Views: 1 Author: Site Editor Publish Time: 2022-04-18 Origin: Site
CleanroomA large threat of pollution comes from the user itself. In medical and pharmaceutical industries, microbial control is very important, especially possible from the skin to depose microorganisms in the airflow. The study of clean room microbiological districts is of great significance for microbiologists and quality control personnel to evaluate changes, especially for the screening of drug-resistant strains and cleaning and disinfection methods.
Typical clean chamber flora is mainly associated with human skin, and there will be other sources of microorganisms, such as from environmental and water, but few quantities. Common bacteria include microbacterial, Staphylococcus, and Bacillus, and Bacillus, fungi include custutal and Penicillus.
Keep cleaning of clean rooms to pay attention to the following three aspects
1. Inner surface of clean room and its internal equipment
The principle is that the selection is important, and daily cleaning and disinfection is more important. In order to meet the GMP and reach cleanliness specification, all surfaces of the clean room should be smooth and gas-free, and do not produce their own pollution, that is, do not produce dust, or turned, corrosion, easy to clean, otherwise the microbial breeding site The surface should be sturdy and durable, can't crack, crush or depression. There are a variety of materials to choose from, there is expensive Dagad panel, glass, etc., the most beautiful choice is glass. Regular cleaning and disinfection in accordance with the requirements of the clean room at all levels, the frequency can be used for each operation, and each day, every day, every few days, once a week, clean and disinfection. It is recommended that the operating desk should clean and disinfect each other, the floor is disinfected, the wall is per week, the space is per month, according to the standard specification of clean room and set standard specification, and record it.
2, clean indoor air control
In general, choose the appropriate clean room design, regular maintenance, and make daily monitoring. In particular, it is to note that the floating bacteria monitoring of the pharmaceutical clean room is monitored. The floating bacteria in the space extracts a certain volume of air in the space, and the airflow is passed through the contact dish of the filling particular medium, the contact dish will capture the microorganism, and then The dish is placed in the incubator to cultivate the number of colonies and calculate the number of microorganisms in the space. Microorganisms of the laminar layer also need to be detected, with the corresponding laminar layer floating bacteria sampling instrument, the working principle is similar to the space sampling, but the sampling point is to be placed in the laminate layer. If the compressed gas is required in the aseptic chamber, it is necessary to perform microbial detection against compressed air, and the corresponding compressed air detector needs to be adjusted to the appropriate range to prevent microbial and medium from being destroyed.
People working in clean room should regularly accept pollution control theory training. They entertake room through the air brake, air shower and / or locker room, they must wear specialized clothes, wrapped in the skin and the natural natural pollutants.
According to the classification or function of the clean room, the staff's dress may only need the simple protection of the experimental service and the header, and it is also possible to completely package system protection that is not exposed to any skin.
Clean clothes are used to prevent particles and or microorganisms from being released and polluted from the wearer. Clean clothes do not release the particles or fibers to prevent contamination. This type of personnel pollution can reduce product properties in the semiconductor and pharmaceutical industry, and it can lead to cross-infections between medical personnel and patients in the healthcare industry.
Clean protective equipment including protective clothing, boots, shoes, aprons, beard, round cap, mask, tooling / laboratory suit, robe, gloves and fingertips, sleeves and shoes, boots. The type of clean suit used should reflect the clean room and product category. Low-level clean rooms may require special shoes, the soles are completely smooth, will not stand on dust or dirt. However, considering safety reasons, the soles cannot cause slipping dangers. Entering clean room usually needs to be cleaned. The 10,000-level clean room can use simple experimental services, head cascades and shoe covers. For a 100-level clean room, a whole body is required, a zipper protective clothing, goggles, masks, gloves and boots.
In addition, it is necessary to control the number of clean indoor people, with an average of 4 to 6 m2 / person, and the operation should be gentle and avoid moving significantly.
Typical ABCleanroomDisinfection method commonly used in protective supplies clean room
A, UV lamp sterilization
B, ozone disinfection
C. Gas sterilized disinfectant has formaldehyde, epoxy alkane, peroxide acid, hydraulic acid and mixed liquid of lactic acid and lactic acid, etc. Toxic acid (75%), ethanol (75%) , Aldehyde, Joer off. The traditional aseptic room disinfection method of our country's pharmaceutical factory is to use formaldehyde as fumigation. Foreign pharmaceutical plants believe that formaldehyde has a certain harm to the human body. The extempacted blend is sprayed with glutaraldehyde, and the sterile room must be in biosafety. Filter film sterilization filtration in the cabinet.
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