When designing ventilation systems for clean rooms used in the production of microelectronics, laboratories medical institutions, operating rooms, aseptic wards and departments, rooms with a 3d printer, etc. - it is necessary to follow the SNiP norms and requirements of GOST, based on the customer's recommendations and the required cleanliness class.

Sanitary standards, technical specifications, manuals and installation rules

• Ventilation design stages
• Ventilation systems in hospitals
• Reliable ventilation of medical laboratories

The main rule of a modern designer of "clean" ventilation is an individual approach that excludes standard solutions. The basis for organizing the correct air exchange in "clean" rooms are the following requirements and standards:

• SNiP 41-01-2003 (8), determining the balance of supply and exhaust ventilation, taking into account the presence or absence of a transfer lock (vestibule, window);
• GOST ISO 14644-1-2002, classifying 9 types of cleanliness of premises, depending on the size and number of particles suspended in the air.

Purpose and classification of "clean" ventilation systems

Modern design guidelines are based on mandatory requirement that the air prepared for the premises of medical institutions, laboratories, operating rooms and aseptic departments must be sterile. The implementation of such a project requires the installation of industrial antibacterial filters with a high lower threshold for filtering harmful particles and microorganisms - HEPA and ULPA.

In the production of microelectronics, unidirectional and mixed zone ventilation is used. The cleanliness class of such an object varies depending on the area - working, technological (service), service.

A separate room is planned for a clean room with a 3D printer. Maintaining the required cleanliness is ensured by the installation additional devices air conditioning, pass window or airlock.

Air exchange in complexes with "clean" rooms

In industrial, warehouse, office, medical complexes of clean rooms and rooms, a modular ventilation scheme is used, including air diffusers, air filters, transfer gates, boxes and windows, monitoring and automation system units. Ventilation equipment and air conditioning ducts are finished with special sealants. The construction of such objects is carried out from special materials - plastic, gypsum-metal wall panels, sandwich panels for suspended ceilings, skirting profiles, sealed doors, windows and lamps, floors with sticky rugs. To minimize air pollution, the metal furniture... Clothes, footwear, technological equipment are stored in isolated lockers and boxes.

An important point in the design process of clean complexes is good manufacturing practice - the GMP standard, which allows not only to calculate the cleanliness class for the technological environment of a room or room, but also to responsibly carry out the installation of air conditioning and ventilation systems. Facility for the production of microelectronics, pharmaceuticals, medical equipment, food, etc. must not only pass the certification of HVAC equipment, but also undergo constant monitoring of its operation, including service, Maintenance, disinfection and cleaning.

Medical center climate project

When performing design work at the Moscow Doctor medical center, our company's specialists performed the calculation, delivery, installation of ventilation and air conditioning systems for its clean rooms. GOST requirements were fulfilled according to ISO-2002, taking into account ISO class 5 of purity for suspended particles.

Air supply was carried out by an intake device with prom. a SHUFT fan that blows air through a multi-stage system with a HEPA filter. Heat recovery and air recirculation in the clean aseptic room of the clinic was carried out with a Funke heat exchanger. The required degree of sterility was maintained by a transfer lock.

At the request of the customer, 2 operating modes of ventilation equipment were prepared. The clean ventilation mode supplied air through a separate automation unit that was not connected to other premises of the medical institution building. The second mode made it possible to control the air exchange from the dispatching console, for the purpose of emergency notification, in the absence of personnel in the building.

The purpose of the projected aseptic department in the medical center is operating room and sterilization room. The clean room was to be used to treat dermatitis.

Perioral dermatitis

This type of dermatitis is a rare skin disease. Most often, representatives of the beautiful half of humanity between the ages of 20 and 40 are exposed to this skin disease. Doctors - dermatologists sometimes call perioral dermatitis perioral dermatitis or perioral dermatitis. The last disease comes from the name of the place of its localization.

