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Views: 0 Author: Site Editor Publish Time: 2025-07-31 Origin: Site
The advancement of computers, microelectronics, and information technology has driven the rapid growth of the electronics manufacturing industry, driving the development of cleanroom technology and placing higher demands on Cleanroom Design. Cleanroom design for the electronics manufacturing industry is a comprehensive skill. Only by fully understanding the design characteristics of cleanrooms in the electronics manufacturing industry and ensuring a sound design can the defective rate of products in the electronics manufacturing industry be reduced and production efficiency improved.
High cleanliness levels are required. Air volume, temperature, humidity, pressure differential, and equipment exhaust are controlled as needed. Illumination and cross-sectional air velocity in the cleanroom are controlled according to design or specifications. Furthermore, these cleanrooms have extremely strict requirements for static electricity control, especially regarding humidity. Excessively dry workshops are prone to static electricity generation, which can damage CMOS integrated circuits. Generally speaking, the temperature in electronics factories should be controlled at around 22°C, and the relative humidity between 50-60% (specialized cleanrooms have specific temperature and humidity regulations). This effectively eliminates static electricity and provides a comfortable environment. Chip production workshops, integrated circuit cleanrooms, and disk manufacturing workshops are important components of cleanrooms in the electronics manufacturing industry. Due to the extremely stringent requirements for indoor air quality and quality during the manufacturing and production of electronic products, the primary focus is on controlling particulate matter and floating dust.
The noise level (airborne) in a Class 10000 cleanroom in an electronics manufacturing plant should not exceed 65dB(A).
The vertical flow clean room coverage ratio of the electronic manufacturing plant should not be less than 60%, and the horizontal unidirectional flow clean room should not be less than 40%, otherwise it will be a partial unidirectional flow.
The static pressure difference between the clean room and the outside of the electronic manufacturing plant should not be less than 10Pa, and the static pressure difference between the clean area and the non-clean area with different air cleanliness should not be less than 5Pa.
The amount of fresh air in the 10,000-level clean room of the electronic manufacturing industry should be the maximum of the following two items: (1) The sum of the amount of fresh air required to compensate for the indoor exhaust volume and the amount of fresh air required to maintain the indoor positive pressure value. (2) Ensure that the amount of fresh air supplied to each person in the clean room per hour is not less than 40m3. (3) The heater of the clean room purification air conditioning system in the electronic manufacturing industry should be equipped with fresh air and over-temperature power-off protection. If point humidification is used, waterless protection should be set. In cold areas, the fresh air system should be equipped with anti-freeze protection measures. (4) The air supply volume of the clean room should take the maximum value of the following three items: the air supply volume that ensures the air cleanliness level of the clean room of the electronics manufacturing plant. The air supply volume of the clean room of the electronics factory is determined based on the heat and moisture load calculation. The amount of fresh air supplied to the clean room of the electronics manufacturing plant.
Biopharmaceutical factories not only have high equipment costs, complex production processes, and strict cleanroom and sterility requirements, but also place stringent demands on the quality of production personnel.
Potential biohazards arise during the production process, primarily including infection risks; toxicity, allergenicity, and other biological reactions to humans and other organisms caused by dead bacteria or cells, their components, or their metabolism; toxicity, allergenicity, and other biological reactions caused by products; and environmental effects.
A room where environmental contamination by particulate matter and microorganisms must be controlled. Its construction, equipment, and use are designed to prevent the introduction, generation, and retention of contaminants within the area.
A segregated space with two or more doors, located between two or more rooms (e.g., between rooms of different cleanroom levels). The purpose of an airlock is to control airflow when personnel or materials enter and exit the space. Airlocks are divided into personnel airlocks and material airlocks.
The fundamental characteristic of a biopharmaceutical cleanroom is that it must target particulate matter and microorganisms. Pharmaceutical production workshop cleanliness levels are classified into four categories: Class 100, Class 1000, Class 10000, and Class 30000 within a Class 100 or Class 10000 environment.
Cleanroom Temperature: Unless otherwise specified, maintain a temperature range of 18-26°C, with relative humidity controlled between 45% and 65%.
