2024-03-11
Compressed air quality requirements for pharmaceutical plants
Compressed air of pharmaceutical enterprises is mainly used in 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 gas, powder material conveying, drying, blowing and purging, pneumatic instrument components, automatic control gas, etc.
Because the compressed air used for the preparation is in direct contact with the drug, the compressed air must be purified; it must be verified to prove that the system meets the production requirements; it must also pass the GMP certification inspection. The gas used in the preparation, such as drying and pressing, must control the content of oil, water, solid particles and biological particles in the compressed air, and at the same time, it is required to be odorless. Instrument gas is mainly used for pneumatic instruments and precision (pressure, flow) regulators. Except that biological particles are not controlled and no odor is required, other control items are the same as preparation gas. The quality standard of instrument gas can be determinedGB/T13277It can be found in the General Compressed Air Quality Grade. This standard is based on the size and content of solid particles, water vapor content and oil content.4The control indicators are divided into quality grades, as shown in the table.1.Requirements for gas quality grade of pneumatic instrument, recommended4The indicators are3level, the specific indicators are:Maximum particle size5μm,Particle content5mg/m3,Maximum water content (pressure dew point)-20℃, the maximum oil content is1mg/m3.At present, the requirements for the dust particle size of the air source for the pneumatic actuator are generally ≤1μm.
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.
The role of compressed air in pharmaceutical plants:
(1) The function of compressed air used in the extraction tank is to provide power for slag discharge and facilitate slag discharge;
(2) for traditional Chinese medicine grinder, rotary tablet press, capsule polishing machine, etc. is to play the role of purging, can timely remove dust, impurities, etc;
(3) for traditional Chinese medicine sterilization device can provide a sealed environment for the sterilization process, so that the sterilization effect is better;
(4) The capsule filling machine is used as a power to discharge the filled capsules in time to prevent the filling process from being interrupted due to untimely discharge;
(5) The ultrasonic bottle washing machine is used to provide power for completely removing impurities in the bottle;
(6) Used for blister packaging machine isPVCMaterial blow molding provides power;
(7) Used for spray drying granulation is to provide power for spraying liquid medicine or adhesive by spray gun and to provide the necessary power for timely removal of dust;
（8）Used for high-speed mixing granulation is to provide a sealed environment and a certain amount of power for this process, so that the materials are evenly mixed to achieve the best effect of mixing granulation, and it also provides greater power for discharging and feeding.
Requirements, used, provided, compressed air, preparation, power, content, instrument, pneumatic
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