introduction 　　
As soon as people enter the clean room, the clean room will be changed. People's outer skin constantly releases particles to the surrounding environment. This happens because the outer skin cells are constantly replaced by new cells under them. The friction between clothing and jewelry will increase the number of particles released from the skin. Because there will be more activities when people are working, the number of particles released will increase accordingly。 　　
Man is a pollution generator 　　

Table 27 shows the number of particles released by people in various activities. 　　
Because it is impossible to seal people completely in the micro filter or shape a complete aerodynamic shape, people always have an impact on the surrounding environment. It depends on the work of people in the class 10000 or level 1 clean room. For very critical process steps, we have tried to replace people with automation devices or robots. Although automation devices or robots can reduce particles released to the environment, they cannot be removed completely. Although good buildings and good air supply system will make various production processes have more suitable environment, thus reducing pollution. However, most importantly, pollution control and cleanroom technology are based on highly conscious and highly skilled personnel, and these two people are in clean clothes and work in accordance with the specified procedures. 　　
Table 27 relationship between number of particles released by human body and activity 　　
The number of particles greater than or equal to 0.5 micron per minute generated by the activity content 　　
Sitting, standing still 100000 　　
Sitting posture, head and arm movement 500000 　　
Sitting posture, arm, leg and head movement 1000000 　　
Stand up 2500000 　　
Walk slowly 5000000 　　
Normal walking 7500000 　　
Walk 10000000 at 2.5 meters per second 　　
15000000-30000000 working hours 　　

Table 28 pollution sources and their impact on the environment 　　
Particle size of pollution source (micron) 　　
Friction with painted surfaces 90 　　
Origami 65 　　
Friction epoxy treated surface 40 　　
The ballpoint pen writes on plain paper for 20 minutes 　　
Rubbing skin 4 　　
Activity content (under normal breathing condition) particle size (micron) 　　
Brush clothes 1.5-3 　　
Stomping (without shoe cover) 10-50 　　
Stomp (with shoe cover) 1.5-3 　　
Take a handkerchief from your pocket 3-10 　　
Normal breathing 1 　　
Smokers' breathing (after 20 minutes of smoking) 2-5 　　
Sneezing 5-20 　　
Rubbing hands or face 1-2 　　
4-5 people walking together 1.5-3 　　
Normal walking 1.2-3 　　
Sit in 1-1.2 　　
Clean room area with microfilter 0.01 　　

Table 28 shows the various pollution sources and how these pollution sources improve the particle level of the surrounding environment. In the field of pollution control, cosmetics often cause problems. Therefore, cosmetics are generally not allowed in clean rooms. Table 29 shows the number of particles produced when using various cosmetics for full make-up. 　　
smoke 　　
Smoking is prohibited in controlled clean areas and clean rooms. Even after the cessation of smoking, particles will still remain in the trachea and lungs, constantly from the body to the surrounding air. This actually means that smokers are a powerful particle generator. Some companies prohibit smoking for 20 minutes before returning to the clean area. Some companies don't有时间上的规定，但禁止在洁净室吸烟。 　　
Some companies in the United States believe that a smoker drinking a glass of water after smoking can reduce the number of particles exhaled to the clean room area. That sounds strange. After 12 hours of smoking, according to the medical report, the smoker still produces a cigarette. 　　
Requirements of quality management standard for drug production on personnel 　　
Drug production quality management specifications contain specifications and requirements on the number of personnel and personnel health. Only a limited number of people are allowed to be present in the workshop at one time. This is particularly important in aseptic production. Process control and visual inspection should be carried out outside the clean room as far as possible. Construction workers, service personnel and other external personnel who do not have the professional knowledge of clean room rules and are not directly engaged in clean room technology should briefly and comprehensively explain the precautions of clean room before entering the clean room. If visitors visit, they should be accompanied by an employee who is familiar with the hygiene regulations of the clean room. 　　
All personnel, including cleaning and maintenance personnel, should be regularly trained. These trainings should also be conducted in the areas related to the production process. The training content for employees engaged in aseptic product production should also include hygiene requirements and basic knowledge of microbiology. 　　
Education, training and management 　　
The staff in the clean room must clearly understand the steps they need to follow and the activities they should not carry out. A complete training plan should include the following contents: 　　
Basic knowledge of cleanliness and hygiene. 　　
Special training for certain process steps. 　　
Employees should consciously do a good job. 　　
The training staff should know what inappropriate activities are and try to avoid them. Personnel should wear appropriate work clothes. And fully understand how to wear special clean clothes. 　　
Personnel should be equipped with appropriate tools to carry out the work. 　　
The whole environment should be built and maintained so that people can enjoy working in it. 　　
Cleaner production workers should be aware that due to the nature of their work, their private lives will be restricted, such as not smoking, drinking or eating at work. 　　

rules 　　
All staff in the cleanroom, regardless of their background and level of training, must comply with specific codes. With the help of technicians, the code can be written to ensure that all personnel understand and follow it. 　　
Why such specific regulations and codes should be observed, as well as the consequences of not strictly abiding by the codes, must be explained. All rules and regulations must be consistent with each other, and all members of the unit must abide by them without exception. 　　
The basic issues mentioned above are very important. Because the clean room is different from the general working environment, it is impossible to monitor all the activities of the indoor staff. It is for this reason that people working in the clean room have a greater responsibility to understand, accept and implement the regulations related to the working procedures of the clean room than people working in other environments. 　　

