Ventilation of clean rooms - rules, types of systems of their requirements. Air conditioning systems of hospitals, pharmacies, polyclinic Is it possible to turn off the ventilation in clean rooms

GOST R 56190-2014

National Standard of the Russian Federation

Clean rooms

Energy saving methods

Cleanrooms. Energy Efficiency

OX 13.040.01;
19.020
OKP 63 1000.
94 1000

Date of introduction 2015-12-01

Preface

1 Developed by the All-Russian Public Organization "Association of Microlls Control Engineers" (ACINCOM) with the participation of Open Joint Stock Company "Research Center for Control and Diagnostics of Technical Systems" (NIC CD JSC)

2 Submitted by the Technical Committee on Standardization of TC 184 "Ensuring Industrial Purity"

3 approved and commissioned by order of the Federal Agency for Technical Regulation and Metrology of October 24, 2014 N 1427-ST

4 introduced for the first time

The rules for applying this standard are established inGOST R 1.0-2012 (Section 8). Information on the changes to this standard is published in the annual (as of January 1 of the current year) the information indicator "National Standards", and the official text of the amendments and amendments - in the monthly information indicator "National Standards". In case of revision (replacement) or cancels of this standard, the appropriate notification will be published in the nearest issue of the National Standards Information Index. Relevant information, notice and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet (GOST.RU)

Introduction

Clean rooms are widely used in electronic, instrument-making, pharmaceutical, food and other industries, in the production of medical products, in hospitals, etc. They became an integral part of many modern processes and a means of protecting humans, materials and products from pollution.

At the same time, clean rooms require significant energy consumption, mainly on ventilation and air conditioning, which may exceed energy consumption in conventional premises in tens of times. This is caused by high multiples of air exchange and, as a result, significant needle needs, cooling, moisturizing and drying air.

The current practice of creating clean rooms is focused on providing specified purity classes without proper attention to the tasks of energy savings.

Maintaining a predetermined cleanliness in the room is a difficult and comprehensive task. It is necessary to accurately know the characteristics of particle release and based on their basis the calculations of air flow and the multiplicity of air exchange, which is not always possible. The concentration of particles in the air is probabilistic and depends on many factors: the effects of man, process, equipment, materials and products that are difficult to assess exactly, especially at the design stage. Because of this, project decisions are accepted with a large margin so that when certification and operation, it is guaranteed to obtain a given class of purity.

Well thought-out and built clean room has a margin of purity. The existing practice of certification and operation of clean premises This stock does not take into account that leads to excessive energy consumption.

Another reason for the excessive highstands of the air exchange laid in projects is to apply regulatory requirements that do not apply to this object. For example, Appendix 1 to GOST R 52249-2009 "The Rules of Production and Quality Control Quality Control" (GMP) establishes that the restoration time of clean room in the production of sterile drugs should not exceed 15-20 minutes. To fulfill this requirement, the multiplicity of air exchange can significantly exceed the values \u200b\u200brequired to provide a class of purity in the steady mode.

Dissemination of requirements for the production of sterile drugs into non-sterile drugs and other products, including non-medical destination, leads to a significant overvoltage of energy.

Recommendations for energy savings in clean rooms are given in the standards of Great Britain BS 8568: 2013 * and society of German engineers VDI 2083 Part 4.2.
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* Access to international and foreign documents mentioned here and then on the text, you can get by clicking on the link to the site http://shop.cntd.ru. - Note database manufacturer.

This standard provides requirements for determining the real reserve of power at the stages of certification and operation based on the actual consumption of energy resources when guarantees compliance with the specified class of purity. Energy savings should be provided not only at the stage of designing clean rooms, but also ensured in certification and operation.
________________

A.fedotov. - "Saving Energy In Cleanrooms". Cleanroom Technology. London, August, 2014, PP.14-17 Fedotov A.E. "Energy savings in clean rooms" - "Cleanliness technology" N 2/2014, p. 5-12 clean rooms. Ed. A.E.Fedotova. M., Assinkom, 2003, 576 p.

When certification and operation of clean rooms, the actual separation of particles should be estimated and on the basis of this to determine the necessary air flow and the multiplicity of air exchange, which can be significantly lower than the design values.

This standard provides a flexible approach to determining the multiplicity of air exchange, taking into account the actual separation of particles and the process.

1 area of \u200b\u200buse

This standard establishes the methods of energy saving in clean rooms.

The standard is intended for use in designing, certification and operation of clean rooms in order to save energy resources. The standard takes into account the specifics of clean rooms and can be used in various industries (electronic, instrument-making, pharmaceutical, medical, food, etc.).

The standard does not affect ventilation and air conditioning requirements established by regulatory and regulatory legal documents for working with pathogenic microorganisms, toxic, radioactive and other hazardous substances.

2 Regulatory references

This standard uses regulatory references to the following standards:

GOST R EN 13779-2007 Ventilation in non-residential buildings. Technical requirements for ventilation and air conditioning systems

GOST R ISO 14644-3-2007 Clean rooms and related environments associated with them. Part 3. Test Methods

GOST R ISO 14644-4-2002 Clean rooms and related environments associated with them. Part 4. Design, Construction and Commissioning

GOST R ISO 14644-5-2005 Clean rooms and associated controlled environments. Part 5. Operation

GOST R 52249-2009 Rules for the production and quality control of medicines

GOST R 52539-2006 Purity of air in medical institutions. General requirements

GOST ISO 14644-1-2002 Clean rooms and associated controlled environments. Part 1. Classification of air purity

Note - When using this standard, it is advisable to check the action of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or on the National Standards Annual Information Signal, which is published as of January 1 of the current year, and on issues of the monthly information pointer "National Standards" for the current year. If the reference standard is replaced, to which the undated link is given, it is recommended to use the current version of this standard, taking into account all changes made to this version. If the reference standard is replaced by a dated reference, it is recommended to use the version of this standard with the above-mentioned approval (adoption). If, after approval of this standard in the reference standard, to which the dated reference is given, the change has been made affecting the provider to which the link is given, this provision is recommended to be applied without taking into account this change. If the reference standard is canceled without replacement, the position in which the reference is given to it is recommended to be applied in a portion that does not affect this link.

