What is the classification of the clean room grade based on.

Workshop air purification level.

Workshop cleanliness level; Maximum allowable number of microorganisms ; Cubic meters of plankton; When to use it.

300,000 level; 1000 ；Pill and granule packaging workshop.

100,000 level; 500；Injection concentration workshop.

10,000 level; 100 ；Small-volume injectable filling workshop, final processing workshop for packaging materials that are in direct contact with pharmaceutical products.

Level 100 ; 5 ；Filling workshop for high-volume injections.

The cleanroom grade is divided according to the cleanliness. A grading standard for grading per unit volume of air that is greater than or equal to the maximum concentration limit of particles for the size of the particle under consideration.

level

It is also known as "clean room" and "clean room". Maximum allowable number of microorganisms: 5 m; The particles are controlled within 100 m. Applications: Aseptic manufacturing processes in the pharmaceutical industry.

level

Maximum allowable number of microorganisms: 1000 m; It is mainly used in the production of high-quality optical products, but also for testing, assembling aircraft gyroscopes, assembling high-quality miniature bearings, etc.

Class W

Maximum allowable number of microorganisms: 100 m; The particles in the workshop are controlled within 1wm. Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

Class W

Maximum allowable number of microorganisms: 500 m; Each particle in the workshop is controlled within 10w m, and it is suitable for injection concentration workshop.

Class W

Maximum allowable number of microorganisms: 1000 m; The particles in the workshop are controlled within 30w m, and the applicable occasions are: pill and granule packaging workshop.

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Class 100,000 cleanroom rooms are used in many industrial sectors, such as the manufacture of optical products, the manufacture of large electronic systems for smaller components, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and are often used in the medical and pharmaceutical industries. The cleanroom class five classes 10,000 clean rooms are used for the assembly of hydraulic or pneumatic equipment and, in some cases, in the food and beverage industry. In addition, the 10,000-level dust-free workshop is also commonly used in the medical industry.

The Class 1,000 clean room is mainly used for the production of high-quality optical products, as well as for testing, assembling aircraft snake snails and assembling high-quality miniature bearings. Class 100 Many people consider this level of cleanroom to be the most commonly used, and therefore the most important. Class 100 cleanrooms are often mistakenly referred to as clean rooms to explain the environmental requirements of "sterile" or "dust-free".

Class 100 cleanrooms can be used for aseptic manufacturing processes in industries such as pharmaceuticals. This type of cleanroom is widely used in the manufacture of items implanted in the human body as well as in surgery, including surgery, the production of integrators, and the isolation of patients who are particularly sensitive to bacterial infections**, such as after bone marrow transplantation**. Class 10 clean room is mainly used in the semiconductor industry with a bandwidth of less than 2 microns.

The Class 1 dust-free workshop is mainly used for microelectronics manufacturing and integrated circuits, and the accuracy requirements for integrated circuits are sub-micron. The GMP clean ABCD classification standard "Good Manufacturing Practice (2010 Revision)" (new GMP) came into effect on March 1, 2011. The main parameters of the cleanliness level A, B, C, D of the new GMP workshop:

GMP clean ABCD classification standard Class A clean area: The air temperature of Class A clean area should be 20-24 degrees Celsius. The relative humidity of the air in the Class A clean area should be 45%-60%.

Wind speed in clean area: horizontal wind speed in meters and seconds; Vertical wind speed in meters and seconds. 300lx-600lx。

Noise 75dB (dynamic test). Class B clean area: The air temperature in class B clean area should be 20-24 degrees Celsius.

The relative humidity of the air in the Class B clean area should be 45%-60%. The room is ventilated 25 times a day. Differential pressure:

The B area is 10Pa relative to the outdoor area, and different areas of the same level should maintain a certain pressure difference according to the direction of the airflow. Noise 75dB (dynamic test) Class C clean area: The air temperature in class C clean area should be 20-24 degrees Celsius.

The relative humidity of the air in the Class C clean area should be 45%-60%. The room is ventilated 25 times a day. Differential pressure:

The grade standards of the clean workshop are as follows.

Purification level.

This level of cleanliness is mainly used in the microelectronics industry, and it is also the industry with the highest requirements for purification level. This is due to the fact that integrated circuits are very sensitive, even 1 micron dust will have a great impact on the product, such as affecting the stability of the product, short circuit, and reducing the service life. The production of liquid crystals and optical fibers also requires this purification level.

