Clean room characteristics
1. The clean room is a space where the cleanliness of the air reaches a certain level for human activities and production. Its function is to control the pollution of particles. This shows that the cleanliness of the clean room is not generally clean, but achieves a certain level of air cleanliness. In China's pharmaceutical industry, the lowest level is 300,000, and the purification workshop must have the ability to control particulate pollution and resist external interference.
2, clean room is a multi-functional comprehensive break, multi-function is reflected in the following two aspects:
(1) Multi-professional - construction, air conditioning, purification, pure water, pure gas.
(2) Multiple parameters - air cleanliness, bacterial concentration, and air volume (air volume), pressure (pressure), sound (noise), light (illuminance).
3. For the quality of the clean room, in terms of importance, design, construction and operation management each account for 1/3, which means that the clean room itself reflects its quality through the whole process from design to management. This is also in line with the spirit of the GMP control process.
Monitoring of 100,000 class clean room
1. The monitoring of the clean room system is mainly the filter replacement cycle, and the clean room has strict regulations on the environment humidity, temperature, fresh air volume, status, illumination, etc., to ensure the production quality and personnel of the product. The working environment is comfortable.
2. The whole clean room system is equipped with a three-stage air purification system using primary, medium and high efficiency filters to control the number of dust particles in the clean area. As a high-efficiency filter for the end filter unit, the operation of the entire purification system is determined. The clean room decoration is therefore very important for the replacement time of the high-efficiency filter.
3. In the decoration of the clean room, whether it is a large air volume high efficiency air filter installed at the end of the clean air conditioning unit or a high efficiency air filter installed at the high efficiency air supply port, these must have accurate running time record and cleanliness. The air volume is used as a basis for replacement. For normal use, the service life of the high efficiency filter can be as long as one year or more. If the front-end protection of a good high-efficiency filter can last for more than two years, of course, this depends on the quality of the high-efficiency filter, such as a high-efficiency air filter installed in the purification equipment, such as automatic wind. The high-efficiency filter inside the shower room, if the front end is well protected, has a service life of more than three years.
Purification workshop renovation requirements
1. For the building envelope area and interior decoration of the industrial purification workshop, materials with good air tightness and small deformation under the influence of temperature and humidity changes should be selected. The surface of the walls and ceilings in the purification workshop should be smooth, smooth, crack-free, tightly interfaced, and free of particles.
2. For the building envelope area and interior decoration of the industrial purification workshop, materials with good air tightness and small deformation under the influence of temperature and humidity changes should be selected.
3. The surface of the wall and ceiling of the purification workshop should be smooth, smooth, no cracks, tight interface, no particulate matter falling off, and should be resistant to cleaning and acid and alkali resistance. The wall and the ground and ceiling joints should be curved, and the kicking feet should not be suitable. Above the wall, when using lightweight materials to break, anti-collision measures should be taken.
4. The floor of the purification workshop should be good in integrity, smooth, wear-resistant, impact-resistant, not easy to accumulate static electricity, easy to dust and clean, the floor cushion should be reinforced, and the wet area should be treated with moisture.
5. When the technical interlayer is a light ceiling, set up the inspection passage. The interior surface decoration standards of the building air duct and the return air trench should be compatible with the entire air return air system and easy to remove dust.
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