Medicinal compressed air standard

The standards for pharmaceutical compressed air are usually very strict to ensure that the air quality during the drug production process complies with relevant regulations and quality requirements. The following is a detailed summary of the standards for medical compressed air: 1. Main standard indicators

1. Cleanness
   • Compressed air must not contain impurities, dust and other pollutants.
   • There must not be impurities such as engine oil in the compressed air. The Chinese Pharmacopoeia and GMP (Good Manufacturing Practice for Drugs) require that the oil content of compressed air is ≤0.1mg/m³. In addition, according to certain standards, the oil content should be less than 0.01 mg/m³ (surface area method) or less than 0.08 mg/m³ (weight method).
2. Humidity
   • The relative humidity of compressed air should be maintained between 40% and 60%.
   • The dew point should be lower than -40℃. According to the provisions of “GB/T13277.1-2023 Compressed Air Part 1: Pollutant Purification Level”, compressed air of different levels has clear requirements for the dew point temperature, such as the dew point temperature value of compressed air of level 1 should be ≤-70℃.
3. Microorganisms and particulate matter
   • There should not be obvious particulate matter, oil, microorganisms, etc. in the compressed air.
   • The microbial limit standard usually requires less than 1 CFU/m³ (colony formation units per cubic meter).
   • The particle size of the solid particles should be less than or equal to 0.1μm.
4. Odor
   • Compressed air should be free of odor.
5. Other gas components
   • Compressed air must not contain gases other than normal air composition, such as carbon monoxide, and its content should be less than 5mg/m³.

2. Detection method and frequency

• Detection method:
  • Use gas detection tubes to detect specific pollutants in compressed air through specific chemical reactions.
  • Use advanced detection instruments, such as dew point instruments, dust particle counters, plankton samplers, etc. to accurately measure moisture, particulate matter, microorganisms, etc. in compressed air.
• Detection frequency:
  • Detection frequency is determined based on system status and product risk. The inspection cycle of newly installed systems can be set to 3 months, and mature systems can be extended to 6 months to 1 year for testing.

3. Control measures and quality assurance

• Control measures:
  • Clear the compressed air quality requirements and corresponding control measures in each link.
  • Strengthen employee training to ensure that employees are familiar with and master relevant requirements and operating procedures.
  • In order to remove pollutants such as dust, microorganisms and harmful gases in compressed air, appropriate filters and purification equipment should be selected, and regular inspection, maintenance and replacement should be carried out to ensure their normal operation and purification effect.
• Quality Assurance:
  • Real-time monitoring of quality indicators of compressed air. Once abnormal situations are found, corresponding measures should be taken in a timely manner to ensure the quality of the drug and production safety.
  • With the continuous advancement of technology and changes in market demand, pharmaceutical companies should continue to improve and optimize production process flow. During the improvement process, the requirements of compressed air quality standards should be fully considered, and more advanced, efficient and environmentally friendly equipment and processes should be adopted to improve the quality and production efficiency of drugs.

IV. Other precautions

• Equipment selection: The pharmaceutical industry recommends using oil-free screw units as compression systems to prevent impurities such as engine oil from entering the compressed air.
• Material selection: It is recommended to use 304 or above stainless steel material for the pipelines and pipeline valves through which compressed air flows to ensure the corrosion resistance and stability of the system.

In summary, the standards for medicinal compressed air cover multiple aspects to ensure that it meets the strict requirements in the drug production process. When choosing and using air compressors, pharmaceutical companies should strictly abide by relevant standards and regulations to ensure the safety and quality of drug production.