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Dust -free rooms and cleanliness characteristics of various industries reference

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Dust -free room

Electronic manufacturing:
With the development of computers, microelectronics and information technology, it has promoted the rapid development of the electronic manufacturing industry, and has also led to the development of clean room technology. At the same time, the design of the clean room has higher requirements. Design is a comprehensive technology. Only by fully understanding the design characteristics of the dust -free workshop in the electronic manufacturing industry and a reasonable design can we reduce the product's productive rate of the electronic manufacturing industry and improve production efficiency.

Electronic manufacturing clean room

Features of the clean room of the electronic manufacturing industry:
The level of cleanliness is high, and the air volume, temperature, humidity, pressure difference, and equipment exhaust are controlled. The wind speed of the illumination and clean room section of the cross section is controlled by design or specifications. In addition, this type of clean room has extremely strict electrostatic requirements. The requirements for humidity are especially. Because the too dry plant is very easy to produce static electricity, causing CMOS integration damage. Generally speaking, the temperature of the electronic plant should be controlled at about 22 ° C, and the relative humidity should be controlled between 50-60%(special cleaning workshops have related temperature and humidity regulations). At this time, it can effectively eliminate static electricity and make people feel comfortable. Chip production workshop, integrated circuit dust -free room, and disk manufacturing workshop is an important part of the cleaning room of the electronic manufacturing industry. Due to the strict requirements for indoor air environment and quality during the manufacturing and production process, the electronic products are mainly controlled by controlling particles and particle Floating dust is the main object, and at the same time, the temperature and humidity, fresh air volume, noise, etc. of the environment are strictly strictly stipulated.
1. The noise level (air state) of the 10,000 -level clean room of the electronic manufacturing plant: It should not be greater than 65DB (A).
2. The vertical cleaning room of the clean room of the electronic manufacturing plant should not be less than 60%, and the horizontal unidirectional cleaning room should not be less than 40%, otherwise it will be a local unidirectional flow.
3. The static pressure difference between the cleaning room and outdoor of the electronic manufacturer should be less than 10Pa. The static pressure difference between the cleanliness of different air cleanliness and the non -clean area should be less than 5Pa.
4. The fresh air volume of the fresh and clean rooms in the electronic manufacturing industry should be taken in the following two items:
(1) Compensation for indoor exhaust volume and the sum of fresh air volume required for indoor pressure.
(2) Ensure that the fresh air per person in a clean room is not less than 40m3 per hour.
(3) The clean -down air -conditioning system heater of the clean room of the electronic manufacturing industry shall be set up with fresh air and ultra -temperature interruption protection. If you use point humidification, water -free protection should be set. In cold areas, anti -freezing protection measures should be set up. The amount of air supply in the dustless room should be taken below: ensure that the air cleanliness level of the dustless room of the dust room of the electronic manufacturer; according to the heat, calculate the clean room of the clean room of the electronics factory; Fresh air supply provided by factory cleaning room.
Biological manufacturing:
Features of biopharmaceutical factories:
1. Biopharmaceutical factories not only have high equipment costs, complex production processes, clean levels and sterile requirements, but also have strict requirements on the quality of production personnel.
2. In the process of production, there will be potential biological hazards, mainly infection risk, dead bacteria or dead cells and ingredients or metabolism to the human and other biological reactions to the human body and other biological reactions. Sales and other biological reactions, environmental effects.
Clean area:
The room (region) that needs to be controlled by dust particles and microbial pollution in the environment, and its building structure, equipment and its use all have the functions that prevent the introduction, production and retention of pollutants in the area.
Qi lock room:
Set between two or several rooms between two or several rooms (such as rooms with different cleanliness levels) with two or multiple doors. The purpose of setting up the air lock is to control the airflow when the personnel or materials enter and exit. There are people in the air lock between the people's qi locks and the qi lock between the gas locks.
Basic characteristics of the purification room of biopharmaceuticals: It is necessary to use dust and microorganisms as an environmental control object.
The cleanliness of the pharmaceutical production workshop is divided into four levels: the local 100, 1000, 10,000 and 30,000 levels of the local 100 or 10,000 levels in the context of 100,000.
The temperature of the clean room: At no special requirements, at 18 ~ 26 degrees, the relative humidity is controlled at 45%to 65%.
Pollution control of biopharmaceutical cleaning plants: pollution source control, spread process control, and cross -pollution control.
The key technology of the purification room is mainly to control dust and microorganisms. As pollution substances, microorganisms are the top priority of the environmental control of the purification room. The equipment and pollutants accumulated in the clean area of ​​the pharmaceutical plant can directly pollute the drug without affecting the detection of cleanliness. The level of cleanliness is not suitable for the physical, chemical, radioactivity and life of suspended particles. Not familiar with the production process and process of drugs, do not understand the causes of pollution and place where pollution material accumulates, and do not master the methods and evaluation standards for removing pollution substances.

