Pharmaceutical compressed air humidity standard
In the pharmaceutical industry, humidity control of compressed air is crucial because it directly affects the quality and safety of the drug. The humidity standards for compressed air for pharmaceuticals usually involve two aspects: relative humidity and moisture dew point. The specific requirements are as follows: 1. Relative humidity
The relative humidity of compressed air in pharmaceutical production workshops should be kept within a certain range to avoid affecting drug production. Generally speaking, this range is between 40%~60%.
2. Moisture dew point
Moisture dew point refers to the temperature when the water vapor content in 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. The specific requirements are as follows:
- General requirements: The dew point temperature should be less than -40℃. This means that when the temperature of the compressed air drops to -40°C, the water vapor in it condenses into water, ensuring the dryness of the compressed air.
- Higher requirements: In some occasions where humidity requirements are extremely high, such as the production environment of sterile drugs, the dew point temperature may be less than -20℃ or even lower.
In addition, according to the provisions of “GB/T 13277.1-2023 Compressed Air Part 1: Pollutant Purification Level”, the humidity and moisture dew point of compressed air are divided into different levels. For example, the dew point temperature value of the compressed air of the second stage should be ≤-40°C, which is equivalent to the water vapor content ≤127.34ppmv.
3. The importance of humidity control
In the pharmaceutical process, if the humidity of compressed air is too high, it may lead to the following problems:
- Equipment corrosion: Moisture may corrode compressed air pipes and equipment, shortening its service life.
- Drug Contamination: Moisture may carry microorganisms and bacteria, causing pollution to drugs and affecting the quality and safety of drugs.
- Process failure: Moisture may affect the stability of the pharmaceutical process, resulting in 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 relevant standards.
IV. Humidity control method
In order to ensure that the humidity of compressed air meets the standards, pharmaceutical companies can take the following measures:
- Select a suitable air compressor: Choose an air compressor with efficient dehumidification function, such as a refrigeration dryer, suctionAttached dryer, etc.
- Installation of post-processing equipment: Install post-processing equipment, such as filters, dryers, etc., at the air outlet of the air compressor, further reducing 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 after-treatment equipment are regularly maintained to ensure their normal operation.
To sum up, the humidity standards for compressed air for pharmaceuticals involve two aspects: relative humidity and moisture dew point. The specific requirements should be determined based on 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.
