Standard for compressed air moisture content of sterile preparations

Standard for Moisture Content of Compressed Air in the Production of Sterile Preparations; Description of the Suitability of Gelanklin Water Lubricated Air Compressors

core Requirements for Compressed Air Moisture Content of 1. Sterile Preparations

the production environment of sterile preparations (such as injection, freeze-dried powder injection, etc.) shall be strictly followed. No microorganisms, no impurities, low moisture principle, compressed air as a key power source, its moisture content should meet the following standards:

1. dew point temperature requirement
   the dew point temperature of compressed air shall be ≤-70 ℃ (corresponding to water content of about 0.003 g/m & sup3;) to ensure that liquid water will not precipitate under high pressure or low temperature environment to avoid contamination of sterile preparations or corrosion of pipelines. For example, in the production of freeze-dried powder, if the water content of compressed air exceeds the standard, it may lead to moisture absorption and agglomeration of drugs, affecting the quality stability.

2. Layering standard in actual production

   • highly sensitive scene(such as direct contact with drugs or containers): dew point ≤-40 ℃ (water content of about 0.11 g/m & sup3;), suitable for filling, sub-packaging and other core links of sterile preparations.
   • General sensitive scene(such as pneumatic conveying, mixing and stirring): dew point ≤-20 ℃ (water content of about 1.07 g/m & sup3;), suitable for raw materials, ordinary Chinese medicine and other production links that are not sensitive to moisture.

3. Synergistic control of microorganisms and particulate matter
   the moisture content shall be managed in conjunction with the standards of microorganisms and particulate matter. For example, the compressed air entering the sterile area needs to be sterilized and filtered, and the microbial limit is ≤ 1 CFU/m & sup3;, and the particulate matter (≥ 0.5 μm) is ≤ 3520 grains/m & sup3; to prevent water from becoming the carrier of microbial growth.

Risk Analysis of Excessive Moisture Content in 2.

1. drug quality risk
   excessive moisture in the compressed air may cause:
   • sterile preparation moisture absorption deterioration (such as freeze-dried powder needle caking);
   • microbial contamination of pharmaceuticals (moisture promotes bacterial reproduction);
   • the sealing of the package is reduced (water vapor causes the aluminum-plastic package to bulge).
2. Equipment operation risk
   • pipeline corrosion: the combination of liquid water and trace impurities in compressed air (such as rust) accelerates the corrosion of the inner wall of the pipeline and shortens the life of the equipment;
   • pneumatic component failure: moisture into the cylinder or solenoid valve, resulting in slow action or stuck, affecting the continuity of production.

Solution of 3. Grankering Water Lubricated Single Screw Air Compressor

granklin water lubricated single screw air compressor through oil-free compression, efficient water removal, intelligent control technology to precisely match the requirements of the production of sterile preparations for the moisture content of compressed air:

1. oil-free compression to avoid secondary pollution
   the equipment adopts water-lubricated single screw and star wheel meshing compression technology, completely abandoning the oil lubrication system, eliminating the risk of oil pollution from the source and ensuring the purity of compressed air.

2. Multi-stage water removal system ensures stable dew point

   • pre-cooling water removal: Reduce the temperature of the compressed air to below 40°C through the air cooler, and precipitate most of the liquid water;
   • deep drying integrated freeze dryer and adsorption dryer can stably control the dew point below -70 ℃ to meet the requirements of the core link of aseptic preparation;
   • precision filtration equipped with 0.01μm precision filter to further remove residual moisture and tiny particles to ensure the output air quality.

3. Intelligent monitoring and dynamic regulation
   the equipment is equipped with a dew point monitoring sensor to feedback the moisture content of compressed air in real time, and automatically adjust the operating parameters of the dryer through the frequency conversion control system to ensure that the dew point temperature is always lower than the set value. For example, when the ambient humidity increases, the system can automatically enhance the drying capacity to avoid fluctuations in moisture content.

4. epilogue

the production of sterile preparations has extremely stringent requirements on the moisture content of compressed air and requires the adoption dew point control, microbial filtration, particulate removal and other multi-dimensional technical support. With its advantages of oil-free compression, efficient water removal and intelligent control, Granklin water-lubricated single screw air compressor can provide stable and pure compressed air solutions for aseptic preparation enterprises, helping enterprises to achieve drug quality improvement and production efficiency optimization.