[Overview] The clean level control of the aseptic drug production workshop is an important part of the quality assurance of pharmaceutical production. There are two main factors controlling the cleanliness of a sterile production area, one is dust particles and the other is microorganisms. Production clean areas can be generally divided into four levels, namely A/B area and C/D area. Different levels of production areas must maintain stable pressure difference and buffer zone isolation for different production processes and different levels of clean areas. . The parameters of the control factors are also subject to the corresponding regulations. Difficulties in the clean room of the microbial control room, not only to be efficient but also to disinfect the space, in order to kill stubborn spores and spores. At present, the space disinfection scheme for the production of clean areas in pharmaceutical factories is varied, but it seems difficult to find a rapid space disinfection solution. Is there really a rapid space disinfection solution that meets the new GMP cleanliness requirements and is highly effective in killing bacteria? The birth of the Orpheum hydrogen peroxide dry mist sterilization system is a good answer to the above questions. The results of the exploration and research of foreign experts for ten years are a solution to effectively kill microbial rapid space disinfection .
[Keywords] clean area, clean room, fast space disinfection, space disinfection , solution, killing spores
Clean room space disinfection dry mist hydrogen peroxide sterilization system, also known as: atomized hydrogen peroxide clean area space sterilization system. It is through the gasification method of stable hydrogen peroxide and reactive colloidal silver ion dry mist to sterilize the whole sterile clean area and surface of the clean area. Through the professional sterilization scheme and software, it is a sterile clean area for pharmaceutical customers. Sterile clean room sterilization provides a complete set of thorough sterilization methods that are thorough, convenient, safe and environmentally friendly. The challenge test for B. subtilis indicator organisms can achieve a log 4-6 power killing effect.
Its principle of action: the spraying process is completed by spreading dry mist to the area that needs to be sterilized. When the average diameter of the droplets is less than 10 microns, the ejected mist can be said to be "dry"; the small droplets will bounce off the wall and will not rupture and adhere to the surface. All conditions are established to effectively move the sterilant in a gasified form to a designated area. This form of characteristics determines that they can be moved to areas that are difficult to reach at ordinary times.
Dry fog has the following properties:
1. The dry mist droplets carry out random motion (Brown motion principle) and will not settle;
2. Dry mist droplets do not aggregate together to produce large droplets;
3. The dry mist will rebound after contact with the surface without rupturing and moistening the surface;
Therefore, these properties of the dry mist gas make it difficult to achieve a good sterile clean area and surface sterilization effect.
Advantages of dry mist sterilization system:
1. The sterilizing agent can be controlled to be sprayed in the form of dry mist. The size of the dry mist particles is controlled at a precise and consistent level, which reduces the risk of condensing liquid and ensures the penetration and disinfection effect on the more complicated and difficult to reach.
2. Can effectively reach all areas of the clean area.
3, A/B area efficient sterilization, can achieve the killing effect of 6 logs of Bacillus subtilis
4, rapid sterilization, only 2 to 3 hours to complete the entire sterilization process
5, low corrosivity, non-toxic, the first choice for pharmaceutical companies worldwide, the perfect replacement for formaldehyde
6. Complete verification data, residue verification, complete compatibility verification, template after purchase, easy to pass the new GMP
7, flexible use, simple operation, small size and easy to move, very suitable for pharmaceutical companies
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