Practices and procedures for personnel in cleanrooms and associated controlled environments. The quality of non-food products Maintaining the required level of its

In accordance with the terminology adopted according to GOST product quality management - these are actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality. Consider the classification of quality management methods.

Consider the classification of quality management methods.

Quality management methods are ways and means of carrying out management activities and impact on managed objects (means and products of labor) to achieve the goals in the field of quality. In the practice of quality management, mainly organizational and administrative (administrative), engineering and technological, economic and socio-psychological methods.

Quality management as a targeted impact is implemented by management subsystems that have an appropriate organization. AT general view quality management tasks are as follows: *

Define the right quality goals;

Achieve the goal, optimally using resources;

Establish and maintain appropriate relationships between people in the labor process (necessary culture);

Ensure continuous improvement.

The third of the above tasks is of particular importance. Its successful solution largely determines the effectiveness of the controlled process. When disparate forces are organized and directed towards achieving a single goal, a new productive force is born, which differs significantly from the simple arithmetic sum of its terms.

Let's consider separate groups of quality management methods.

ORGANIZATIONAL AND MANAGEMENT QUALITY MANAGEMENT METHODS are carried out through binding directives, orders and other instructions aimed at improving and ensuring the required level of quality.

The group of organizational and administrative methods of quality management should include methods:

- regulation (organizational, functional, official, structural);

– standardization (on the basis of standards of various levels and status);

- rationing (based on the norms of time, abundance, correlation, numerical values);

- instructions (introduction, explanations, advice, warnings, clarifications);

- administrative influences (on the basis of orders, directives, instructions, resolutions, control over execution using preventive and operational actions, etc.).

Among them it is necessary to note:

– development and implementation of a quality policy approved by the first heads of organizations; development and implementation of STP, guidelines, procedures and other NTD and NMD for quality management;

– development and implementation of regulations on subdivisions and job descriptions; selection, placement, education and certification of quality management personnel; introduction of best practices in quality management;

– enforcement targeted programs by quality; orders and orders for quality management; ensuring compliance with the requirements of MS, GOST and TU;

– control over the fulfillment of the requirements of PDD, NMD and decisions on management and quality assurance.

The quality policy is one of the most important constituent parts quality management. This document should be the primary one in the documentation when using organizational and administrative methods of quality management, this is due to the need for top managers to take responsibility for maintaining a quality policy, which in principle becomes the initial one when implementing systemic quality management.

When shaping policy enterprises in the field of quality should take into account the requirements for it: management should determine the policy in writing(signed by the first head); it must be consistent with other activities of the enterprise; management should ensure that each member of the team understands the developed quality policy, steadily implement and enforce it; it must be formulated in such a way that its provisions apply to each member labor collective and not just product quality. The document disclosing the quality policy should be concise, simple, intelligible and memorable, reflecting the quality requirements of each employee's work.

Essentially acceptable policy in the field of product quality, one can be recognized that positively answers a number of questions:

- is it short, does it concern each employee of the enterprise team;

- whether standards are established in it (requirements for the quality of work, does it cover all aspects of the quality of products and services supplied to the consumer (this issue should also be referred to the terms of delivery of products, price, quality of the final results of the enterprise, including services);

– whether the quality policy is signed by the first person of the enterprise

In foreign practice, the quality policy is formulated in such a way that it answers many of the questions listed above. For example, IBM included the following in its Presidential Quality Policy, among other things:

"We will deliver defect-free, competitive products and services to our customers on time." Analysis of this statement shows that it:

1) addressed to each employee of the corporation;

2) clearly defines indicators of the level of work quality (it is expected from everyone to supply defect-free products and services just in time, and it would be better to write it down so that everyone understands: they are required to work without errors);

3) covers all aspects of quality (including price, delivery time and performance);

4) signed by the first person of the corporation.

One example of the formulation of a quality policy by a foreign enterprise is given below.

Johnson Plastic Co.

Product quality management- these are actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality. The activity of the enterprise in the field of quality is aimed at:

Improvement of the economic situation of the enterprise;

Expansion and conquest of new sales markets;

Achieving a technical level of products that exceeds the level of leading enterprises and firms;

Orientation to meet the requirements of the consumer of certain industries or regions;

development of products, functionality which are implemented on new principles;

Improvement key indicators product quality;

Reducing the level of defectiveness of manufactured products;

Increase in terms of realization (guarantees) of production;

Service development.

Managed by the quality of products and services understand the constant, systematic, purposeful process of influencing factors and conditions at all levels, ensuring the creation of products of optimal quality and its full use.

Quality management is a process carried out in stages:

Development of a quality improvement plan and measures to create products with the desired (designed) properties;

Assessment of the conformity of the properties of manufactured products with the requirements provided for in the plan;

Taking the necessary measures to influence the process if it was not possible to ensure compliance;

Study of operating conditions in order to determine the direction for further quality improvement.

There are four levels of quality:

- compliance(technical conditions, contracts);

- suitability for use(standards and operational requirements);

- conformity actual market requirements(fulfillment of the requirements of buyers about high quality and low price of goods)

- compliance with the hidden needs of buyers.

So, quality management is first of all: customer orientation; systems approach; coverage of all phases life cycle products.

Product life cycle(LCP) is a set of interrelated processes of changing the state of products during its creation and use. Stage (stage) ZhCP- this is a conditionally allocated part of it, which is characterized by the specifics of the work performed at this stage and the final results.

Product quality considered throughout "life cycle": from design, manufacture and before her implementation.Product life cycle- the sequence of stages of existence of products.

Life stages of products:

At the stage marketing research sales markets and consumer requirements for the company's products, the capabilities of suppliers are being studied material resources regarding the quality and discipline of deliveries.

At the stage of design and development of products identified by marketing results consumer requirements are transformed into technical requirements, the result of the design is technical documentation(design, technological) and a prototype.

In Procurement the organization evaluates and selects suppliers based on their ability to supply raw materials, materials, products in accordance with the requirements of the organization.

In production preparation and maintenance of the manufacturing process is carried out; development and verification of the process, mastering the practical skills of manufacturing products.

Product Check includes control, measurements and tests (if necessary) carried out at all stages of the life cycle. final stage inspection is the acceptance control, the results of which must confirm the conformity of the finished product with the established requirements.

Packaging and storage should contribute to the preservation of quality in the areas of production and circulation, transportation, sale and storage.

Distribution and implementation are in the purchase of goods wholesale organizations for the purpose of selling goods to stores and selling goods to customers by retail organizations.

During the operation phase(use and consumption) the consumer of the product is connected to the management. The service life of the product (product) will, in particular, depend on how competently he will use (exploit) the product.

At the disposal stage must be warned harmful effect used products on the environment.

The recycling stage does not end the activity of the organization. By this time, the organization begins to study the anticipated needs, clarify the current needs, and after marketing activities starts designing new products. This is how new round activities in the field of quality - from the marketing stage to the disposal stage.