Pharmaceutical plant engineering


GMP technology transformation pharmaceutical plant projects generally exist in the following situations:
Due to the misunderstanding of subjective understanding, the cleaning technology in the process of pollution control is unfavorable, and the drug quality has not improved significantly after some pharmaceutical factories have invested huge capital transformation.
The design and installation of the manufacturing and installation of the equipment and facilities in the factory of the pharmaceutical clean production plant, the quality of the original and auxiliary materials, the quality of the packaging materials, the unfavorable implementation of the net facilities of the net facilities of the human net material will affect the quality of the product.
The reason for the construction of product quality in construction is that there are problems with the process control link. There are hidden dangers in the installation construction process.
① Purify the inner wall of the air -conditioning system, the inner wall of the air -conditioning system is not clean, the connection is not tight, and the leakage rate is too large;
② The colored steel plate enclosure structure is not tight, and the seal measures of the clean room and the technical expansion (ceiling) are improperly closed, and the closed doors are not closed;
③ The decorative profile and process pipeline formed dead ends and dust in the clean room;
④ The construction requirements are not constructed in accordance with the design requirements, and the relevant requirements cannot be met;
⑤ The quality of the sealing glue used is not closed, easy to fall off, and deteriorates;
⑥ Returning and exhaust color steel plates are connected, dust from exhaust to entering the airway;
、 The inner wall welding seams are not formed when welding of stainless steel hygiene pipes such as water purification water, injection water;
⑧ The actions of the air duct to stop the valve failure, and the air infusion of the air causes pollution;
量 The installation quality of the drainage system is not available, the pipe frame, and the accessories are easy to accumulate;
整 The pressure difference between the clean room is unqualified and failed to meet the production process requirements.


Printing and packaging industry:
With the development of society, products in the printing industry and packaging industry have also increased. Large printing equipment has entered the purification workshop. This can greatly improve the quality of printing products, and the qualification rate of products has also increased significantly. This is also the integration of the purification industry and the printing industry. Printing most mainly reflects the temperature and humidity of the product in the coating space environment and the amount of dust particles, which directly plays an important role in the product quality and qualification rate. For the temperature and humidity of the space environment, the amount of dust particles in the air, and the quality of water quality. Of course, the standardized operation procedures for production personnel are also important.

Dust -free spraying is an independent closed production workshop with steel clip core board, which can effectively filter the pollution of the product to the product and reduce the adverse rate of dust products in the spray area. The application of dust -free technology has further improved the appearance quality of the product, such as TV/computer, mobile phone case, DVD/VCD, game console, recording machine, PDA palm computer, camera case, audio, hair dryer, MD, makeup combined , Toys and other workpieces. Process: upper parts → manual dust removal → static dust removal → manual/automatic spraying → drying area → UV paint curing zone → cooling area → silk print area → product inspection area → receiving area.