Symptoms of perioral dermatitis

Very often, the onset of perioral dermatitis is expressed by several pimples on the skin around the mouth. Patients complain that the use of common hygiene products that prevent acne only gets worse and the area of ​​the affected area becomes larger. You should immediately contact a medical center that specializes in skin conditions if you have any of the following symptoms:

The skin on the chin and around the mouth is covered with a pronounced rash. Red rash, itching, burning of the affected skin. The skin seems to be tightening.

Pimples around the mouth do not cover the entire area of ​​the skin, but some areas. That is, they are located in localized areas.

Sometimes it is accompanied by pimples containing heads filled with clear liquid. When these heads burst, then the fluid contained in them enters the skin. The red rash turns into ulcers over time.

The affected areas of the skin are covered with transparent scales, which periodically peel off the surface and fall off. Other diseases of the human body can have similar symptoms.

Causes of perioral skin disease

Like any dermatitis, this is caused by a decrease in the protective function of the skin. The following factors can provoke malfunctions in the skin's immune system:

• Failure in the hormonal background of the body (endocrine system).
• Reduced cellular immunity of skin tissues.
• A sharp change in climate and prolonged exposure to direct sunlight. Ultraviolet light is bad for the skin.
• Allergies of a bacterial nature.
• Allergic reactions to cosmetical tools and hygienic chemistry.

A skin reaction can appear from the use of allergenic medications. Before starting treatment for any disease, the doctor must make sure that the patient is not allergic to the constituent elements of the drug.

• Genetic predisposition to allergies.
• Rhinitis, asthma.
• Gynecological problems that cause a hormonal disorder in a woman.
• Hypersensitivity of the skin around the mouth and chin.
• Dental prostheses, cleaning pastes, especially fluoride ones.
• Problems with digestive system especially in the gastrointestinal tract.
• Stressful situations, depressive states, that is, all situations that lead to disorders nervous system the human body.

The cost of designing ventilation for a clean room is from 199 rubles. per 1 m2

"Clean" prices for ventilation of clean rooms on a turnkey basis

The climatic company StroyEngineering LLC will carry out projects for public catering facilities (canteens, cafes, restaurants), production workshops (welding places, spray booths), workshops (jewelry, microelectronics), healthcare institutions (medical and preventive complexes, pharmacies, swimming pools, maternity hospitals, laboratories), office, server, residential, warehouse and retail premises ( shopping centers, shops) - in accordance with modern requirements, according to the parameters of GOST and SNiP standards.

A high-tech, convenient and practical air purification scheme is required for private and public medical centers, rented and "own" clean rooms in Moscow and the region - with dispatching? We offer fair and "clean" prices (no markups) for design and installation work with subsequent service for construction and repair organizations, owners of sports clubs, tenants, healthcare institutions and public catering establishments!

The services of our organization include the selection and installation of specialized equipment for air locks and pass-through windows. Industrial air conditioners, filters, air distributors, control units, recuperators, etc. will create optimal conditions to perform any tasks at your "clean" facilities.

Development and implementation of ventilation projects for clean rooms

• An example of installation of ventilation in a polyclinic according to SanPiN
• Ventilation rates for ultrasound, X-ray, physiotherapy, massage rooms
• Ventilation requirements in dentistry with an X-ray machine
• SNiP pharmacy ventilation
• An example of ventilation for a sports hall with a gym and a swimming pool
• Dry cleaning ventilation project at a consumer services enterprise

Previous material - ventilation of living quarters!

Ventilation in clean rooms is one of the most important tasks in maintaining a working environment. Why is ventilation so important? It is air purification that allows you to regulate the condition of the room, the norms of which are prescribed in the GOST. There are several criteria by which a room is assigned to one of nine cleanliness classes, each of which is characterized by the degree of air purification from impurities. Therefore, in technologically clean rooms, ventilation at several levels must be used.

What should be the air in a clean room?

Dust and bacteria are found in any air in the form of aerosol particles. Ventilation of clean rooms allows maintaining the maximum allowed amount of dust and bacteria for a given class of premises.