In addition to managing all stages of the product life cycle, product quality management has the following features:

- duration of the whole cycle from the beginning of quality formation to its implementation can take several years, i.e., the quality management process can be extended in time;

- level of individual quality indicators when moving from one stage of the life cycle to another tends to decrease- this objective circumstance should be taken into account when forming the goals and criteria of quality management at each stage of the life cycle;

- under the influence of various factors, the level of quality decreases, including its physical and moral aging;

- additional efforts and costs are required to maintain the quality level of products in the field of operation.

The text of the document provides links to reference materials containing a detailed description of theories, practices and research results related to pollution control. From these materials, the reader, if necessary, will be able to obtain more detailed information. These materials are presented in the Literature section.

Glossary of terms and definitions

Special shoes for the building - a pair of footwear used by personnel in certain areas of the changing room and cleanroom, or in ancillary areas, to prevent entry of contaminants found on outdoor shoes into these areas.

Special clothing for the building - a suit made of 100% polyester or other synthetic fabrics. The shape resembles a two-piece tracksuit, the upper part of which is removed over the head or fastened with a zipper. The suit is worn over one's own underwear under cleanroom clothing.

Dressing room - a room adjacent to the cleanroom, designed to control the passage of personnel, as well as to put on, take off and store items of clothing or other accessories.

Class(airborne particle content) - Room cleanliness class according to ISO 14644-1.

clean room - a room that requires the control of airborne particles and includes one or more clean zones.

Second layer clothes (comfort suit) - see "special clothing for the building".

Pollutant — any substance whose presence on or within a material, or on any surface in a cleanroom, is undesirable.

Pollution- the result of a contaminant entering a material or any surface within a cleanroom.

Controlled environment - an environment in which the compliance with the permissible limits of parameters such as temperature, pressure, humidity and pollution level is controlled.

Strip- the process of removing clothes for cleanrooms. The process is strictly controlled to protect clothing from contamination and damage.

Putting on- the procedure for donning a set of clothes for cleanrooms. Clothes are put on in a certain order in a strictly defined way to prevent contamination and deterioration of protective properties.

Putting on gloves - an additional pair of gloves used when putting on cleanroom clothing to protect it from direct contact with the hands and to prevent contamination by grease or particles on the skin. Gloves can be worn over work gloves when dressing or used only during dressing and then changed to work gloves.

Electrostatic discharge (ESD) is the transfer of an electrostatic charge between two objects that have different electrostatic potential.

Cleanroom clothing - specially designed garments to reduce or prevent the spread of contaminants by personnel. It can be represented by overalls, shoes, shoe covers, gloves, hats, etc.

Set of clothes- A complete set of clothing and consumables used to protect personnel from external influences or protection environment from pollutants emitted by humans. The kit may include a face mask (beards), hair cap (net), helmet, other items of clothing (overalls, shirts, pants or gowns), cleanroom shoes, safety shoes, shoe covers, shoe covers, boots, changing gloves and technological gloves.

HEPA filter(High Efficiency Air Filter) - Dry type filter with increased surface area, placed in a solid frame. The minimum efficiency of such a filter when tested with a fixed air flow rate in accordance with the MIL-STD-282 standard should be 99.97% for particles of dioctyl phthalate with a mass median diameter of 0.3 µm.

Maintenance of clean rooms - maintenance or cleaning of premises carried out to maintain the required level of cleanliness.

Micrometer(µm) is a unit of length equal to one millionth of a meter (approximately 0.00003937 inches).

Air particle counter - A device for the continuous counting of airborne particles larger than allowable limit. The device can be optical, electrical, aerodynamic, etc.

Pre-dressing - Necessary procedure carried out after entering the building and before entering the changing room.

Clothing processing - A process carried out to ensure that clothing and accessories are clean and suitable for use in a controlled environment.

Mechanical Shoe Shine Machine - An electrical device consisting of rotating or movable brushes and a vacuum dirt collection system. Shoes are placed inside the device and slowly moved back and forth. At this time, the brushes remove dust and dirt from its surface, which are collected by the vacuum system.

Shoe covers- Disposable covers worn over outdoor shoes in designated areas of the changing room and cleanroom, or in ancillary areas to reduce the transfer of contaminants on outdoor shoes.

Sticky mat- A disposable or cleanable mat with a sticky surface that, when stepped on, removes particles from the sole of the shoe.

ULPA filter- Disposable dry type filter with increased surface area, placed in a solid frame. The minimum efficiency of such a filter when tested by the methods described in IEST-RP-CC007 must be 99.999% (i.e. the filter must pass no more than 0.001% of particles).

Material cleaning zone - An area in the changing room dedicated to the cleaning of materials used in the clean room.


The Recommended Practice can form the basis for the development of procedures and training programs for personnel to work in cleanrooms and contamination control environments. The presented material does not contain specific information on the performance of operations requiring the control of microbiological contamination.
Individual designs, equipment, protocols and procedures are used to control contamination on a case-by-case basis, many of which are described below. However, the selection of the most appropriate and appropriate contamination control options is entirely up to the user.

Most cleanroom operations require the presence of personnel. Even completely automated system needs to be controlled and maintained by the operator. People and their clothes are sources of a large amount of pollution, which necessitates the use of effective system contamination control to reduce risks to the product, process outlet and cleanroom environment. In addition, since the activity of personnel can contribute to the transfer of contaminants from one place to another within the cleanroom, a system of work protocols must be developed and carefully monitored to ensure an adequate level of control. The main requirements relating to these aspects are presented in ISO standard 14644-5. Meeting these requirements is necessary minimum to create a cleanroom control program.

In order to select employees who will not allow excessive contamination of the product, and will also follow all dressing procedures and work practices adopted for a controlled environment, it is necessary to pay attention to and follow recommendations for determining cleanroom personnel qualifications, physical and intellectual characteristics, as well as professional skills of the staff.

Recruitment
Responsibility for recruitment

Responsibility for the selection of personnel should be assigned to a department that has all the necessary information about the physical and intellectual characteristics of employees, as well as their professional skills, without which it is impossible to perform the duties specified by the head of the cleanroom, for example, the personnel department or the personnel management department.

Whenever possible, candidates for cleanroom jobs should be interviewed for a tour of the facility, during which the candidate's readiness to comply with established requirements, their qualifications for working in the room, and their ability to understand instructions can be determined. In addition, if the candidate does not have experience working in this type of premises, the tour will help the candidate decide if he is ready for the inconvenience associated with the use of special clothing for the building, as well as to check the availability of clothing of the right size before the candidate begins work.

Special requirements for the physical and medical characteristics of potential cleanroom personnel

1. Smoking staff . Smoking is prohibited in cleanrooms, changing rooms or any other area where it may have an undesirable effect on product quality or on the health of other employees due to passive smoking. For work in cleanrooms of certain cleanliness classes, companies have the right to hire exclusively non-smokers. If smoking is on site manufacturing enterprise allowed, the employee who smokes should be warned that smoking breaks may be shortened, as the process of changing clothes takes some time and, combined with the length of the break, this may adversely affect the quality of the product.

2. Worker dimensions . Although, as a rule, the physical dimensions of employees cannot be an obstacle to hiring in a clean room, in some cases this aspect must be taken into account. Firstly, special clothing of a non-standard size may be required, secondly, it may be necessary to modify the seat or bench, and thirdly, it depends on the dimensions total area body of an employee, which can be taken into account when assigning employees to work areas.