3 Terms and Definitions

This standard uses the terms and definitions of GOST ISO 14644-1, as well as the following terms with the corresponding definitions:

3.1 recovery time: The time of reducing the concentration of particles in the room is 100 times compared with the initial, sufficiently large concentration of particles.

Note - The method for determining the recovery time is given in GOST R ISO 14644-3 (paragraph 12.3).

3.2 multiplicity of air exchange N.: The ratio of air flow L. (m / h) to the size of the room V. (m), N \u003d L / V, h

3.5 air consumption L.: The amount of air supplied to the room per hour, m / h.

ventilation efficiency : The effectiveness of ventilation characterizes the relationship between the concentration of contamination in the supply air, exhaust air and in the respiratory area (inside the zone operated). Effective ventilation is calculated by the formula

where c.- concentration of contamination in exhaust air;

c. - concentration of pollution indoors (in the respiratory area within the exploited zone);

c. - Concentration of contamination in the supply air.

The efficiency of ventilation depends on the air distribution, as well as on the type and location of the sources of air pollution. It can be different for different types of pollution. If there is a complete removal of contaminants, the ventilation efficiency is equal to one. The concept of "ventilation efficiency" is discussed in more detail in CR 1752.

Note - To designate this concept, the term "efficiency of removal of contaminants" is also widely used.

[GOST R EN 13779-2007, Article 3.4]

4 Principles of Energy Saving in Clean Rooms

4.1 Energy Saving Measures

Energy saving measures can be common to any buildings, industries and ventilation and air conditioning systems or special for clean rooms.

4.2 General measures

Total measures include:

- minimization of the flow and loss of heat, insulation of buildings;

- heat recovery;

- air recycling with bringing the share of outdoor air to a minimum, where it is not prohibited by mandatory norms;

- placement of energy-intensive industries in climatic zones that do not require excessively high heating costs and air humidification in winter, cooling and drying in the summer;

- the use of highly efficient fans, air conditioners and chillers;

- elimination of unnecessarly rigid ranges of temperature and humidity;

- maintaining air humidity in the winter at the minimum level;

- removal of excess heat from equipment mainly built into the equipment with local systems, and not to means of ventilation and air conditioning, etc.

- the use of equipment protection and exhaust cabinets that do not require removal of large amounts of air when working with harmful substances (for example, closed equipment, systems with limited access, insulators);

- use of equipment with a power reserve (for example, air conditioners, filters, etc.), having in mind that equipment with a greater rated power consumes less energy to perform this task;

Note - with the same air consumption at the fan (air conditioner) with a greater rated power, energy consumption will be less.

- Other measures according to 4.4.2.

4.3 Special measures

These measures take into account the peculiarities of clean rooms and include:

- reduction to a reasonable minimum area of \u200b\u200bclean rooms and other air conditioning rooms;

- elimination of the task of unreasonably high classes of purity;

- justification of the dies of the air exchange, avoiding overly high values, including due to unreasonably strict requirements for the recovery time;

- use of HEPA and ULPA filters with reduced pressure drop, for example membrane teflon filters;

- sealing of looseness in the joints of the enclosing structures;

- application of local protection when specifying a high class in a limited zone based on the process requirements;

- reducing the number of personnel or the use of deserted technologies (for example, the use of closed equipment, insulators);

- reduction of air consumption overotherly;

- determination at the stages of certification and operation of the real value of the power reserve, the project;

- strict adherence to operating requirements, including clothing, personnel hygiene, training, etc.;

- determination of really necessary air costs during testing and during operation and regulation of air expenditures to minimum values \u200b\u200bbased on this data;

- exploitation of clean room with reduced energy consumption, subject to compliance with the requirements for the purity class;

- confirmation of the possibility of working with reduced energy consumption by current control of purity (monitoring) and re-certification;

- Other measures according to 4.4.2.

4.4 Stages of energy saving

4.4.1 General

Evaluation of energy needs is performed at the design stages, certification and operation.

The main factor determining the need for energy resources is air consumption (air exchange).

Air flow must be defined at the design stage. At the same time, some reserve is envisaged, taking into account the uncertainty due to the lack of accurate data on the separation of particles with equipment, process and for other reasons.

At the stage of certification, the correctness of the design solutions is checked and the real reserve of ventilation and air conditioning systems is determined by air consumption.

When operating, the compliance of the clean room is the specified class of purity.

Note - This approach differs from existing practice. Traditionally, air consumption is determined at the design stage (in the project), in the constructed premises, attestation, the air flow correspondence specified in the project and this air flow is maintained during operation. In this project, the redundancy of air consumption is laid due to the presence of some uncertainty, but this redundancy is detected during testing. Further, the room is operated when the air exchange is excessively high, which leads to an energy overrun.

This standard provides for the definition of a real reserve in the design solutions and operating clean rooms with the actually necessary air flow, which turn out to be less project values \u200b\u200bby the value of the reserve set.

The standard shows a flexible order to determine the multiplicity of air exchange.

4.4.2 Design

Common and special measures should be taken (see 4.2-4.3), taking into account real possibilities.

Along with this, it should be provided:

- regulation of air expenditures by automation tools, including setting modes for working and non-working time and ensuring microclimate parameters depending on specific conditions;

- the transition from providing a class of purity throughout the room to local protection, at which the purity class is specified and monitored and monitored, or the working area provides a higher class of purity than in the rest of the room;

- Accounting for laminar cabinets and laminar zones. In this case, air consumption of air from the laminar cabinet (zone) is added to the air conditioning air conditioning.

