Humidity standard for pharmaceutical compressed air

In the pharmaceutical industry, the humidity control of compressed air is very important because it directly affects the quality and safety of pharmaceutical products. The humidity standard of compressed air for pharmaceutical use usually involves two aspects of relative humidity and moisture dew point, and the specific requirements are as follows:

1. relative humidity

the relative humidity of the compressed air in the pharmaceutical production workshop should be kept within a certain range to avoid affecting the production of drugs. In general, this range is in 40% to 60% between.

2. moisture dew point

the moisture dew point is the temperature at which the water vapor content in the compressed air reaches saturation. In the pharmaceutical industry, the dew point temperature of compressed air has strict requirements to ensure the dryness of compressed air. Specific requirements are as follows:

• general Requirements: Dew point temperature shall be less -40 ℃. This means that when the temperature of the compressed air drops to -40°C, the water vapor in it will condense into water to ensure the dryness of the compressed air.
• Higher requirements in some occasions with high humidity requirements, such as the production environment of sterile drugs, the dew point temperature may be less -20 ℃ even lower.

In addition, the humidity and moisture dew point of compressed air are divided into different levels according to GB/T 13277.1-2023 Compressed Air Part 1: Pollutant Purification Levels. For example, the dew point temperature value of level 2 compressed air should be ≤-40 ℃, which is equivalent to the water vapor content ≤ 127.34ppmv.

The Importance of 3. Humidity Control

in the pharmaceutical process, if the humidity of the compressed air is too high, it may cause the following problems:

• equipment corrosion: Moisture may corrode compressed air pipes and equipment and shorten their service life.
• drug contamination: Moisture may carry microorganisms and bacteria, which may cause pollution to drugs and affect the quality and safety of drugs.
• Process failure: Moisture may affect the stability of the pharmaceutical process, leading to failures and losses in the production process.

Therefore, pharmaceutical companies must strictly control the humidity of compressed air to ensure that the dryness of compressed air meets the requirements of relevant standards.

4. humidity control method

in order to ensure that the humidity of the compressed air meets the standard, pharmaceutical companies can take the following measures:

• selection of suitable air compressor: Choose air compressors with high-efficiency dehumidification function, such as refrigeration dryers, adsorption dryers, etc.
• Install post-treatment equipment: Install post-processing equipment, such as filters, dryers, etc., at the air outlet of the air compressor to further reduce the humidity of the compressed air.
• Regular inspection and maintenance regularly test the humidity of compressed air to ensure compliance with relevant standards. At the same time, the air compressor and post-processing equipment are regularly maintained to ensure their normal operation.

In summary, the humidity standard of compressed air for pharmaceutical use involves two aspects of relative humidity and moisture dew point, and the specific requirements should be determined according to the production process and quality requirements of the drug. Pharmaceutical companies must take effective measures to strictly control the humidity of compressed air to ensure the quality and safety of drugs.