Purification level.

This grade is now mainly used in the semiconductor industry with bandwidths of less than 2 microns. Its air purification level is second only to level 1, and it is also a relatively high level. China's semiconductor industry is in continuous development, and the requirements for purification levels may be higher in the future.

Purification level.

It is the most commonly used purification grade, which has clear requirements for the number of dust and the concentration of bacteria in the air. It is mainly used in aseptic manufacturing in the pharmaceutical industry, laboratory animal feeding environment in medical science experiments, genetic engineering experiments, etc. As well as operating room environments such as surgery and transplant surgery, isolation environments for patients sensitive to bacteria, and burn wards are generally among the requirements of the 100-level purification project.

In addition, the 100-level purification process can also be used for integrated circuit production. Class 1000 purification level: generally only the dust concentration is required. It is mainly used for high-quality production of optical devices, miniature shafts, gyroscopes for testing and assembling aircraft, etc.

Purification level.

It is generally used in the production of hydraulic equipment or pneumatic equipment, and in some cases is also used in the production of food and beverages.

Purification level.

This level can be used in many purification projects with relatively low requirements, and can be used in many industrial production departments, such as food and beverage, pharmaceutical industry, and parts assembly.

1,000,000 purification level: This level is the lowest, which means that the number of dust particles with a diameter greater than or equal to 1 million per cubic meter of air is less than 1 million, and can be used in many industries that do not require high cleanliness. Such as printing plants, packaging factories and so on.

Clean workshopLevels of five levels:

100,000-level dust-free workshop.

It is used in many industrial sectors, such as the manufacture of optical products, the manufacture of small components and large electronic systems, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and the medical and pharmaceutical industries often use this level of dust-free workshop.

Class 10,000 dust-free workshops are used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases also used in the food and beverage industry, in addition, Class 10,000 dust-free workshops are also commonly used in the medical industry.

This level of dust-free workshop is mainly used for the production of high-quality optical products, but also for testing, assembling aircraft snake snails, assembling high-quality miniature bearings, etc.

Many people believe that this class of clean room is the most commonly used and therefore the most important clean room, and people often mistakenly refer to the class 100 clean room as a clean room to describe the "sterile" or "dust-free" environmental requirements.

This class of clean room is mainly used in the semiconductor industry with a bandwidth of less than 2 microns.

The main situation of the clean workshop

1. Clean room, also known as clean room, dust-free workshop, clean room or clean room. The main function of the clean room is indoor pollution control, without which it is impossible to mass produce pollution-sensitive parts.

2. In FED-STD-2, a clean room is defined as a room equipped with air filtration, distribution, optimization, construction materials and devices, where specific rules of operating procedures are used to control the concentration of airborne particulates to achieve an appropriate level of particulate cleanliness.

3. The cleanliness degree of the clean workshop and the continuous stability of pollution control are the core standards for testing the quality of the clean room, which is divided into several levels according to the regional environment, purification degree and other factors, and is commonly used in international standards and domestic regional industry standards.

The highest grade is ISO Class 1 and the lowest is ISO Class 9. Among them, the ISO Class 1 cleanroom is the highest cleanliness level, which requires the number of particles with a particle size of microns per cubic foot of air to be no more than 3500, the ambient humidity is below 50%, the temperature is about 24, and the pressure difference is stable between 10-30Pa. Such a cleanliness level is usually used in high-precision, high-demand industrial production environments, such as semiconductor manufacturing, pharmaceutical manufacturing, fine chemicals, etc.

ISO Class 1 cleanroom has the following features:

1.High air cleanliness and strict control of particulate pollution;

2.Precise control of ambient humidity and temperature;

3.The differential pressure is stable, which can effectively prevent the spread of pollutants;

4.The internal layout of the clean workshop is strict, and a certain space planning and airflow organization are followed;

5.The internal equipment and materials of the clean workshop are strictly managed to ensure that there is no pollution in the production process.

In addition to ISO Class 1, there are also ISO Class 2, ISO Class 3, ISO Class 4, ISO Class 5, ISO Class 6, ISO Class 7, ISO Class 8 and ISO Class 9 cleanroom halls with different levels of cleanliness corresponding to different particulate pollution control requirements and environmental conditions.

