanita", "Shine-2", | | | | | | | "PChD" etc. | | | | | | |_______________________|___________|___________|____________________| | | |2) Chloramine B | 1 | |2 times wiping | | | |_______________________|___________|___________|____________________| | | |3) Chloramine B with |0.75 | |Same | | | |0.5% detergent | | | | | | | means | | | | | | |_______________________|___________|___________|____________________| | | |4) Hypochlorite | | |2 times abundant | | | |sodium | 1 | |irrigation | | | |_______________________|___________|___________|____________________| | | |5) Hypochlorite |0.25 | 60 |2 times wipe | | | | sodium obtained in | | |followed by | | | |electrochemical | | |exposition | | | |installation ELMA-1 | | | | | | |_______________________|___________|___________|____________________| | | |6) Peroxide | 3.0 | 60 |Irrigation with | | | |hydrogen with 0.5% | | |subsequent | | | | detergent | | |wiping | | | | | | |rags moistened | | | | | | | in disinfectant solution | | |___________||_______________________|___________|___________|_____________________|______________| After finishing the treatment (disinfection), the premises must be ventilated. * - See Collection of the most important official materials on the issues of disinfection, sterilization, disinsection, and deratization. T.1, T.2, M., 1994 ** After finishing work, hands are washed with warm water and treated with emollients. After disinfection by immersion, the products must be washed in running water until the smell of the disinfectant is completely removed. The disinfectant solution should be used once. Head of the Department for the Supply of Medicines and Medical Equipment T.G. Kirsanova Appendix 9 to the Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) Processing of closures and auxiliary material 1. New rubber stoppers are washed manually or in washing machine in a hot (50-60 C) 0.5% solution of detergents such as "Lotus", "Astra" for 3 minutes (the ratio of the weight of plugs and detergent solution is 1:5); washed 5 times hot tap water, each time replacing it with fresh and once purified water; boil in 1% sodium bicarbonate solution for 30 minutes, wash 1 time with tap water and 2 times with purified water. Then they are placed in glass or enamel containers, filled with purified water, closed and kept in a steam sterilizer at 120 C for 60 minutes. The water is then drained and the plugs are washed again with purified water. 2. After processing, the plugs are sterilized in containers in a steam sterilizer at 120 C for 45 minutes. Sterile stoppers are stored in closed containers for no more than 3 days. Once the bottles are opened, the caps must be used within 24 hours. When harvesting for future use, after processing, without sterilization, rubber stoppers are dried in an air sterilizer at a temperature not exceeding 50 C for 2 hours and stored for no more than 1 year in closed containers or jars in a cool place. Before use, rubber stoppers are sterilized in a steam sterilizer at 120 C for 45 minutes. 3. After inspection and rejection, aluminum caps are kept for 15 minutes in a 1-2% solution of detergents, heated to 70-80 C. The ratio of the mass of the caps to the volume of the washing solution is 1:5. Then the solution is drained and the caps are washed with running tap water, then with purified water. Clean caps are placed in containers and dried in an air sterilizer at a temperature of 50-60 C. Stored in closed containers (boxes, jars, boxes) under conditions that prevent their contamination. 4. New polyethylene plugs are washed several times with tap water (50-60%). If the plugs become dirty during storage, they are pre-washed using detergents. Then the corks are rinsed with purified water and sterilized by immersion in a fresh 6% solution of hydrogen peroxide for 6 hours, after which they are washed with purified water and dried in an air sterilizer at 50-60 C. The dried corks are stored in sterile jars with ground corks, bottles for 3- x days in conditions that prevent their contamination. 5. New plastic screw-on plugs are washed several times with tap water (50-60 C), and contaminated ones - using detergents, then dried in an air sterilizer at 50-60 C. The dried plugs are stored in closed boxes, drawers, etc. under conditions that prevent their contamination. 