People and technology 　　
One of the main requirements of the clean room is to keep the staff away from the process they are engaged in. This requirement can be met by isolating the process and supplying air separately so as to blow away the pollutants in the key process parts. 　　
Therefore, only when the operation of the system needs to be corrected for some reason, can someone be needed in the key area, such as when ampoules or vials fall off the filling line, or when some parameters need to be adjusted. 　　
In this way, well-designed tools and appliances are the prerequisite to minimize human intervention. Assembly work and other production work are the key steps in the process. If they can be done according to the requirements of the code, the risk of pollution can be reduced. In other words, a high-speed and good process requires minimal intervention. This is the goal of all manufacturers. 　　
The activities of service and maintenance personnel will also reduce the cleanliness of the cleanroom. There are two ways to overcome this problem, and all items to be repaired are placed in the service area of the clean room; if the equipment cannot be removed from the clean room, it is necessary to maintain the maintenance in the clean room, but keep the maintenance work to the minimum. Service personnel entering the cleanroom, especially those who step by step from outside the clean area, should be trained in the correct steps to minimize pollution. The air flow mode and process steps produce various pollutants which spread out, which will affect the result of process production. Good arrangement of logistics and human flow in and out of the clean room can ensure the correct implementation of the established steps. To determine whether the various methods are correct, the air flow movement can be observed with naked eyes and hazard analysis can be done. The air flow movement can be observed by smoke, and it is usually observed at the simulated condition and punctuality. The method of hazard analysis is very effective because it is sensitive to both particle pollution and microbial pollution. 　　
In order to ensure the effective interaction among personnel, production process and clean room, we need not only well-trained personnel, logistics records of clean room, but also spacious storage area, wide placement, orderly storage area of clean equipment, spacious airlock and changing room。 　　
Clean room work guide 　　
The following is the clean room and clean area work guide: 　　
Keep hands, nails and face clean. Personnel hygiene is extremely important. 　　
Carefully select well-designed clothing system. The clothing system for clean production is composed of different parts. Such a garment system must be complete and worn in the right way to ensure its overall protective performance. 　　
The glasses must be cleaned and disinfected before entering the clean room. But the routine cleaning of glasses is easy to forget. 　　
Try to keep the parts and tools clean. 　　
Work can only be done on clean surfaces. 　　
No smoking or snuff. Smokers or snuffers emit millions more particles into the air than nonsmokers. 　　
No smoking or snuff. Smokers or snuffers emit millions more particles into the air than nonsmokers. 　　
Cosmetics are not generally allowed in clean rooms. All cosmetics have particles attached to the skin. If you talk, cough, sneeze, touch an object (such as a mask), these particles fall off the skin and are at risk of becoming pollutants. 　　
Ban the use of nail polish. Nail polish is usually harder than nails, so after a period of time, nail polish will crack. Dust and microbes can hide in it and spread everywhere. 　　
Jewelry and watches are not allowed in the clean room. Because they are difficult to clean and can be a source of infection or contamination. 　　
No eating, drinking, chewing gum or candy in the clean room. 　　
It is not allowed to carry the clean clothes around, and the personnel shall not touch or turn over the clean clothes. Otherwise, hands or gloves will pollute the clean clothes. Even if the clean clothes are moved, the particles received in the clothes will spread to the surrounding environment. 　　
Avoid all unnecessary activities. Increasing body activity increases the amount of particles emitted from the body surface. Unnecessary activities of personnel will make the surrounding air eddy. It is suggested that slow motion be used in production. 　　

Personnel hygiene 　　
It is not too important to emphasize the importance of staff hygiene in a highly clean environment. However, the provisions and suggestions on personnel health are not always well understood, although some are very basic rules. The most direct correlation with pollution diffusion is the handling of materials and components, etc., so hand washing must be carried out frequently. Especially after coughing, sneezing, going to the toilet, smoking (including using snuff), and returning to work after rest, wash your hands. Hands should also be thoroughly cleaned after they are exposed to contaminated materials and animals. According to specific cleaning requirements, in some cases, hand washing is also required after using the telephone and computer. It's all good practice. 　　
The health requirements for the personnel related to the quality management of drug production can be summarized as follows: 　　
Each person should be responsible for his own personal hygiene. 　　
Personal hygiene education and training should be carried out for all personnel related to drug production management. 　　
Personnel is one of the main pollution sources in clean production area. 　　
The epidermal cells shed from the human body are "dead" particles, but they are often stained with bacteria and other microorganisms, so personnel should avoid contacting equipment and products. 　　
In addition to regular bath or shower, shampoo should be carried out regularly. From the perspective of health, shower is more advocated. 　　
All hair, including beard, should be covered with hair protector. 　　
The hand is a major source of pollution, and it is one of the main culprits in transferring pollutants from one place to another. Therefore, special attention should be paid to hand hygiene, especially nails, nail roots and hand injuries. 　　
Mouth is also a major source of pollution, so good oral hygiene is important. In the clean room, the shouting or speaking voice should be avoided as much as possible; coughing and sneezing should be avoided as much as possible. If it is impossible to avoid, avoid the working area. 　　
Personnel working in highly clean areas should be in good health. 　　

Human related pollution risks 　　
The following human related pollution risks will have an impact on the clean room environment: 　　

Personnel selection 　　
Personnel education and training 　　
Safety requirements of clean room 　　
Human behavior and human health 　　
Health status of personnel 　　
Who should be in the clean room 　　
Status of maximum occupancy (maximum number of personnel allowed) 　　
Rules of access 　　
Passage for people flow in and out of clean room 　　

conclusion 　　
It is self-evident that clean room work requires good personnel hygiene. It is also clear that appropriate clean clothes must be worn for different jobs in the clean room. 　　
These requirements for hygiene apply not only to those working in the clean room, but also to all those entering the clean area. In order to protect the clean area, it is necessary to let all kinds of visitors understand the current regulations and abide by the regulations that the general staff of the clean room should abide by as usual.