dust-free workshop

In order to prove that the food and dust -free workshop work is satisfactory, it must prove that it meets the requirements of the following standards:
1. Food packaging has sufficient air supply to dilute or eliminate pollution generated indoors.
2. The air in the food packaging dust -free workshop flows from a clean area to a poorly clean area. The flow of pollution air reaches the degree of flow, and the flow of the air at the door and indoor building is correct.
3. Food packaging dust -free room air supply will not significantly increase indoor pollution.
4. The motion of the indoor air of the food and dust -free workshop can ensure that there are no high concentrations in the dense room.
If the cleaning room meets the requirements of these standards, it can measure its particle concentration or microbial concentration (if necessary) to determine that it meets the specified clean room standard.
Test of food packaging dust -free workshop:
1. Venture and discharge volume: If it is a clean and clean room, then measure the amount of air delivery and exhaust volume. If it is a unidirectional clean room, the wind speed is measured.
2. The airflow control between each district: In order to prove that the direction of the air flow movement between the districts is correct, that is, flowing from a clean area to a poor area, it is necessary to detect: (1) the pressure difference between each interval is correct; (2) at the entrance at the door Either walls, flooring, etc. The airflow movement is correct, that is, flowing from a clean area to a district with poor degree of cleanliness.
3. Filter leakage: Check the high -efficiency filter and its frame to ensure that the suspended pollutants will not pass through: (1) the damaged filter; (2) the gap between the filter and the frame; (3) Other parts of the filter device invade the room.
4. Isolation and leakage: This test is to prove that the suspended pollutants do not pass through the building materials invading the clean room.
5. Indoor airflow control: The type of air flow control test should be based on the airflow mode of the clean room -whether it is turbulent or one -way flow. If the airflow of the clean room is a turbulent flow, it must be verified that there is no area where the airflow is insufficient in the room. If a unidirectional clean room, it must be understood that the wind speed and wind direction of the entire room must meet the design requirements.
6. Suspension particles concentration and microbial concentration: If the above test meets the requirements, measure the particle concentration and microbial concentration (time), so as to understand the technical conditions that meet the clean room design.
7. Other tests: In addition to the tests in the above pollution control, sometimes one or several items of tests must be performed: temperature; relative humidity; indoor heating and cooling capacity; noise value; light degree; vibration value.
Pharmaceutical packaging dust -free workshop:
1. Environmental control requirements:
(1) Provide the air purification level required for production. The number of air dust particles and living microorganisms in the packaging workshop purification project should be tested and recorded regularly. The static pressure difference between different levels of packaging workshop should be kept within the specified value.
(2) The temperature and relative humidity of the purification project of the packaging workshop shall be compatible with its production process requirements.
(3) Penicillin, high sensitivity and anti -tumor drug production areas should have an independent air -conditioning system, and the exhaust should be purified.
(4) Effective dust catcher should be set up for rooms that generate dust to prevent cross -pollution of dust.
(5) For auxiliary production rooms such as storage, its ventilation facilities and temperature and humidity should be compatible with the requirements of drug production and packaging.

Cleanroom

2. Cleanlined partition and air replacement times: The cleaning room should strictly control the air cleanliness and the temperature, humidity, fresh air volume and pressure difference of the environment.
(1) The purification level of the drug production and packaging workshop and the number of air replacements and the purification engineering air cleanliness of drug production and packaging workshop are divided into 4 levels of levels of 100, 10,000, 100,000, and 300,000. To determine the number of air replacement of clean rooms, comparison of various air volume is required. In actual, the number of air changes at 100 levels is 300 to 400 times / h, the 10,000 levels are 25-35 times / h, and the 100,000 level is 15-20 times / h.
(2) The cleanliness of the purification project of the pharmaceutical packaging workshop is the specific partition of the drug production and packaging environment of the drug production and packaging environment in accordance with the national standard purification standard.
(3) Determination of other environmental parameters of the packaging workshop.
(4) The temperature and relative humidity of the purification project of the packaging workshop should meet the drug production process.
Temperature: Grade 100 and 10,000 Taking 20-23 ~ C (Summer), 100,000 and 300,000 levels take 24-26 ~ C, general area 26-27 ~ C. Level 100 and 10,000 -level sterile rooms. Relative humidity: 45-50 % (summer), 50 % to 55 % of solid-system agents such as tablets, and 55 % to 65 % of water needles and oral solution.
(5) The cleanliness of the clean room should keep the indoor cleanliness in the interior. For cleaning rooms such as dust, harmful substances, and producing penicillin strong sensitivity drugs, they should prevent external pollution or regional relative negative pressure. The flow of static stains in different rooms in different rooms and the outflow of internal air. The indoor pressure must be maintained, the difference from the adjacent room is greater than 5Pa, and the static pressure difference between the clean room and the outdoor atmosphere is greater than 10Pa.


