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    Home > Biochemistry News > Biotechnology News > Cleanroom grade standards, classification, basic composition and other knowledge summary.

    Cleanroom grade standards, classification, basic composition and other knowledge summary.

    • Last Update: 2020-08-10
    • Source: Internet
    • Author: User
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    Clean room is also known as a clean room or clean room, refers to a certain space within the air particles, harmful air, bacteria and other pollutants excluded, and indoor temperature, cleanliness, indoor pressure, air flow speed and air flow distribution, noise vibration and lighting, static control in a certain range of demand, and given a specially designed room.
    is that no matter how external air conditions change, its interior can maintain the original requirements of cleanliness, temperature and humidity and pressure and other properties.
    the following small compilation to introduce for you to clean room related knowledge, including: clean room grade standards, classification, basic composition, prevention of cross-contamination methods, internal management system, price determinants, air delivery of the new air volume determination method.
    hope that these points of knowledge can help you learn more about clean rooms! Clean room grade standard 1, clean area design must meet the corresponding "static" standards, in order to meet the "dynamic" clean requirements.
    "static" means a state where the installation is complete dislocation and running, but there is no operator present.
    and "dynamic" refers to the production facility operating in a predetermined process mode and has a specified number of operators on-site operation status.
    2, the production operation is all over, the operator sahies from the production site and after 15 to 20 min (guidance value) since the net, the clean area should meet the "static" standard in the table. The dynamic test results of direct exposure of environmental particles by
    drugs or open containers should meet the standards of A in the table.
    3, sterile operation of the isolation operator in the environment level should be at least D level.
    4, in order to determine the level of the A-zone, the sample volume of each sampling point must not be less than 1m3. the level of air dust particles in the
    A-class region is ISO 4.8, with a limit of 0.5 m of dust particles.
    the level of air dust particles in the B-level (static) region is ISO 5 and includes the dust particles of the two particle sizes in the table.
    for C-levels (static and dynamic), the levels of air-dust particles are ISO 7 and ISO 8, respectively.
    level son iSO 8 for D-level (static) air dust particles.
    test method can be referenced to ISO14644-1.
    5, when confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the settling of the dust particles in the sampling tube of the long sampling system of the remote sampling system.
    in one-way flow system, the sampling head of isodynamic should be used.
    6, can be tested during routine operation, medium simulation filling process, proved to reach a dynamic level, but the medium simulation test requires dynamic testing in the "worst case".
    cleanroom classification i, turbulence flow (Flow): that is, air from the air conditioning tank through the duct and clean room air filter (HEPA) into the clean room, and by the clean room on both sides of the compartment wall panel or elevated floor rewind.
    the flow of air flow is not linear motion and is in an irregular flow or vortex state.
    this type is suitable for cleanroom grades 1,000-100,000.
    its advantages are: simple construction, system construction costs, the expansion of clean room is relatively easy, in some special-purpose sites, can be used with dust-free workbench, improve the clean room level.
    disadvantages: the microdust particles caused by the turbulence float in the indoor space is not easy to discharge, easy to pollute process products.
    if the system stops running and is activated, it often takes a long time to get the cleanliness of the demand.
    ii, laminar: layer flow air flow into a uniform straight line, air from the coverage of 100% of the filter into the room, and by the elevated floor or the two sides of the wall panel back wind, this type is suitable for clean room grade needs to be set higher environment use, generally its clean room class 1-100.
    its pattern can be divided into two types: 1, horizontal layer flow: horizontal air from the filter single direction blowout, from the opposite wall of the wind system back wind, dust with the wind out of the outside, generally in the lower side of the pollution is more serious.
    advantages: simple construction, after running a short period of time can become stable.
    disadvantages: construction costs are higher than turbulence, and indoor space is not easy to expand.
    2, vertical flow: room ceiling is completely covered by ULPA filter, air blowing from top to bottom, can be a higher cleanliness, in the process or staff generated dust can be quickly discharged outside without affecting other work areas.
    advantages: easy management, operation can be a short period of time to achieve a stable state, not easy to be affected by the status of work or operators.
    disadvantages: high construction costs, flexible use of space difficult, ceiling hanger quite occupied space, repair and replacement of filters more trouble.
