The Air Purification Principles of Dust-free and Sterile Production Workshops for Guangzhou Medical Devices
2024.11.12
In the field of medical device production, especially in Guangzhou where the medical industry is booming, the air purification in dust-free and sterile production workshops is of crucial importance. It is a key link in ensuring the quality and safety of medical devices. Let's take a detailed look at the air purification principles involved.
I. Analysis of Air Pollution Sources
Before understanding the air purification principles, we must first be clear about the types of air pollution sources in the production workshop. They mainly include the following aspects:
(A) Brought in by External Air
The air outside the workshop contains a large number of pollutants such as dust particles and microorganisms. Even in a relatively clean environment, there may still be tens of thousands of dust particles per cubic meter of air, and these particles may carry microorganisms such as bacteria and viruses. When the external air enters the workshop through gaps in doors and windows, ventilation systems, etc., it becomes one of the sources of pollution.
(B) Generated during the Production Process
During the production process of medical devices, such as the machining and assembly of components, particulate matter such as debris and fibers will be generated. In addition, some production operations may cause the spread of microorganisms. For example, the activities of personnel and the handling of materials may lead to the spread of microorganisms in the air. If these pollutants generated during the production process are not controlled, they will seriously affect the quality and sterility of the products.
II. Goals of Air Purification
For the dust-free and sterile production workshops of Guangzhou medical devices, air purification has clear goals.
(A) Control of Dust Particles
The number of dust particles in the air inside the workshop should be reduced to an extremely low level. According to different clean level requirements, such as ISO 5 level (the number of dust particles with a diameter of 0.5μm or more per cubic meter of air should not exceed 3520), the concentration of dust particles should be strictly controlled to prevent them from adhering to the surface of medical devices and affecting the precision and performance of the products.
(B) Control of Microorganisms
The number of microorganisms in the air must be effectively reduced, including bacteria, fungi, and viruses. Through air purification, it should be ensured that the content of microorganisms in the production environment will not contaminate medical devices, thus ensuring the safety of medical devices during use and avoiding medical accidents caused by microbial infections.
III. Air Purification Principles and Technologies
(A) Filtration Principles
1. Primary Filtration
The first line of defense in air purification is the primary filter. It mainly filters larger-sized dust particles, such as those with a diameter greater than 5μm. Primary filters generally use materials such as non-woven fabrics and glass fibers. Through physical actions such as interception and inertial collision, large particle dust is blocked on the surface of the filter. This process can remove most of the visible dust, hair, and other pollutants in the air, protecting the subsequent medium-efficiency and high-efficiency filters.
2. Medium-Efficiency Filtration
Medium-efficiency filters target dust particles with a diameter between 1 and 5μm. Their filtering materials are more refined and can further intercept the smaller particles that have passed through the primary filter. Medium-efficiency filtration plays a connecting role in the air purification system. It can not only improve the air cleanliness but also extend the service life of the high-efficiency filter. Common medium-efficiency filtering materials include synthetic fibers. By increasing the density and complexity of the filtering medium, the filtering effect is enhanced.
3. High-Efficiency Filtration (HEPA)
High-efficiency filters are one of the core devices for achieving a dust-free and sterile environment. They can filter dust particles with a diameter of 0.3μm or more, with a filtering efficiency of over 99.97%. The filtering principle of HEPA filters is mainly based on the combined action of multiple mechanisms such as Brownian diffusion, interception, inertial collision, and gravitational settling. The special materials such as ultra-fine glass fiber filter paper inside them have extremely small pore sizes and extremely high densities, which can effectively block tiny dust particles and microorganisms, ensuring that the filtered air reaches an extremely high level of cleanliness.
(B) Airflow Organization Principles
1. Unidirectional Flow
In some areas of medical device production with extremely high cleanliness requirements, such as the production workshops of implantable medical devices, the unidirectional flow air purification method is often used. In a unidirectional flow system, air flows in parallel streamlines at a uniform speed, "sweeping" dust particles and microorganisms out of the work area. This airflow organization method can ensure that the air in the work area always remains in a highly clean state, effectively preventing the accumulation of pollutants.
2. Non-unidirectional Flow (Turbulent Flow)
For some areas with slightly lower cleanliness requirements, the non-unidirectional flow air purification method is more suitable. In this system, after the air enters the workshop through the supply air outlet, it forms a complex airflow mixture inside the room. Although the airflow does not flow in a single direction, through the reasonable layout of the supply air outlet and the return air outlet and sufficient air changes, the indoor air can be fully purified and diluted, and the concentration of dust particles and microorganisms can be controlled within the specified range.
(C) Disinfection and Sterilization Principles
In addition to filtration and airflow organization, disinfection and sterilization are also important aspects of air purification.
1. Ultraviolet Disinfection
Ultraviolet light has a bactericidal effect. By destroying the DNA or RNA structure of microorganisms, it makes them lose their ability to reproduce and survive. In the air purification system, installing ultraviolet lamps can further disinfect the filtered air. Ultraviolet disinfection has the advantages of being fast and pollution-free, but attention should be paid to the harm of ultraviolet light to the human body. It is generally turned on when there is no one operating.
2. Chemical Disinfectants
Certain chemical disinfectants can also be used for air purification. For example, hydrogen peroxide vapor and other disinfectants can be used for fumigation disinfection in the workshop when there is no one. These chemical disinfectants can react with the cell membranes and proteins of microorganisms to kill them. However, when using chemical disinfectants, attention should be paid to their residue problems, ensuring that the residue amount of the disinfectant in the workshop before production meets the safety standard.
Guangzhou Kunling Purification Equipment Co., Ltd. has been committed to providing high-quality air purification solutions for medical device production enterprises in Guangzhou. We deeply understand the importance of air purification principles in ensuring the environmental quality of production workshops. Through advanced technologies and equipment, we help enterprises produce high-quality, safe and reliable medical devices.
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