Pollution control in biopharmaceutical cleanrooms involves source control, process control, and cross-contamination control.
Key cleanroom technologies for pharmaceuticals focus on controlling dust and microorganisms. As contaminants, microorganisms are a paramount concern in cleanroom environmental control. Contaminants accumulated in equipment and piping within clean areas of pharmaceutical plants can directly contaminate pharmaceuticals without affecting cleanliness testing. Cleanliness grades are not suitable for characterizing the physical, chemical, radioactive, or bioactive properties of suspended particles. Lack of familiarity with pharmaceutical production processes, the causes of contamination, the locations where contaminants accumulate, and the methods and evaluation criteria for removing contaminants are essential.
Due to subjective misunderstandings and inadequate application of clean technology during pollution control, some pharmaceutical plants have experienced significant improvements in drug quality despite significant investments.
The design and construction of pharmaceutical clean production plants, the manufacture and installation of equipment and facilities within the plants, the quality of raw and auxiliary materials, packaging materials, and the implementation of clean personnel, equipment, and facility control procedures can all affect product quality. The reasons for the impact on product quality during construction were problems with process control, which left hidden dangers during installation and construction. Specific manifestations include:
The inner walls of the air ducts in the purification and air conditioning system were unclean, connections were loose, and air leakage was excessive.
The color-coated steel plate enclosure was not tight, the sealing measures between the cleanroom and the technical mezzanine (ceiling) were inadequate, and the airtight doors were not airtight.
Decorative profiles and process pipelines created dead corners and accumulated dust in the cleanroom.
Construction in some locations did not comply with design requirements and failed to meet relevant regulations.
The sealant used was of poor quality, easily peeling and deteriorating.
The return and exhaust color-coated steel plate ducts were connected, allowing dust to enter the return air duct from the exhaust.
The inner wall welds of stainless steel sanitary pipes for process purified water and injection water were not formed properly.
The air duct check valve malfunctioned, allowing air backflow and contamination.
The drainage system installation quality was poor, and dust easily accumulated on the pipe racks and accessories.
The cleanroom pressure differential setting was unqualified, failing to meet production process requirements.
With the development of society, the products of the printing and packaging industries have also become more sophisticated. Large-scale printing equipment has been incorporated into cleanrooms, significantly improving the quality of printed products and significantly increasing the yield rate. This represents a perfect integration of the cleanroom and printing industries. In printing, the temperature, humidity, and dust particle count of the coating environment are crucial for product quality and yield rate. In the packaging industry, the most important factors are the temperature, humidity, dust particle count, and water quality of the coating environment, particularly for food and pharmaceutical packaging. Of course, standardized operating procedures by production personnel are also crucial.
Dust-free spraying uses steel sandwich panels to construct an independent, enclosed production workshop, effectively filtering out contaminants from adverse air environments and reducing dust in the coating area and product defect rates. The application of dust-free technology further enhances the appearance quality of products such as television/computer housings, mobile phone cases, DVD/VCDs, game consoles, VCRs, PDAs, camera housings, speakers, hair dryers, MDs, makeup cases, toys, and other workpieces. Process: loading area → manual dust removal → electrostatic dust removal → manual/automatic spraying → drying area → UV paint curing area → cooling area → silk screen printing area → quality inspection area → receiving area.
Air supply and exhaust volume: If it is a turbulent cleanroom, then its air supply and exhaust volume must be measured. If it is a unidirectional cleanroom, then its wind speed must be measured.
Airflow control between zones: To prove that the direction of airflow between zones is correct, that is, it flows from the clean area to the area with poor cleanliness, it is necessary to test: (1) the correct pressure difference between zones; (2) the correct direction of airflow at the door or openings in the wall, floor, etc., that is, it flows from the clean area to the area with poor cleanliness.
Filter leak detection: The high-efficiency filter and its outer frame must be inspected to ensure that suspended pollutants do not penetrate the following: (1) damaged filters; (2) the gap between the filter and its outer frame; (3) other parts of the filter device and invade the room.
Isolation leak detection: This test is to prove that suspended pollutants do not penetrate the building materials and invade the cleanroom.