3. Hairline on the face . Where facial hair is present, the employee must be covered by cleanroom clothing such as a face mask, hood or beard mask.

4. Sensitivity to high temperature . The temperature and humidity levels in a clean room are generally maintained within the specified limits, however, in some cases, the temperature in certain areas of the room may go beyond these limits. It is important that personnel working in such areas do not sweat profusely, which releases excess particles and moisture that contaminate the product and environment.

5. Skin condition, allergies, respiratory disorders . Employees with the following skin conditions or upper respiratory disorders should not work in cleanrooms:
a. Allergy to synthetic fabrics, solvents, or other cleanroom chemicals.
b. Profuse nasal discharge.
c. Diseases of the skin, accompanied by increased exfoliation of particles from the scalp, hands or body.
d. Increased acidity of the skin of the hands in a humid environment.
e. Serious nerve disorders that cause itching, itching, or rubbing of the skin.
f. Emphysema.
g. Sunburn (in this case, the employee may be temporarily suspended from work in a clean room).
6. Claustrophobia. An employee who suffers or has suffered from claustrophobia in the past should not be allowed to work in cleanrooms.

Professional skills

1. Personal qualities. In addition to the professional skills and abilities required to carry out their duties, employees must understand the goals and practices of contamination control in cleanrooms. Maximum cooperation and self-discipline is required of them, since most of the airborne pollution is emitted by the employees themselves or as a result of their activities.

2. Language skills. All personnel performing cleanroom operations should be properly trained and informed about the tasks and practices of contamination control. In this regard, it is very important that they can correctly understand the information received during training and the instructions set out in the language used by the supervisory personnel, not only at the beginning of their professional activities, but also in the future. Any misunderstanding between the control personnel and the operator may adversely affect the results of the control.
The factors described above may change temporarily or permanently over time. In this regard, it is recommended to organize continuous monitoring of operators by supervisory personnel.

Compliance Training

Performing a cleanroom entry procedure requires certain skills and knowledge of specific practices and behaviors required for cleanroom operations. Preparation for work in a clean room is of great importance, regardless of the frequency of entry into it or its classification, and is also carried out for all employees without exception entering a clean room. When conducting training (training), the requirements of the ISO14644-5 standard should be observed.

Responsibility

Each organization should appoint a person responsible for training staff. Training may be provided by line management, a training department, quality assurance, or third-party instructors. Those responsible for training should be familiar with special requirements to train personnel to work in a cleanroom, and to have the skills necessary to train others.

Employee training programs

The training program usually consists of several modules dealing with specific aspects of cleanroom operation and should include basic training for personnel with no prior experience in such work, more advanced training given when new products are introduced, and refresher or special training. to solve individual problems.

Modules or training courses should cover all aspects of cleanroom operations, including:

a) understanding the nature of contaminants and their control;
b) required conduct and discipline;
c) personnel hygiene;

• changing procedures;
• cleaning standards and methods;

d) security measures;

e) specific contamination control procedures for certain types of work;
f) wiping technique (see Recommended Practice IEST-RP-CC026).

For each module of the training program, specific tasks should be established that can be analyzed for performance.

The content of each module of the program is determined in the course of a study of what the trainee needs, carried out through consultation with management and a survey of direct supervisors. Each of the modules should include controls to ensure that the material developed for the training is delivered and understood by the staff.

The program should define the timing of the training, the persons or trainers responsible for the training, the methods of training, and the criteria for testing and assessing knowledge for each module.

Teaching methods

The training program should include the definition of teaching methods, such as:

a) standard lectures;
b) remote learning using video or audio materials;
c) on-the-job training;
d) conducting courses by specially invited instructors;
e) attending courses offered by other organizations;
f) group discussion;
g) seminars;
h) role play.

To carry out the program, the premises and materials necessary for preparation should be provided, as well as, if necessary, the organization of coffee breaks or lunch breaks.

The persons participating in the training should clearly understand their roles (lecturer, mentor, consultant or trainer) and be familiar with all the necessary theoretical and practical material before proceeding with the training.

Usually a person remembers:

10% of the information presented in the form of oral speech;
50% visual information;
80% of the information when participating in a group discussion.

Changing the speed of presentation of information, as well as the use of additional visual aids improve the effectiveness of training. In addition to product samples and equipment demonstrations, learning aids such as flip charts, whiteboards, CD-ROMs, electronic projectors and role-playing games can be used in the workplace.

Assessment of knowledge

After the completion of the training, an assessment of the knowledge gained by the trainees should be carried out. Such assessment may include an oral or written examination or performance of any operations. The progress and results of each assessment should be documented along with brief description the examinee's previous work experience.

Training Documents

Employee training records should be updated regularly and can be used as one of the means to control entry into a cleanroom or for follow-up monitoring of employees. Examples of a matrix and an individual preparation card are presented in.

Hygiene and health

It is necessary to have and comply with hygiene and health standards for cleanroom personnel. Compliance with these recommendations will help reduce the likelihood of contamination of the cleanroom environment by human particulates/fibers. Conducting a risk assessment for each room of different cleanliness classes will allow planning for the control of contamination in each individual situation, and is also of great importance for ensuring product quality, its yield and the efficiency of processes in a clean room environment.

Personal hygiene

Cleanroom personnel should bathe or shower daily to prevent the accumulation of fats, salts, dirt and bacteria on the skin that can contaminate the environment.

Hair also retains and is a source of many particles and should be washed daily; they must be cut to a controlled length, neatly assembled and secured. Cleanroom clothing should cover hair completely.
Staff's fingernails should be kept short so that they cannot tear cleanroom gloves.

Cleanroom personnel should not use cosmetics, perfumes, hairspray or nail polish as these products contain contaminants.

Diseases

Illnesses accompanied by occasional coughs, sneezes, or nasal discharge can interfere with an employee's job performance and can also lead to environmental pollution. If such symptoms appear, the employee should not be allowed to work in a clean room until they completely disappear.

Work in indoors can cause fainting or claustrophobia. Such conditions create uncomfortable working conditions for employees, and also threaten their safety. The absence of such conditions should be one of the conditions for hiring employees in order to legally protect the employer in the event that the employee concealed the presence or did not know about the existence of such conditions at the time of hiring.

Skin diseases accompanied by skin flaking can lead to contamination of the cleanroom environment. The absence of such diseases should be one of the conditions for hiring employees in order to legally protect the employer if the employee concealed the presence or did not know about the existence of such diseases at the time of employment.

If there is a skin allergy to certain items of clothing or materials (for example, latex gloves), employees should be provided with items made from other materials.

Cleanroom employees should notify management if they cough or sneeze due to a cold or seasonal allergy. AT similar cases it is necessary to determine whether the use of a face mask is sufficient to minimize the risk to drugs or processes in the cleanroom, or whether it is necessary to temporarily transfer the employee to another place of work outside the premises.

A cleanroom worker must refrain from smoking for 30 minutes prior to entering the cleanroom to ensure that tobacco smoke particles are completely removed from the lungs and mouth. In addition, employees who smoke must rinse their mouth several times with water and take several sips of water before entering the premises.