- For premises, where only local protection is required, the expediency of using horizontal air flow instead of vertical. In some cases, it is possible to create a stream of air at an angle, for example, at an angle of 45 ° in relation to the ceiling;

- Reducing the resistance of the air flow on all elements of the air movement path, including due to the low air velocity in the air duct.

Methods of energy saving differ for the premises (zones) with a unidirectional and non-unified flow.

4.4.2.1 Unidirectional Air Flow

For zones with unidirectional flow, the air flow rate is a key factor. It is recommended to maintain the speed of the unidirectional flux of about 0.3 m / s, if the regulatory documents are not provided otherwise. In the event of a contradiction, it is envisaged by the speed value established by the regulatory documents. For example, GOST R 52249 (Appendix 1) provides for the rate of unidirectional air flow within 0.36-0.54 m / s; GOST R 52539 - 0.24-0.3 m / s (in the operating and chambers of intensive therapy).

4.4.2.2 Insolidated Air Flow

For clean rooms with an indispensable (turbulent) stream, the crucial factor is the multiplicity of air exchange (see section 5).

4.4.3 Certification

Certification (tests) of clean rooms is carried out according to GOST R ISO 14644-3 and GOST R ISO 14644-4.

In addition, it is necessary to check the possibility of maintaining a class of purity with a reserve with reduced multiples and real values \u200b\u200bof particle release values, i.e. Determine the reserve of ventilation and air conditioning systems. This is performed for equipped and operated clean rooms.

4.4.4 Operation

It is necessary to confirm the possibility of working with reduced multiple air exchange in real mode when performing a technological process with a set of personnel, the use of this clothing, etc.

For this purpose, periodic and / or continuous control of particles concentration is envisaged.

Measures should be taken to reduce the separation of particles by all possible sources, the flow of particles to the room and the effective removal of particles from the room, including personnel, processes and equipment, clean design structures (convenience and efficiency of cleaning).

The main measures to reduce particle release are:

1) Staff:

- use of appropriate technological clothing;

- compliance with hygiene requirements;

- proper behavior based on the requirements of cleanliness technology;

- training;

- the use of sticky rugs at the entrance to clean rooms;

2) Processes and equipment:

- cleaning (washing, cleaning);

- use of local suns (removal of pollution from the place of allocation);

- the use of materials and structures that do not adsorb pollution and ensuring efficiency and convenience of cleaning;

3) Cleaning:

- Proper technology and the necessary periodicity of cleaning;

- application of inventory and non-particle materials;

- Control over cleaning.

5 Multiplicity of air exchange

5.1 Quest of the speed of air exchange

Taking into account the key role of air consumption in energy consumption, you should perform an assessment of the multiplicities of air exchange in all factors affecting them:

a) the need for external air through sanitary standards;

b) local exhaust compensation (suns);

c) maintaining pressure drop;

d) removal of excess heat;

e) providing a specified class of purity.

Measures should be taken to reduce air costs that are not related to the provision of purity (enumeration A-D) to values \u200b\u200bsmaller than necessary to ensure purity (E).

To calculate the ventilation and air conditioning system, the worst (highest value) is taken.

The required multiplicity of air exchange (air flow) depends on the requirements for the purity class (maximum permissible concentration of particles in the air) and the recovery time.

Method of calculating the multiplicity of air exchange to ensure purity is given in Appendix A.

5.2 Ensuring a class of purity

Classification of clean rooms is given in GOST ISO 14644-1.

Requirements for cleanliness classes are set in accordance with regulatory documents (for the production of drugs - according to GOST R 52249, medical institutions - according to GOST R 52539) or the task for designing (technical assignment to the development) of clean room based on the specifics of the technological process and by agreement between the customer and performer.

At the design stage, the intensity of the separation of particles can only be estimated approximately, in this connection, the margin of the multiplicity of air exchange should be provided.

5.3 Recovery Time

The recovery time is accepted in accordance with the regulatory requirements for cases provided for in them. For example, GOST R 52249 sets the recovery time of 15-20 minutes for the production of sterile drugs. In other cases, the customer and the performer can set other values \u200b\u200bof the recovery time (30, 40, 60 min, etc.) based on specific conditions.

The method of calculating the decrease in the concentration of particles and the recovery time is given in Appendix A.

The concentration of particles in the air and the recovery time is strongly influenced by clothing of personnel and other operating conditions (see example in Appendix B).

In the presence of a zone with a unidirectional air flow, its effect on air purity should be taken into account (see Appendix A).

Appendix A (Reference). The dependence of the concentration of particles and the recovery time from the multiplicity of air exchange

Appendix A.
(Reference)

The main source of pollution in pure room is a person. In many cases, the emission of pollution from equipment and structures is small compared to the discharge from a person and it can be neglected.

Concentration of particles C. In the air of premises with supply ventilation at the time of time t. calculated (generally) by formula

where C. - particle concentration at the initial moment (when the ventilation system is turned on or after entering air pollution) t.\u003d 0, particles / m;

n. - intensity of separation of particles indoors, particles / s;

V. - the size of the room, m;

k. - coefficient calculated by the formula (A.2);

k. - coefficient calculated by the formula (A.3).

where - the efficiency coefficient of the ventilation system, for clean rooms with an inener-controlled (turbulent) stream taken \u003d 0.7;

Q. - consumption of supply air, m / s;

q. - the volume of air penetrating the inside of the room due to leakage (air infiltration), m / s;

- the proportion of recycling air;

- The effectiveness of filtering recycling air.

where - the effectiveness of filtration of outer air;

C. - particle concentration in outer air, particles / m;

C is the concentration of particles in the air coming by infiltration, particles / m.

