Standard for Compressed Air for Medicinal use

The standards for medicinal compressed air are usually very strict to ensure that the air quality in the pharmaceutical production process meets relevant regulations and quality requirements. The following is a detailed summary of medicinal compressed air standards:

main standard indicators of 1.

1. Cleanliness

   • the compressed air shall not contain impurities, dust and other pollutants.
   • Impurities such as oil must not be present in the compressed air. The Chinese Pharmacopoeia and GMP(Good Manufacturing Practice for Drugs) require the oil content of compressed air to be less than or equal to 0.1 mg/m & sup3;. Furthermore, according to certain standards, the oil content should be less than 0.01 mg/m & sup3;(surface area method) or less than 0.08 mg/m & sup3;(gravimetric method).

2. Humidity

   • the relative humidity of compressed air should be maintained between 40% and 60%.
   • Dew point shall be lower than -40 ℃. According to the provisions of "GB/T13277.1-2023 Compressed Air Part 1: Pollutant Purification Level", different levels of compressed air have clear requirements for dew point temperature, such as the dew point temperature of level 1 compressed air should be ≤-70 ℃.

3. Microorganisms and particulate matter

   • there should be no obvious particles, grease, microorganisms, etc. in the compressed air.
   • Microbial limit standards usually require less than 1 CFU/m & sup3;(colony forming units per cubic meter).
   • The particle size of the solid particles should be less than or equal to 0.1 μm.

4. Smell

   • the compressed air shall be free of odor.

5. Other gas components

   • compressed air shall not contain gases other than normal air composition, such as carbon monoxide, and its content shall be less than 5 mg/m & sup3;.

2. detection method and frequency

• detection method:

  • A gas detection tube is used to detect specific contaminants in compressed air through specific chemical reactions.
  • Use advanced detection instruments, such as dew point meter, dust particle counter, floating bacteria sampler, etc., to accurately measure the moisture, particulate matter and microorganisms in the compressed air.

• Detection frequency:

  • the detection frequency is determined according to the system status and product risk. The inspection cycle of the newly installed system can be set at 3 months, and the mature system can be extended to 6 months to 1 year for inspection.

3. Control Measures and Quality Assurance

• control measures:

  • clear each link of the compressed air quality requirements and the corresponding control measures.
  • Strengthen staff training to ensure that employees are familiar with and master the 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 its normal operation and purification effect.

• Quality Assurance:

  • real-time monitoring of compressed air quality indicators. Once the abnormal situation is found, corresponding treatment measures should be taken in time to ensure the quality of drugs and production safety.
  • With the continuous advancement of technology and changes in market demand, pharmaceutical companies should continue to improve and optimize the production process. In the process of improvement, 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 drug quality and production efficiency.

4. Other Considerations

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

In summary, the standard for medicinal compressed air covers several aspects to ensure that it meets the stringent requirements of the pharmaceutical manufacturing process. When selecting and using air compressors, pharmaceutical companies should strictly abide by relevant standards and regulations to ensure the safety and quality of drug production.