Dressing

Proper dressing procedures avoid contamination of clothing during dressing and its transformation from a particle-trapping barrier to a source of contamination. The procedures described include activities conducted in three different locations: at home, at work (outside the cleanroom), and in a controlled environment changing room.

Home preparation

Clothing should be chosen that covers as much of the surface area of ​​the skin as possible. Streetwear, if possible, should not be made from natural fabrics that release fibers. It is recommended to wear clothing made from synthetic materials such as polyester, nylon or acrylic under cleanroom clothing.

On-the-job training:

1. All outerwear (coats, hats, gloves, galoshes, etc.) and personal items (bags, umbrellas, food bags, etc.) must be stored in special lockers located as close as possible to the changing room.
2. Remove all jewelry not permitted by the protocol.
3. Report any respiratory problems, sunburn, or skin problems to supervisory personnel before entering the changing room.
4. Remove all make-up from your face.
5. Cover all hair with a hair cap and, if necessary, cover facial hair (beard, mustache, sideburns) with a mask.
6. Put on shoe covers over street shoes (if provided).
7. Proceed to the cleanroom shoe lockers (if provided).
8. If special cleanroom shoes are used, remove street shoes and put on cleanroom shoes on each foot in turn (do not put your bare foot on the floor). Outdoor shoes must be left in the locker.
9. Proceed to the changing room for men or women, put on a special suit for the building (if provided) over your underwear.
10. Wash and dry hands before each entry into a cleanroom. This reduces the amount of contaminants on the hands and can prevent skin irritation.
11. Apply lotion to your hands (only if provided by the company, you cannot use your own lotion).
12. Put on and secure the disposable face mask behind the ears, if intended. Before putting on a pleated mask, it is necessary to straighten all its folds. After putting on the mask, press the fabric of the mask against the bridge of the nose so that it fits snugly against the face.
13. Wear cleanroom gloves. Then put on a second pair of special gloves for changing clothes (if provided). As an alternative, inexpensive polyethylene gloves can be used, thrown away after changing clothes and replaced with technological gloves.
14. Select the desired clothing size.
15. Proceed to the dressing room.

Dressing technique

1. Attach the removable face mask (if provided) to the hood so that there are no gaps between the mask and the hood.
2. Put on the helmet so that the identification label is on the outside. Using zippers or drawstrings, adjust the hood so that it fits snugly without being uncomfortable.
3. Remove the coverall from the packaging and check for damage. Unzip. Take the end of the right sleeve and the right leg, as well as the middle of the torso of the overalls with your right hand at a distance of approximately 15 cm from the edge of the zipper. In the same way, take the left part of the overalls with your left hand. Insert both legs in turn into the trousers so that the overalls do not touch the floor. Raise the helmet and insert your hands into the sleeves.
4. Tuck the helmet into the overalls and make sure that the lower part (bib) of the helmet is evenly distributed over the shoulders, chest and back.
5. Fasten all zippers, coverall collar, and, if applicable, ankle fasteners.
6. Unscrew the top of the changing gloves. Fasten, if available, fasteners on the cuffs. Depending on the established procedure, technological gloves are tucked under or pulled over the cuffs.
7. Sit on a bench (if provided), put on your right foot, move it over the bench to a clean area, without touching the surface of the bench.
8. Put on the second leg and also transfer it to a clean area without touching the surface of the bench.
9. Using a full-length mirror in the dressing room, check that the clothes are worn correctly and that there are no defects. Remove and discard changing gloves (if used). Make sure that the work gloves are still tucked under or pulled up over the cuffs. Enter a clean room.
10. Dispose of all packaging materials in appropriate containers.

Entrance to the clean room

The procedure for entering a cleanroom may vary depending on the design of the cleanroom and changing room. The clean room entrance area is usually equipped with sticky mats, to which contaminants remaining on the sole adhere. Mats can be placed anywhere where soil transfer to the sole of the shoe is to be controlled. A diagram of the recommended placement of mats in a clean room is shown in Figure 1.

Figure 1 - Standard layout of the changing room

The entrance to the cleanroom from the changing room can be equipped with:

• air shower,
• interlocked double door or single door.

If used, the air shower must comply with the following parameters:

A. Description. An air shower is a tunnel or passage leading to a clean room. Passing through it, a person is blown by strong jets of air purified with HEPA and ULPA filters. Additionally, the air shower is equipped with an air ionization system.
b. Task. The air shower acts as an air barrier for the cleanroom and is used to remove large particles from personnel clothing. However, the effectiveness of such a system is ambiguous, and in many cases an air shower is installed to improve the discipline of employees. The time and effort required to pass through such a system allows personnel to focus and mentally prepare for entering the cleanroom.
c. Location. An air shower is installed immediately before entering protected areas (i.e. before entering clean rooms or between rooms of different cleanliness classes). Installing an air shower at the entrance to the changing areas is ineffective.
d. Exploitation. Air shower technology is based on the assumption that strong air currents have sufficient speed to blow off large and loose particles from clothing. The air ionization system is used to neutralize the static charge that attracts particles to the surface and prevents them from being blown away. At the same time, to remove small particles, a greater force is needed, which is achieved by using turbulent air flows. However, after turning off the turbulent flow, particles can again settle on surfaces. Thus, the air shower does not do a good enough job of removing small particles. For effective work system needs regular maintenance and monitoring.
e. Design. There are many different air shower designs available, each with its own benefits depending on the application. To work most effectively, such a shower should have a ceiling that is completely covered with HEPA or preferably ULPA filters, through which high speed(0.45-0.6 m / s) a unidirectional downward air flow is supplied; perforated or slatted floor; as well as at least five adjustable nozzles installed in the walls for supplying high-speed jets of air.

1. Air tunnel. A passage that acts as an air barrier and contributes to the psychological preparation for entering a clean room.
2. Airlock. The air nozzles are turned on for a certain time (usually 10-15 seconds), during which the employee turns 360° at least three times with his arms up. The system must be programmed to turn off the nozzles at least 8 seconds before the airlock exit opens. In this case, the vertical unidirectional air flow is not turned off, because. it blows airborne particles down.
3. Air lock with indirect passage. The employee must walk along a curved corridor in order for the clothes to be processed from all sides.

f. cleaning. Cleaning of walls, ceiling, ventilation louvers and floors should be carried out daily or at regular intervals.

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• 28.02.2019 question contest
  

  Get a book as a gift for best question about chromatography

  The Analytics Expo exhibition and Vialek Group of Companies announce a competition for the best question for Ilya Mikhailovich Kaitlin, an expert in the field of pharmacoanalysis, author of articles and training courses on validation and transfer of analytical methods.

  In the spring of 2019, the Vialek publishing house publishes a book "Problems of HPLC, validation and transfer of analytical methods in questions and answers".
  The work is based on communication with attendees of seminars on high-performance liquid chromatography, validation of analytical methods, analytical transfer, and questions and problems that have arisen in the course of professional activity.
  The information offered in the book may be useful to specialists of analytical laboratories of pharmaceutical, chemical and other enterprises where HPLC is used, analytical methods are developed, validated (verified) and transferred.
  Visitors to the Analytics Expo exhibition have a unique opportunity to become the owner of a book autographed by the author.

