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Three points effectively maintain the cleanliness level of the clean room
2023/9/8
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 is more important. In order to comply with GMP and achieve cleanliness specifications, all surfaces of the clean room should be smooth and airtight, and do not produce their own pollution, that is, do not produce dust, or chips, corrosion resistance, easy to clean, otherwise it will provide a place for microbial reproduction, the surface should be strong and durable, not cracked, broken or dented. There are a variety of materials to choose from, there are expensive Dagard panels, glass, etc. The best and most aesthetically pleasing choice is glass. According to the requirements of clean rooms at all levels of regular cleaning and disinfection, the frequency can be after each operation, several times a day, every day, every few days, once a week, etc. It is recommended that the operating table should be cleaned and disinfected after each operation, the floor should be disinfected every day, the wall should be cleaned and disinfected every week, and the space should be cleaned and disinfected strictly according to the clean room level and the set standard specifications, and records should be made.
2. Control of clean indoor air
In general, it is necessary to choose the right clean room design, regular maintenance, and daily monitoring. Special attention should be paid to the monitoring of plankton in the pharmaceutical clean room. A plankton sampler is used to extract a certain volume of air in the space, and the air flow is passed through the contact dish filled with specific media. The contact dish will capture microorganisms, and then the dish is placed in the incubator to count the number of colonies and calculate the number of microorganisms in the space. The microorganisms in the laminar layer also need to be detected, and the corresponding laminar plankton sampler is used. The working principle is similar to that of spatial sampling, only the sampling point should be placed in the laminar layer. If compressed gas is needed in the aseptic room, it is also necessary to detect microorganisms in the compressed air. With the corresponding compressed air detector, the pressure of the compressed gas needs to be adjusted to the appropriate range to prevent the destruction of microorganisms and media.
3. the requirements of personnel in the clean room
Clean room staff should receive regular training on pollution control theory. They enter and exit the cleanroom through airlocks, air showers, and/or changing rooms, and they must wear specially designed clothing that encloses the skin and naturally occurring pollutants in the body. Depending on the classification or function of the clean room, the dress of the staff may be simple protection with lab clothes and head covers, or it may be completely covered with full-body protection without exposing any skin. Clean clothing is used to prevent particles and microorganisms from being released from the wearer's body and contaminating the environment. The clean clothing itself must not release particles or fibers to prevent pollution of the environment. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries, and it can lead to cross-infection between medical personnel and patients in the healthcare industry, for example. Clean protective equipment includes protective clothing, boots, shoes, aprons, beard covers, round hats, masks, work/lab coats, robes, gloves and finger covers, sleeves and shoes and boot covers. The type of clean clothing used should reflect the cleanroom and product category. Low-level cleanrooms may require special shoes with completely smooth soles that do not pick up dust or dirt. But for safety reasons, the sole should not pose a slip hazard. Entering the clean room usually requires wearing clean clothes. Class 10,000 clean rooms can use simple lab coats, head covers and shoe covers. For Class 100 cleanrooms, full body wrap, zippered protective clothing, goggles, face mask, gloves and boot covers are required. In addition, the number of personnel in the clean room should be controlled, with an average of 4 to 6m2/ person, and the operation should be gentle and slow to avoid large and rapid movement.