Food Industry:
People take food as the sky, and the disease comes from the mouth, so the safety and hygiene of the food industry occupy an important position in our daily life. The safety and hygiene of food must be controlled: first, the standardized operation of the production personnel; the second It is to control external environmental pollution (to establish a relatively more cleanliness operation space. Third, the purchase source to eliminate problem -problem product raw materials.
The area of ​​the food production workshop is compatible with production, the layout is reasonable, and the drainage is smooth; the floor of the workshop is built on non -slip, sturdy, impermeable, and corrosion -resistant materials. , Equipped with mouse, flies and insect -proof facilities. The inner wall, ceiling, and doors and windows of the workshop use non -toxic, light -colored, waterproof, mildew, non -shedding, easy -to -clean materials. The corner, ground corner, and top angle should have arc (curvature radius should not be less than 3cm). The operating table, conveyor belt, transport vehicle, and equipment in the workshop shall be made of non -toxic, corrosion -resistant, rust, easy to clean and disinfected, and sturdy materials. There should be sufficient amounts of hand washing, disinfection, and drying equipment or supplies at the appropriate place. The faucet should be a non -manual switch. According to product processing needs, shoes, boots and wheel disinfection facilities should be provided at the entrance of the workshop. There should be a locker room connected to the workshop. According to product processing needs, toilets and shower rooms connected to the workshop should also be established.


Optical optical:
The dust -free workshop of photoelectric optical products is generally suitable for electronics instruments, computers, semiconductor factories, automotive industries, aerospace industry, photocalism, microcomputer manufacturing and other industries. In addition to air cleanliness, it is also necessary to ensure the requirements of removing static electricity. The following takes the most representative LED industry in modern times as an example to introduce the dust -free purification workshop of the optoelectronics industry.
LED purification workshop engineering installation construction case analysis: In this design, it refers to some purified dust -free workshop installations of the end process. Its purification and cleanliness generally is generally installed by a thousand or 10,000 or 100,000 levels of purification. The installation of the dust -free workshop of the backlight class is mainly the stamping workshop and assembly of such products. The cleanliness is generally a 10,000 -level or 100,000 -level purification dust workshop.
LED dust -free workshop installation room air parameter requirements:
1. Temperature and humidity requirements: The temperature is generally 24+2 ° C, and the relative humidity is 55+5 %.
2. New air volume: Because there are many people in this type of purifying dust-free workshop, the following values ​​should be taken according to the following values: non-one-way flow purification room workshop total air supply of 10-30 % And keep the fresh air required for the indoor positive pressure; ensure that the fresh air volume per hour per person indoors is ≥40m3/h.
3. Large air supply. In order to meet the cleanliness and hot and humid balance in the dust -free purification workshop, a large amount of air delivery is required. For a 300 -square -meter workshop, the ceiling height is 2.5 meters. It takes 300*2.5*30 = 22500m3/h to send air delivery (the number of air changes, is ≥25 times/h); if it is 100,000 -level purification dust -free workshop, the amount of air supply will require 300*2.5*20 = 15000m3/ H's air delivery (the number of ventilation times is ≥15 times/h).


medical hygiene:
Clean technology is also called clean room technology. In addition to meeting the temperature and humidity requirements of the air -conditioned room, through various facilities and strict management of engineering technology, the content of the indoor particles, air flow, and pressure are also controlled within a certain range. This kind of room is called a clean room. And a clean room was built and used in the hospital. With the development of medical and health care and high -tech, the application of cleaning technology in the medical environment is more extensive, and its technical requirements are higher. The cleaning rooms used in medical care are mainly divided into three categories: clean operating room, clean care ward and clean laboratory.

Clean operating room



Clean operating room:
The cleaning operating room takes indoor microorganisms as the control target, running parameters and grading indicators. Air cleanliness is a necessary guarantee condition. Clean operating room can be divided into the following levels according to the degree of cleanliness:
1. Special cleaning operating room: The cleanliness of the surgical area is 100 levels, and the surrounding area is a thousand levels. It is suitable for sterile surgery such as burns, joint conversion, organ transplantation, brain surgery, ophthalmology, plastic surgery and cardiac surgery.
2. Cleaning operating room: The cleanliness of the surgical area is a thousand levels and the surrounding area is 10,000. It is suitable for sterile surgery such as thoracic surgery, plastic surgery, urology, hepatobiliary and pancreatic surgery, orthopedic surgery and egg retrieval.
3. General cleaning operating room: The cleanliness of the surgical area is 10,000 levels, and the surrounding area is 100,000. It is suitable for general surgery, dermatology and abdominal surgery.
4. Quasi -clean operating room: The cleanliness of air is 100,000, which is suitable for surgery such as obstetrics and anorectal surgery.
Except for the cleanliness level of the cleaning surgery, the concentration of the bacterial concentration should meet the corresponding level. The relevant technical parameters should also meet the relevant regulations. The plane layout of the cleaning surgery department shall be divided into two parts: clean and non -clean areas. The operating room and functional rooms directly serving the operating room should be located in a clean area. When people and things are regions in different cleanliness in the surgical department, air gates, buffer rooms or passing windows should be set up. The operating room is generally set in the core part. The internal plane and channel forms should meet the principles of functional flow and clear pollution.