  Send a question to the exhibition management to an expert or describe the problem that you encountered in the process of validating analytical methods, analytical transfer, high-performance liquid chromatography studies. The author of the most interesting question, Ilya Mikhailovich, will hand over a book with his autograph as part of the presentation, which will be held as part of the Analytics Expo exhibition on April 25 from 12.30 to 13.30 at the Analitika Show site.

  We are waiting for your questions until April 10, 2019 e-mail: [email protected].
  Head of the scientific and business program of the exhibition Elizaveta Kalenchuk.

  To visit the exhibition "Analytics Expo" and the presentation of the book, get

serious competitive fight caused in developed countries market economy development of quality improvement programs. There was a need to develop objective indicators to assess the ability of firms to produce products with the necessary quality characteristics. These objective indicators constitute the so-called enterprise quality system.

According to Okrepilov V.V., product quality management at an enterprise is the actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality. These actions include input, operational, acceptance and inspection controls.

With the development of economic reforms in Russia, more and more attention is paid to quality.

Currently one of serious problems for Russian enterprises is the creation of a quality system to ensure the production of competitive products. The quality system is important when negotiating with foreign customers who consider prerequisite the manufacturer has a quality system and a certificate for this system issued by an authoritative certification body.

The quality system should take into account the characteristics of the enterprise, ensure the minimization of product development costs. The consumer wants to be sure that the quality of the supplied products will be stable and sustainable.

In the theory and practice of quality management, two problems are identified: product quality and quality management.

Quality assurance is costly. Until recently, the main share in the cost of quality fell on physical work. But today the share of intellectual labor is high.

The problem of quality cannot be solved without the participation of scientists, engineers, managers. There should be a harmonious combination of all components of professional influence on quality.

The importance of product quality lies in the fact that only high-quality products open the export road to solvent Western markets. Special competitions are called upon to play a major role in ensuring the quality of products of Russian manufacturers and their successful competition in world markets.

Various kinds of competitions with the awarding of honorary awards to their winners are widely used in world practice.

The quality system is created to manage the quality of the production of works directly related to product quality (assessment of the quality of development and design of products being introduced; incoming materials; control over ensuring the technological accuracy of equipment used in the production of products; control over the quality of performance technological processes, timely detection of marriage, etc.).

The quality system of an enterprise should take into account the characteristics of the enterprise, ensure the minimization of costs for product development and its implementation. The consumer wants to be sure that the quality of the product will be stable and sustainable.

The quality system is important when negotiating with foreign customers, who consider it a prerequisite for the manufacturer to have a quality system and a certificate for this system issued by an authoritative certification body.

To help organizations implement and maintain effective quality systems, a number of standards have been developed under the general name ISO 9000.

The International Organization for Standardization defines quality (ISO-8402 standard) as the totality of properties and characteristics of a product or service that gives it the ability to satisfy stated or implied needs. This standard introduced such concepts as "quality assurance", "quality management", "quality spiral". Quality requirements at the international level are defined by the ISO 9000 series of standards. First edition international standards The ISO 9000 series was released in the late 1980s and marked the rise of international standardization to a qualitatively new level. These standards intruded directly into the production processes, the scope of management and established clear requirements for quality assurance systems. They initiated the certification of quality systems. There was an independent direction of management - quality management. Currently, scientists and practitioners abroad associate modern methods quality management with the methodology TQM (total quality management) - general (all-encompassing, total) quality management.

The ISO 9000 series standards established a unified globally recognized approach to contractual conditions for assessing quality systems and at the same time regulated the relationship between manufacturers and consumers of products. In other words, ISO standards are a rigid focus on the consumer with strict adherence to the production culture.

To improve the performance of the organization, eight principles of the quality system are defined in the quality standards:

1. Orientation to the consumer.

Businesses depend on their customers and must understand their present and future needs, meet their requirements and strive to exceed their expectations.

2. Leadership of the head.

To ensure the unity of purpose and direction of the organization, the leader must create and maintain internal environment in which employees are fully involved in solving the problems of the organization.

3. Involving employees in the work of the quality system to get the most benefit from their abilities.

4. Process approach.

The desired outcome is all the more effective when activities and resources are managed as a process.

5. System approach to management.

Understanding interconnected processes as a system improves the efficiency of organizations.

6. Continual improvement in the performance of the organization as a whole should be seen as its permanent goal.

7. Decision making based on facts.

8. Mutually beneficial relationships with suppliers.

These eight quality management principles form the basis for quality system standards.

Quality management systems can help organizations improve customer satisfaction.

Consumers need products that meet their needs and expectations. These needs and expectations are usually reflected in specifications on products and are generally considered to be customer requirements. Requirements may be specified by the customer in a contract or defined by the organization itself. In any case, the acceptability of the product is ultimately determined by the consumer. As customer needs and expectations change, organizations are also under pressure from competition and technical progress, they must constantly improve their products and their processes.

A systematic approach to quality management encourages organizations to analyze customer requirements, identify processes that contribute to obtaining products acceptable to customers, and keep these processes in a controlled state.

The quality management system can be the basis for continual improvement in order to increase the likelihood of increased satisfaction for both customers and other interested parties. It gives confidence to the organization itself and customers in its ability to deliver products that fully comply with the requirements.

Analysis of the works of Akhmin A.M. allows us to conclude that the approach to the development and implementation of a quality management system consists of several stages, including:

a) establishing the needs and expectations of customers and other interested parties;

b) development of the organization's quality policy and objectives;

c) establishing the processes and responsibilities necessary to achieve the quality objectives;

d) establishing and determining the necessary resources and providing them to achieve quality objectives;

e) developing methods to measure the effectiveness and efficiency of each process;

e) applying these measurements to determine the effectiveness and efficiency of each process;

g) determining the means necessary to prevent nonconformities and eliminate their causes;

i) developing and applying a process for continual improvement of the quality management system.

This approach is also used to maintain and improve the existing quality management system.

An organization that adopts the above approach builds confidence in the capability of its processes and the quality of its products, and provides a basis for continual improvement. This can lead to increased customer and other interested party satisfaction and organizational success.

The processes required for a quality management system should include management, resource management, product life cycle and measurement processes.

The quality management system documentation should include:

a) documented statements of quality policy and objectives;

b) quality manual;

c) documented procedures;

d) documents necessary for the organization to ensure effective planning, implementation and management of processes.

Top management should ensure that there are certifications and commitments to develop and implement the management system.

quality, as well as continuous improvement of its effectiveness through:

a) communicating to the organization the importance of meeting customer, statutory and regulatory requirements;

b) development of a quality policy;

c) ensuring the development of quality objectives;

d) conducting a management review;

e) providing the necessary resources.

Top management should ensure that the quality policy:

a) is consistent with the objectives of the organization;

b) includes a commitment to meet requirements and continually improve the effectiveness of the quality management system;

c) created the basis for setting and analyzing quality goals;

d) has been brought to the attention of the personnel of the organization and is understandable to him;

e) analyzed for continued suitability.

The organization's top management shall ensure that quality objectives, including those necessary to meet product requirements, are established at appropriate departments and levels. Quality objectives should be measurable and consistent with the quality policy.