Formula (A.1) includes two terms: variable C. And constant C..

C \u003d C.+ C., (A.4)

where
.

The variable part characterizes the transition process when the concentration of particles in the air of the room decreases after turning on the ventilation or make contaminants into the room.

The constant part characterizes the established process, in which the ventilation system removes particles generated in the room (staff, equipment, etc.) and entering the room from outside (with infiltration, due to infiltration).

In practical calculations accept:

- air infiltration equal to zero, q.=0;

- filtration efficiency is 100%, i.e. \u003d 0 and \u003d 0.

Then the coefficients are equal

k.= · Q \u003d 0.7 · Q,

k.=0

Formula (A.1) is simplified

where N. - multiplicity of air exchange, h;

Q \u003d n · v. (A.6)

Example A.1 Clean room in a equipped condition (without personnel, the process is not conducted)

Consider a clean room with the following parameters:

- Volume V \u003d 100 m ;

- Cleaning class 7 ISO; equipped with a state; The specified particle size of 0.5 μm (352000 particles / m );

0.5 μm indoors =10 particles / s;

- FROM =10 particles / M. , particles with dimensions 0.5 microns;

- the multiplicity of air exchange N, corresponds to the row 15 *, 10, 15, 20, 30;
___________________

- air flow q, m / C, calculated by the formula (A.6)

where 3600 is the number of seconds in 1 hour;

- The efficiency coefficient of the ventilation system for clean rooms with an ineffined (turbulent) stream is accepted =0,7.

The calculation of the decrease in the concentration of particles after time t is carried out by formula (A.5):

where .

Note - When calculating, express time in seconds.

The calculation data is shown in Table A.1.

Table A.1 - change of particle concentrations with dimensions 0.5 μm in the air depending on the multiplicity of air exchange over time in the equipped state

Table data A.1 in graphic are given in Figure A.1. *
___________________
* The text of the document corresponds to the original. - Note database manufacturer.

From Table A.1 and Figure A.1, it can be seen that the condition of the recovery time is less than 15-20 minutes (decrease in the concentration of particles in the air 100 times) is performed for multiplicities of air exchange 15, 20 and 30 h . If you allow the recovery time to 40 minutes, then the multiplicity of the air exchange can be reduced to 10 hours . In operation, this means switching the ventilation systems to operate 40 minutes before the start of work.

Figure A.1 - Changing the concentration of particles with dimensions of at least 0.5 μm in the air depending on the multiplicity of air exchange over the time of the equipped state

Figure A.1 - Change the concentration of particles with dimensions 0.5 μm in the air depending on the multiplicity of air exchange over the time of the equipped state

Example A.2. Pure room in operation

Clean room is the same as in Example A.1.

Conditions:

- exploited condition;

- the number of personnel 4 people;

- intensity of particle selection with dimensions 0.5 μm one person is equal to 10 particles / s (used clothing for clean rooms);

- The separation of particles with equipment is practically absent, i.e. Only the separation of particles by personnel is taken into account;

- N. \u003d 4 · 10 particles / s;

- FROM =10 particles / M. .

Calculate the decrease in the concentration of particles over time by formulas

The calculation results are indicated in Table A.2.

Table A.2 - Changing the concentration of particles with dimensions

Table A.2 data is shown in graphic form in Figure A.2.

Figure A.2 - Change the concentration of particles with dimensions of at least 0.5 μm in the air depending on the multiplicity of air exchange over time (used clothing for clean rooms)

Figure A.2 - Changing the concentration of particles with dimensions 0.5 μm in the air depending on the multiplicity of air exchange over time (used clothing for clean rooms)

As can be seen from Example A.2, with multiplicity of air exchange 10 h class 7 ISO is achieved 35 minutes after the start of the ventilation system (if there are no other contamination sources). Reliable maintenance of a class of purity 7 ISO is provided with a margin when the air exchange rate of 15-20 hours .

Appendix B (Reference). Evaluation of the influence of clothes on the level of pollution

Appendix B.
(Reference)

Consider the effect of clothing on the concentration of particles in the air for cases:

- Normal clothes for clean rooms - jacket / pants, particle selection intensity 10 particles / s;

- Highly efficient clothing - overalls for clean rooms, the intensity of separation of particles 10 particles / s.

The data in Table B.1 was obtained by the method described in Appendix A.

Table B.1 - particle concentrations with dimensions 0.5 μm in the air for various types of clothing for clean rooms with multiplicity of air exchange 10 h

Note - It is assumed that the staff complies with the requirements of hygiene, behavior, dressing and other conditions for operating clean rooms according to GOST R ISO 14644-5.

Table data B.1 are shown in graphic form in Figure B.1.

Figure B.1 - particle concentrations with dimensions of at least 0.5 μm in the air for various types of clothing with multiplicity of air exchange 10 hours _ (- 1)

Figure B.1 - Concentration of particles with dimensions of 0.5 μm in the air for various types of clothing with multiplicity of air exchange 10 h

Table B.1 and Figure B.1 shows that the use of highly efficient clothing allows you to reach the level of purity of class 7 ISO with the multiplicity of air exchange 10 chi recovery time 40 min (if there are no other sources of contamination).

Bibliography


		Cleanroom Energy - Code of Practice for Improving Energy In Cleanrooms and Clean Air Devices
	VDI 2083 Part 4.2	Cleanroom Technology - Energy Efficiency, Beuth Verlag, Berlin (APRIL 2011)


UDC 543.275.083: 628.511: 006. 354.	OX 13.040.01;

Keywords: clean rooms, energy saving, ventilation, air conditioning, air consumption, air exchange rate

Electronic document text
prepared Codex JSC and drilled by:
official edition
M.: Standinform, 2015

Pure room (Clea NR OOM) is a room in which the concentration of suspended particles weighted in the air, built and used so as to minimize the receipt, isolation and hold of particles indoors, and allowing, as needed to control other parameters, for example, temperature, humidity. and pressure.

