In order to maintain the cleanliness of clean indoor air, the 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 integrity of equipment and personnel. The daily maintenance and management of the clean room has been introduced in the preceding article.
I. Management of Entry and Exit Clean Room
1. Personnel entering the clean room shall strictly enforce the system, route and sequence of personal purification. When leaving the clean room, it must follow the above order and route. Clean articles are not allowed to be taken out of the hall.
2. 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%.
3. In order not to interfere with the clean air flow pattern in the room, no articles should be placed on the upper side of the working area, and no objects should be piled up near the return air outlet; no clogging and stacking should be done under the air supply orifice plate, and the production operation should be carried out on the clean workbench or upstream of the air flow.
4. It is not allowed to bring dustproof and non-production-related articles into the clean room.
5. Smoking, diet and unproductive activities in clean rooms are strictly prohibited.
6. Before entering the clean room, personal belongings should be put in designated cabinets, cosmetics and jewelry removed, and designated clean clothes and shoes replaced.
7. 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.
8. When stripping clean work clothes, it is necessary to avoid the clothes touching the ground, tables and other items. Generally, the clothes should be stripped from bottom to top and stored in cabinets or hanging in prescribed places.
9. 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.
10. When you exit the clean room, you can enter the replacement area without air showering.
II. Management of Operators in Clean Room
1. Hands are 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.
2, do not allow the following persons to enter the clean room: Patients with cold, cough, eczema and other diseases; do not wash cosmetics, nail polish and those who do not wear clean work clothes according to regulations; operators should wash their hair frequently, change clothes and cut nails.
3. 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 to wear clean work clothes to go to the toilet.
4. In clean rooms, gloves should be worn as required, and wrists should not be exposed. Gloves should be replaced frequently.
5. 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, cleaning, cleaning and disinfection of the clean room, the safety facilities and safety management regulations of the clean room. Fixed.
6. Clean work clothes should be made of clothes that produce less dust and can resist static electricity. 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.
7. 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 room should ensure the timeliness and continuity, and the localization management should be carried out by field managers.
3. Cleaning and sterilization of clean rooms.
Cleaning of the clean room should generally be done after the end of the production process; if it is necessary to clean before production, the process production must be started after the start-up time of the clean air-conditioning system meets the requirements of cleanliness. 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 towel, 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.
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 and production process equipment in the production process, or operation errors will cause an increase in indoor dust; in view of the situation of these sources of pollution, 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 equipment is the main equipment to ensure the cleanliness of indoor air, including all kinds of filters, clean workbenches, laminar flow hood, air shower room, transfer window, air conditioning equipment, etc. Their normal maintenance and regular inspection are the important conditions to ensure the cleanliness of the clean room. Specific requirements are shown in the following table:
Name of device
Management projects
Management content
Use Instruments
Testing requirements
1. Filter
1. Cleanliness
2. Air duct
3. Airflow velocity
4. Static pressure difference between indoor and outdoor
Site Monitoring Scanning Test and Sealing Pad Leakage Detection in Clean Room
Particle counter
Anemometer
Differential pressure gauge
According to cleanroom grade, according to regulations
2. Initial filter,
Intermediate effect filter
1. Pollution
2. Air handling capacity
3. Static pressure difference
Site monitoring of clean room
Visual examination
Standard determination method
Anemometer
Differential pressure gauge
Timing and continuity
3. Clean Workbench
Clean Room
1. Cleanliness
2. Air volume
3. Airflow velocity
4. Vibration
5. Calorific value
6. Illumination
High-efficiency filters are fully scanned for leak detection, 5 points for each test.
visual
touch
Particle counter
Anemometer
Differential pressure gauge
Illumination photometer
Determine according to production process requirement
4. Fans
1. Voltage and current
2. Belt relaxation
3. Motor speed
4. Noise and fever
5. Equilibrium Degree of Fan Impeller
Fixed-point monitoring
visual
visual
Voltmeter
Ammeter
Tachometer
Dynamic Balancer
Daily Timing
Dynamic Balance March-June
5. Control Instruments,
Control valves, etc.
