The production environment can affect the medicine to a certain extent. In order to ensure drug safety, the environmental requirements of pharmaceutical companies are becoming higher and higher. Clean room as a basis for pollution control, to remove particle, the spatial range of the air of harmful air, bacteria and other pollutants, and the indoor temperature, cleanliness, chamber pressure, gas flow rate and air distribution, noise, vibration and lighting, electrostatic control in a certain range of needs.
However, clean rooms need to achieve a good clean effect, not only to adopt reasonable air conditioning cleaning measures, but also have a standardized design, and its proper use and scientific maintenance management. Cleanliness and the continuous stability of pollution control are the core criteria for testing the quality of the cleanroom. The standard will be divided into several grades according to the regional environment, purification degree and other factors. The commonly used standards are international standards and domestic regional industry standards. In order to meet the grade standard, the clean room should have the following four requirements.
First of all, the air supply cleanliness. In terms of air supply cleanliness, the key to achieving the requirements is the performance and installation of the final filter of the purification system. The final filter of the purification system usually uses HEPA filter or sub HEPA filter. Therefore, we should consider the cleanliness requirements, with low levels of clean room with low performance filter, high level cleanroom with high performance filter principle.
However, to select the right filter, consider the characteristics of the clean room, the filter characteristics and the characteristics of the cleaning system. To ensure air supply cleanliness, only qualified filter is not enough, but also to ensure that the transport, installation process does not damage the filter, to ensure strict installation.
Followed by airflow. The air distribution in a clean room is different from that in a general air-conditioned room. It requires the most clean air to be sent to the operating area first. Its function is to limit and reduce the pollution to the processed products. For this reason, the following principles should be considered in the design of air distribution.
First of all, to reduce the eddy current, avoid working outside the area pollution into the work area; secondly, to prevent dust flying two times to reduce dust pollution on the chance of the workpiece; finally, the airflow work area to uniform, and the wind speed to meet the technical and health requirements, when the gas flows to return air flow to make the dust in the air can be effectively removed. According to the different cleanliness requirements, choose different ways of air supply and return.
Then there is the air supply or the wind speed. Sufficient ventilation is needed to dilute and eliminate indoor air pollution. According to the different requirements of the cleanliness of clean room, when the height is high, can increase the number of appropriate. Among them, the ventilation rate of the 1 million clean room is considered by the high efficiency cleaning system, and the rest is considered by the high efficiency cleaning system. When the HEPA filter is arranged at the end of the computer room or the end of the system in the 100 thousand stage clean room, the ventilation rate can be increased by 10-20% when the sub HEPA filter is used.
Finally, the static pressure difference. Maintaining a certain positive pressure in a clean room is one of the essential conditions to keep it from contamination or to maintain the cleanliness level of the design. Even if the negative pressure clean room, but also must not have less than its cleanliness level adjacent rooms or suites to maintain a certain positive pressure, negative pressure clean room cleanliness can be maintained.
It is reported that the air volume required for maintaining the positive pressure of the clean room is determined mainly according to the tightness of the maintenance structure. The design code of our country stipulates that the static pressure difference between the clean rooms of different grades and the clean and non clean areas shall be no less than 0.5mmH2O (~5Pa), and that the static pressure difference between the clean area and the outside should be no less than 1.OmmH20 (~l0Pa).
In addition to meeting the standards, you should pay attention to the following points when using clean rooms. The operator should have dress standards, to meet the health requirements; regular cleaning and fire control work; regular replacement disinfectant resistance to anti microbial; to ensure the safety of the door must be able to open, secure channel from accumulation of debris, fire safety equipment should always check. To maintain good operating habits and maintenance habits in order to clean the room will play the best role and effect.