What are the cleanliness requirements for compressed air?

Requirements for Compressed Air Cleanliness in Pharmaceutical Industry and Suitability of Water Lubricated Single Screw Air Compressor

compressed air cleanliness core requirements for 1. pharmaceutical industry

the cleanliness requirements of compressed air in pharmaceutical production are very strict. It is necessary to ensure that the air quality meets the pharmaceutical production specifications and avoids the risk of pollution:

1. solid Particle Control compressed air must not contain visible particles, small particles (such as diameter> 0.1μm dust) must be intercepted by high-efficiency filters to prevent physical pollution of drugs.
2. Microbial limit when compressed air is in direct contact with drugs or production environment, the content of microorganisms (such as bacteria and fungi) should be strictly controlled at a very low level, usually ≤ 1 CFU/m & sup3;(colony forming units per cubic meter of air) to avoid microbial contamination leading to drug deterioration.
3. Moisture and Oil Control: The compressed air shall be completely free of oil pollution, and the moisture content shall be reduced to the pressure dew point below -40 ℃ through drying equipment to prevent microbial growth or equipment corrosion caused by moisture condensation.

Guarantee Mechanism of 2. Water Lubricated Single Screw Air Compressor for Cleanliness

the enterprise water lubricated single screw air compressor through innovative design, from the source to eliminate the risk of pollution, to ensure the cleanliness of compressed air:

1. zero oil pollution technology:
   • using water lubrication instead of traditional lubricating oil, no oil molecules enter the air flow during the compression process, completely avoiding the risk of cross-contamination of drugs caused by oil pollution.
   • The water medium is circulated through a special waterway to achieve lubrication, cooling and sealing of components to ensure that the compressed air is absolutely pure.
2. Efficient solid-liquid separation design:
   • the water lubrication in the compression chamber forms a liquid film, which can absorb and scour tiny particles and reduce the residual solid impurities.
   • Equipped with high-efficiency gas-water separator, the moisture and residual particles generated in the compression process are completely separated to ensure that the output air is dry and clean.
3. Microbial Control Support:
   • the internal material of the equipment is corrosion-resistant, easy-to-clean stainless steel and food-grade materials to avoid microbial breeding.
   • The temperature of the compressed air is controllable, and the post-processing equipment (such as sterile filter) can further reduce the microbial content and meet the production requirements of sterile preparations.

Supporting Measures for 3. Cleanliness Guarantee

in order to ensure that the compressed air continues to meet the requirements of the pharmaceutical industry, it is necessary to combine the post-treatment equipment and regular maintenance:

1. multistage filtration system:
   • primary filtration: intercept large particles of impurities and protect subsequent equipment.
   • Precision filtration: remove particles above 0.01μm to ensure air cleanliness.
   • Activated carbon filtration: adsorption of trace odor and volatile organic compounds (VOCs).
2. Drying equipment collaboration:
   • freeze dryer: reduce the air temperature, so that the water condensation discharge, pressure dew point -20 ℃ to -40 ℃.
   • Adsorption dryer: adsorb residual moisture through molecular sieve, further reduce the dew point to below -70 degrees C, to meet the needs of high cleanliness scene.
3. Regular inspection and maintenance:
   • quarterly microbiological testing and particulate analysis of compressed air to ensure continued cleanliness standards.
   • Regularly replace the filter element and desiccant to avoid the risk of contamination due to performance degradation.

4. application cases and effects

the water lubricated single screw air compressor has been successfully applied to many pharmaceutical enterprises, covering the whole process from the production of raw materials to the preparation processing:

1. sterile preparation workshop:
   • after the compressed air is treated by multi-stage filtration and adsorption dryer, the microbial limit is ≤ 1 CFU/m & sup3;, and the particle content is <0.01 μm, which meets the requirements of aseptic filling environment.
2. Solid preparation production line:
   • compressed air is used for tablet presses, coating machines and other equipment, zero oil pollution characteristics to avoid drug moisture absorption agglomeration, improve product stability.
3. Biological fermentation workshop:
   • compressed air directly contacts the fermentation broth, and water lubrication technology prevents oil pollution, ensures the purity of fermentation products, and improves production efficiency.

5. Summary

the company's water-lubricated single-screw air compressor provides compressed air solutions that meet stringent cleanliness requirements for the pharmaceutical industry through zero-oil pollution design, efficient solid-liquid separation and microbial control technology. Its technical characteristics are highly compatible with the needs of pharmaceutical production, which can help enterprises improve product quality and ensure that the production environment meets the requirements of GMP standards.