6. Auxiliary material placed for sterilization in jars (jars) in a ready-to-use form (parchment and filter paper, gauze cut into pieces the right size; tampons are made from cotton wool, etc.). Sterilize in a steam sterilizer at 120 C for 45 minutes. Store in closed containers or jars for 3 days, after opening the material is used within 24 hours. Head of the Department for the Organization of Supply of Medicines and Medical Equipment T.G. Kirsanova Appendix 10 to the Instructions for the sanitary regime of pharmaceutical organizations (pharmacies) Processing of pharmaceutical glassware Processing of glassware includes the following technological operations: - disinfection; - soaking and washing (or washing-disinfecting treatment); - rinsing; - drying (or sterilization); - processing quality control. 1. Disinfection of used utensils Used pharmaceutical utensils received from the population or from infectious diseases departments of medical institutions must be disinfected. For disinfection, use a 1% solution of activated chloramine with immersion of dishes for 30 minutes or a 3% solution of hydrogen peroxide with immersion for 80 minutes. Disinfectant solutions are prepared in containers (tanks) made of glass, plastic or enamel-coated (enamel without damage) in quantities necessary to completely immerse the dishes being treated. Solutions of activated chloramine are prepared by dissolving chloramine in tap water (100 g per 10 liters of working solution) followed by adding an equal amount of activator (ammonium chloride or sulfate or nitrate). To prepare 10 liters of 3% hydrogen peroxide solution, take 1200 ml of hydrogen peroxide, adding it to the appropriate amount of water. Storage of prepared disinfectant solutions should not exceed 24 hours. Reuse the same solution is not allowed. The dishes in a perforated container are dipped into a tank with a disinfectant solution and left for a certain time (30 or 80 minutes). After disinfection, the dishes are washed with running tap water until the smell of the disinfectant disappears and washed with detergent solutions. 2. Washing pharmaceutical glassware Pharmaceutical glassware (new and used after disinfection) is soaked in a solution of an existing detergent of the appropriate concentration: ________________________________________________________________________________ | Name of detergent | Concentration | Consumption in g per | | | | 10 l worker | | | | solution | |_______________________________________________|________________|_______________| | 1. Mustard (powder) | 5.0 | 500.0 | |_______________________________________________|________________|_______________| | 2. Sodium bicarbonate | 0.5 | 50.0 | |_______________________________________________|________________|_______________| | soap shavings | 0.5 | 50.0 | |_______________________________________________|________________|_______________| | 3. SMS - detergent | | | | synthetic | 1.0 | 100.0 | |_______________________________________________|________________|_______________| | 4. Lotus, Astra, etc. | 0.5 | 50.0 | |_______________________________________________|________________|_______________| | 5. Progress (liquid) | 0.2 | 20.0 | |_______________________________________________|________________|_______________| | 6. Dishwasher | 0.5 | 50.0 | |_______________________________________________|________________|_______________| The detergent is dissolved in water heated to 50-60 s. The dishes are soaked in the solution for 25-30 minutes at full immersion . Heavily soiled dishes are soaked for a longer time. The dishes are washed in the same solution using a brush. When washing dishes with mustard, scrubbing is done with hot water. When using synthetic detergents, washing and rinsing with a washing machine is possible. 3. Washing and disinfecting treatment of dishes It is most rational to treat returnable dishes with solutions of detergents and disinfectants. For this purpose, for heavily soiled dishes, it is advisable to use a 1% solution of chlorcin or 0.2% DP-2 with immersion for 120 minutes. For the rest of the dishes, use a 0.5% solution of chlorcin, a 0.1% solution of DP-2 or a 3% solution of hydrogen peroxide with the addition of 0.5% detergent. To prepare working solutions, use closed containers made of glass, plastic or coated with enamel (the enamel is not damaged). For 10 liters of working solution, 50.0 chlorcinate or 10.0 DP-2 or 1.2 liters of perhydrol with the addition of 50.0 detergent is required. The dishes are completely immersed in a warm solution (40-50 C), kept in it for 15 minutes, then washed in the same solution using a brush. After this, rinse with running tap water (hot) until the smell of the disinfectant completely disappears, but at least 5-7 times. The final washing of the dishes is carried out with purified water. 