What are the quality standards for air compressed in pharmaceuticals

The quality standards for compressed air for pharmaceuticals are very strict to ensure safety and reliability in the production process of pharmaceuticals. The following is a detailed summary of the quality standards for compressed air for pharmaceuticals: 1. Main standard indicators

1. Cleanness
   • Solid particles: The compressed air for pharmaceuticals must not contain impurities, dust and other pollutants. The particle size of the solid particles should be less than or equal to 0.1 microns to meet the cleanliness requirements of GMP for the sterile drug production environment.
   • Oil content: There must be no impurities such as engine oil in the compressed air. The Chinese Pharmacopoeia and GMP require that the compressed air oil content is ≤0.1mg/m³. According to the requirements of Appendix C, 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
   • Relative Humidity: The relative humidity of compressed air for pharmaceuticals should be maintained between 40% and 60%.
   • Dew point: The dew point of compressed air should be lower than -40℃. According to the provisions of “GB/T13277.1-2023 Compressed Air Part 1: Pollutant Purification Level”, the dew point temperature value of Level 1 compressed air should be ≤-70℃.
3. Microbial Limitation
   • Microbial Number: There should be no obvious microbial contamination in the compressed air for pharmaceuticals. Microbial limit standards usually require less than 1 CFU/m³ (colony formation units per cubic meter).
4. Other requirements
   • No odor: The compressed air for pharmaceuticals should be free of odor.
   • Gas composition: Compressed air must not contain gases other than normal air composition, such as carbon monoxide, whose content should be less than 5mg/m³.
   • Special Requirements: Depending on the specific application, there may be other specific requirements, such as pressure, flow rate, temperature, etc.

2. Detection and monitoring

1. Detection methods
   • Gas detection tube: Detect specific pollutants in compressed air through specific chemical reactions.
   • Professional Instrument Testing: 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.
2. Monitoring frequency
   • New installation system: The inspection cycle of the newly installed system can be set to 3 months.
   • Maturity System: Maturity System can be extended to 6 months to 1 year for testing. The specific inspection cycle should be determined based on the system verification results and product risks.

3. Quality control measures

1. Clarify standards
   • Develop standards: Pharmaceutical companies should clarify the compressed air quality requirements and corresponding control measures in each link.
   • Employee Training: Strengthen employee training to ensure that employees are familiar with and master relevant requirements and operating procedures.
2. Purification Equipment
   • Filters and Purification Equipment: In order to remove pollutants such as dust, microorganisms and harmful gases in compressed air, appropriate filters and purification equipment should be selected, and periodically tested, maintained and replaced.
   • Real-time monitoring: Monitor the quality indicators of compressed air in real time. Once abnormal situations are found, corresponding measures should be taken in a timely manner.
3. Continuous improvement
   • Optimize process flow: Pharmaceutical companies should continuously improve and optimize production process flow, and should fully consider the requirements of compressed air quality standards during the improvement process.
   • Using advanced equipment: Adopt more advanced, efficient and environmentally friendly equipment and processes to improve the quality and production efficiency of drugs.

IV. Summary

The quality standards of compressed air for pharmaceuticals cover multiple aspects to ensure the safety and reliability of compressed air in the pharmaceutical process. Pharmaceutical companies should strictly follow relevant standards and strengthen quality management and monitoring to ensure the quality and safety of drug production.