Draft, dry air or high humidity are the enemies of a clean room. Therefore, the ventilation system regulates the air condition, creating optimal conditions for working in this environment.

The air supply is controlled by automatic equipment, which means that there should be no pressure drops caused by the transfer of air from one room to another. Thus, the sterility and tightness of the premises is maintained automatically.

The air purification system in clean rooms is a complex automated group of filters. Cleanroom air filters are divided into filters rough cleaning, fine purification and microfilters.

The air is filtered from coarse particles, fine cleaning, and then ultrafine cleaning in microfilters. Thus, only air that meets the standards of GOST enters the room, which means it is 99.9% free of dust and microorganisms.

What is the ventilation and air exchange mechanism?

In any room, sooner or later, foreign impurities in the form of aerosol particles accumulate. A fresh portion of purified air enters the room in such a way that the fresh air stream displaces impurities. This is called laminar flow because it is directed in one direction. Several of these flows create air exchange in the room. They are directed either parallel to each other, or, as is often the case in large rooms, in different directions so that the streams do not intersect. V large rooms the flows are regulated so that the air flows directly into working area... The air intakes are located below, the "dirty" air, thanks to the created ventilation, moves towards them.

Supply and exhaust ventilation system clean rooms also includes heat exchangers and a humidifier. They create a microclimate that is comfortable for humans and maintains an optimal working environment.

Ventilation allows you to maintain constant values ​​of temperature, humidity, gets rid of dust and most microorganisms.

Tab. 2. Optimal filter selection scheme used in Switzerland for cleanroom classes according to ISO 14644-1 (GOST R ISO 14644-1)

To date, engineering practice has developed standard solutions, the adherence to which allows avoiding inaccuracies and avoiding unnecessary capital and operating costs. These typical solutions relate to:

• principles of construction of ventilation and air conditioning systems;
• determination of the required structure and parameters of the air conditioner;
• the choice of the number of stages of filtration and types of filters;
• determination of the frequency of air exchange;
• ensuring the required temperature and humidity conditions in the room;
• creating thermal comfort for staff.

The experience of the Invar Cleanroom Testing Laboratory in the attestation of projects (DQ stage) and constructed cleanrooms (IQ, OQ and PQ stages) also revealed typical errors.

Initial data in the design of ventilation and air conditioning systems

Before starting the design, you should clearly formulate its purpose and determine the initial data. Errors and inaccuracies at this stage will lead to incorrect execution of all work. Such initial data include:

• requirements for air cleanliness, and for clean rooms - setting the cleanliness class in accordance with GOST ISO 14644-1 or GOST R 52249;
• microclimate parameters for technological process(temperature and humidity with permissible deviations);
• the number of workers in the room;
• the release of heat and moisture from equipment and processes;
• the release of harmful substances;
• area and height of premises;
• technology requirements, based on the characteristics of technological processes and performed, used materials and products;
• pressure drops between rooms and air flow rates (if necessary).

The structure of ventilation and air conditioning systems

Several types of air flows are involved in the ventilation and air conditioning system:

• exhaust - air leaving the room through the system forced ventilation... Part of the extract air (L in) can be removed directly to the atmosphere by local extractors, part of it can be recycled;
• outside - atmospheric air taken by the ventilation and air conditioning system for supply to the serviced room, L n;
• supply air - air supplied to the room by the ventilation and air conditioning system, L p;
• recirculation - air mixed with the outside and again directed into the ventilation system, L p;
• removed - air taken from the room and no longer used in it, L у.

It should also take into account air leaks from rooms with increased pressure (air exfiltration, L e) and air infiltration into a room with reduced pressure, L and. The simplest scheme ventilation and air conditioning is a direct-flow system when 100% of the outside air is supplied to the room (Fig. 1). This system is uneconomical, since all the air entering the room goes through a full cycle of preparation - from the parameters of the outside air to the required parameters of the clean room air. This system is characterized by high rates energy consumption and reduced filter life.

where i is the room number. To a certain extent, the performance of this system can be improved by heat recovery (Fig. 2). Due to the recuperation, energy savings for heating up to 60% are achieved.