1. Inductive action
2. Recorder action
3. Pen Tip
4. Recording paper
Standard Value Correction for Set Value Change Tests
Manual test
Sensor cleaning, especially
The temperature sensor is excellent, and the shaft part should be carefully checked.
Visual measurement
Standard hanging type
Standard instruments for thermometers, hygrometers, galvanometers, etc.
Daily timing, calibration, etc. shall be carried out in accordance with the regulations.
V. Clean room air
(1) The air in the clean room should be monitored in accordance with the provisions of Schedule 2.
Frequency of air monitoring in clean rooms Schedule 2
Testing items
Air cleanliness grade
One hundred
One thousand
Ten thousand
One hundred thousand
humidity
Twice a class
temperature
Twice a class
Barotropic value
Once a week
Once a month
Cleanliness
Once a week
Once every three months
Every six months
(2) When high-efficiency vacuum cleaners are used for cleaning in clean workshops, the dust concentration at the exhaust outlet of the cleaners must be checked regularly.
(3) Maintenance of the following major equipment
1. Replacement Conditions of High Efficiency Filters
1) The airflow velocity drops to the minimum, even if the primary and intermediate air filters are replaced, the airflow velocity can not be increased.
2) The resistance of the high efficiency filter is twice that of the initial resistance.
3) The leakage of high efficiency filter can not be repaired.
4) It is recommended to replace it once a year.
2. Inspection and cleaning of medium-effect filters.
Each bellows is equipped with a bag-type medium-effect filter, which can be used to further filter fresh air and return air. It is suggested that the filter should be inspected and replaced every three months, or when the frequency of inspection increases or decreases or replacement is changed according to the situation, care should be taken not to pierce the filter bag or knock the frame into deformation, so as to avoid affecting the filtering effect.
3. Initial effect filter inspection and cleaning.
Each air conditioning unit has an initial filter near the entrance of its fresh air duct, which is mainly used to prevent dust and mosquitoes from entering the air conditioning system. Therefore, it needs to be inspected and replaced. It is suggested to inspect and replace it every 45 days, or to increase or decrease the frequency of inspection and replacement as the case may be.
4. Regulating valves are installed on the air supply and return pipes of each air conditioning unit. In order to ensure its safety and reliability, it should be inspected in accordance with the relevant regulations of the state.
5. In order to ensure the accuracy of the temperature in the workshop, operators should check the air conditioning unit regularly every day to determine whether the unit is running normally and whether there is abnormal sound.
6. Operation and management of air and cargo shower rooms
The air-cargo shower room is the necessary passageway for people to enter and leave the dust-free room. It also acts as a closed dust-free room of the air lock room. It is an effective equipment for people to dust and prevent outdoor air pollution. "
In order to reduce the large amount of dust particles brought about by people's entry and exit, the clean air filtered by high-efficiency filter is sprayed from rotating nozzles to people from all directions. The dust particles are effectively and rapidly removed, and then the dust particles are filtered by primary and high-efficiency filters and recycled to the air and goods shower area.
Use of air/cargo shower room:
(1) Personnel entering the barrier environment should take off their coats in the outdoor dressing room, except for watches, mobile phones and accessories.
(2) Enter the underwear changing room and wear purifying clothes, hats, masks and gloves.
(3) Close the outside door immediately after the personnel enter, and the air/cargo shower will start automatically for 1 minute (set up).
(4) Wind and cargo will end and enter the barrier environment.
Management of air shower room:
(1) The air shower room is managed by the responsible person and the initial filter material is regularly replaced quarterly.
(2) Replace the high-efficiency filter material of the air shower chamber every two years.
(3) Open and close the indoor and outdoor doors lightly.
(4) When a malfunction occurs in the air shower room, it shall be reported to the professional maintenance personnel for repair in time. Normally, it is not allowed to start the manual button. 3 y + Recommendation:
1. In the process of wind and goods shower, please raise your hands and rotate 360 degrees to facilitate all-round dust removal. )
2. Put a dust mat on the air and goods shower room, it can stick the dust under the feet, and the cleaning effect is better.
