Introduction to Cleanroom, What is Cleanroom?

The popular point of clean room is that it is a very clean space. Because dust and bacteria, if the particles are very small, they will float in the air, which may not have much impact on the human body, but it will have a great impact on some production processes.

For example, in the semiconductor industry, when the size of particles reaches half the size of an integrated circuit node, they become destructive particles, which have an impact on the manufacturing of integrated circuits. Therefore, the semiconductor industry has very high requirements for cleanliness.

For example, in the new energy vehicle industry, whether it is lithium iron phosphate or ternary lithium battery, it needs to be completed in a clean room. The spraying process of the car also needs to be completed in the clean room, which is one of the reasons why the repair shop and 4S shop will never be able to meet the original paint standard.

For example, in the pharmaceutical industry, sterility, high cleanliness, and constant temperature and humidity can produce qualified products.

In addition to the above, there are many other industries where cleanroom technology is widely used. The clean room is also divided into levels, and there are currently three ways to divide them.

The first is the United States Federal 209e, which has been abolished in the United States, but China is still accustomed to using this name, such as ten, hundred, thousand, 100, 100,000, 300,000, etc. When you hear these statements, they are all based on the American 209e standard. The lower the number, the higher the level.

The second is the latest international standard ISO14644-1, which is generally divided into 9 levels, with level 1 being the highest.

The third is the WHO classification standard adopted by the GMP pharmaceutical industry, which uses ABCD to distinguish the level of clean zones.

These three levels are interoperable, and the international ISO14644 class5 is equivalent to GMP class A, class B (the 100 level of the United States 209E), class 7 is equivalent to class C (10,000 level), and class 8 is equivalent to class D (100,000 level).

Clean room refers to the air suspended particle concentration and bacterial concentration are controlled, to meet certain requirements or standards of the room (limited space) room construction and use of the room to reduce the introduction, generation and retention of particles (including dust particles and bacteria) as much as possible, other relevant parameters in the room, such as: temperature, pressure and the corresponding humidity to be controlled according to the requirements. The function of the clean room is to control the cleanliness, temperature and humidity of the atmosphere that the product is exposed to, so that the product can be produced in a good environment and ensure that the quality of the product meets the requirements.

Airborne particles refer to solid and liquid particles of various sizes, some of which are living (such as bacteria, viruses, etc.) and some are inanimate (such as dust particles), which are used to classify air cleanliness. In order to more effectively achieve the specified cleanliness level, control the pollution of particles, and enable people to engage in production and scientific experiment activities in the clean room, the clean room is by no means limited to "clean", but must be a multi-functional complex with considerable requirements for heat and cold, noise, illumination, static electricity, etc., and is a comprehensive product integrating various professional technologies such as building decoration, air conditioning purification, dust-free workshop, purification workshop, electrical control and so on.

Clean room refers to a specially designed room that excludes particles, harmful air, bacteria and other pollutants in the air within a certain space range, and controls the indoor temperature, cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting, and static electricity within a certain range of needs.

Definition: Clean room refers to the elimination of particles, harmful air, bacteria and other pollutants in the air within a certain range, and the indoor temperature, cleanliness, indoor pressure, air velocity, static electricity, etc. are controlled within a certain range of requirements. And give a specially designed room.

Applications: electronic information, semiconductors, precision manufacturing, medicine and health, biological engineering, aerospace, automotive painting, etc.

Structural Materials for Cleanrooms:

1. The materials of the clean room wall and roof are generally made of 50mm thick sandwich color steel plate and alumina profiles for purification. The door is a purified airtight door, and the window is made of aluminum alloy glass fixed window.

2. The floor is made of epoxy self-leveling or high-grade wear-resistant plastic clean flooring.

3. The purification and ventilation pipes are made of galvanized thin steel plates, and the "PEF" flame retardant insulation board is used for thermal insulation.

Composition of the clean room:

Ceiling purification and air-conditioning system (including air shower).

Partition panels (including equipment doors and transfer windows).

Anti-static flooring.

Lighting and others.

Purification principle of clean room:

Airflow, primary air treatment, air conditioning, intermediate air treatment, fan pressurized air supply, purified air supply pipe, high-efficiency air outlet, clean room, dust particles (bacteria) removed, return air clamp, fresh air, primary air treatment.

Repeat the above process to achieve the purpose of purification.

A cleanroom, also known as a clean room or clean room. It is the basis for contamination control, and without a clean room, mass production of contamination-sensitive parts is impossible. In FED-STD-2, a cleanroom is defined as a room with air filtration, distribution, optimization, and construction materials and devices with specific rules of operating procedures to control the concentration of airborne particulates to achieve the appropriate level of particulate cleanliness.

Clean room refers to a specially designed room that excludes particles, harmful air, bacteria and other pollutants in the air within a certain space range, and controls the indoor temperature, cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting, and static electricity within a certain range of needs. That is to say, no matter how the external air conditions change, the interior can maintain the characteristics of cleanliness, temperature, humidity and pressure that were originally set. The main function of the clean room is to control the cleanliness day, temperature and humidity of the atmosphere that the product (such as silicon chips, etc.) is exposed to, so that the product can be produced and manufactured in a good environmental space, which we call clean room.