L n = L p = ΣL pi = ΣL bi = ΣL bi + L e, L y = ΣL bi,

where i is the room number. Direct-flow systems, due to their inefficiency, are used only where they are needed and where air recirculation is unacceptable (work with harmful substances, dangerous pathogenic microorganisms), Ch. 17. Wherever possible, recirculation systems are used, which makes it possible to reduce energy costs by several times in comparison with direct-flow systems. An example of a single-level recirculation system is shown in fig. 3.

L в = ΣL вi, L у2 = ΣL вмi,

L p = L n + L p = ΣL pk, L y = L y1 + L y2 = L v - L p + L y2 = ΣL v i - L p - ΣL v mi, L p = L v - L y1,

where L vmi is the air flow rate of the local suction unit from the i-th room; L bi - air flow supplied to the air conditioner from the i-th room. In cold winters or hot summers, as well as when servicing clean rooms with several air conditioners, a two-level system is used. In it, the outside air is prepared to certain parameters in a separate (central) air conditioner, and then supplied to the recirculation air conditioners (Fig. 4).

Local filtration or recirculation units (Fig. 5) are widely used to create zones with unidirectional air flow, for example, in operating rooms and other critical areas. The given schemes give a general approach to the design of ventilation and air conditioning systems, they do not cover the whole variety of options for fundamental solutions, which in each specific case should be developed based on the task at the lowest capital and operating costs.

The above types of air flows should be determined for each room and system as a whole. On this basis, the balance of air exchange is calculated, the results of which are drawn up in the form of a table and applied to the basic diagram of ventilation and air conditioning (Fig. 6). To regulate the balance of air exchange, it is advisable to install valves on the inlet and outlet.

The meaning of building a balance of air exchange is to check that the total volume of air entering the room should be equal to the total volume of air removed from the room. Violation of this condition leads to the impossibility of ensuring the required pressure drops, difficulties in opening and closing doors, etc. For clean rooms this plays a special role, since it is necessary to maintain different pressures in different rooms.

In the air exchange balance table, the total intake air flow rate and the total exhaust air flow rate must be equal for each room (for each row of the table). For each cleanroom, the supply and exhaust air are calculated, and air leaks are also taken into account (exfiltration - air leakage into rooms with a lower pressure, air infiltration - air intake from a room with more high pressure). The main initial data for the development of the design of the ventilation and air system for clean rooms:

1. planning solutions with indication of cleanliness classes and pressure drops;
2. Purpose of clean rooms (clean areas): product and process protection, personnel protection and environment;
3. the release of harmful substances;
4. the release of heat and moisture from equipment;
5. number of staff;
6. characteristics of the climate of the construction area.

The outdoor air flow is calculated based on the need:

• compliance with sanitary and hygienic standards;
• compensation of exhaust air (both from individual rooms due to the operation of exhaust units, and removed through the air conditioning system);
• compensation of leaks due to pressure differences in clean rooms and the environment.

The outdoor air flow for the entire ventilation system is equal to the sum of the air flow for each room. The air flow for a single room is equal to the sum of the air volume removed by the local exhaust unit and the losses due to leaks. This amount should not be less than the minimum outdoor air consumption in accordance with regulatory documents.

Supply air calculation for each room

The supply air has the following functions:

• ensuring the required cleanliness class;
• ensuring the requirements for microbiological air purity where they are imposed;
• supply of the required amount of outdoor air;
• removal of excess heat and moisture and maintaining the required parameters of the microclimate in the room;
• compensation for air leaks due to pressure drops.

The required air exchange rate is influenced by all the above functions of the supply air. For each of them, the required air exchange rate is determined and the highest value is laid down in the project. Let's consider each of the listed functions.