In such premises, the content pollutants in the air, on the surfaces of the walls and ceiling must be supported at a minimum level.

Specified particles There may be materials such as dust, exhaust gases for anesthesia, as well as microorganisms.

Extremely clean indoor air can be achieved only when the inner air is removed and the filtered outstanding air conditioned air.

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

Clean premises technology serves the following tasks:

protection of products from pollution;
environmental protection against pollution;
creating a protective environment for indoor people;
protection of people in the room, from microbes carrying people;
environmental protection against dangerous products;
environmental protection from microbes carrying people.

Clean room involves the presence of a clean atmosphere , pure gas, clean surfaces, clean equipment, pure products and clean technology.

No projects and investments should be carried out before determining hygienic requirements for clean room.

It is necessary to ensure guaranteed hygienic quality and maintain the necessary degree of air purity indoors (not necessarily as possible).

High hygienic quality can be provided with the realization of an expensive project of protection.

The main approach should provide for the satisfaction of hygienic requirements, where necessary, the most inexpensive methods and with maximum efficiency, but only to the extent that it is necessary for a particular room.

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

The criteria for comfortable air parameters are:

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

These parameters are important for the assimilation of heat dissipation from external and internal sources, as well as to compensate for heat loss and to ensure comfortable conditions in the room.

Criteria of hygienic air parameters:

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

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

In this regard, the concentration of pollutants should be at the minimum required level, the air movement between the premises must be monitored.

but during the design, these parameters should be considered in their totality . For the assimilation of insulating insulation, providing the necessary air quality, the amount of air-conditioned air should be checked, as well as the amount of displacing air necessary to maintain the concentration of microorganisms in the room below a certain level.

Scope of clean rooms

Clean rooms are used in areas such as medicine, microelectronics, micromechanics and food industries.

In medicine, operational, premises for the preparation of drugs, biochemical and genetic laboratories are purified from solid particles and microorganisms.

Clean rooms are used in microelectronics, cosmic technology, thin-film technology, the production industry industry and in the adjacent directions of these areas, where the removal of polluting particles is necessary.

In the food industry, both particles of pollutants and microorganisms are removed from the industrial premises.

Clean room with turbulent air flow

Terms used in pure room 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 on rough surfaces. The most common source of microorganisms is the human body that distributes about 1,000 types of bacteria and fungi.

Pollutants other than microorganisms. Weighted in the atmosphere of substances and substances other than microorganisms are present in the atmosphere as a result of windquarters, earthquakes and volcanic activities. These are usually called dust or aerosol. This group includes particles of smoke, which is the result of industrial processes, systems for the heating of buildings and emissions of car exhaust gases. In 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 in the air of this room, about 100,000 particles of less than 3 microns are falling.

Sterility. So it is possible to characterize the situation in the room at which there are no microorganisms in products and devices.

Sterilization. Technique of destruction or destruction of microorganisms in products or devices.

HIGH EFFICIENCY PARTICULATE AIR FILTER is a highly efficient aerosol filter). Such filters are a variety of highly efficient air filters. They are used directly in air treatment plants, as well as in the end points of air supply to the room as the final cleaning level. The effectiveness of these filters for particles of 0.3 μm particles varies from 97.8 to 99.995%. Such filters are designed for rooms having a purity class of 100-100,000.

ULPA filters (also known as Ultra-HEPA). These are very effective special air filters. The effectiveness of these filters for particles of 0.3 μm particles lies in the range from 99.9999 to 99.99995%. Such filters are designed for rooms having a purity class 1-100.

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

Clean rooms with turbulent air flow. In such clean rooms, air conditioned air is supplied through HEPA filters located directly in the suspended ceiling. Air refund holes are at the floor level. This cleaning method is designed for premises with a purity class of 10,000-100,000 (Fig. 1).

Clean rooms with laminar air flow. In this method, the flow of air flowing at constant speed tolerates pollutants into the return air channel, and then to the air treatment plant. This method is suitable for premises with a class of purity 1, 10, 100, 1000

Clean rooms with laminar air flow

Air gateway. At the entrance to the clean room there must be an air gateway, providing access to the room according to the rules. The air gateway is a small chamber with two doors, in which air-conditioned air is served through two HEPA filters.

Class of cleanliness of the room.Depending on the type of production, which should be performed in a clean room, the class of purity of this room is determined. For the classification of clean rooms, various standards apply. Currently, the VDI 2083 standard is used in Germany, in France - US 209 in AFNOR 44001, in England - BS 5295.

In the clean room, all equipment and all systems (including air treatment installation, air ducts, channel equipment) should be able to clean, replace and service.

In the premises in which a high degree of sterility is necessary, a three-stage filtering is used:

Filter of the first stage. Designed for content in the purity of the air treatment installation, is located in the input section of this installation. (Class F4-F5).
Filter of the second stage. It is used as a final element for the content of the air duct. (Class F7-F9).
Filter of the third stage. It is placed at the entrance to the clean room to provide hygienic conditions. (Class H13-H14).

The hygienic installation of air treatment should, on the one hand, to prevent the penetration of microorganisms and polluting particles into the room, and, on the other hand, should exclude the formation and accumulation of foreign substances in its design.
Systems should have a high degree of tightness, the share of air penetrating the room, bypassing the filter cassettes, should be very small.
Another place in the system associated with the possibility of penetration of microorganisms is to connect drainage and a drain line overlooking the air treatment system. In this place there should be a siphon system with two bends that have no connection to urban sewage.
To eliminate the need to open the door in it, we must be installed in it, in addition, the lighting system should be provided.
To prevent the accumulation of microorganisms and polluting particles, the installation of air treatment must have very smooth surfaces without cracks and wavy forms.
On the joints of the panels, hygienic sealing elements should be used, preventing the accumulation of pollutants in these places and facilitating service procedures. In addition, for the possibility of visual control of the degree of clogging of filters, differential pressure gauges should be used.
Air ducts must have smooth surfaces and be made of galvanized steel, stainless steel and similar materials.
The possibility of condensate formation is eliminated by the right choice of thermal insulation thickness. In the air duct system, it is important to have a sufficient number of service holes with a good seal.
The air flow parameter measurement devices must have service holes with convenient access. These devices should provide data on air flow and pressure, even when clogged filters.

