Clean room daily maintenance and operation management

In order to maintain clean indoor air cleanliness, relevant maintenance regulations must be strictly implemented to prevent the generation, retention, and reproduction of dust particles and microorganisms in the clean room, and to ensure the safety of equipment and personnel.
First, the management of entering and leaving the clean room
1. Personnel entering the clean room should strictly implement the personal purification system, route and sequence. When exiting the clean room, it must be carried out in the above order and route. It is not allowed to take the cleaning products out of the hall.
2. If there is a shower room, it must be blown as required before entering the clean room. At the same time, in strict accordance with the specifications and usage requirements of the air shower, the number of people entering the air shower chamber every time is controlled, and it is not allowed to forcibly shut down the running fan or power supply in the air shower room. Generally, after passing through the air, the number of dust particles emitted from the human body is reduced by 40-60%.
3. In order not to interfere with the clean airflow type in the room, no objects should be placed on the upstream side of the work area, and no objects should be stacked near the return air outlet; the air supply plate should not be blocked and stacked under the air supply plate, and the production operation should be on the clean workbench or airflow. Go upstream.
4. Items that are not related to production and are prone to dust are not allowed to be brought into the clean room.
5. It is strictly forbidden to smoke, eat and carry out non-productive activities in the clean room.
6. Before entering the clean room, personal items must be placed in the designated cabinet, remove makeup and jewelry, and put on the designated clean clothes and shoes.
7. When wearing a cap, cover all the hair, and the shoe cover should be tightly wrapped around the shoe cover.
8. When removing the work clothes, avoid the work clothes touching the ground, tables and other items. Generally, take off the work clothes from the bottom to the top, and store them in the cabinet or hang in the prescribed space.
9. When exiting the clean room, do not take off the clean overalls before the dressing area; if you go into the clean room after removing the overalls, you still need to follow the order of entering the clean room.
10. When exiting the clean room, you can enter the replacement area without blowing through the air.
Second, the clean room operator management
1. The hand is a medium of cross-contamination. When the operator enters the clean room, he needs to wash his hands. Do not touch the high-purification products and high-purification packaging materials by hand; the pharmaceutical production workers need to be disinfected.
2, the following personnel are not allowed to enter the clean room: patients with colds, coughs, eczema and other diseases; cosmetics, nail polish and clean clothes are not washed according to the regulations; workers should wash their hair, change clothes and cut nails frequently.
3. When the operator is working in the clean room, the action should be light, strictly follow the operating procedures, do not make a large movement that is easy to dust, do not drag enough to walk, do not perform unnecessary movements; do not wear clean overalls to go to the toilet.
4, in the clean room, wear gloves as required, do not reveal the wrist, gloves should be replaced frequently.
5. Relevant training and education should be carried out for personnel entering the clean room: master the characteristics of the clean room, general knowledge of the clean technology, personnel purification procedures and material purification route requirements, clean work clothes use, cleaning requirements, clean room cleaning, cleaning And disinfection, clean room safety facilities and safety management regulations.
6, clean overalls should be selected to produce less dust, but also anti-static clothing production, generally 1 to 100,000 clean room with split type, 100 to 1000 with a connected type. The clean shoe cover is easy to use, and the clean shoes are washable. Generally, when wearing clean clothes, the number of particles emitted on the surface is 40-60 times smaller than that of ordinary clothes, so this point is very important for the maintenance and management of high-cleanliness workshops.
7, clean overalls should be managed by a special person, regular inspection, cleaning. It is usually cleaned once a week. After cleaning for 50 to 100 times, it should be checked to determine whether it is scrapped.
8. The [5S" operation in the clean room needs to ensure the continuity and continuity, and the on-site management personnel perform regionalized positioning management.
Third, clean room cleaning and sterilization .
Cleaning of the clean room is generally carried out after the end of the production process; if it is necessary to clean before production, the process must be started after the clean-up air-conditioning system has been cleaned up. In order to prevent cross-contamination, cleaning and cleaning plant facilities should be dedicated to product characteristics, process requirements, and cleanliness levels. Cleaning tools generally use centralized fixed and portable mobile vacuum cleaning equipment. If the above conditions are not met, it can also be wiped with a fiber-free material such as a silk scarf or a nylon cloth, usually once or several times a day. The workbench and tools are generally cleaned once a day; the walls and floors of the 10~1000-level factory are cleaned, usually once a week, once a month from 10,000 to 100,000. The air-conditioning system should be cleaned 1 or 2 times a year and commissioned by special cleaning personnel.
In addition, the entire cleaned and sterilized clean room should be returned to the air duct to form a circulating state, and air-sterilized for 1 to 1.5 hours every day; if it is necessary to disinfect the surface of the clean room wall, the ground and equipment, etc. About 2 hours.
Fourth, equipment management
1. Anti-pollution management of process equipment Production process equipment in the production process, or operational errors will cause an increase in indoor dust generation; for the situation of these pollution sources, it is necessary to develop corresponding management measures and necessary countermeasures, so strictly implement the process And the management system of equipment is very necessary.
2. The air conditioning system device is the main equipment to ensure the indoor air cleanliness level, including various filters, clean workbench, laminar flow hood, air shower, transfer window, air conditioning device, etc. Their normal maintenance and regular inspection are ensured. Important conditions for clean room cleanliness. The specific requirements are as follows:

