Aseptic Room

About aseptic as well as sterile room: the diameter of bacteria is generally more than 5 microns, and clean room air filters can reach 99.99% efficiency in 0.5 microns particle size, bacteria are generally attached to the dust, so the clean room using high-efficiency air filters can achieve the purpose of sterility, while some of the aseptic room through the use of ultraviolet lamps emitting ultraviolet irradiation for more than 30 minutes to strengthen the sterilization effect of measures. The clean room can be sterilized by using high-efficiency air filters.

In the aseptic manufacturing process, sterilized products, containers and seals exposed to the environment area should be paid special attention to. Operational activities in this area include the handling of these sterile materials and products prior to filling and during the filling and sealing process, which is usually carried out in the aseptic operation area. Because in this area the product is in the open state, very susceptible to contamination, and the product filling and sealing is no longer made after further sterilization. In order to ensure product quality, especially the sterility index, aseptic operation should be carried out in the best quality environment, which is realized by the air purification system.

 One of the main elements of the evaluation of the aseptic manufacturing environment is the quality of the air, mainly the suspended particle content of the air in the manufacturing environment. Suspended particles in the air are important because of their potential to enter the product and cause contamination.

 Under dynamic conditions, in the article exposure environment sampling monitoring, clean area per cubic meter of air containing ≥ 0.5 supply particles should not exceed 35000000 (100,000), the content of airborne bacteria should not exceed 500CFU / m3. In order to maintain air quality in the clean area, there should be enough airflow to quickly replace the indoor air, and at the same time, the neighboring non-clean or non-sterile operation of the clean area to maintain a positive pressure. Maintain positive pressure in the neighboring non-clean or non-sterile operation clean area. The indoor airflow rate should be sufficient to ensure that at least 20 air changes per hour, in general, the pressure difference between the air of adjacent lower clean class areas should not be less than 5 Pa under the condition that all the doors are closed. when the doors are open, the outward airflow should be sufficient to minimize the risk of contaminant intrusion.

 In addition to the aseptic operation area needs to be fed with high-quality purified air, the interior of some equipment also needs to be fed with high-quality filtered air, especially in the case of equipment where the air will come into contact with sterile materials, or materials that require very low microbial and particle content. For example, vacuum relief ports on drying ovens for freeze dryers vacuum drying processed pharmaceuticals, ventilation ports on dry or moist heat sterilizers, and ventilation ports on storage tanks for water for injection or purified water should all use sterilizing filters to ensure that the air that will come into contact with the sterile product for the purpose of completing the equipment's process is sterile and will not contaminate the pharmaceuticals while the equipment is processing them.

Similarly, air entering containers with sterile liquids should be sterilized and filtered. Air entering tanks containing materials of high microbiological quality must also be sterilized and filtrated, and filters must be kept dry to prevent clogging of filters or penetration by microorganisms due to humidity.

Generally speaking, the standard of the sterile room is a hundred standard, that is, the clean area of the number of stray bacteria plate shall not exceed an average of 1 colony. Aseptic room - generally small area, about 5 square meters, while the indoor elevation of about 2.5-2.8 meters. The most difficult control requirements of aseptic room is how to maintain the sterile state, so the ability to control bacteria and control the stability of bacteria is the core indicators of the aseptic room. Thorough sterilization on the one hand and prevention of contamination on the other are the two aspects of aseptic technology. It is also important to prevent the microorganisms under study, especially pathogenic microorganisms or genetically engineered microorganisms that do not exist in nature, from escaping from our experimental containers to the outside environment.

Currently, aseptic chambers are found in microbiology factories, while general laboratories use ultra-clean benches. The main function of the ultra-clean bench is to remove all kinds of tiny dust including microorganisms from the upper part of the working surface by using an air laminar flow device. Through the motorized device, the air passes through the high-efficiency filter and then enters the work surface, so that the work surface is always kept under the control of the flow of sterile air.