4. Rinsing pharmaceutical glassware Rinsing glassware is carried out with tap and purified (distilled) water. Pharmaceutical containers are rinsed with tap water 7 times, then with purified water - 1 time. When treating dishes with mustard, it is enough to rinse with tap water 5 times. Glassware intended for making sterile solutions is rinsed with tap water 5 times, and with purified water - 3 times. It is optimal to carry out the last rinse with water for injection filtered through a 5 micron filter. 5. Drying and sterilizing dishes Clean dishes are dried and stored in closed cabinets. Bottles intended for injection solutions and eye drops are sterilized. Sterilization mode: hot air - at 180 C - 60 minutes or saturated steam under pressure at 120 C - 45 minutes. After the temperature in the sterilizer has decreased to 60-70 C, the dishes are removed, closed with sterile stoppers and used for bottling solutions. 6. Processing quality control Control of the cleanliness of washed dishes is carried out visually (selectively for the absence of foreign inclusions, stains, smudges, and for the uniformity of water flowing from the walls of the bottles after rinsing them. If it is necessary to detect possible fatty contaminants on the surface of the dishes, control is carried out with a reagent containing Sudan III . To do this, the inner surface of the washed and dried dishes is moistened with 3-5 ml of the coloring solution, distributed over the surface under study for 10 seconds, then quickly washed off with a copious stream of water. There should be no yellow spots or smudges on the inner surface of the cookware. Preparation of the coloring solution: 0.2 g of crushed paint Sudan III and methyl blue are dissolved in 70 ml of ethyl alcohol heated to 60-90%, then 10 ml of a 20-25% ammonia solution and 20 ml of distilled water are added and shaken. The solution is good for 6 months. The completeness of rinsing of synthetic detergents and detergents-disinfectants is determined by the pH value using the potentiometric method. The pH value of the purified water after complete rinsing of the dishes should correspond to the pH of the source water taken for the control rinse. Approximately the presence of detergent residue can be determined by a pink coloration with phenol-phthalein. 7. Precautions when working with detergents and disinfectants and first aid The clothing of personnel involved in the preparation and use of solutions of detergents, disinfectants and disinfectants should consist of a robe, scarf, and rubber gloves. When dosing the drug, you must use safety glasses and a respirator (or a 4-layer gauze bandage). If perhydrol gets on the skin, wash it off immediately with water. If a powdered chlorine-containing product comes into contact with the skin, wash this area of ​​skin with water and soap and treat with a 2% solution of sodium hyposulfite or sodium bicarbonate. If the drug solution gets into the eyes, the eyes should be rinsed immediately with a stream of clean water, then with a 2% sodium bicarbonate solution for several minutes. If there are signs of inflammation of the mucous membrane, it is necessary to drip a solution of sodium sulfacyl into the eyes; if there is pain, a 2% solution of novocaine. After finishing work, your face and hands should be washed with soap. Head of the Department for the Organization of Supply of Medicines and Medical Equipment T.G. Kirsanova Appendix 11 to the Instructions on the sanitary regime of pharmaceutical organizations (pharmacies) Regimes and methods of sterilization of individual objects I. Steam method (saturated water steam under excess pressure) II. Air sterilization method (dry hot air) III. Chemical method sterilization (solutions of chemicals) Table 1 I. Steam method (saturated water steam under excess pressure) ________________________________________________________________________________________________________________ |Name | Sterilization mode * |Conditions |Term | |object |__________________________________________________________|sterilization in |preservation | | |Steam pressure in |Working |Time |steam sterilizer|sterility| | |sterilization|temperature in |sterilization | | | | |sterilization|holding chamber, min. | | | | |MPA (kgf/cm2) |chamber, C | | | | | |________________|________________|_________________| | | | |nom.