The greatest threat to cleanroom contamination comes from the users themselves. In the medical and pharmaceutical industries, the control of microorganisms is very important, especially microorganisms that may be shed from the skin and deposited into the air stream. Studying the microbial flora of clean rooms is of great significance for microbiologists and quality control personnel to evaluate the changing trend, especially for the screening of drug-resistant strains and the research of cleaning and disinfection methods.
A typical cleanroom flora is predominantly those associated with human skin, although there are also microorganisms from other sources, such as the environment and water, but in smaller quantities. Common bacterial genera include Micrococcus, Staphylococcus, Corynebacterium, and Bacillus, and fungal genera include Aspergillus and Penicillium.
There are three major aspects to keeping a cleanroom clean.
1. The inner surface of the clean room and its internal equipment
The principle is that material selection is important, and daily cleaning and disinfection are more important. In order to comply with GMP and achieve cleanliness specifications, all surfaces in the clean room should be smooth and airtight, and not produce their own pollution, that is, not produce dust, or shedding, corrosion-resistant, easy to clean, otherwise it will provide a place for microbial reproduction , the surface should be durable and not cracked, broken or dented. There are various materials to choose from, expensive Dagard paneling, glass, etc. The best and most aesthetic option is glass. Carry out regular cleaning and disinfection in accordance with the requirements of clean rooms at all levels. The frequency can be multiple times a day after each operation, every day, every few days, once a week, etc. for cleaning and disinfection. It is recommended that the operating table should be cleaned and disinfected after each operation, the floor should be disinfected every day, the walls should be cleaned every week, and the space should be cleaned every month. Strict cleaning and disinfection operations should be carried out according to the clean room grade and set standards, and records should be kept.
2. Control of clean indoor air
In general, it is necessary to choose a suitable clean room design, regular maintenance, and daily monitoring. Special attention should be paid to the monitoring of planktonic bacteria in the pharmaceutical clean room. The planktonic bacteria in the space use a planktonic sampler to extract a certain volume of air in the space. The air flow passes through the contact dish filled with a specific medium, and the contact dish will capture the microorganisms, and then remove them. Put the dish into the incubator to culture and count the number of colonies, and calculate the number of microorganisms in the space. Microorganisms in the laminar layer also need to be detected. Using the corresponding laminar planktonic sampler, the working principle is similar to that of space sampling, except that the sampling point should be placed in the laminar layer. If compressed gas is used in the sterile room, microbial detection of compressed air is also required. With the corresponding compressed air detector, the pressure of compressed gas needs to be adjusted to an appropriate range to prevent the destruction of microorganisms and culture medium.