Several kind of clean care ward in the hospital:
The cleaning care ward is divided into isolation ward and intensive care unit. The isolation ward is divided into four levels of P1P2P3P4 according to biological risk. The P1 ward is basically the same as the general ward, and it is not prohibited to outsiders in and out. The district is separated from the outside world, the indoor negative pressure is constant 30Pa, and the medical staff wearing a protective service to prevent infection. The intensive care unit includes ICU (intensive care room), CCU (cardiovascular patient care room), NICU (premature infant care room), and white blood ward. The room temperature of the white blood ward is 242, the wind speed is 0.15 ~ 0.3/m/s, the relative humidity is below 60 %, and the cleanliness is 100 levels. At the same time On the side, the horizontal flow is better. The measurement of the burning ward by the concentration of the bacteria shows that the use of vertical stratum flow has obvious superiority for open treatment. The laminate rate is 0.2m/s, the temperature is 28 to 34, and the cleanliness is 1,000. The respiratory organ ward is rare in China. This ward has stricter temperature and humidity in the room. The temperature is controlled at 23-30, and the relative humidity is 40-60 %. The ward can be adjusted according to the patient itself. Between 10,000 levels, noise is less than 45DB (A). Personnel should be replaced by changing clothes, blowing, etc. in the ward, and kept pressure in the ward.

Clean laboratory

Clean laboratory
The clean laboratory is divided into ordinary clean laboratories and biological safety laboratories. The experiments conducted in the ordinary cleaning laboratory are not contagious, but the environment is required to not have an adverse effect on the experiment itself. Therefore, there is no protective facilities in the laboratory, and the cleanliness must meet the experimental requirements.

The biological safety laboratory has a first -level protective facilities that can achieve secondary protection biological experiments. Scientific experiments in the fields of microbiology, biomedical, functional experiments, and genetic reorganization require biological safety laboratories. The core of the biological safety laboratory is safety. It is classified as P1, P2, P3, and P4 according to the degree of biological danger.

The P1 laboratory is suitable for a very familiar source of the disease. The source of the disease does not often cause healthy adult diseases, and it is dangerous for experiments and environmental magic weapons. The door should be closed in the experiment, and the operation is performed according to ordinary microorganisms;

The P2 laboratory is suitable for the sources of potentially dangerous to people and the environment. Limited to enter the experimental area, experiments that may occur in the II -solid oscillating should be performed in the II biological safety cabinet, and a high -pressure sterilization device should be prepared at the same time;

The P3 laboratory is applied to clinical, diagnosis, teaching, or production facilities, and conducts work on endogenous and exogenous diseases in this level. If exposure and inhalation of the disease can cause serious and possible diseases. The laboratory has a dual -door or air gates room and external isolation experimental area. The staff of the non -this office prohibit the intranets. The laboratory is full negative pressure. To outdoor;

The P4 laboratory has stricter requirements than the P3 laboratory. Some dangerous exogenous diseases have high individual risks that cause laboratory infections and cause dangerous diseases due to the transmission of gas solution. The relevant work should be carried out in the P4 laboratory. Adopt the structure of an independent building internal isolation area and external partition, keep the indoor negative pressure, use the III biological safety cabinet for experiments, set the air partition device, shower room, and operating staff should wear protective clothes. enter. The core of the design of the biological safety laboratory is dynamic isolation, and air exhaust measures are the focus. Emphasizing local disinfection, paying attention to cleanliness diversion, preventing accidents from spreading, and needing moderate cleanliness.

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