Sterile Compressed Air Standard

The aseptic compressed air standard involves multiple aspects to ensure the sterility, purity and suitability of compressed air. The following is a detailed summary of sterile compressed air standards:

1. pressure

for sterile compressed air, it is usually required that the air pressure at the outlet of the air compressor is controlled within a certain range, such as 0.2~0.4MPa (gauge pressure). The pressure in this range can not only meet the production demand, but also avoid the high air pressure at the compressor outlet, thereby saving power consumption and reducing production costs.

2. air flow

the determination of the air flow needs to be calculated according to the overall requirements of the specific application scenario. In the fermentation industry, the required compressed air flow rate is usually determined by the aeration ratio of the pilot plant or VVM (volume of air per unit time per unit volume of medium introduced under standard conditions). Aseptic compressed air requires a continuous flow of compressed air to meet production needs.

3. temperature and relative humidity

in order to reduce the relative humidity of the air, the compressed air is sometimes appropriately heated. In the fermentation industry, it is common practice to control the temperature of the compressed air entering the fermentation tank to be about 10 ℃ higher than the fermentation temperature. However, with the development of technology, many factories have canceled the heating treatment of the air before entering the tank, but directly after the air is dehumidified by the cold dryer. In addition, in order to ensure the filtering effect, the relative humidity of the compressed air entering the filter needs to be controlled within a certain range, such as between 60% and 70%.

4. cleanliness

the cleanliness of sterile compressed air is one of its core standards. When designing an air filter, a cleanliness index is usually set, such as 10-3. This means that in a certain volume of air, the number of particles greater than or equal to a certain particle size should be controlled to an extremely low level. In the fermentation industry, "sterile air" refers to the clean air that has been sterilized and the bacteria content in the compressed air is reduced to zero or reaches cleanliness level 100. The 100 air standard here means that the concentration of particles with a particle size of ≥ 0.5 μm in the air is 100pc/ft & sup3;, that is, the number of particles with a particle size of ≥ 0.5 μm per cubic foot of air does not exceed 100. For the pharmaceutical industry, the compressed air used in sterile pharmaceutical clean rooms must meet at least C standards, or even higher.

5. microbial limit

sterile compressed air has strict requirements on the limit of microorganisms. According to the international standard ISO 8573 series, the microbial limit of compressed air for pharmaceutical use is usually less than 1 CFU/m & sup3;(colony forming units per cubic meter). In China, according to the requirements of the "Pharmaceutical Production Quality Management Regulations", the production gas (including compressed air) entering the sterile production area should be sterilized and filtered, and the number of microorganisms should be less than 1 CFU/m & sup3;.

6. other indicators

in addition to the above indicators, sterile compressed air also needs to control the content of other pollutants, such as water content, oil content, dust particle number, etc. Together, these standards constitute a system of quality requirements for sterile compressed air. For example, in order to prevent the system from condensing water, the dew point temperature needs to be adjusted according to the region and season; the oil content needs to be controlled at a very low level to ensure that the compressed air is oil-free; the number of dust particles also needs to be controlled within the specified range To ensure the purity of the air.

In summary, aseptic compressed air standards involve pressure, air flow, temperature, relative humidity, cleanliness, microbial limits and other indicators. Together, these standards ensure the quality and sterility of sterile compressed air to meet the needs of various application scenarios. In actual operation, it is necessary to formulate and implement corresponding standards according to specific application scenarios and product requirements.