Indoor airflow control: The type of airflow control test depends on the airflow pattern of the cleanroom - whether it is turbulent or unidirectional. If the cleanroom airflow is turbulent, verify that there are no areas of insufficient airflow. For unidirectional cleanrooms, verify that the air velocity and direction throughout the room meet the design requirements.
Particle and Microbial Concentration: If the above tests meet the requirements, final measurements of particle and microbial concentrations (if necessary) are performed to verify compliance with the cleanroom design specifications.
Other Tests: In addition to the above pollution control tests, one or more of the following tests may be necessary: temperature; relative humidity; indoor heating and cooling capacity; noise levels; light levels; and vibration levels.
Provide the air purification level required for production. The number of air dust particles and live microorganisms in the packaging workshop purification project should be regularly tested and recorded. The static pressure difference between packaging workshops of different levels should be kept within the specified value.
The temperature and relative humidity of the packaging workshop purification project should be compatible with its production process requirements.
The production area of penicillins, highly allergenic and anti-tumor drugs should be equipped with an independent air-conditioning system, and the exhaust gas should be purified.
For rooms that generate dust, effective dust collection devices should be installed to prevent cross-contamination of dust.
For auxiliary production rooms such as storage, their ventilation facilities and temperature and humidity should be compatible with the requirements of pharmaceutical production and packaging.
The clean room should strictly control the air cleanliness, as well as the environmental parameters such as temperature, humidity, fresh air volume and pressure difference.
Purification level and ventilation frequency of pharmaceutical production and packaging workshops The air cleanliness of the purification project of pharmaceutical production and packaging workshops is divided into four levels: 100, 10000, 100000 and 300000. To determine the ventilation frequency of the clean room, it is necessary to compare the air volume of each item and take the maximum value. In practice, the ventilation frequency of 100-level is 300-400 times/h, 10,000-level is 25-35 times/h, and 100000-level is 15-20 times/h.
Cleanliness zoning of pharmaceutical packaging workshop purification project The specific zoning of cleanliness in pharmaceutical production and packaging environment is based on the national standard of cleanliness.
Determination of other environmental parameters of the packaging workshop purification project.
Temperature and humidity of the packaging workshop purification project The temperature and relative humidity of the clean room should comply with the pharmaceutical production process. Temperature: 20~23°C (summer) for Class 100 and Class 10,000, 24~26°C for Class 100,000 and Class 300,000, and 26~27°C for general areas. Class 100 and Class 10,000 are sterile rooms. Relative humidity: 45-50% (summer) for hygroscopic drugs, 50%~55% for solid preparations such as tablets, and 55%~65% for injections and oral liquids.
Clean room pressure To maintain indoor cleanliness, positive pressure must be maintained. For clean rooms that produce dust, harmful substances, and produce penicillin-like highly allergenic drugs, external contaminants must be prevented from flowing in and internal air must be kept out. The static pressure of rooms with different cleanliness levels must be kept positive, with a difference of more than 5Pa from adjacent rooms, and a static pressure difference of more than 10Pa between the clean room and the outdoor atmosphere.
Food safety and hygiene play a crucial role in our daily lives. Food safety and hygiene primarily focus on three key areas: first, ensuring standardized operations by production personnel; second, controlling external environmental contamination (maintaining a relatively clean operating environment); and third, eliminating problematic raw materials from the source.
Food production workshops must be appropriately sized for production, with a rational layout and adequate drainage. Floors must be constructed of non-slip, durable, impermeable, and corrosion-resistant materials, be flat, free of stagnant water, and kept clean. Exit areas and drainage and ventilation areas connecting to the outside world must be equipped with rodent-, fly-, and insect-proofing devices. The walls, ceilings, doors and windows in the workshop should be constructed with non-toxic, light-colored, waterproof, mildew-proof, non-shedding and easy-to-clean materials. Wall corners, floor corners and top corners should be curved (the radius of curvature should be no less than 3cm). The operating tables, conveyor belts, transport vehicles and tools in the workshop should be made of non-toxic, corrosion-resistant, rust-proof, easy-to-clean and disinfect, and sturdy materials. A sufficient number of hand-washing, disinfection and hand-drying equipment or supplies should be installed in appropriate locations, and the faucets should not be manually switched. According to the needs of product processing, shoe, boot and wheel disinfection facilities should be installed at the entrance of the workshop. There should be a changing room connected to the workshop. According to the needs of product processing, toilets and showers connected to the workshop should also be set up.
