[Overview] Space disinfection in the clean area is simply the use of microbial killing technology to disinfect all exposed surfaces and space air in the clean area. With the new version of GMP to promote space disinfection has become a key part of the pharmaceutical factory verification, it is also one of the important items for inspection and identification. According to incomplete statistics, most pharmaceutical companies still use traditional sterilization technology, but today's science and technology are advancing by leaps and bounds, especially the renewal of pharmaceutical technology. The traditional disinfection methods are increasingly exposed to the drawbacks of the enterprise itself and related regulations. Pharmaceutical companies are looking for disinfection technologies that have both excellent bactericidal effects and economical costs, as well as occupational health factors that consider safety and health. This paper introduces a new technology for disinfection of space in the clean room - hydrogen peroxide dry mist sterilization system, looking forward to the guidance of domestic pharmaceutical experts.
[Keywords] clean area, clean room space disinfection, space disinfection, disinfection new technology
Sterile clean room space disinfection hydrogen peroxide dry fog space sterilization system is mainly to use physical means to convert the liquid sterilizing agent (main component hydrogen peroxide + active colloidal silver ion) into a "dry fog" of aerosol state, Allow it to be dispersed in a sterile clean area that requires sterilization to achieve a thorough sterilization effect, which can replace formaldehyde fumigation.
Sterile clean area dry mist hydrogen peroxide sterilization system, also known as: atomized hydrogen peroxide sterile clean area 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 diffuse the sterilant into a specific area in the form of gasification. This form of characteristics determines that they can diffuse into 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
Technical Parameters:
Spray particle size: average 5 μm (particle diameter is the measured value of laser refraction method)
Kinetic energy: power supply
Spray speed: 80m/s
Spray amount: 1000ml/60min
With sporicide dosage: 1000ml
Power: 1.1 kW
Applicable liquid: space sporicide
Sterilization volume: 50-1000 cubic meters
Material: HDPE
Size: 50cmx33cmx34cm (length × width × height)
The sterilization effect of the dry mist sterilization system in the sterile clean area can be verified:
Fully in line with the provisions of the United States Pharmacopoeia (USP), using Bacillus subtilis as a challenge test bacteria, to achieve the kill rate of log4-6, can prove the system to kill various microorganisms in the sterile purification process ability.
Applicable places: Suitable for biosafety laboratories, pharmaceutical factory GMP workshops, infectious wards, etc., where regular disinfection and sterilization are required.
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Technical Information
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