Cleanliness class

It is provided by multi-stage air filtration and the choice of filters of the appropriate classes, by setting the air flow rate (for a unidirectional air flow), and the frequency of air exchange.

Air exchange rate

Sets the air flow rate for clean rooms of ISO classes 6-9 (zones B, C, D). For zone A, the air flow rate is determined by the unidirectional flow rate. There are several approaches to determining the air exchange rate to ensure cleanliness:

• use of various recommendations, standards and rules;
• calculation method.

Removing excess heat and moisture

Process equipment and personnel generate heat and moisture, which must be removed using a ventilation and air conditioning system. Providing the required microclimate while maintaining temperature and humidity - important condition ensuring the normal work of personnel in clean rooms. In addition, certain technological processes (for example, photolithography in the manufacture of microcircuits) impose strict requirements on temperature and humidity.

Compensation for the operation of the exhaust units

The total volume of extract air for the given room is determined. The quotient of dividing it by the volume of the room gives the air exchange rate required to compensate for the hoods.

Leak compensation

Differential pressure between different premises causes exfiltration (leakage) of air from the room through the cracks in the doorways and all sorts of leaks. The leakage rate must be calculated for each room and taken into account in the air exchange balance. Air leakage must be compensated for with an equal amount of outside air in the supply air supply. Air infiltration should also be taken into account in the balance of air exchange, i.e. air intake from adjacent rooms.

Air exchange rate in general premises

In such rooms, the calculation of the air exchange rate is carried out in accordance with sanitary standards and according to the calculations of excess heat and moisture. In Western countries, the following air exchange rates are used (data from Airflow, England) for some rooms (Table 1).

Selecting filter types

Typically, clean room air preparation systems are performed in three stages:

• first stage: medium efficiency filter type F to protect the air conditioner from pollution;
• second stage: high-efficiency filter type F to ensure cleanliness in the air ducts;
• third stage: HEPA or ULPA filter for guaranteed high quality of air supplied directly to clean rooms.

In addition, the use of a three-stage air filtration system guarantees long term operation for HEPA and ULPA filters. Recommendations for the optimal selection of filters are presented in table. 2.

Common mistakes

Cleanliness classes

The most common misconception is the requirement to manufacture non-sterile medicines in clean rooms. It is generated by the notorious and illiterate OST 42-510-98 and previous documents of the same sort. Nowhere in the world is there a requirement to produce non-sterile molds in clean rooms! The only document that provides specific data on the cleanliness of supply air for the production of solid forms is the Guidelines of the International Organization of Pharmaceutical Engineers (ISPE).

It contains recommendations on the effectiveness of the final filters for various stages of the process. In world practice, these recommendations are widely used without specifying purity classes. No one prohibits the use of clean rooms, and many specify the production of solid forms in zones D, and liquid non-sterile forms in zones C. But which way to choose - to use clean rooms or simply to limit ourselves to a certain level of purity of the supply air and the quality of the enclosing structure is a matter of the customer.

This logic is followed by the EU GMP Regulations (GOST R 52249) and the US guidelines. If someone wants to force an enterprise to apply an optional cleanliness class, then we recommend a simple and effective means: to legally formalize this compulsion so that the initiator himself bears the costs of it. No arguments (like “our“ advanced ”neighbors are doing this) should not be taken into account.

Overestimation of cleanliness classes in sterile production is also widespread. There is one more factor to keep in mind. Other design organizations artificially overestimate the cleanliness classes and sizes of clean zones. The cost of the project and the fees of the contractors directly depend on the classes of cleanliness and the volume of costs. In the practice of the author, there was a project in which the emission of particles by the staff was overestimated by a factor of 100!

Unreasonably strict requirements for temperature and humidity

There are, for example, requirements to maintain an air temperature of 22 ° C with an accuracy of ± 1 ° C and humidity within 45-50% without justification from the technological process. A simple expansion of the limits of regulation of microclimate parameters within the framework of existing standards can significantly simplify the entire system.

