The clean room of the pharmaceutical industry is different from other industrial clean rooms, especially for aseptic production, not only to control the aerosol particles in the general suspension state in the air, but also to control the number of living microorganisms, that is, to provide so-called “Aseptic” environment (sterile room). Of course, “sterile” is relative, and it can be expressed by the Sterilty Assurance Level (STA). The methods of obtaining sterile air in the pharmaceutical industry can be roughly divided into two categories:
1, sterilization by heating (dry heat, damp heat), chemical reagents (such as formaldehyde, epoxy hexane), Ozone, radiation (such as ultraviolet light irradiation) and other methods, the bacteria in the air protein denatured to sterilize.
2. Sterilization Dust and bacteria in the air are captured and trapped by using filter media (such as various air filters, high-efficiency filters) or electrostatic dust removal methods.
In fact, the sterilization method for industrial applications is often not a single one, but a combination of the two. For the flowing air (such as HVAC system, compressed air), the filter medium is often used for sterilization. The air in a static environment is often sterilized and used for sterilization of sterile rooms, culture rooms, transfer windows, clothes, and the like. Using filter media to sterilize we have already introduced the previous HVAC system verification.
It is reasonable to say that in the HVAC system, the air filtered through the high-efficiency filter can control the number of living microorganisms in the room within the specified range. In fact, in actual production, due to the operation of the machine, the entry and exit of personnel, dust particles will be generated on the surface of the building, which will breed bacteria and be easily blown off again. Especially the pollution of personnel is almost the only source of bacteria, one person About 1000 dead skin cells (equivalent to 20μm particles) are distributed every hour. Therefore, the indoor building materials and clean clothes of the clean room should be washed, dried and packaged in a clean environment. The sterile clothes should be autoclaved. Sterilization; personnel, equipment, and instruments enter the sterile room should be strictly disinfected and sterilized; (hands need to use disinfectant drugs or spray); regular indoor disinfection and sterilization operations. All national GMPs have strict regulations on airborne bacteria and surface bacteria in clean rooms. For example, USP recommends that the allowable values of bacteria in a clean environment are as shown in Table 6: Due to the production of drugs, the floor, wall, ceiling, in the clean room, There may be living microbial particles on the surface of machines and human clothes. When the temperature and humidity are appropriate, the bacteria will multiply on these surfaces and be blown into the room by the airflow from time to time. Therefore, clean rooms (especially sterile rooms) are generally not produced in three shifts, and there must be sufficient time each day for cleaning and disinfection.