Optoelectronics and optics cleanrooms are generally used in industries such as electronic instrumentation, computers, semiconductor factories, the automotive industry, aerospace, photolithography, and microcomputer manufacturing. In addition to ensuring air cleanliness, they must also meet static electricity requirements. Below, iwuchen will introduce cleanrooms in the optoelectronics and optics industry, using the modern LED industry as an example.
LED cleanroom installation and construction case study: In this design, this refers to the installation of cleanrooms for end-of-line processes, typically requiring Class 1000, 10,000, or 100,000 cleanrooms. Backlight screen cleanrooms primarily involve stamping and assembly facilities for these products, typically requiring Class 10,000 or 100,000 cleanrooms.
Indoor air parameter requirements for LED cleanroom installation:
Temperature and humidity requirements: The temperature is generally 24°C ± 2°C, and the relative humidity is 55% ± 5%.
Fresh Air Volume: Because these cleanrooms often have a high number of people, the following maximum values should be used: 10-30% of the total air supply volume for non-unidirectional cleanrooms; the amount of fresh air required to compensate for indoor exhaust and maintain positive indoor pressure; and ensuring a fresh air volume of ≥40 m³/h per person per hour.
High Air Supply Volume. To maintain cleanliness and thermal and humidity balance within a cleanroom, a high air supply volume is required. For a 300-square-meter workshop with a ceiling height of 2.5 meters, for a Class 10,000 cleanroom, the required air supply volume would be 300*2.5*30 = 22,500 m³/h (with an air change rate of ≥25 times/h). For a Class 100,000 cleanroom, the required air supply volume would be 300*2.5*20 = 15,000 m³/h (with an air change rate of ≥15 times/h).
Cleanroom technology, also known as cleanroom technology, not only meets standard temperature and humidity requirements for air-conditioned rooms, but also uses various engineering and technical facilities and strict management to control indoor particulate matter levels, airflow, and pressure within certain limits. This type of room is called a cleanroom. A cleanroom is typically constructed and used in a hospital. With the advancement of healthcare and high technology, the application of cleanroom technology in medical environments has become more widespread, and the technical requirements have become increasingly stringent. Cleanrooms used in medical settings are primarily divided into three categories: clean operating rooms, clean nursing wards, and clean laboratories.
Clean operating rooms target indoor microbial control, and air cleanliness is a crucial operating parameter and grading indicator. Clean operating rooms are classified into the following levels based on cleanliness:
Special Clean Operating Room: The operating area has a cleanliness level of Class 100, and the surrounding area has a cleanliness level of Class 1000. Suitable for sterile procedures such as burns, joint replacements, organ transplants, neurosurgery, ophthalmology, plastic surgery, and cardiac surgery.
Clean Operating Room: The operating area has a cleanliness level of Class 1000, and the surrounding area has a cleanliness level of Class 10,000. Suitable for sterile procedures such as thoracic surgery, plastic surgery, urology, hepatobiliary and pancreatic surgery, orthopedics, and egg retrieval.
General Clean Operating Room: The operating area has a cleanliness level of Class 10,000, and the surrounding area has a cleanliness level of Class 100000. Suitable for procedures such as general surgery, dermatology, and abdominal surgery.
Semi-Clean Operating Room: The air cleanliness level of Class 100,000 is suitable for procedures such as obstetrics and anorectal surgery. In addition to ensuring that cleanliness levels and bacterial concentrations meet the corresponding levels, the relevant technical parameters of clean operating room rooms must also comply with relevant regulations. See the table of main technical parameters for rooms at all levels in clean operating rooms. The floor plan of a clean operating room should generally be divided into clean and non-clean areas. Operating rooms and functional rooms directly serving the operating rooms should be located within the clean area. Airlocks, buffer rooms, or transfer windows should be installed when people and objects pass through different cleanliness levels within the operating room. Operating rooms are generally located in the core area. The internal layout and passageways should conform to the principles of streamlined functional processes and clear separation of clean and dirty areas.
