Special topic: Cleaning and disinfection of clean rooms in pharmaceutical enterprises

When necessary, the internal surface of the clean workshop of pharmaceutical enterprises can be cleaned and disinfected regularly by chemical, physical or other means to kill pathogenic microorganisms, so as to control the total amount of microorganisms within the daily monitoring range of clean environment and prevent the possible impact and pollution of microorganisms on the production workshop environment. The commonly used disinfection methods in clean environment include formaldehyde fumigation, ozone fumigation, lactic acid fumigation, hydrogen peroxide fumigation and other disinfectants fumigation. Each sterilization method has its specific scope of application, and the sterilization process must meet the requirements of registration and approval, and should be verified. In production, the best disinfection method should be selected according to the specific situation to ensure that the clean environment meets the specified requirements. 1 Requirements for cleaning agents and disinfectants Cleaning agents should have the characteristics of high efficiency, environmental protection, no residue, strong water solubility, clear concentration or simple configuration. Suppliers should have professional qualifications. Each minimum packaging unit has a clearly marked production date and expiration date. Disinfectant should have the characteristics of high efficiency, environmental protection, less residue and strong water solubility. Use disinfectants that meet the requirements of the "Disinfection Management Measures" promulgated by the Ministry of Health, and use them alternately every month to prevent microorganisms from producing tolerance. 2 The cleaning standard requires all cleaning items to pass through a clean and tidy workshop to achieve dust-free, no trace, no shedding and neatness. Dust-free: refers to the absence of dust and dust on the surfaces of walls and ground facilities. No trace: it means that there are no construction traces on the ground, walls and facilities, and there are no traffic traces on the ground. No shedding: refers to no shedding of fiber, wall skin, etc. Cleanliness: It means that the cleaning process is orderly, the site is clean, and the instruments used are clean and tidy. 3 Cleaning and disinfection operation ① Develop standard operating procedures, define the preparation method of disinfectant, and use it on site. ② Make appropriate cleaning and disinfection methods and frequencies for different disinfection objects. Cleaning and disinfection objects include walls, ground equipment, floor drains, sinks, air conditioning outlets, etc. ③ In the clean area, after cleaning one workshop, used cleaning tools such as mops and car washes need to be cleaned before cleaning the next workshop. (4) After cleaning and disinfection, records shall be made in time. ⑤ Evaluate the effectiveness of cleaning and disinfection methods through data analysis of quarterly and annual environmental monitoring reports.