Top management shall review, at planned intervals, the organization's quality management system to ensure its continued suitability, adequacy and effectiveness. The review should include an assessment of opportunities for improvement and the need for changes to the organization's quality management system, including the quality policy and objectives.

The task of the organization is to determine and provide the resources required to:

a) implementing and maintaining the quality management system and continuously improving its effectiveness;

b) improving customer satisfaction by meeting their requirements.

Personnel performing work affecting product quality must be competent in accordance with their education, training, skills and experience.

The organization must:

a) determine the necessary competence of personnel performing work that affects product quality;

b) provide training or take other actions to meet these needs;

c) evaluate the effectiveness of the measures taken;

d) ensure that its personnel are aware of the relevance and importance of their activities and their contribution to the achievement of quality objectives;

e) maintain appropriate records of education, training, skills and experience.

The control system needs to define, provide and maintain the infrastructure needed to achieve product compliance.

To do this, you need to define:

a) requirements specified by customers, including requirements for delivery and post-delivery activities;

b) requirements not specified by the customer, but necessary for a specific or intended use, when known;

c) legislative and other mandatory requirements related to products;

d) any additional requirements specified by the organization.

In the field of quality management, it is important to analyze the requirements related to the product. This review should be carried out prior to the organization's commitment to deliver product to a customer (e.g. participation in tenders, acceptance of contracts or orders, acceptance of amendments to contracts or orders) and should ensure:

a) definition of product requirements;

b) negotiation of contract or order requirements that differ from those previously formulated;

c) the organization's ability to meet specified requirements.

Records of the results of the analysis and subsequent actions arising from the analysis should be maintained.

If customers do not make documented requirements, the organization shall confirm them with the customer before acceptance.

If product requirements change, the organization shall ensure that the relevant documents are corrected and that the affected personnel are made aware of the changed requirements.

Fundamental to the organization is the identification and implementation of effective customer communication measures relating to:

a) product information;

b) passing inquiries, contract or order, including amendments;

in) feedback from consumers, including consumer complaints.

In addition to the costs of designing and manufacturing a product, they include the costs of service maintenance consumer and maintaining a given level of quality during the warranty period. All listed costs are the total costs of the supplier. The difference between the selling price and its cost is equal to the income from the sale of one product.

Traditionally, quality costs were determined by summing the costs of the producer and the consumer. This point of view on the cost of quality in determining the optimum cost of quality does not reflect new realities and does not allow seeing the benefits for the manufacturer, for example, increasing profits by increasing the value of the product for the consumer or increasing the cost of rejection prevention by reducing the costs of control and inspection.

The development of engineering and technology over the last two decades of the twentieth century has made it possible to create industries that provide a minimum variation in product parameters through the introduction of new methods of product design, production preparation, new technologies and quality management.

According to researchers, about 80% of all defects that are detected during the production and use of products are due to the insufficient quality of the processes for developing the product concept, designing and preparing for its production. Approximately 60% of all failures that occur during the warranty period of a product are due to erroneous, hasty and imperfect development.

ISO 9000 series, TQM, LSUK allow you to create a product with a high level of quality at an early stage of the product life cycle. The producer of goods (services) needs to know the costs in order to have information for acceptance optimal solution. Where to "look" for low quality costs? To achieve your goals, you should find out the costs of the manufacturer with poor product quality. In the initial assessment, it is usually, using the traditional approach, to determine the costs of:

Alteration;

Tests;

The control;

Return from consumers;

Product recall.

The costs listed above are typically 4-5% of sales.

If you have a desire to get a complete picture of losses due to low level activities of the company, it is necessary, in addition to traditional ones, to take into account hidden costs for:

Delays in the implementation of plans;

Discounts for consumers on non-compliance;

Additional transportation;

The urgency of correcting inconsistencies;

Incomplete fulfillment of accepted orders;

Refinement of the design of non-conforming products;

The need to produce an additional volume of products for rapid replacement;

Unused production facilities.

At the same time, it is clear that the traditional part of the costs, in essence, is only the visible part of the iceberg, constituting 15-20% of the total costs.

It is important to note that the costs due to poor quality can be completely eliminated if each activity is constantly carried out without any discrepancies.

On fig. 1.2.1. presents the costs that arise when the quality of products is low.

The cost of assessment and quality control will be justified provided that the non-conformity is detected before the product reaches the consumer.

Rice. 1.2.1.

These actions can be:

Testing products or checking documentation before it is handed over to the consumer;

Checking documents to correct errors before they get to the mail;

Monitoring the operation of equipment for suppliers;

Checking reports or correspondence;

Checking prepared invoices before sending them to consumers for payment.

Identification of nonconformities at this stage includes significant costs for failures and failures in the future, and also helps to develop more effective methods control.

The main task of this stage is to eliminate excess costs.

The costs of nonconformities identified within the company are due to the repair of products, the replacement of nonconforming parts, or the reworking of improperly performed work. All these works are usually invisible to the consumer. Examples of such actions could be:

Replacement of stamped products that do not meet technical requirements;

Restoration of damaged surfaces;

Re-calculation due to computer failures;

Replacement of components damaged during inter-shop movements;

Re-registration of individual parts of the project;

Processing to ensure timely implementation of the plan;

Correction of errors in databases;

Keeping an excess stock of components to replace defective ones;

Write-off of products that do not meet the established requirements.

Additional time to correct errors in invoices for payment;

Correction of errors in specifications and drawings, etc. These

costs can affect customer service indirectly.

Costs of nonconformities identified outside the company. These inconsistencies directly affect the interests of consumers, and their elimination is usually especially expensive. Costs in this category can be caused by the following obligations:

Satisfaction of warranty claims;

Investigation and satisfaction of complaints;

Reducing the possible level of dissatisfaction due to product recalls;

Fulfillment of unreasonably assumed obligations;

Correction of errors in accounts;

Replacement or repair of damaged or lost goods;

Servicing passengers of canceled or delayed flights;

Refusal to provide discounts due to delays in payment of invoices issued by your suppliers;

Departure of specialists directly to the consumer in case of malfunctions;

Compensation for losses to the consumer caused by untimely fulfillment of obligations.

It should be noted that consumers and the market determine the quality, and this, in turn, leads to an increase in the profits of enterprises, and the lower the cost of quality, the higher the profit of the enterprise.

In the company "Toyota" the following stages of activity in the field of quality assurance are distinguished: product planning, product design, pre-production, production, production control, sales and service, quality control in operation. At the same time, certain responsibilities and actions of each unit are a guarantee of quality at these stages.

If we imagine the activities of the enterprise vertically (Fig. 1.2.3), then in this case, the relevance of cost management is obvious.

They are formed both from the bottom up and from the top down, differing in composition, size, method of formation and attribution to the product.

The figure helps to understand that quality costs are associated not only directly with the production of products, but also with the management of these productions.

The costs of correcting defects and inconsistencies are usually present in every department of the organization working even in the non-material sphere. They should not be taken as normal, they should be minimized.

Depending on the goals, objectives of quality cost analysis and opportunities to obtain necessary information management methods can be different, as this can be influenced by the passage of products through a certain stage of the enterprise.

