Daily Maintenance and Operation Management of Clean Room
In order to maintain the cleanliness of clean indoor air, relevant maintenance regulations must be strictly implemented to prevent the generation, detention and reproduction of dust particles and microorganisms in clean rooms and to ensure the safety of equipment and personnel.
I. Management of Entry and Exit Clean Room
_Personnel entering the clean room should strictly enforce the personal purification system, route and order.
Preface. When leaving the clean room, it must follow the above order and route, and no clean articles are allowed to be brought with it.
Lobby.
If there is a shower room, it must be blown according to the regulations before entering the clean room. At the same time, in strict accordance with the specifications and use requirements of the air shower room, control the number of people entering the air shower room each time, and do not allow forced closure of the running fan or power supply in the air shower room. Generally, the number of dust particles emitted from the surface of the human body decreases by 40-60%.
_For the purpose of not disturbing the clean air flow pattern in the room, no articles should be placed on the upper side of the working area, and no piles should be placed near the return air outlet; no clogging and stacking of articles should be carried out under the air supply orifice plate, and the production operation should be carried out on the clean workbench or upstream of the air flow.
_It is not allowed to bring into the clean room articles which are not related to production and which are easy to produce dust.
Smoking, diet and unproductive activities are strictly prohibited in clean rooms.
Before entering the clean room, personal belongings should be put in the designated cabinet, make-up and jewelry removed, and the designated clean clothes and shoes should be replaced.
When wearing a hat, you should cover all your hair, and the shoe cover should tightly wrap the bottom of your pants around the shoe cover.
_When taking off clean work clothes, we should avoid the work clothes touching the ground, tables and other items. Generally, we should take off the work clothes from bottom to top, and store them in cabinets or hang them in prescribed places.
_When leaving the clean room, it is not allowed to take off the clean work clothes before the changing area; if you take off the work clothes and enter the clean room again, it still needs to proceed in the prescribed order of entering the clean room.

When leaving the clean room, you can enter the replacement area without air shower.

II. Management of Operators in Clean Room
_Hand is the medium of cross-contamination. Operators should wash their hands when entering the clean room. They should not touch high-purified products and packaging materials with their hands. They should also disinfect the pharmaceutical production workers.
The following persons are not allowed to enter the cleanroom: Patients with cold, cough, eczema and other diseases; the cosmetics, nail polish and unclean work clothes are not removed according to the regulations; operators should wash their hair frequently, change clothes and cut nails.
_When working in a clean room, the workers should be light in action, strictly implement the operation procedures, do not make large-scale dusty movements, do not drag along, do not do unnecessary actions, and do not allow wearing clean work clothes to go to the toilet.
In clean rooms, gloves should be worn as required, and wrists should not be exposed. Gloves should be replaced frequently.
_Relevant training and education should be carried out for the personnel entering the clean room: mastering the general knowledge of the characteristics, structure and cleaning technology of the clean room, the requirements of personnel purification procedures and material purification routes, the use and cleaning requirements of clean work clothes, the cleaning, cleaning and disinfection of the clean room, the safety facilities and safety management regulations of the clean room. Fixed.
_Clean work clothes should be made of clothes with less dust production and antistatic properties. Generally, they are divided into 1-100,000 grade clean rooms and 100-1000 grade connected ones. Clean shoe covers should be disposable. Clean shoes should be washable. Generally speaking, the number of particles emitted from the surface of people wearing clean clothes is 40-60 times less than that of people wearing ordinary clothes, so this point is very important for the maintenance and management of high-cleanliness workshop.
_Clean work clothes should be managed by special personnel, checked regularly and cleaned. Usually cleaning once a week, usually 50 to 100 times after cleaning should be checked to determine whether scrap.
8. The operation of "5S" in clean rooms should ensure timeliness and continuity, and the localization management should be carried out by field managers.