Unjustified use of direct-flow systems

Previously, under the conditions of a costly mechanism of state financing, direct-flow systems were widely used, even where they were not needed. In world practice, air recirculation is used wherever it is permissible from a safety point of view. V otherwise recirculation heats the outside air in winter and cools it down in summer. significant costs literally fly into the pipe.

Excessive air exchange rate Wrong choice of filters

Designs often include low filter classes (for example, G3) at the first stage of filtration. This increases the dust load on the downstream filters and shortens their service life.

Absence schematic diagram and tables of air exchange balances

You cannot judge the project without them. Their development is required. These errors are typical examples and do not exhaust the entire list of shortcomings encountered in practice.

Clean room (clea nr oom) is a room where the concentration of airborne particles is monitored, built and used to minimize the intake, emission and retention of particles inside the room, and allowing other parameters to be monitored as needed, such as temperature, humidity and pressure.

In such premises, the content air pollutants, on wall and ceiling surfaces should be kept to a minimum.

Specified particles there may be materials such as dust, anesthetic waste gases, and microorganisms.

Extremely clean indoor air can only be achieved by removing indoor air and supplying filtered, displaced conditioned air.

In addition, as in classical system, the parameters should be monitored comfortable conditions such as temperature, relative humidity, noise level, air pressure and speed, and minimum outdoor air flow.

Cleanroom technology serves the following purposes:

• protection of products from contamination;
• protection of the environment from pollution;
• creating a protective environment for people in the room;
• protecting people in the room from germs carried by people;
• protecting the environment from hazardous products;
• protecting the environment from microbes carried by humans.

A clean room assumes a clean atmosphere, clean gas, clean surfaces, clean equipment, clean products and clean technology.

No projects and investments should be carried out until the hygiene requirements for the cleanroom have been determined.

It is necessary to ensure the guaranteed hygienic quality and maintenance necessary degree air purity in the room (not necessarily the highest possible).

High hygienic quality can be ensured with an expensive protection project.

The basic approach should be to ensure that hygiene requirements are met, where appropriate, in the most inexpensive ways and with maximum efficiency, but only to the extent that it is necessary for a particular room.

Parameters affecting implementation necessary conditions can be divided into two groups: provision parameters comfort and hygiene.

The criteria for comfortable air parameters are:

• acceptable temperature range;
• acceptable moisture content;
• required flow rate of the supplied air (l / s);
• permissible noise level.

These parameters are important for assimilation of heat dissipation from external and internal sources, as well as for compensating for heat losses and for ensuring comfortable conditions in the room.

Air hygiene criteria:

• ensuring the concentration of microorganisms within the specified limits;
• removal of pollutants from the room, such as evolved gases;
• control of air movement in the room.

The parameters for maintaining hygienic conditions are the concentration of microbes and polluting gases, as well as the movement of air between rooms.

In this regard, the concentration of pollutants should be at the minimum required level, the movement of air between rooms should be controlled.

but during the design, consideration of these parameters in their totality should be carried out... To assimilate the surplus heat to ensure the required air quality, the amount of conditioned air should be checked, as well as the amount of displacement air required to keep the microorganism concentration in the room below a certain level.

Cleanroom Applications

Cleanrooms are used in areas such as medicine, microelectronics, micromechanics and food processing.

In medicine, operating rooms, preparation rooms drugs, biochemical and genetic laboratories are cleared of particulate matter and microorganisms.

Clean rooms are used in microelectronics, space technology, thin-film technology, manufacturing industry printed circuits and in adjacent directions of these areas where removal of contaminants is required.

In the food industry, both contaminant particles and microorganisms are removed from production facilities.

Clean room with turbulent air flow

Terms used in cleanroom literature

Live microorganisms. Bacteria, fungi and viruses fall into this category. Microorganisms can develop in the form of colonies in air, water, and especially in cracks and rough surfaces. The most common source of microorganisms is the human body, which sorts about 1,000 types of bacteria and fungi.