Clean workshop refers to a special production environment built to ensure product quality and safety in the production process. Typically, cleanroom grading is based on the number of particulates in the air. Here are five common cleanroom grades:

Level 10: This is the highest level of clean room and the most stringent. There can only be no more than 10 microns of particles per cubic meter of air, which means that the cleanroom needs to be equipped with a very advanced air purification system to ensure that the environment is absolutely clean.

Class 100: This is a slightly lower cleanroom grade. There can only be no more than 100 microns of particles per cubic meter of air. This grade is typically used in the production of semiconductors and other high-precision electronic components.

Class 1000: This is the general clean room grade. There can only be no more than 1,000 microns of particles per cubic meter of air. This grade is often used in production areas such as pharmaceuticals and medical devices that require a high degree of hygiene.

Class 10,000: This is a relatively low clean room grade. There can only be no more than 10,000 microns of particles per cubic meter of air. This grade is usually used in the manufacture of common electronic components, precision machinery, and other fields.

Class 100,000: This is the lowest level of clean workshop. There can be no more than 100,000 microns of particles per cubic meter of air. This grade is usually used in the manufacture of general machinery, plastic products, and other fields.

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The clean room dust-free workshop can be divided into the following levels: the 100,000-level dust-free workshop is used in many industrial sectors, such as the manufacture of optical products, the manufacture of smaller components, the manufacture of large electronic systems, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and the medical and pharmaceutical industries often use this level of dust-free workshop. Class 10,000 clean room is used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases also used in the food and beverage industry, in addition, Class 10,000 clean room is also commonly used in the medical industry.

The dust-free workshop of this level is mainly used for the production of high-quality optical products, and is also used for testing, assembling aircraft snake screws, assembling high-quality miniature bearings, etc. Class 100 clean room can be used in the aseptic manufacturing process of the pharmaceutical industry, etc., this clean room is widely used in the manufacture of implants in vivo, surgery, including transplant surgery, the manufacture of integrators, and the isolation of patients who are particularly sensitive to bacterial infections, such as the isolation of bone marrow transplant patients after surgery**. Class 10 This class of clean room is mainly used in the semiconductor industry with a bandwidth of less than 2 microns.

Class 1 This level of dust-free workshop is mainly used in the microelectronics industry for the manufacture of integrated circuits, and the precise requirements for integrated circuits are sub-microns.

Summary. Hello, for your situation to make the following analysis: the five levels of clean workshop level are clean workshop level, and the five grades are also known as "sterile room" and "clean room".

Maximum allowable number of microorganisms: 5 m; The particles are controlled within 100 m. When to use it.

The maximum allowable number of microorganisms in the aseptic manufacturing process of the pharmaceutical industry: 1000 m; It is mainly used for the production of high-quality optical products, and is also used for testing, assembling aircraft gyroscopes, assembling high-quality miniature bearings, etc. The maximum allowable number of W-class microorganisms: 100 m; The particles in the workshop are controlled within 1wm.

Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs The maximum allowable number of W-level microorganisms: 500 plankton m; Each particle in the workshop is controlled within 10wm, applicable occasions:

The maximum allowable number of W-level microorganisms in the injection concentration workshop: 1000 m; The particles in the workshop are controlled within 30w m, and the applicable occasions are: pill and granule packaging workshop.

Hello, for your situation to make the following analysis: the five levels of clean workshop level are clean workshop level, and the five grades are also known as "sterile room" and "clean room". Maximum allowable number of microorganisms ;

5. Plankton m; The particles are controlled within 100 m. Applicable occasions: aseptic manufacturing process in the pharmaceutical industry Maximum allowable number of microorganisms:

1000 plankton m; It is mainly used for the production of high-quality or high-quality optical products, and is also used for testing, assembling aircraft gyroscopes, assembling high-quality miniature bearings, etc. The maximum allowable number of W-class microorganisms: 100 m; The particles in the workshop are controlled within 1wm. When to use it.

Small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs Maximum allowable number of microorganisms in class W: 500 m; Each particle in the workshop is controlled within 10W m, and the applicable occasions: the maximum allowable number of W-level microorganisms in the injection concentration workshop:

1000 plankton m; The particles in the workshop are controlled within 30w m, which is suitable for the occasion of pills and granules packaging hail in this workshop.

The following is the relevant expansion, I hope it will help you: these five levels of clean workshop testing standards are also different, the smaller the value, the higher the testing standard requirements, and the higher the cleanliness.