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Maintenance methods for air showers
Maintenance methods for air showers1. PRE-FILTER: The pre-filter is located underneath the unit. The pre-filter can be easily removed by removing the recirculating air return. The clogging of the pre-filter varies depending on the frequency of use and the state of cleanliness. Please observe the clogging time at the beginning of use and clean it regularly with compressed air, water or vacuum. Depending on normal use, cleaning is necessary 2-3 times a month.2. (MAIN FILTER) This filter is located after the AIR NOZZLE, its renewal period can be determined by the anemometer to test the wind speed value (wind value halved) or by the differential pressure meter to measure the differential pressure (differential pressure value doubled) to decide whether to change or not, its testing cycle is about two to four times a year. 3. As the circulation and return air parts of the machine are located underneath the machine, there will be a large accumulation of dirt in the corners of the floor, so please clean them with a hoover more than once a week. Make sure that the fan is rotating in the correct direction. If you find that the fan is rotating in the opposite direction (wind speed is obviously insufficient), please switch any two of the three phases of the power supply and make sure that it is rotating in the correct direction. Controlled maintenance of air showersThe control of the dust particle count in the clean room, the environmental control, and daily maintenance of the clean room air shower room are very important, the air purification system plays a very key role.When the air cleanliness requirement of the injection production is 100 level, use vertical and horizontal one-way flow type, airflow wind speed is greater than 0.25 m / s and 0.35 m / s respectively; when the air cleanliness requirement is 10000 level, 100000 level, use non-one-way flow, air change times are greater than 25 times/hour and 15 times/hour (300000 level air change times are not less than 12 times/hour), to take away the dust and powder produced during the production process in time and maintain the cleanliness of the clean room environment. There are two types of cleanrooms: biological and non-biological. The air purification system for biological cleanrooms must be in continuous operation; the air purification system for non-biological cleanrooms should be switched on 4 hours in advance of use. Dust particle counters are used to detect dust particles and are carried out after a buffer of 0.5 to 1 hour after sanitary cleaning of the environment.To avoid contamination caused by human beings, the clean room is limited to two people during static testing. Critical control points should be monitored dynamically during the production of injectables. Control of microbial content. The control of microbial content in the cleanroom environment is still dependent on good air purification system facilities, whose filtration efficiency can reach 99.9% to 99.99% to filter out bacteria and dust from the air. The temperature in the clean room during production is strictly controlled at 18 to 26°C and the relative humidity at 45% to 65% to destroy conditions conducive to bacterial growth, coupled with the cleaning and disinfection of disinfectant solutions. Regarding daily disinfection with disinfectant solution, after daily production, wipe the machine, desktop, doors, and windows, automatic air shower room, purification bench, clean shed, FFU fan filtration unit, walls, etc. with 75% ethanol or 2‰ Neosporin solution, and wipe the ground with 3% to 5% Lysol to disinfect. After every 3 days of production, use 75% ethanol or 2‰ Neosporin solution to wipe and disinfect the surfaces of all the facilities in the clean room and the surfaces of the roof and lighting, etc., and 3%-5% Lysol to disinfect the ground. The strict control of the pressure difference between the clean room and the adjacent rooms is also an important part of ensuring the cleanliness of the air in the production room. The pressure difference between clean rooms of different clean levels and clean areas and non-clean areas should be greater than 5 Pascal, and the pressure difference between clean areas and outdoor areas should be greater than 10 Pascal, and the opening and closing of air supply, return and exhaust systems should be interlocked and operated in sequence, to avoid backflow of air and reduce the pollution of the clean room environment by low-level dust. Before each production and after a certain production cycle, the clean room must be tested for dust particles under static conditions to evaluate and grasp the dust particle content of the clean room. The purpose of environmental control and daily maintenance of clean room air showers is to kill bacterial colonies generated by the production process and to control the microbial content of the clean room. These measures only control the number of bacteria and the type of miscellaneous bacteria in the clean room air. If there are more molds, we have to spray the room comprehensively with 5% carbolic acid and then fumigate it with formaldehyde to achieve sterility, and this is the only way to kill bacteria and miscellaneous bacteria spores. At the end of each production cycle, the clean room with aseptic requirements is first disinfected with disinfectant before the next cycle of production, and after testing the dust particle count in the clean room to meet the regulations, the clean room is then fumigated with formaldehyde gas, and from the results of long-term testing, this method of environmental sterilization is very effective. Formaldehyde gas sterilization techniques. Formaldehyde fumigation not only has a good sterilization effect on molds that are not easy to kill, but also has a better effect on killing bacterial spores in the environment. Formaldehyde fumigation operation requires attention: firstly, to ensure that the room temperature reaches above 35°C and the relative humidity is above 60%; secondly, to ensure that the amount of formaldehyde reaches a ratio of 10 g/m3 of the room volume; in addition, the room disinfection time is not less than 12 hours; it is particularly worth reminding that the same proportion of ammonia is used to neutralize the formaldehyde before it is replaced, which will minimize the harm to humans and the pollution of the environment. To prevent bacteria from becoming resistant to formaldehyde, alternating with ozone will be more effective. Reduce the impact of people on the sterile environment. People are the biggest source of pollution in a sterile environment, therefore, the number of people working in the clean area and the number of people in the operating room, the magnitude of the operating action, and the style, texture, and wearing of the work clothes have a clear impact on the content of particles and bacteria. |