Contaminants other than microorganisms. Substances suspended in the atmosphere, other than microorganisms, are present in the atmosphere as a result of the action of wind, earthquakes and volcanic activity. These are commonly referred to as dust or aerosols. This group includes smoke particles from industrial processes, building heating systems and vehicle exhaust emissions. The same group also includes suspended particles, the sources of which are moving parts of machines in clean rooms. In addition, as a result of the actions of people in a clean room, about 100,000 particles less than 3 microns in size are released into the air of this room.

Sterility. This is how you can describe the situation in a room in which there are no microorganisms in products and devices.

Sterilization. A technique for destroying or killing microorganisms in products or devices.

HEPA filters (high efficiency particulate air filter). These filters are a kind of high efficiency air filters. They are used directly in air handling units, as well as at the end points of the air supply to the room as the final stage of cleaning. The efficiency of these 0.3 micron filters ranges from 97.8% to 99.995%. These filters are designed for rooms with a cleanliness class of 100-100,000.

ULPA filters (also known as ULTRA-HEPA). These are very effective special air filters. The efficiency of these filters for 0.3 µm particles ranges from 99.999 to 99.99995%. These filters are designed for rooms with a cleanliness class of 1-100.

DOP test. Testing the effectiveness of HEPA filters in real conditions after installation.

Clean rooms with turbulent air flow. In these clean rooms, conditioned air is supplied through HEPA filters located directly in the false ceiling. The air return vents are at floor level. This cleaning method is intended for rooms with a cleanliness class of 10,000-100,000 (Fig. 1).

Clean rooms with laminar air flow. In this method, an air stream at a constant speed carries contaminants into the return air duct and then into the air handling unit. This method is suitable for rooms with cleanliness class 1, 10, 100, 1000

Clean rooms with laminar air flow

Air lock. An air lock must be located at the entrance to the cleanroom, providing access to the room in accordance with current regulations... The airlock is a small chamber with two doors, into which conditioned air is supplied through two HEPA filters.

Room cleanliness class. Depending on the type of production to be carried out in a clean room, the cleanliness class of this room is determined. Various standards apply for the classification of clean rooms. Currently, Germany uses VDI 2083, France uses US 209 at AFNOR 44001, and England uses BS 5295.

In a clean room, all equipment and all systems (including air handling units, air ducts, duct equipment) must be able to be cleaned, replaced and service.

In rooms that require a high degree of sterility, three-stage filtration is used:

• First stage filter. Designed to keep the air handling unit clean, it is located in the inlet section of this unit. (Class F4-F5).
• Second stage filter. It is used as a final element for keeping the duct clean. (Class F7-F9).
• Third stage filter. Placed at the entrance to the cleanroom to ensure hygienic conditions. (Class H13-H14).

1. A hygienic air handling unit must, on the one hand, prevent the penetration of microorganisms and polluting particles into the room, and, on the other hand, must exclude the formation and accumulation of foreign substances in its structure.
2. The systems must have a high degree of tightness, the proportion of air entering the room bypassing the filter cassettes must be very small.
3. Another point in the system associated with the possibility of intrusion of microorganisms is the drain connection and the drain line from the air handling system. In this place must be installed siphon system with two bends, not connected to the city sewage system.
4. To eliminate the need to open the door once again, a peephole must be installed in it, in addition, a lighting system must be provided.
5. To prevent the buildup of microorganisms and contaminants, air handling units must have very smooth surfaces without cracks or wavy shapes.
6. Hygienic sealing elements should be used at the panel joints to prevent the accumulation of contaminants in these areas and to facilitate service procedures. In addition, differential pressure gauges should be used to visually check the degree of filter clogging.
7. Air ducts should have smooth surfaces and be made of galvanized steel, of stainless steel and similar materials.
8. The possibility of condensation formation is eliminated by choosing the correct thickness of the thermal insulation. In the duct system, it is important to have a sufficient number of well-sealed service openings.
9. Air flow measuring devices should have easy access service ports. These devices should provide data on air flow and pressure in the room, even if the filters are clogged.