|prev. |nom.|prev. |nom.|prev. | | | | |meaning |off |meaning |off |meaning |off | | | |____|______|_________|______|_________|______|__________|_____________________|____________| |Glass | | | | | | |Sterilization |Term | | dishes, mortars, | | | | | | | carried out without | saving | |products from: | | | | | | |packaging or in |sterility| |glass, textiles |0.20 |+-0.02 |132 | +-2 | 20 | +2 |sterilization |products | |(robes, |(2.0) |(+-0.2) | | | | |box | in packaging | | cotton wool, gauze, | | | | | | |or in packaging | 3 days | | filter | | | | | | |made ​​of 2-layer | | |paper) | | | | | | |parchment | | |corrosion-resistant|______|_________|______|_________|______|__________|grade A paper | | |metal |0.11 |+-0.02 |120 ​​| +-3 | 45 | +3 |or B or c | | | |(1,1) |(+-0,2) | | | | |glass | | | | | | | | | |banks | | |____|______|_________|______|_________|______|__________|_____________________|____________| |Products from |0.11 |+-0.02 |120 ​​| +-3 | 45 | +3 |Sterilization | | |rubber, latex |(1.1) |(+-0.2) | | | | |carry out either/or | | | and individual | | | | | | |- without packaging | | |polymer |______|_________|______|_________|______|__________|_____________________|____________| |materials | | | | | | |- in sterilization | | |(polyethylene | | | | | | |boxes | | |high density,|______|_________|______|_________|______|__________|_____________________|____________| | |filters made of | | | | | | |soft packaging | | |fluoroplastic and | | | | | | |calico | lavsan) | | | | | | |- in parchment | | | | | | | | | | paper grade A or B | | | |______|_________|______|_________|______|__________|_____________________|____________| | | | | | | | |- in glass | | | | | | | | | | jars, flasks | | |____|______|_________|______|_________|______|__________|_____________________|____________| * Control temperature regime steam sterilization is carried out with a maximum thermometer with a scale of 150 C or thermocouples. A mixture of benzoic acid and fuchsin (10:1), melting point 121 C, is used as a chemical thermal test. Table 2 II. Air sterilization method (dry hot air) _______________________________________________________________________________________________ | Name |Sterilization mode* |Conditions |Term | | object |_________________________________|carrying out |saving | | |Working |Time |sterilization in |sterility | | |temperature in |sterilization|steam | | | |sterilization|exposure, min. | sterilizer | | | | camera, C | | | | | |________________|________________| | | | |nomin. |prev. |nom.|prev. | | | | |meaning |off |meaning |off | | | |__________________|_________|______|______|_________|______________________|__________________| |Glassware,|180 |+2 -10| 60 | +5 |Sterilization |- Products, | |mortars, products from| | | | |exposed |sterilized| |silicone rubber|_________|______|______|_________|______________________|packed, | | | | | | | dry products. |stored for 3 days | | |160 |+2 -10| 150 | |Sterilization is carried out:| | | | | | | |______________________|_________________| | | | | | |- in packaging | | | | | | | |made ​​of paper |- Without packaging | | | | | | | (bag or | must be | | | | | | | moisture-resistant) | used | | | | | | |______________________|directly | | | | | | |- or without | after | | | | | | | packaging in | sterilization | | | | | | |open | | | | | | | | containers | | |__________________|_________|______|______|_________|______________________|__________________| Note: After the temperature in the sterilizer has decreased to 60-70 C, pharmaceutical containers are removed and immediately closed with sterile stoppers. * Air sterilization is controlled using indicator paper (based on thermal indicator paint N 6), which changes color at 160 C, or chemical thermal tests are used: sucrose, thiourea, melting point 180 C; hydroquinone, melting point 170 C. Table 3 III. Chemical method of sterilization (solutions of chemicals) ___________________________________________________________________________________________________ |Name |Disinfectant|Disinfection mode |Conditions |Term | |object |agent |thermal methods |carrying out |preservation | | | |__________________________|disinfection |sterilized | | | |temperature |time | |products | | | |From |excerpts | | | | | |___________|___________| | | | | |nomin.|prev.|nomin.