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What is a Cleanroom?
Generally, pharmaceutical factories require cleanliness such as drug production should reasonably divide the workshop into different areas according to the types and dosage forms of the drugs produced.
Such as general production area, control area, clean area and sterile area. The quality of each preparation can only be guaranteed when it is produced in the corresponding workshop, otherwise the medicine will be easily contaminated during the production process.
What is the level of cleanliness？
The air cleanliness of the pharmaceutical production clean room is divided into four levels, namely 100, 1000, 10000 and 100,000. The lower the number, the higher the cleanliness.
Personnel are the main pollution sources of dust and bacteria in clean rooms, such as human dander, saliva, hair and other pollutants; in order to reduce personnel pollution, operators must wash, change clothes, shoes, etc. before entering the clean room.
How to design the changing room?
Separate rooms for different stages of changing, such as changing shoes (taking off coats), wearing clean clothes (wearing sterile underwear, sterile outerwear), air locks (washing hands, hand disinfection), etc. The last air lock acts to isolate the airflow between the dressing area and the production area.
The GMP clean room requires that "the static level of the rear section of the changing clothes is consistent with the cleanliness level of the corresponding clean area". And the rear part of the changing, refers to the wearing of clean clothes (wearing sterile coats) and subsequent air locks, and the cleanliness level of these areas is consistent with the level of the production area they serve. The front part of the dressing area, as an auxiliary area for purifying and dressing, needs to be fed with air filtered by the HEPA filter, has a certain number of ventilation times, and has a certain pressure gradient, but it belongs to the non-classified area.
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