Clean room components

Running procedures for clean rooms.After completion of test procedures and commissioning, under the positive results of these procedures, work can be started in the clean room.

The most important tests for clean room are: testing air ducts on density, air treatment devices - to ensure the desired flow, diffusers - to ensure the specified temperature and humidity values, pressure tests and measurement of comprehensive substances. Applications used for these purposes should be repeated calibration before testing.

Outdoor air processing devices, exhaust dampers, parameters, parameters, filter labels, and all sections of the air processing system should have free access and possibilities of visual control and service.

Another important problem is to train pure room personnel. Be sure to use sterile clothing personnel.

As for many engineering systems, regular maintenance procedures should be carried out in a clean room, aimed at ensuring continuous operation without accidents and problems. To continuously maintain hygienic parameters, it is necessary to regularly check the filters for clogging before any problems occur.

Air preparation systems for clean rooms

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

Pharmaceutical industry;
Microelectronics;
Medicine;
Biotechnology;
Laboratories and scientific research;
Aviation and Space Industry;
Medical industry;
Food industry;
Optics.

Classes of purity

Class of purity room - This is clearly regulated by the level of content in the air of various kinds of impurities and particles. Cleanity classes differ in the number of colony-forming bacteria per unit volume.

On the example of clean rooms of medical institutions - installed 3 classes of purity:

The premises with the first class of purity should have the lowest concentration of bacteria - not more than 10 bacteria / m3. The first-class premises include transplants for transplants, complex orthopedic and cardiac surgery, chambers of intensive and burn therapy, leukemia therapy;
The second class of purity includes premises with a low microbial semination - in the range of 50-200 Bact / M3. These are operational for urgent operations, the premises of operating blocks (including corridors), maternity, prenatal chambers, chambers for premature and injured children;
The third-class premises have a concentration of bacteria 200-500 pcs / m3. This is the chambers of intensive therapy for people with heart disease, newborns, sterilization, children's dressings and treatment rooms.

The task of the climate system for "clean premises"

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

Reducing the spread of pathogens of microorganisms, which implies the removal of air pollutants, the supply of clean air, the fencing of the room from microbes and microparticles contained in the air, as well as to prevent air flow from the neighboring less "clean" premises;
Control of the required air parameters: temperature, humidity, mobility, as well as concentration of harmful impurities that do not exceed the MPC;
The elimination of the occurrence and accumulation of static electricity to prevent the risk of explosion associated with this.

Solving tasks

The task of ensuring cleanliness in the room The most effectively solved on the basis of a comprehensive approach, which takes into account both the specific features of each particular room (volume-planning characteristics, the technological purpose imposed on cleanliness and climatic parameters) and features characterizing the room as an element of the set of premises. This provision is reflected in the creation of clean rooms complexes, the basic principles of the design of which are:

ensuring the required settlement air exchange;
preparation of the supply air with the required parameters for humidity, temperature and microbiological cleanliness;
the rational organization of air flows from cleaner modules into less pure;
air distribution in modules with the organization of a given direction of its movement, which takes into account the peculiarities of the room and the technological process;
highly efficient cleaning of inner air.

Constructive execution The complex is determined by the specific purpose of clean rooms, their configuration and dimensions that are operating regulatory requirements for the air environment. In general, the proposed inteach complexes are performed according to the modular principle and include the following functional systems and elements:

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

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In the design of any clean room, a significant place is given to the ventilation system. From how qualitatively air will be cleaned, the ability to maintain the required level of purity without much effort. Incorrectly equipped ventilation of clean rooms can cross all efforts to equip them.

Our company specializes in the design and installation of the turnover system and cleaning air flows for clean premises for a long time, so employees use exclusively modern techniques and tools. And this is the key to a successful and durable system of the system as a whole.

Class ISO. (classification number N)	Limits of maximum concentrations (particles / m3 of air) particles in size equal and large below, microns						MK
Class ISO. (classification number N)	0,1	0,2	0,3	0,5	1,0	5,0	MK
Class1 ISO.	10	2	-	-	-	-	ND
Class2 ISO.	100	24	10	4	-	-	ND
Class3 ISO.	1 000	237	102	35	8	-	ND
Class 4 iso.	10 000	2 370	1 020	352	83	-	ND
Class5 ISO.	100 000	23 700	10 200	3 520	832	29	5+
Class 6 iso.	1 000 000	237 000	102 000	35 200	8 320	293	50
Class7 ISO.	-	-	-	352 000	83 200	2 930	100
Class8 ISO.	-	-	-	3 520 000	832 000	29 300	100
Class9 ISO.	-	-	-	35 200 000	8 320 000	293 000	500

What is the installation of clean rooms ventilation

This element of building equipment with the need to create elevated cleanliness conditions is at the moment modern systems that provide circulation and air filtration. For this purpose, a large number of elements are used directly to ensure the supply and outflow of air, a group of filters and equipment for controlling control.

All this should be in a clean room necessarily, since this equipment allows you to solve a group of important tasks:

Maintaining aerosol particles in the air in permissible limits.

Control and creation of indicators of the correct microclimate in the room such as humidity, temperature, air mobility.

Preventing the appearance of pressure drops between clean rooms and rooms that borders with them.