|prev. | | | | | |meaning |off|value |off | | | |_________________|_______________|______|_____|______|______|________________|____________________| |Products from |6% solution* | 18 | - | 360 | 3 |Closed |In a sterile container| |glass and | | | | | |containers made of |(sterilization | |corrosion-resistant|_______________|______|_____|______|______|glass, |box), | |metals |Peroxide | 50 | 32 | 180 | 35 | plastic | lined | |and certificates, |hydrogen | | | | |or covered |sterile | | polymer | (GOST | | | | | enamel | sheets - 3 days | | materials, | 177-88) | | | | |(enamel without | | |rubber | | | | | |damage) | | | | | | | | |________________| | | | | | | | |Sterilization | | | | | | | | | carried out at | | | | | | | | |complete | | | | | | | | |immersion | | | | | | | | |products in | | | | | | | | | solution on | | | | | | | | |time | | | | | | | | |sterilization| | | | | | | | |excerpts, | | | | | | | | |after which | | | | | | | | |product | | | | | | | | |wash | | | | | | | | |sterile | | | | | | | | | water in | | | | | | | | |sterile | | | | | | | | | containers | | |_________________|_______________|______|_____|______|______|________________|____________________| * - Technology, quality control and shelf life of 6% hydrogen peroxide solution produced in pharmacies ( Guidelines approved 07/18/1996) Head of the Department for the organization of supply of medicines and medical equipment T.G. Kirsanova Appendix 12 to the Instructions for the sanitary regime of pharmacy organizations (pharmacies) Requirements for microbiological purity medicines __________________________________________________________________________________ | N |Object name |Requirements for | Normative | |p/p|control |microbiological purity | document | |___|_________________________|___________________________|_______________________| | 1 | 2 | 3 | 4 | |___|_________________________|___________________________|_______________________| |1. |Purified water |No more than 100 microorganisms|FS 42-2619-97 | | | |in 1 ml in the absence of | | | | |Enterobacteriaceae; | | | | |P.aeruginosa, S.aereus | | |___|_________________________|___________________________|_______________________| |2. |Water for injection |Pyrogenicity |FS 42-2620-97 | |___|_________________________|___________________________|_______________________| |3. |Injection solutions |Sterility |GF XI, issue 2, | | |after sterilization* | |page 187 | |___|_________________________|___________________________|_______________________| |4. |Eye drops after |Sterility |GF XI, issue 2, | | |sterilization | |page 187 | |___|_________________________|___________________________|_______________________| |4.1|Eye drops, |Sterility |GF XI, issue 2, | | |cooked in | |page 187 | | |aseptic conditions | | | | |on sterile water | | | |___|_________________________|___________________________|_______________________| |5. |Main raw materials |No more than 100 bacteria and |Change to | | | (substances) for | mushrooms in total 1 g or | Article of the Global Fund XI, | | | production of sterile | 1 ml in the absence | issue 2, p. 187 | | |preparations |Enterobacteriaceae; | "Methods | | | |P.aeruginosa, S.aereus |microbiological | | | | |control of | | | | |medicines | | | | |drugs" (1995 | | | | |) | |___|_________________________|___________________________|_______________________| |6. |Medicines |Sterility |Order of the USSR Ministry of Health | | |for newborns | |N 1026 from | | |(solutions for internal | |10.19.82 "About | | |and external use, | |strengthening control | | |eye drops, | |for sanitary | | |homes, orphanages | | | | |therapeutic and preventive | | | | |institutions and pharmacies" | |___|_________________________|___________________________|_______________________| |7. |Children's medicinal |No more than 50 bacteria and |Change to | | | means (from 0 to 1 | mushrooms in total in 1 g or | article of the Global Fund XI, | | | of the year) | 1 ml in the absence | issue 2, p. 187 | | | |Enterobacteriaceae; | "Methods | | | |P.aeruginosa, S.aereus |microbiological | | | | |control of | | | | |medicines | | | | |drugs" (1995 | | | | | ) | | | | |_______________________| | | | |Methodological | | | | |instructions for | | | | | manufacturing | | | | |sterile | | | | | solutions in | | | | |pharmacies | | | | |(1994) | |___|_________________________|___________________________|_______________________| * The time interval from the start of preparing the solution to sterilization should not exceed 3 hours. Head of the Department for organizing the provision of medicines and medical equipment T.G. Kirsanova