1 air conditioning purification system
The control of clean room is mainly around the control of dust production and effective dust discharge, which is the essence of comprehensive control of clean room. The environment of clean room is not single, including wall materials, clean room structure, water system, air conditioning purification system and so on. The air conditioning purification system has been verified and can meet the requirements of clean room cleanliness under general working conditions. There are two kinds of pollution caused by air conditioning system: one is the pollution formed objectively during operation, and the other is the control factor is not up to standard.
1. 1 Pollution caused by system operation:
Because the system will generate moisture (or high humidity) and dust particles will accumulate in some places during operation, which may cause the growth of microorganisms. The filter can not completely prevent microbial metabolites from entering the room, and the particle size of microbial metabolites is very small, so it is easier to enter the room through the filter, so the cleanliness of the clean room drops rapidly. At the same time, we must pay attention to the fact that the disinfection effect is not sustainable in the disinfection process, which is easy to cause secondary pollution. Long-term use of disinfectants will make microorganisms resistant to drugs, so at least two methods should be combined in disinfection selection. In order to avoid the problem of dust retention, do not choose soft joints and hoses in the selection of joints and pipes, and regularly clean the system components in the air conditioner to avoid moisture, particles and local high humidity.
1.2 control factor:
The air conditioning system has an influence on the humidity, air pressure, temperature, noise and illumination of the clean room, and these elements are clearly required in GMP. How can we meet this requirement? The requirement of cleanliness can be achieved by controlling the number of air changes, suspended particles and positive pressure.
When the number of air changes in the clean room is unreasonable, the cleanliness of the clean room can not be guaranteed, and at the same time, it will cause higher costs. The number of air changes in the clean room is related to the indoor heat balance calculation data. Generally, the air exchange rate of Class C must be kept above 25 times per hour, and that of Class D should be above 15 times per hour.
2 an important source of pollution-people
Human activities will bring a lot of pollutants into the room, and people will also bring some pollutants into the clean room. According to the analysis of the test results, it is concluded that about 80% of the pollution in the clean room comes from workers, and the movement of workers leads to a significant increase in dust and a significant decrease in cleanliness, which proves that people are the main cause of clean room pollution. Producers are always in direct or indirect contact with drugs, and if they carry pollution and dust, the quality of drugs will decline. Human pollution mainly comes from two aspects: one is the health of the producers themselves, and the other is the personal hygiene habits. Therefore, it is necessary to strictly manage and supervise the production personnel.
2. 1 Establishment of health records:
When recruiting employees, pharmaceutical companies must carry out strict physical examination on employees to understand their health status. Clean room staff and producers should have a regular physical examination at least once a year, and those who fail should be transferred from their posts immediately. The establishment of health records is helpful to track and monitor the health status of employees in real time and facilitate timely control.
2.2 Maintain good personal hygiene habits:
Pharmaceutical workers should have good living habits and hygiene habits, wash their hands and bathe frequently to ensure the cleanliness of their hands and other parts of the body. Before entering the clean room, the production personnel must change their clothes (they must wear protective clothing made of antistatic materials), use corresponding facilities to clean their bodies, and completely cover their nose, mouth and head when producing drugs. This not only ensures that operators are not affected by adverse factors in the production environment, but also prevents people from affecting drugs.
2.3 quantity control:
There shouldn't be too many people in the clean room. Although people have to go through some treatment before entering the clean room, some walking and operation in the operation process will still bring some dust. When there are too many people (things) in the clean room, the cleanliness of the clean room will not be able to send away the dust, and the cleanliness will decline at this time. GMP stipulates that microbial particles and dust particles must be monitored regularly, and the monitoring results must be recorded and archived. If the data difference is too large in a short time in the production process, it means that the clean room can't bear such a large amount of people (things).
2.4 working procedures:
When pharmaceutical companies do not provide adequate health training for employees, the cleanliness of clean rooms will be greatly reduced. GMP practice shows that a lot of pollution comes from employees' incorrect hygiene habits and neglect of hygiene laws and regulations. The staff in the clean room should move as slowly as possible, and it is forbidden to make loud noises and bring food or other irrelevant items into the clean room. Workers are not allowed to work when they are sick. Sneezing and coughing can also increase dust particles and microorganisms in the surrounding air. In addition to the above procedures, pharmaceutical companies can formulate procedures according to actual conditions.
3 control production materials
Production facilities also affect the cleanliness of the clean room, so production facilities should be considered when designing and installing, and equipment should be cleaned regularly in daily use.
3. 1 material purification:
The materials entering the clean room must be cleaned of particles and microorganisms on the surface before being sent to the clean room, so the design of the material cleaning room must include the clean room, the transfer window or the air lock room. After removing the outer packaging, put the materials in a clean container for later use. Before entering the clean room, the materials must pass through the airlock room or the transfer window, and the materials in the sterilization room should be sterilized. It must be noted that the transmission window should be equipped with a device to block the penetration of air flow to ensure cleanliness. The conveyor belt can only be transported in sections on both sides of the transmission window, and it must be transported from the area with high cleanliness level to the area with low cleanliness level.
3.2 material channel:
The purification path of materials should be separated from the purification path of people, and the logistics personnel should also be separated from the flow of people, so as not to cross back and forth and avoid passing through the operation area. A comprehensive workshop can be equipped with multiple inlets, but they cannot affect each other. The doors on the production site should be opened as little as possible to ensure the air tightness and cleanliness of the operation room. In addition, the operation area should not be used as a transfer channel for materials.
As the person in charge of the clean room project of pharmaceutical factory in South China, you can ask Ai Wuchen for more details.