Regular feed to the room of clean air and removing the air stagn by there.

With the help of innovative systems, all this works automatically and does not require special efforts from the staff of the room. Manufacturers of modern ventilation equipment guarantee a long service life, and constantly improve it so that the operation of the devices create a minimum of noise and did not interfere with the comfortable stay of people in the room.

Principle of operation of the system

Pure room ventilation works properly and allows you to provide all regulatory indicators thanks to the right organization of all system elements:

· Before air flow, it passes 4 steps of filtration on 4 different filters, each of which cleans the flow from a certain group of pollution.

· A laminar flow of air is provided, which allows you to create a directional movement of purified air, and in turn, in turn, removes aerosol particles from an existing air.

· The main element of the entire installation is the central air conditioning system created in a special "hygienic" execution. It is here that most of the processes of cleaning and air preparation occurs.

· Easy to manage and maintain permanent indoor cleanliness performance allows equipment for automation and dispatching the operation of the entire system, which includes a mass of sensors to control the indicators, elements of remote transmission of commands, etc.

The status of all devices in the system after its commissioning is easily controlled by the facilities operating in the room, and if there are any deviations in the work or emergency situations, the software will quickly report it.

The main task for the proper functioning of such equipment is competent initial design and installation. Otherwise, the owners and workers do not have the slightest problems.

Features of proposals from our company

We will help to avoid mistakes in the preparation and installation of ventilation equipment to each client, since the company employs only the highest categories. In addition, in the catalog of goods, exclusively modern and reliable elements of ventilation systems are collected.

If you contact us, then you will receive:

· System integrated with related systems such as power supply, software, etc.

· Energy efficient equipment that will work with minimal costs of electricity, and, accordingly, financial investments.

· Equipment that functions with minimal noise and does not create discomfort to all in the room.

· Reliable equipment equipped with quality certificates and with a guarantee.

Our specialists will help to choose an optimal solution for each particular room, which will reduce financial investments and achieve maximum efficiency. All this gives us the opportunity to argue that the ventilation systems ordered from us will serve for many years and will not create problems.

Without clean rooms, it is impossible to present the production of electron microcircuits, pharmaceutical industry, effective treatment of patients, conducting research in various sectors of medicine and cooking. Pure is considered a room in which the number of aerosol particles and the number of bacteria in the air is supported by a permissible level. There are nine classes of clean rooms depending on the concentration of dust and bacteria in the air. They are fixed in GOST ISO 14644-1-2000, which is based on the international standard ISO 14644-1-99 "Clean premises and related environments".

As part of the usual air (which we breathe in everyday life) is a large number of impurities (I was able, dust, pollen flower, viruses, fungi). The listed impurities are unacceptable for clean rooms, as they adversely affect the work. Therefore, the creation of ventilation and air conditioning systems in clean rooms is a mandatory component of the suitable microclimate.

Features of the design of the ventilation system of clean rooms

Designing and installation of ventilation and air conditioning systems requires skills in working with special equipment, as well as knowledge of the norms and requirements for clean premises.

There are three schemes for organizing air exchange in clean rooms:

all air flows are moving in parallel;
an unordered direction - the supply of clean air occurs in different directions;
the mixed direction is observed in large rooms when the air is moving in one part in parallel, and in another part - disordered.

Depending on the size of the room and the location of the working area, the optimal project of the ventilation system is chosen, but the most optimal solution is ventilation with a unidirectional flow of clean air.

For clean rooms, an exclusively impressive ventilation system and air conditioning is used. Its essence is as follows: a flow of clean air, which "squeezes" contaminated air, which is indoors, is amenable to top under pressure at a certain speed.

The cooled air is amenable to low speed, as a rule, into the upper part of the room (about 1/4 of the room) through the ceiling panels. It seems to be strengthened by space, lowering dust down, to the exhaust, and the minimum level of irritation is created. With such ventilation there are no drafts, whirlwinds of dust that have seen on the floor. In addition, the air supplied is pre-prepared to the desired temperature and humidity.

The basis of the ventilation and air conditioning system serves a supply-exhaust installation with recycling consisting of the following elements:

housing;
filters;
humidifier;
heat exchangers;
fans.
General scheme of the system of ventilation of clean rooms.

Special requirements are presented to filters. The filtration system consists of three groups of filters through which the air flow passes:

coarse filter (first degree of filtration) - removes mechanical pollution from the air;
filter of fine cleaning (the second degree of filtration) - removes bacteria and other microorganisms;
microfilter HEPA and ULPA with absolute cleaning (removes 99,99995% of microorganisms).

Coarse and fine filters are located in the central air conditioner, and the HEPA and ULPA filters are directly in the air distributors.

Hepa and ULPA filters

Depending on the size of the room, air pressure, the method of placing furniture is determined by the number and characteristics of air intakes and air distributors.

There are a number of rules that need to be taken into account during the design of exhaust ventilation of clean rooms:

It is necessary to maintain a positive air pressure imbalance in clean rooms. Pressure drop must be at least 10 Pa with closed doors.
At the design stage, it is important to take into account the height of the ceilings. If they are higher than 2.7 m, then more rationally use the method of local ventilation of the workplace. In this case, the flow of clean air comes directly to the place where the person works.
For premises long before 4.5 M. Instead of raised floor, wall lattices are installed at height from 0.6 m to 0.9 m . The directional air jet envelops the room and moves to the lattices, gradually displacing polluted air.
"Clean" rooms should be placed near those rooms in which the purity level is as high as possible.
For the construction of clean rooms, extremely environmental materials with high tightness are used, which will allow maintaining stable air circulation.
In clean rooms you need to use HEPA filters and CAV regulators: the first to provide high quality cleaning of the air supplied, and the latter determines the portion of its feed.

Below are the most optimal systems for ventilation and air conditioning clean rooms.