According to international practice, the dust-free purification level is mainly based on the number of particles whose particle diameter per cubic meter of air is greater than the classification standard. In other words, the so-called dust-free is not 100% free of a little dust, but is controlled in a very small unit. Of course, the particles that meet the dust standard in this standard are already small and insignificant compared to our common dust, but for optical structure, even a little dust will have a very large negative impact, so in the production of optical structure products, dust-free is an inevitable requirement.

The number of fine dust smaller than micron particles per cubic meter is controlled below 3,500, which meets the international dust-free standard Class A. At present, the dust-free standard applied to chip-level production and processing has higher requirements for dust than Class A, and such a high standard is mainly used in the production of some higher-grade chips. The number of fine dust of 5um and below is strictly controlled within 1000 per cubic meter, which is commonly known as the 1k level in the industry.

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A cleanroom is a room or area where the concentration of airborne particles and microorganisms is controlled. Its building structure, equipment and use should have the function of reducing indoor induction, generation and retention of pollution sources. Other relevant indoor parameters such as temperature, humidity, pressure, etc. are controlled as required.

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Clean room refers to the room designed to remove particles, harmful air, bacteria and other pollutants in the air within a certain space range, and control indoor temperature, cleanliness, indoor pressure, air velocity and air distribution, noise, vibration and lighting, and static electricity within a certain range. That is to say, no matter how the external air conditions change, the interior can maintain the original cleanliness, temperature, humidity, pressure and other performance requirements.

Specifically, the clean room has the following three characteristics:

1) A clean room is a space where the cleanliness of the air reaches a certain level for human activities, and its function is to control the pollution of particles and microorganisms. The cleanliness of the cleanroom is not ordinary clean, but reaches a certain level of air cleanliness.

2) The clean room is a multi-functional integrated whole, which requires multi-professional cooperation with a building, air conditioning, purification, pure water, pure gas, etc. In the case of pure gas, the process gas also needs to be purified. - In the injection molding workshop, because the compressed air involved in the process has not undergone special purification treatment, the machine discharges a large amount of unpurified compressed air every time the product is molded, so that the air in the workshop cannot meet the requirements and pollutes the molded product.

Therefore, dry air, compressed air and inert gases in direct contact with pharmaceuticals should be purified to meet production requirements. Secondly, it is necessary to control a number of parameters, such as: air cleanliness, bacterial concentration, air volume (air volume), pressure (pressure), sound (noise), light (illuminance), temperature (temperature), humidity (humidity), etc.

3) To evaluate the quality of the clean room, the design, construction and operation management are all very important, that is, the clean room reflects its quality through the whole process from design to management.

The cleanliness level of the clean room is divided into 10 grades, 100 grades, 1000 grades, 1000 grades, etc.

According to the GB50073-2013 clean workshop design specification, it can be divided into 9 levels, and the 5 levels of the clean workshop level we often say are 4-8 levels (compared with ISOCLASS4-CLASS8 level), namely: 10 grades, 100 grades, 1000 grades, 100,000 grades, these five levels are the most widely used cleanliness levels.

Cleanroom cleanliness standards:

10,000 level. The cleanliness level is 300,000, the maximum allowable number of dust particles is 10,500,000 per cubic meter, the maximum number of dust particles of 5 m is 60,000 per cubic meter, the maximum allowable number of plankton is 1,000 per cubic meter, and the maximum allowable number of sedimentation and bacteria is 15 per dish.

10,000 level. The cleanliness level is 100,000, the maximum allowable number of dust particles is 3,500,000 per cubic meter, the maximum number of dust particles of 5 m is 60,000 per cubic meter, the maximum allowable number of plankton bacteria is 1,000 per cubic meter, and the maximum allowable number of sedimentation bacteria is 10 per dish. <>

Generally, enterprises requiring cleanliness in drug production should reasonably divide the workshop into different areas according to the type and dosage form of the production drugs, such as general production area, control area, clean area and sterile area. Each preparation can only be of high quality if it is produced in the corresponding workshop, otherwise the drug will be easily contaminated during the production process.

Clean room (area) refers to the room (area) that needs to control the content of dust particles and microorganisms, and the air entering the clean room (area) must be purified, and the air cleanliness level must be divided according to the requirements of the production process. The number of microorganisms and dust particles in the air in the clean room (area) should be regularly monitored and recorded.

The air cleanliness of the pharmaceutical production clean room (area) is divided into four levels, namely 100, 10,000, 100,000 and 300,000. The lower the number, the higher the cleanliness, i.e. the cleaner the cleanroom. Personnel are the main source of pollution of dust and bacteria in clean rooms, such as human dander, saliva, hair and other pollutants; In order to reduce the pollution of personnel, operators must wash and change clothes, shoes, etc. before entering the clean room.