Cleanroom components

Cleanroom Startup Procedures. After completion of the test procedures and commissioning, if these procedures are successful, work can begin in the cleanroom.

The most important tests for a clean room are: duct density tests, air handling devices to ensure the required flow, diffusers to ensure the specified temperature and humidity values, pressure tests and measuring the content of foreign matter particles. Instruments used for these purposes must be re-calibrated prior to testing.

Air handling system air intake devices, exhaust dampers, rating plates, filter labels and all sections of the air handling system must be freely accessible and must be visually inspected and serviced.

Another important issue is the training of cleanroom personnel. Use of sterile clothing is mandatory.

As with many engineering systems, the cleanroom must be subject to regular maintenance procedures to ensure uninterrupted, trouble-free operation. To maintain hygienic parameters at all times, the filters should be checked regularly for clogging before any system malfunctions occur.

Cleanroom air preparation systems

INTECH company carries out a full range of works related to design, supply of equipment and materials, as well as directly installation of complexes engineering equipment and "clean rooms" systems for heating, ventilation and air conditioning with a multi-stage, high-quality air filtration (purification) system. Using specialized climatic equipment for the maintenance of clean rooms in the industries:

• Pharmaceutical industry;
• Microelectronics;
• Medicine;
• Biotechnology;
• Laboratories and Scientific research;
• Aviation and space industry;
• Medical industry;
• Food industry;
• Optics.

Cleanliness classes

Cleanliness class- these are clearly regulated requirements for the level of various types of impurities and particles in the air. The cleanliness classes differ in the number of colony-forming bacteria per unit volume.

On the example of clean rooms of medical institutions, 3 classes of cleanliness have been established:

1. Premises with the first class of cleanliness must have the lowest concentration of bacteria - no more than 10 bacteria / m3. First-class premises include operating rooms for transplantation, complex orthopedic and cardiac surgery, intensive care and burn therapy wards, leukemia therapy;
2. The second class of cleanliness includes rooms with a low level of microbial contamination - in the range of 50-200 bct / m3. These are operating rooms for urgent operations, rooms for operating units (including corridors), maternity, prenatal wards, wards for premature and injured children;
3. Premises of the third class have a bacterial concentration of 200-500 pcs / m3. These are intensive care wards for people with heart disease, newborns, sterilization, children's dressing and treatment rooms.

The task of the climate system for "Clean rooms"

Technological requirements for ventilation and air conditioning systems for "clean rooms" are as follows:

• Reducing the spread of pathogens, which means removing air pollutants, supplying clean air, protecting the room from microbes and microparticles contained in the air, as well as preventing air from coming from neighboring less "clean" rooms;
• Control of the required air parameters: temperature, humidity, mobility, as well as the concentration of harmful impurities that do not exceed the MPC;
• Eliminate the generation and build-up of static electricity to prevent the associated risk of explosion.

Solving problems

The challenge of ensuring cleanliness in the room it is most effectively solved on the basis of a comprehensive approach, taking into account both the specific features of each specific room (space-planning characteristics, technological purpose, requirements for cleanliness and climatic parameters), and the features that characterize the room as an element of the totality of premises. This provision is reflected in the creation of complexes of clean rooms, the main design principles of which are:

• ensuring the required calculated air exchange;
• preparation of supply air with the required parameters for humidity, temperature and microbiological purity;
• rational organization of air flows from cleaner modules to less clean ones;
• air distribution in modules with the organization of a given direction of its movement, taking into account the characteristics of the room and the technological process;
• highly efficient cleaning of indoor air.

Constructive execution the complex is determined by the specific purpose of the cleanrooms, their configuration and dimensions, the current regulatory requirements for the air environment. V general view The complexes offered by INTECH are made on a modular basis and include the following functional systems and elements:

• air preparation, disinfection and distribution system;
• room microclimate control system.

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