9. As the production place of pharmaceutical enterprises, clean rooms have strict regulations and requirements for the environment and personnel. Environmental on-line monitoring system (EMS) can be used to strictly manage and control the environment of clean areas, and personnel can control and manage the environment through management systems and norms. However, to a certain extent, there are management gaps in the operation behavior of personnel, operation status of equipment and production operation process in the clean area. As a management area with high requirements of environment and human flow, the clean area is essentially different from other management areas of pharmaceutical enterprises. It is impossible to control the above three processes on the spot. It is an inevitable choice to realize the management mode of remote off-site supervision in the clean area. Long-distance off-site supervision of clean areas can be achieved through multi-point and fixed-point arrangement of embedded dedicated cameras in clean areas. Embedded special camera for clean area is a special camera for real-time monitoring of important equipment/key positions in clean area and clean room. The design style of the pure flat panel of the camera adopts the installation method of embedded color steel plate. After installation, the panel of the camera is flat with the wall of the color steel plate. It realizes zero hygienic dead angle of the camera in the clean area, which is clean and convenient. At the same time, it realizes the cleaning of the camera while cleaning the wall. The camera uses standard POE power supply mode, which can be controlled quickly and multi-point, and compatible with mainstream video system. Because of these incomparable advantages of embedded camera in clean area, it has been widely used in pharmaceutical enterprises.
3. Cleaning and sterilization of clean rooms.
1. Cleaning of the clean room is usually done after the end of the production process; if it is necessary to clean before production, the process production must be started after the clean requirements of the clean air conditioning system are met during the start-up and operation time. In order to prevent cross-contamination, cleaning facilities should be dedicated to different product characteristics, process requirements and cleanliness levels.
Cleaning tools generally use centralized fixed and portable portable vacuum cleaning equipment. If you do not meet the above requirements, you can also use non-fiber materials such as mercerized towels, nylon cloth for wiping, usually once or several times a day.
Workbenches and tools are usually cleaned once a day; walls and floors are cleaned once a week and once a month in grades 10,000 to 100,000. Cleaning air conditioning system should be cleaned 1 to 2 times a year and entrusted to special cleaning personnel.
2. Sterilization of clean rooms
For the biological clean room, besides controlling the number of biological or abiotic particles in the air into the clean room, disinfection treatment should also be carried out on the surfaces of indoor appliances, floor, wall and wall panels. Air cleaning technology can not kill bacteria. Sterilization and sterilization measures must be taken in the operation and management of biological cleanroom to reduce the survival and multiplication of microorganisms in the cleanroom.
At present, the traditional sterilization methods are ultraviolet sterilization, pharmaceutical sterilization, heating sterilization and ozone sterilization. They are safe and reliable, and are most widely used.
In addition, the whole disinfected and sterilized clean room should form a circulating state through the return air duct, and start air sterilization for 1-1.5 hours every day; if it needs to sterilize and sterilize the walls, floors and equipment of the clean room, it will take about 2 hours.
IV. Equipment Management
1. Anti-pollution management of process equipment
Production process equipment in the production process, or operation errors will cause an increase in indoor dust. In view of the situation of these pollution sources, it is necessary to formulate corresponding management measures and necessary countermeasures, so it is necessary to strictly implement the management system of process and equipment.
2. Air conditioning system is the main equipment to ensure indoor air cleanliness level, including all kinds of filters, clean workbench, laminar flow hood, air shower room, transfer window.
Management of office facilities
According to the need of clean room maintenance, do well in daily maintenance, regular inspection, testing and certification of water, electricity and gas supply system, communication and safety alarm devices.
VI. Management of Equipment and Personal Safety
Record the operation status and relevant parameters of all kinds of equipment according to the regulations, record and analyze the regular inspection, maintenance and cleaning status, pay special attention to the regular inspection of rotating parts, communication and safety alarm devices and automatic devices in good condition.
Regular inspection and calibration of various testing, measuring instruments and instruments to ensure the accuracy and reliability of measurement control. Operators should strictly implement relevant management requirements and regulations to ensure the safety of operators.