Control and analysis of the implementation of the organizational project of the UK and its improvement:

Control over the implementation of the organizational project (acts, control cards, etc.);

Adjustment of the course of implementation of the organizational project (according to the results of control) (orders, instructions, additions, changes, etc.);

Analysis of the implementation of the organizational project of the UK (certificates, recommendations, etc.);

Carrying out acceptance and transfer works (act);

Organization and certification of IC (application; set of documentation; certificate);

Assessment of the actual effectiveness of the SC (final calculation);

Carrying out work on the development and improvement of the SC (improved organizational project).

Fig.1.2.2.

The design stage of the development of SC includes the stages of work aimed directly at the creation of working projects of these systems. The working draft of each system, as a rule, is developed in accordance with the TOR and is a set of NTD, NMD and other documentation necessary to create, carry out acceptance and transfer works and implement the system, achieve goals and certify the system, as well as ensure the further normal functioning of the system .

Directly during the design is carried out:

1. Selection of a set of NTD, NMD and other necessary literature and documentation, analogue samples, similar to the SC.

2. Development project documentation first technical, and then working projects. Sections of the technical project, their content were worked out quite well earlier. Moreover, the practice of developing the CS of the Criminal Code has shown, especially in relation to medium and small enterprises, and the further improvement of these systems has confirmed that it is objectively possible to confine ourselves to creating only a working draft. The technical project can be borrowed in the main STP for the system in the first edition, for the SC - either the first edition of the STP "SK. SO UK. Basic provisions", or the first edition of the RD "General Quality Guide".

Fig.1.2.3.

It should disclose the structure of the system, the quality policy, the principles of QM, the procedure for maintaining the system in working condition and its improvement.

The development of the working design documentation of the SC is carried out in two sub-stages: at the first stage, documents are developed for the SD of the UK, which is the same for each of the SCs, at the second, documents directly for the SC of each type in accordance with the specific model chosen for it.

The final stage of the creation of the SC is the stage of implementation (implementation) of organizational projects, on which the effectiveness and achievement of the goals of each system largely depends. This stage consists of the following steps, which include:

1. project implementation:

Issuance of an order on the commissioning of the approved design documentation for both the SO of the UK and the SC of products of each type, as well as on the implementation of measures for their implementation. The order should indicate the tasks of managing the enterprise and the working structures of the UK, the timing of the implementation and implementation of activities and the required results;

Implementation of activities for the implementation of working projects, special attention is paid to the implementation of activities aimed at certification of the IC. Obtaining a certificate for such a system is an official recognition of the functioning of an effective system for ensuring proper CP;

Stimulation of the implementation of working projects, which should be carried out in every possible way, combining them with measures for the introduction of new technology;

2. control and analysis of the implementation of working projects of the UK:

Control over the implementation of project documentation. It should be carried out by the GRC and the leaders of the respective SCs. Forms of reflection of control can be different (for example, in acts, control cards, orders, etc.);

Analysis of the implementation of working projects of the UK. It consists in collecting information, studying it and evaluating the results of implementation. On their basis, it is necessary to establish the compliance of the level of organization and implementation of the implementation of the implementation of the goals and requirements of the SC. For this, it is necessary to carry out comprehensive assessment the actual effectiveness of the implemented activities within a particular SC.

The inclusion of new elements in the SC can be carried out in connection with the setting of new goals and objectives of the system, due to changes, for example, in demand, needs, prices and the situation in the sales markets.

Based on the results of the analysis of the quality system, as a rule, a report is drawn up and a current task is developed for improving the quality management system, which should include the following sections: the basis for improvement; characteristics of the current system; the purpose and objectives of improving the system; clarification of the composition and content of the functions of the system during its improvement; the structure of the plan to increase the CP (or the program "Quality"); terms of formation of the project of the improved system; main normative and methodological sources; the prospect of continuing work; additional instructions; applications (lists of units and persons with whom the STP and other NTD systems must be coordinated).

The implementation stage includes the development of an implementation plan for the improved design and its implementation.

Thus, the quality is determined by the action of many random factors. To prevent the influence of these factors on the level of quality, a quality management system is needed. The quality management system can be the basis for continual improvement in order to increase the likelihood of increased satisfaction for both customers and other interested parties. It gives confidence to the organization itself and customers in its ability to deliver products that fully meet the requirements.

Product quality management in an enterprise is the actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality.

The quality system should take into account the characteristics of the enterprise, ensure the minimization of product development costs.

The quality system covers such elements as managerial and production functions, production and organizational structures, management technology, labor processes, methods, information, etc.

To improve the performance of the organization, the quality standards define eight principles of the quality system, such as customer orientation, managerial leadership, involving employees in the work of the quality system to obtain the greatest benefit from their abilities, process approach, a systematic approach to management, continuous improvement of the organization's activities ( should generally be seen as its enduring goal), fact-based decision making, mutually beneficial relationships with suppliers. These eight quality management principles form the basis for quality system standards.

The quality management system can be the basis for continual improvement in order to increase the likelihood of increased satisfaction for both customers and other interested parties.

Top management should ensure that customer requirements are identified and met to improve customer satisfaction.

The task of the organization is to identify and provide resources,

required for the implementation and maintenance of the quality management system, as well as the continuous improvement of its effectiveness, and the improvement of customer satisfaction by meeting their requirements.

Fundamental to the organization is the identification and implementation of effective measures to maintain communication with customers regarding product information; passing inquiries, contract or order, including amendments; feedback from consumers, including consumer complaints.

Economic categories of quality are manifested through the manufacturer's profit from the sale of a quality product and through the costs of the manufacturer to ensure the quality expected by the consumer. Consumers and the market determine quality, and this, in turn, leads to higher profits for enterprises.

During the day, the intake and expenditure of glucose in the human body fluctuate significantly. However, blood glucose levels usually do not rise above 8.0 mmol/L nor fall below 3.5 mmol/L.

This is due to the functioning of a number of regulatory systems that ensure the maintenance of normal blood glucose levels.

Within a short period of time after a meal, blood glucose levels rise as the sugars found in foods are absorbed from the intestines into the blood. Immediately part of the glucose begins to be captured by the cells of organs and tissues and is used for energy needs. At the same time, liver and mouse cells store excess glucose as glycogen. Between meals, when blood glucose drops, it is mobilized from the depot (glycogen) to maintain the required level in the blood. If storage capacity is insufficient, glucose can be obtained from other sources, such as proteins (this process is called gluconeogenesis) or fats.

All these processes ensure the maintenance of the required level of glucose in the blood. At the same time, both the entry of glucose into the cell and its consumption, as well as all its metabolic transformations (aphids cat - iez, glycogenolysis) are under constant control.

The most important regulators of blood glucose levels are the penile nervous system and pancreatic hormones. It has now been established that the central mechanisms for the regulation of carbohydrate metabolism are located in the hypothalamus.