    3, Composite Type: Composite is to mix and use the turbulence and layer flow, to provide local ultra-clean air.
    (1) Clean Tunnel: Increase the cleanness level to 10 or more with 100% coverage of the process area or work area with HEPA or ULPA filter, saving installation and operation costs.
    this type requires the work area of the worker to be isolated from the product and machine maintenance to avoid the work and quality of the machine maintenance, ULSI process mostly uses this type.
    clean tunnels have two other advantages: easy elastic expansion, and easy to carry out when servicing equipment.
    (2) CleanTube: Surroundand and purify the automatic production line through which the product process passes, raising the cleanness level to more than 100 levels.
    because of products and operators and dust environment isolation, a small amount of air can get good cleanliness, can save energy, no manual automated production lines for the most suitable use.
    the pharmaceutical, food and semiconductor industries.
    (3) and install edited local cleanroom (CleanSpot): the clean room grade 10,000 to 100,000 of the disorderly clean indoor product process area of the clean-up level increased to 10 to 1000 levels above, for production purposes; there are also clean workbenches and clean sheds
    . the basic composition of the clean room
    includes: 1, ceiling system: including ceiling rod (Ceilingrod), outline beam (I-Beam or U-Beam), ceiling lattice beam (Ceilinggrid or Ceilingframe frame).
    2, air conditioning system: including air compartment, filter system, windmill and so on.
    3, Partitionalwall: including windows, doors.
    4, flooring: including elevated floorors or anti-static floors.
    5, lighting appliances: including fluorescent lamps, yellow lamps and so on.
    clean room to prevent cross-contamination method one, reasonable layout 1, for indoor layout, according to reasonable process layout, to avoid round-trip.
    reasonable layout is not only conducive to process operation, but also conducive to the integration of space.
    clean room is not the larger the better, air delivery is based on the size of the area and space to determine, but also determines the energy consumption.
    clean room area can not be too large or too small, do not have reserved idle area and space, nor too small to affect operation, maintenance.
    2, reasonable layout is through considering the size of equipment, process operation needs, production area and storage area should be suitable for the scale of production space, to place equipment, materials, easy to operate and maintain.
    general clean room height control at 2.60 meters, for individual higher equipment can be raised in the local, and it is not appropriate to improve the height of the clean area. The
    workshop should have an intermediate station for materials that is large enough to store materials, intermediate products, pending products and finished products, and facilitates clear partitioning to minimize errors and cross-contamination.
    , improve the equipment level equipment material, processing accuracy, degree of containment and management system are related to cross-pollution.
    in addition to reasonable layout, improve the level of automation of equipment and the formation of linked production lines to reduce operators, reduce the frequency of personnel activities, is necessary to prevent cross-contamination measures.
    clean room department management system 1, in and out of the clean room management 1, into the clean room personnel should strictly require the implementation of personal purification system, route and sequence.
    exit the clean room, must be in the order, route, do not allow cleaning supplies to take out of the hall.
    2, if there is a blow-up room, must be carried out in accordance with the provisions of the blow shower, before entering the clean room.
    at the same time, in strict accordance with the rules and usage requirements of the wind shower room, control the number of people who enter the wind shower room each time, not allowed to force the operation of the wind turbine or power supply in the wind shower room.
    generally through the wind, the number of dust particles emitted by the surface of the person decreased by 40-60%.
    3, in order not to interfere with the clean air flow pattern in the room, in the upper flow side of the work area should not be placed items, back to the air port near the do not stack;
    4, do not allow non-production-related and dust-prone items into the clean room.
    5. Smoking, eating and carrying out unproductive activities in clean rooms are strictly prohibited.
    6, before entering the clean room, personal items must be placed in the designated cabinet, remove makeup and jewelry, replace with the designated clean clothes, shoes.
    7, when wearing a hat, should cover all the hair, shoes should be the foot of the pants tightly wrapped in the shoe cover.
