In order to ensure that the microbial limits of the pharmaceutical plastic bottle production environment are maintained at an appropriate level and in a controlled state, in addition to maintaining good operating conditions of the air conditioning system and maintaining good facilities, the clean room personnel should strictly abide by good code of conduct and regularly Environmental monitoring is less effective than reducing human intervention.
The second is to properly control temperature and humidity by effectively controlling the movement of people and items. Microbiological control measures also include good cleaning and sanitation treatment. The drug clean laboratory should be cleaned and disinfected regularly. The microbial contamination of disinfectants and detergents should be tested and used within the specified validity period. Class A/B clean areas Sterile or aseptically treated disinfectants and cleaners should be used.
The chemical disinfectants used sh ould be validated or evidenced to have a disinfecting effect of more than one type and periodically replaced to prevent the development of tolerant strains. Do not use UV disinfection instead of chemical disinfection. If necessary, appropriate methods such as fumigation may be used to reduce the microbial contamination of the sanitary corners in the clean area and verify the residual level of the fumigant.
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