2024-03-11
Compressed air dryer required for pharmaceutical plant
In pharmaceutical factories, compressed air is mainly used for filling machines in liquid preparations, granulating machines, pulping machines, filling machines, packaging machines, printing machines in solid preparations, extraction tanks in extraction processes, in addition, there are test pilot gas, material conveying, drying, purging, pneumatic instruments, automatic control gas, etc. In the above-mentioned compressed air use, in many cases. Compressed air is in direct contact with drugs, so there are strict requirements for the quality of compressed air in the design of pharmaceutical plants.
The quality of compressed air in pharmaceutical factories is mainly to control its water content, oil content, dust particle content and biological particle content, and it also requires compressed air to be odorless.
Direct contact of compressed air containing oil with the drug will contaminate the drug. Compressed air containing liquid water droplets will cause pipeline valves and equipment to rust, and water droplets will also pollute the drug and affect the quality of the drug.
Empty Gas contains a large number of dust particles and microbial particles. For the pharmaceutical industry, particles, especially dust particles, will directly affect the quality of drugs, thereby endangering people's lives. Microorganisms (biological particles) are more harmful to the human body, and microorganisms More refers to bacteria and fungi, contamination of drugs will not only make the drug itself burning bacteria, deterioration, once misused, whether from the intestinal or parenteral into the human body, will directly affect human health, the consequences are more serious. So the pharmaceutical factory The use of compressed air must be controlled mainly by particles and microorganisms, which is one of the main differences between pharmaceutical plants and other plants that only control particles (such as electronics, machinery, etc.).
A, instrument, automatic control and other gas quality standards can be found in GB/T13277-91 "general use compressed air quality grade" (equivalent to ISO8573/1). This standard divides the quality grade according to the four control indexes of solid particle size and content, water vapor content and oil content, as shown in Table 1.
For the quality level requirements of compressed air for instrumentation and automatic control, it is recommended.The four indexes are grade 2.3.3, and the specific indexes are: the maximum particle size is 1μm, the particle content is 1mg/m3, the water content (pressure dew point) is -20 ℃, and the maximum oil content is 1mg/m3.
B, pharmaceutical compressed air quality index
At present, there is no relevant quality standard for pharmaceutical compressed air, and the international standard for equivalent vegetableISO8573/1GB/T13277-97, clear medical compressed air is not included in this standard. Most of the literature only qualitative general requirements, the lack of specific control indicators.
According to the practice in recent years, we in the engineering design of the pharmaceutical plant compressed air quality index is determined as follows:
For solid particles, the highest level of biological clean room in the pharmaceutical industry is currently0.5 μm and 100 grade, so the cleanliness grade of compressed air should be less than 0.5 μm and 100 grade. We generally use GB/T13277-97 in the design of 1, that is, the particle size of 0.1m, particle content of 0.1mg/m3.
The water vapor content in compressed air is usually expressed in terms of pressure dew point or atmospheric dew point. In order to prevent the presence of condensed water in the system, the dew point temperature is generally taken from the dried compressed air pipeline and gas equipment, and the lowest temperature that may be encountered is added.-5 ~-10 ℃. Therefore, the pressure dew point value in Tianjin area can be 5 ~-20 ℃.
The oil content is mainly to control the oil droplets, suspended oil mist and oil vapor in the compressed air. In the design, we refer to the national standards for food and beverage processing of compressed air quality requirements, that is, to control the maximum oil content.0.01mg/m3。
For biological particles, the solid particle index is determined0.5 μm, 100 level, compared with the use of biological 100 level clean room microbial control indicators, to achieve less than or equal to 1CFU/m3 (culture method, colony number), at this time the possibility of detecting viable bacteria is very small.
Determination of Process Flow of Compressed Air Station
Determination of the process flow of compressed air stations in pharmaceutical plants
The process flow of the compressed air station in the pharmaceutical plant is as follows: suction filter-Air compressor-after cooler-gas tank-pre filter-precision filter-drying device-post filter-deodorization filter-sterilization filter-gas transmission pipe network
The above process according to the different size of the pharmaceutical factory, different types of air compressor and different requirements for compressed air quality and have different trade-offs, design should be carefully studied and analyzed the user's gas requirements and gas characteristics, and then develop a reasonable compressed air station process system.
Selection of drying device
Pharmaceutical plants have different requirements for compressed air moisture, such as small-scale Chinese medicine pharmaceutical plants with low levels of automation, which require the pressure dew point of compressed air.5~10 ℃. The high level of automation, pneumatic control instruments and devices more large and medium-sized pharmaceutical factories, the pressure of compressed air dew point to -20 ~-40 ℃.
The drying method of compressed air can generally be divided into two types: refrigeration type and adsorption type. The pressure dew point of the compressed air is required to be greater than or equal3 ℃, the use of adsorption dryer or frozen adsorption combined drying device.
In addition, it should be noted that when selecting the drying device, the equipment should not be selected only according to the nameplate data, but the influence of the compressed air temperature, pressure and ambient temperature at the inlet of the equipment on the output of the dryer should be considered.
Pharmaceutical, compressed air, plant, requirement, control, dew point, pressure, particle, content
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