A) A unidirectional flow is amenable to a ventilation grid.

B) Air is amenable to different sides due to diffusers located on the ceiling.

C) Unidirectional flow enters the room due to the perforated panel on the ceiling.

D) Air is supplied directly to the working area through the air distributor, located on the ceiling.

E) Clean air flow moves in opposite directions due to the equipment of ring air hoses.

Requirements for ventilation of clean rooms

Such requirements are presented to ventilation systems for clean rooms:

Reducing the number of harmful impurities and bacteria, which includes a number of such actions: the removal of the contaminated and supply of clean air, the fence of the workplace from harmful impurities and microorganisms, blocking air intake from other premises.
Providing such air parameters: temperature, mobility, humidity, concentration of harmful impurities.
An obstacle to the accumulation of static electricity.

In addition, the system of ventilation of clean rooms is directed to "blocking" the appearance of such effects:

periodic turbulent twists;
formation of dust in some areas;
deviation of temperature indicators from the norm;
different level of humidity in different parts of the served room.

Requirements for air exchange

The air exchange in the room is determined through air mobility, which is measured in m / s. Only for sterile premises in the pharmaceutical industry consolidated a clear definition of the necessary air exchange - 0.46 m / s ± 0.1 m / s (FDA, USA). Recommended air mobility standards for clean rooms range from 0.35 to 0.52 m / s ± 20%.

Also, the air exchange is affected by the availability of windows. So, in a hermetic room without windows, air performance should be 20% higher than the exhaust, and in the room with windows - by 20%.

With an increase in the construction volumes in our country, health facilities, laboratories, enterprises, microelectronics, drugs, drugs, etc., dramatically increased demand for ventilation systems for "clean rooms", which will be discussed in this publication.

Clean Room Concept

Clean room (PE) It is customary to call a room or a group of premises with all the structures relating to them in which the countable concentration of suspended particles and microorganisms in the air mixture is maintained at a strictly defined level determined by GOST ISO 14644-1-2002; Snip 41-01-2003 (8); Sanitary standards and required class of purity. There is its air mixture cleanliness standards in the USA, Germany, France, the United Kingdom and the European Union.

Depending on the countable amount of suspended particles, the size of 0.1 to 5.0 μm is 1 m 3 in PE, and the concentration of microorganisms in it, 9 classes of sterility are defined.

Based on the PDC of microorganisms, class 5 ISO is divided into two subspecies:

"A" - MPC microorganisms not more than 1 / m 3;
"B" - MPC microorganisms no more than 5 / m 3.

For PE uses its ISO class and condition: "exploited"; "Built" and "equipped".

Equipment for creating a "pure air exchange"

The creation of competent ventilation and air conditioning systems is a complex process that requires knowledge of air exchange features, special equipment and specific technical solutions.

Air to such a room should be supplied already purified from contamination, bacteria and microorganisms, so a special role in creating a sterile microclimate in "clean rooms" is played by the air mixture filtering system. The sought-after cleaning system is the installation after the injection fan of three groups of filter elements:

The first group consists of a coarse filter from mechanical pollution.
The second group of filters consists of a set of filtering elements of fine cleaning and antibacterial filter.
The third group consists of microfilters of non-absolute cleaning air.

In addition to filtering elements, fans, air intake and air distribution equipment, devices, automatic maintenance of the necessary humidity and temperature, shut-off and control equipment, gateways, etc. Air purity object.

When designing an Airborne ventilation systems, attention is paid to the construction and coating of air ducts and filter chambers, which should pass periodic antimicrobial processing.

Features of air exchange

To maintain air purity, in technologically clean rooms should be used ventilation with an excessive amount of the inflow, compared with the exhaust in the rooms adjacent to it.

If the room is without windows, the inflow must prevail over the hood by 20%.
If there are windows that allow infiltration in emergency, then air supply performance should be higher than the exhaust by 30%.

It is this system that the air exchange system prevents the penetration of pollution, and provides the movement of air from the clean room to the adjacent room with it. Much attention of the designers is given to methods for supplying an air mixture to such objects and depends on their purpose.

The inflow in PE with a class of purity from 1 to 6 must be supplied with an air distribution device from top to bottom, creating uniform unidirectional air flows of a small speed, from 0.2 to 0.45 m / s. In rooms with a lower class of cleanliness, it is allowed to create a unidirectional stream, through several ceiling diffusers. The multiplicity of air exchange for PE is established depending on their purpose, from 25 to 60 times per hour.

The most common schemes

When designing ventilation of clean rooms, one of the most important problems is the correct organization of air mixture streams. To date, the designers use several solutions of the location of air distribution devices, the choice of which depends on the purpose of PE. Consider the most common schemes for organizing ventilation operating.

A) air inflow unidirectional, through an inclined ventilation grille;
B) the non-unidirectional air mixture flow is performed by using ceiling diffusers;
C) the trim air into the operating room is fed through the perforated ceiling panel with the creation of a vertical unidirectional airflow;
D) the air mixture is supplied through the ceiling air distributor, which creates a unidirectional air flow into the working area;
E) the air is not unidirectional through the annular air hose.

The exhaust ventilation of clean rooms of the operating room is performed by exhaust fans and overpressure wall grids with check valves.

As practice has shown, the best device for creating a unidirectional laminar airflow in the operating room is the mesh air distributors of the ceiling type. For example, a laminar ceiling with dimensions 1.8 by 2.4 m. In the operating room, 40 m 2, it will create 25 multiple air exchange at the air outlet rate from the device 0.2 m / s. These indicators are sufficient to assimilate inside the equipment and the number of personnel in the operating room.

The design of ventilation and air conditioning systems in PE is a complex process that requires knowledge of the processes of air exchange and the subtleties of the use of air distribution equipment. That is why to create ventilation at such objects should be treated exclusively to professionals.