5. The air in the clean room (1) and the air in the clean room shall be monitored in accordance with the provisions of Schedule 2.
Air monitoring frequency of clean room Schedule 2

(2) When the high-efficiency vacuum cleaner is used for cleaning in the Clean Workshop, the dust concentration of the vacuum cleaner exhaust port must be checked regularly.
(3) The following are the main equipment maintenance
1. High efficiency filter replacement conditions
1) The gas flow rate drops to the low limit of Zui, and the airflow speed cannot be increased even after replacing the primary effect and medium efficiency air filter.
2) The resistance of the high efficiency filter is twice the initial resistance.
3) The high-efficiency filter has an unrepairable leak.
4) It is recommended to change once a year
2. Check and clean the medium efficiency filter.
Each bellows is equipped with a bag-type medium-efficiency filter net, which is used to further filter and remove dust from fresh air and return air. It is recommended to check and replace it every 3 months, or be careful when adding or reducing inspection or replacement frequency according to the situation. The filter bag is punctured and the frame is bumped and deformed to avoid affecting the filtering effect.
3. Primary filter check and cleaning.
Each air-conditioning unit is provided with a primary effect filter near the entrance of its new air duct, which is mainly used to prevent dust and mosquitoes brought in by fresh air from entering the air-conditioning air system. Therefore, it is necessary to inspect and replace it. It is recommended to check and replace it every 45 days, or increase or decrease the frequency of inspection and replacement as appropriate.
4. The regulating valve is installed on the air supply pipe and the return air pipe of each air conditioning unit. In order to ensure its safety and reliability, it should be inspected according to relevant national regulations.
5. In order to ensure the accuracy of the temperature inside the plant, the daily operation personnel should regularly check the air conditioning unit to determine whether the unit is operating normally and whether there is abnormal noise.
Sixth, the use of wind, cargo shower room management and operation instructions
wind \ cargo shower room is the necessary passage for personnel to enter and exit the clean room, and at the same time play the role of air lock chamber sealed clean room, is to carry out personnel dust removal And effective equipment to prevent outdoor air pollution from the clean room. "
`: In order to reduce the large amount of dust particles caused by personnel entering and leaving, the clean airflow filtered by the high-efficiency filter is sprayed from all directions to the human body by the rotatable nozzle, effectively and quickly removing the dust particles, and the dust particles after the removal are further The initial and high-efficiency filters are filtered and recirculated to the wind and cargo areas.
Use of the wind/cargo shower:
(1) Personnel entering the barrier environment should remove the outerwear in the outer locker room and remove the watches, mobile phones, accessories and other items.
(2) Enter the inner locker room and wear a hood, hat, mask, and gloves.
(3) Immediately after the personnel enters, the outer door is closed, and the wind/cargo is automatically started for 1 minute (set).
(4) Wind/ cargo is over and enters the barrier environment.
Air shower management:
(1) The air shower is managed by the responsible person, and the primary filter is replaced regularly every quarter.
(2) Replace the high-efficiency filter material of the air shower every 2 years.
(3) It should be lightly opened and closed to the indoor and outdoor doors.
(4) When the air shower room fails, it should be reported to the professional maintenance personnel for repair. Under normal circumstances, the manual button is not allowed to start.
Suggest:
1. In the process of wind and cargo dripping, please lift the body 360 degrees with both hands to facilitate dust removal. )
2. Put a sticky mat on the wind and cargo shower, it can stick the dust under the foot, and the cleaning effect is better.