Medical device clean room, what is a clean room

The sterile room is generally a small room in the microbiology laboratory, which can be built with plates and glass, and the area should not be too large, about 4 to 5 square meters of sterile room should be set up outside the sterile room, and the door of the buffer room and the door of the sterile room should not be facing the same direction, so as not to bring in miscellaneous bacteria by the air flow.

The sterile room and the buffer room must be sealed, the ventilation equipment equipped in the room must have an air filtration device, the sterile room and the buffer room are equipped with purple disturbance external lights, the ultraviolet lamp of the sterile room is 1 meter away from the work surface, the staff should wear sterilized clothing and hats when entering the sterile room, and the main function of the ultra-clean table is to use the air laminar flow device to eliminate various fine dust including microorganisms on the upper part of the work surface.

Through the electric device, the air enters the work surface after passing through the high-efficiency filter, so that the table top is always kept under the control of the flow of sterile air, and there is a high-speed flowing air curtain near the side of the external excavation to prevent the external germ-carrying air from entering, aseptic operation technology not only plays a pivotal role in microbiology research and application, but also is widely used in many biotechnology.

The sterile room is usually a small room dedicated to the microbiology laboratory. It can be built with sheets and glass. The area should not be too large, about 4-5 square meters, about 1 meter high.

A buffer room should be set up outside the sterile room, and the door of the buffer room and the door of the sterile room should not be facing the same direction, so as to avoid the airflow from bringing in bacteria. Both the clean room and the buffer room must be sealed. Ventilation equipment installed in the room must have an air filter.

The floor and wall in the sterile room must be flat, not easy to hide dirt and dirt, and easy to clean. The workbench should be level. Both the clean room and the buffer room are equipped with UV lamps, which are located 1 meter from the work surface.

Staff entering the sterile room should wear sterilized clothing and hats. At present, the clean room is mostly found in microbial factories, and the ultra-clean table is used in general laboratories. The main function of the ultra-clean table is to use the air laminar flow device to remove all kinds of fine dust including microorganisms on the upper part of the work surface.

The air is passed through the HEPA filter and then fed into the work surface by means of an electric device, so that the table top is always under the control of flowing sterile air. In addition, there is a high-speed flowing air curtain on the side close to the outside to prevent the ingress of germ-carrying air from the outside. In places where the conditions are more difficult, a wooden sterile box can also be used instead of a clean table.

The aseptic box has a simple structure and is easy to move, with two holes in the front of the box, which are blocked by a small push-pull door when not operating, and you can put your arms into it when operating. The upper part of the front is equipped with glass for easy operation on the inside, and the inside of the box is equipped with a UV lamp, and the small door on the side allows you to put utensils and cultures. Aseptic operation technology is not only playing a pivotal role in microbiology research and applications, but is also widely used in many biotechnology applications.

For example, transgenic technology, monoclonal antibody technology, etc.

The sterile room is generally a small room of 4-5 square meters and a height of 4 to 5 meters (isolated from the outside), which is specially located in the microbiology laboratory, and can be built with plates and glass. A buffer room should be set up outside the sterile room, and the door direction should be staggered to accompany and prevent the airflow from bringing in miscellaneous bacteria. The clean room and buffer room must be closed, and the ventilation equipment equipped in the room must have an air filtration device.

Once a sterile environment and sterile material have been obtained, a specific known microorganism can only be studied if it is kept sterile. Therefore, the ability and stability of bacterial control are the core acceptance indicators of the clean room. The acceptance standard in the industry is that the average number of miscellaneous bacteria in the 100-level clean area shall not exceed 1 colony, and the average number of colonies in the 10,000-level clean room shall not exceed 3. However, international brand projects, because they are generally implemented according to European and American environmental indicators, it is difficult to consider the adaptability of domestic building materials, so stability disorders often occur.

In addition to the general standards, it also has its own long-term maintenance and material selection indicators, and its purification capacity and environmental adaptability far exceed that of international brands.

Clean room: The environment where the concentration of suspended particles in the room is controlled is called a clean room, and the cleanliness level is different according to the different concentrations, such as 10,000 levels, 100 levels, 100 levels, etc.

Sterile room: The clean room is mainly used to control the concentration of suspended particles, while the clean room is for the purpose of controlling biological bacteria, etc., and the level is the same as that of the clean room, but the number of colonies such as plankton bacteria and sedimentation bacteria needs to be detected during the test.

Inoculation room: The name of the functional room, which can be inoculated in a clean room or in a sterile room.

About the clean bench is to provide a sterile environment, the principle is the same as the clean room and clean room.

About sterility: the diameter of bacteria is generally more than 5 microns, and the efficiency that the air filter in the clean room can achieve under the micron particle size, the bacteria are generally attached to the dust, so the use of high-efficiency air filters in the clean room can achieve the purpose of sterility.

Ultraviolet lamp: sterilization by ultraviolet irradiation.

One has bacteria, one has no bacteria.

The clean room is a basic supporting industry with a wide range of application industries, which are used in many industries such as electronic information, semiconductors, optoelectronics, precision manufacturing, medicine and health, biological engineering, aerospace, automobile spraying, etc., and according to the precision and dust-free requirements of the industry, the grade difference is also large.

At present, the highest level is the aerospace aviation warehouse, which basically belongs to level 1, which belongs to a special field and has a relatively small area.

In addition, the higher requirements for the level are biochemical laboratories and high-precision nano material production workshops, and the development of Internet of Things chips will be a major direction of future demand.

With the development of electronic components in the direction of miniaturization, LCD panels have been upgraded to the eighth generation, and the industry demand is very huge.