Clean care rooms are divided into isolation wards and intensive care units. Isolation wards are classified into four levels based on biological risk: P1, P2, P3, and P4. P1 wards are essentially the same as regular wards, with no specific restrictions on entry and exit for outsiders. P2 wards are more restrictive than P1 wards, generally prohibiting entry and exit for outsiders. P3 wards are isolated from the outside world by means of a double door or buffer room, and the room is under negative pressure. P4 wards are separated from the outside world by an isolation area, with a constant negative pressure of 30 Pa. Medical staff wear protective clothing to prevent infection. Intensive care units include ICUs (intensive care units), CCUs (cardiovascular care units), NICUs (premature infant care units), and leukemia units. Leukemia units have a room temperature of 242°C, a wind speed of 0.15-0.3/m/s, a relative humidity below 60%, and a cleanliness level of Class 100. The cleanest air delivered should reach the patient's head first, with the mouth and nose breathing area on the air supply side, and horizontal airflow is preferred. Bacteria concentration measurements in burn wards show that vertical laminar airflow offers significant advantages over open-type treatment. The laminar flow velocity is 0.2 m/s, the temperature is 28-34°C, and the cleanliness level is Class 1000. Respiratory wards are rare in China and have strict requirements for indoor temperature and humidity. The temperature is controlled between 23-30°C and the relative humidity is 40-60%. Each ward can be adjusted to suit the patient's needs. The cleanliness level is controlled between Class 10 and Class 10000, and the noise level is less than 45 dB(A). Patients entering the ward must undergo personal decontamination, such as changing clothes and showering, and the ward maintains positive pressure.
Cleanroom labs are divided into regular cleanroom labs and biosafety labs. Experiments conducted in regular cleanroom labs are non-infectious, but the environment must not adversely affect the experiments themselves. Therefore, no protective equipment is installed within the lab, but cleanliness must meet experimental requirements. Biosafety labs are biological labs equipped with level 1 containment facilities and capable of achieving level 2 containment. All scientific experiments in fields such as microbiology, biomedicine, functional experiments, and genetic recombination require biosafety labs. Safety is the core of biosafety labs, and they are categorized into four levels: P1, P2, P3, and P4, based on the degree of biological hazard. P1 labs are suitable for very familiar pathogens that do not frequently cause illness in healthy adults and pose a low risk to laboratory personnel and the environment. The door should be closed during experiments, and procedures should be conducted as for standard microbiology experiments. P2 labs are suitable for pathogens that pose a moderate potential risk to humans and the environment. Access to laboratory areas is restricted. Experiments involving the generation of aerosols should be conducted in a Class II biosafety cabinet equipped with an autoclave. P3 laboratories are used in clinical, diagnostic, teaching, or production facilities. Work involving endogenous and exogenous pathogens, which can cause serious, potentially fatal illnesses if inhaled, is conducted within these laboratories. These laboratories have double doors or airlocks and an external, isolated experimental area. Non-resident personnel are prohibited from entering. The laboratory is under full negative pressure and experiments are conducted using a Class II biosafety cabinet. The indoor air is filtered and exhausted to the outside using a high-efficiency filter. P4 laboratories have stricter requirements than P3 laboratories. Some dangerous exogenous pathogens carry a high risk of laboratory-acquired infections and life-threatening illnesses transmitted through aerosols. These work should be conducted in a P4 laboratory. These laboratories utilize a separate building with an internal isolation area and external partitions. Negative pressure is maintained indoors. Experiments are conducted using a Class III biosafety cabinet with air barriers and showers. Non-resident personnel are prohibited from entering. The core of biosafety laboratory design is dynamic isolation, with exhaust measures as the focus. It emphasizes on-site disinfection, pays attention to the separation of clean and dirty water, prevents accidental spread, and requires moderate cleanliness.
Amber has over 17 years of experience in the cleanroom industry, including design and construction of food, cosmetic, semiconductor, and pharmaceutical cleanrooms, modular operating rooms, and related purification equipment. If you have any further questions about this industry, please contact us.