    8, take off clean work clothes, to avoid work clothes touch the ground, tables and other items, generally from the bottom to the top to take off the work clothes, and stored in the cabinet or hanging in the prescribed premises 9, exit the clean room, in the dressing area before the removal of clean work clothes are not allowed;
    10, exit the clean room, you can enter the replacement area without having to go through the air blow.
    , clean indoor operators management 1, hands are cross-contamination media, operators into the clean room are required to wash their hands, do not touch high purification products and high purification packaging materials by hand, etc. ;
    2, do not allow the following personnel to enter the clean room: cold, cough, eczema and other diseases patients;
    3, operators in clean indoor work, the action should be light, strict implementation of operating procedures, do not make dust-prone large-scale action, do not drag foot walking, do not do unnecessary movements;
    4, in a clean room, to wear gloves as required, do not expose the wrist, gloves to be often replaced.
    5, to enter the clean room personnel to carry out relevant training and education: master the clean room characteristics, construction, clean technology, such as knowledge, personnel purification procedures and material purification route requirements, clean work clothes use, cleaning requirements, clean room cleaning, cleaning and disinfection, clean room safety facilities and safety management regulations.
    6, clean work clothes should be selected to produce less dust, but also anti-static clothing production, generally 1 to 10 million clean indoor sub-packtype, 100 to 1000 levels of the use of conjoined body.
    clean shoes are best used disposable, clean shoes requirements are washable.
    generally, when people in clean clothes walk, the number of particles on the surface than those who wear ordinary clothes is 40-60 times lower, so this point is very important for the maintenance and management of high-clean plant.
    7, clean work clothes to have a dedicated management, regular inspection, cleaning.
    generally cleaning once a week, usually 50 to 100 times after cleaning should be checked to determine whether scrapping.
    8, clean indoor "5S" operation to ensure that the time and continuity, and by the site management personnel to implement regional positioning management.
    the price determinants of clean rooms1, the rate of pollutants in the rooms with the number of ventilation times and the actual particle production are the main factors affecting the number of air ventilation in clean rooms.
    the speed of removing particles is important in the production process without any impact on other factors. other factors
    that may affect the amount of recirculated air are the structure of the room, the location of the equipment, the surface temperature of the equipment, air convection, type of airflow, operating space and regulations, materials used and chemicals.
    2, one-way, turbulent, vertical, or horizontal airflow In many cases, one-way airflow is used only in sensitive areas of small spaces and cleanrooms, and in microenvironments. the source of
    contaminants may be found in glove boxes, filtration modules, etc.
    most of the options designed as a clean outdoor for the overall one-way airflow, one-way airflow can only be achieved when there are no operators, production equipment and exhaust units in these areas.
    the choice of vertical or horizontal airflow, depending on the structure of the room and the placement of the equipment, turbulence can take the contaminants away.
    3, air filtration according to the use of clean outdoor, you can also choose other equipment, for example, in the circulating wind plus new air treatment system, the use of HEPA filter with carbon adsorption or similar functions of synthetic filter treatment VOC, electrostatic filter box, and so on.
    in the cleanroom market, fan filtration is no longer a new product, and the right application provides excellent, economical solutions for many high-level cleanrooms, especially in buildings with limited ceiling heights.
    4, air processor new air treatment air conditioning box for the clean room to provide the necessary new wind.
    multi-cycle air conditioning tank through the air duct, and then through the ULPA filter or HEPA filter, the air is sent to the clean room, in the cleanness of the 10th and 1st level of the ceiling, these filters are usually 100% covered.
    vertical one-way air flow down through the clean room, through the well-holeed overhead floor tiles into the backwind space under the floor, and then through the vertical backwind clip to the ceiling rewind retreat box.
    then, the air again enters the circulating air conditioning box, and the above air circulation repeats again.
    5, air pressure differential clean room supercharged is necessary, its role is to ensure that the clean room away from its adjacent areas of pollution, control the flow of harmful pollutants, to prevent cross-contamination between different areas.
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