The concentration of glucose in the blood plays a central role in eating behavior. Its level very accurately reflects the energy needs of the body, and the difference between the content in arterial and venous blood is closely related to the feeling of hunger or satiety. In the lateral nucleus of the hypothalamus, there are glucoreceptors that are inhibited by an increase in blood glucose levels and are activated when it decreases, leading to a feeling of hunger. Hypothalamic glucoreceptors receive information about the content of glucose and other tissues of the body. This is signaled by peripheral glucoreceptors located in the liver, carotid sinus, and the wall of the gastrointestinal tract.

If food does not enter the body, then the glucose content in the blood decreases and the hunger center induces a person to eat. As a result of food intake, the content of glucose in the blood increases. When a certain concentration is reached, glucose stimulates the satiety center, which leads to a feeling of satiety. In parallel, signals are sent from the saturation center that cause inhibition of the activity of the hunger center.

Thus, the glucoreceptors of the hypothalamus, integrating the information received through the nervous and humoral pathways, are involved in the control of food intake.

In addition to food intake, pancreatic hormones insulin and glucagon play an important role in regulating blood glucose levels.

The endocrine function of the pancreas is associated with the pancreatic islets (Islets of Langerhans). In an adult, the islets of Langerhans make up 2-3% of the total volume of the pancreas. The islet contains from 80 to 200 cells, which, according to functional, structural and histochemical parameters, are divided into three types: a-, (3- and 8-cells. %, 8-cells 3%.In (3-cells of the islets of Langerhans-insulin, and in a-cells, glucagon is synthesized and released.

The main role of the endocrine function of the pancreas is to maintain a normal level of glucose in the blood. This role is performed by insulin and glucagon.

Insulin, the main hormone of the endocrine apparatus (that is, secreting hormones directly into the bloodstream) of the pancreas, is a polypeptide, the monomeric form of which consists of two chains; A (of 21 amino acids) and B (of 30 amino acids). It secreted by pancreatic β-kets in response to an increase in blood glucose concentration.Insulin realizes its effect by binding to insulin receptors on the surface of the membranes of insulin-sensitive cells.Insulin reduces blood glucose levels and thereby:

* promotes the transport of glucose from the blood to the cells of organs and tissues - insulin-dependent tissues (the supply of glucose to the cells of the central nervous system and the liver does not depend on insulin - insulin-independent tissues);

Stimulates intracellular metabolism of glucose to fine acid (glycolysis);

Activates the formation of glycogen from glucose in the liver and muscles (glycogenesis);

Enhances glucose transport in adipose tissue, increases the rate of fatty acid synthesis, inhibits lipolysis and increases fat reserves;

Inhibits the formation of glucose from amino acids (gluconeogenesis).

Insulin is relatively quickly (in 5-10 minutes) destroyed in the liver

(80%) and kidneys (20%) under the action of the enzyme glutathione insulin transhydrogenase.

If the regulation of blood glucose levels was carried out only by insulin, then this level would constantly fluctuate within the limits significantly exceeding the physiological ones (not higher than 8.0 mmol / l and not lower than 3.5 mmol / l), as a result, insulin-independent tissues (the brain ) would experience either a deficiency or an excess of glucose.

However, this can be avoided as a result of the action of the insulin antagonist - glucagon.

Glucagon is a polypeptide consisting of 29 amino acid residues. It is produced by the a-cells of the islets of Langerhans and, like insulin, has a short half-life (several minutes). In contrast to the effect of insulin, the action of glucagon is to increase blood glucose levels. It enhances the release of glucose from the liver in three ways: inhibits glycogen synthesis, stimulates glycogenolysis (formation of glucose from glycogen) and glycogenogenesis (formation of glucose from amino acids). These mechanisms ensure that glucose is available to glucose-dependent tissues between meals. The liver is the main target organ for glucagon.

The dynamics of the level of insulin and glucagon in the blood after a meal, depending on the level of glucose, is presented by n? rice, 5-4. It shows that the concentration of glucose in the blood increases after eating as a result of the absorption of food carbohydrates. Elevated glucose levels stimulate the secretion of insulin by the pancreas. The signal that insulin sends to cells is "glucose in excess", it can be used as an energy source or stored. Insulin promotes the utilization of glucose as an energy source, stimulating its transport to muscle and adipose tissue. It also stores glucose as glycogen in the liver and muscles, as triglycerides in adipose tissue, promotes the uptake of amino acids by muscles and the synthesis of proteins in them. As a result of the action of insulin, the level of glucose in the blood decreases. In turn, hypoglycemia leads to the induction of glucagon secretion, which contributes to an increase in blood glucose levels. Glucagon maintains the availability of stored glucose in the absence of dietary glucose by stimulating the release of glucose from the liver (from glycogen), gluconeogenesis from lactate, glycerol, and amino acids, and in combination with reduced insulin levels, stimulating the mobilization of fatty acids from triglycerides. The signal that glucagon sends is "no glucose".

Insulin and glucagon levels fluctuate continuously in line with dietary intake to maintain optimal blood glucose levels. But not only they take part in these processes.

Adrenaline, norepinephrine, cortisol and somatotropic hormone (STH) are also able to increase blood glucose levels, i.e. have contraceptive activity.

Adrenaline and noradrenaline are synthesized by the adrenal medulla and are stress hormones. In the liver, adipocytes, skeletal muscles, they have a direct effect on the mobilization of glucose from the depot (from glycogen), helping to increase blood glucose levels for use as an energy source in stressful situations (stress -> adrenaline -> glycogen -> glucose). At the same time, they suppress the secretion of insulin, i.e. create the ground for glucose to continue to flow to the place of its utilization while stress impulses are in effect.

Glucocorticoids (hormones of the adrenal cortex, the main representative is cortisol) inhibit the uptake of glucose by many tissues. In muscles, glucocorticoids stimulate the oxidation of fatty acids; in the liver, glycerol and amino acids are directed to the synthesis of glucose (gluconeogenesis) to obtain energy, which is converted into glycogen and deposited, i.e. readily available supplies of glucose are prepared. When a stressful situation arises and a large amount of adrenaline enters the blood, these reserves are easily used,

Intake of high carbohydrate food

STH (growth hormone) inhibits the uptake and oxidation of glucose in adipose tissue, muscles and the liver and thereby increases blood glucose levels. In addition, it promotes the synthesis of glycogen in the liver from other sources (glukzhoneogenesis).

Thus, 4 hormones (glucagon, adrenaline, cortisol, somatotropic hormone) help to raise the glucose level, preventing it from falling too low, and only one insulin prevents an excessive increase in blood glucose concentration. This circumstance reflects the importance of constantly maintaining a minimum level of glucose in the blood. kiowi for the normal functioning of the brain.

However, this circumstance also determines that the normal hormonal response to an increase in blood glucose levels depends on two factors:

Secretion in an adequate situation of the amount of insulin, i.e. from the normal functioning of pancreatic cells;

Quantity and functional activity (sensitivity) of insulin receptors on the surface of insulin-sensitive cells.

If insulin secretion is inadequate (insufficient) or the functional activity of insulin receptors decreases, the concentration of glucose in the blood will be increased, which can turn into a disease - diabetes mellitus. In turn, excessive secretion of insulin (for example, with a pancreatic β-cell tumor - insulinoma) will lead to the development of severe hypoglycemia - a condition that threatens the patient's life.