A clean area refers to an area in the fields of production and manufacturing where a certain degree of air cleanliness and microbial cleanliness needs to be maintained. In order to ensure product quality and safety, the environment and operation of the clean area must be strictly controlled. The following are the four principles of clean area control.
Principle of air quality control
Air quality is one of the main factors affecting microbial contamination in clean areas. Therefore, when building and operating clean areas, effective measures must be taken to control air quality.
Air filtration: Filter the air entering the clean area through high-efficiency filters to remove most harmful particles and microorganisms.
air flow: Through the reasonable design of the Ventilation system and the layout of equipment, the air flows evenly in the clean area and avoids dead corners.
Air pressure difference: Maintain the indoor and outdoor pressure difference by setting positive or negative pressure to prevent external pollutants from entering the clean area.
Principle of personnel behavior control
Personnel is one of the main exogenous pollution sources, so the behavior of personnel must be strictly controlled.
Personnel training: Provide professional training for personnel entering the clean area to make them understand the control requirements and operating procedures of the clean area.
Personnel clothing: Personnel entering the clean area must wear protective clothing and shoe covers that meet the requirements to avoid bringing in external pollutants.
Code of conduct: Personnel entering the clean area must abide by the operating procedures and strictly implement the work procedures to avoid cross-contamination.
Equipment management and control principles
Equipment is one of the most important tools in the production process. While ensuring production efficiency, it is also an important factor affecting product quality and safety. Therefore, equipment must be effectively managed and controlled in the clean area.
Equipment cleaning and disinfection: Clean and disinfect the equipment before and after use to avoid residual microorganisms such as bacteria and viruses.
Equipment maintenance: Regularly inspect, maintain and maintain the equipment to ensure its normal operation, and replace damaged or aging parts in time.
Equipment layout planning: Arrange the equipment location reasonably to avoid cross-contamination between equipment, and facilitate cleaning and disinfection.
Material management and control principles
Material is an indispensable part of the production process, but it is also an important factor affecting product quality and safety. Therefore, materials must be effectively managed and controlled in the clean area.
Material in and out control: strictly check the materials entering the clean area to avoid bringing in external contaminants, and trace the materials out of the warehouse.
Material storage management: classify, partition, and label the materials stored in the clean area to avoid cross contamination.
Material use specifications: standardize the management of the materials used to ensure that they meet the requirements and avoid bringing in external contaminants.
The above are the four principles of clean area control. In actual operation, they need to be refined and improved according to specific circumstances. Only by strictly implementing these principles and continuously strengthening monitoring and improvement work can we ensure that the environment and operations in the clean area meet the requirements and ultimately achieve the goal of ensuring product quality and safety.