Compressed air quality standards for pharmaceutical companies

The compressed air quality standards of pharmaceutical companies usually follow the "Good Manufacturing Practices" (GMP) and related international standards to ensure the safety and reliability of compressed air in the pharmaceutical process. The following are the main contents of the compressed air quality standards for pharmaceutical companies:

main standard indicators of 1.

1. Cleanliness:
   • the compressed air shall not contain impurities, dust and other pollutants. In industries such as pharmaceuticals and food processing, compressed air must meet strict cleanliness standards to prevent contamination of the product by contaminants.
2. Oil content:
   • impurities such as oil must not be present in the compressed air. Chinese Pharmacopoeia and GMP require compressed air oil content ≤ 0.1 mg/m & sup3;. In addition, the oil content shall be less than 0.01 mg/m & sup3;(surface area method) or less than 0.08 mg/m & sup3;(gravimetric method) according to the requirements of Annex C.
3. 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 ℃.
4. 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.
5. Smell:
   • the compressed air shall be free of odor.
6. Other:
   • depending on the specific application, there may be other specific requirements, such as pressure, flow, temperature, etc.
   • 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

1. detection method:
   • gas detection tube: through a specific chemical reaction to detect specific pollutants in compressed air.
   • Professional instrument detection: 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.
2. 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. Implementation Methods

1. develop detailed production process and operating procedures:
   • clear each link of the compressed air quality requirements and the corresponding control measures. At the same time, staff training should be strengthened to ensure that employees are familiar with and master the relevant requirements and operating procedures.
2. Choosing the right filter 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 regular inspection, maintenance and replacement should be carried out to ensure its normal operation and purification effect.
3. Establish a sound monitoring system:
   • 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.
4. Continuous improvement and optimization of production processes:
   • 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.

In summary, the compressed air quality standards of pharmaceutical companies cover many aspects to ensure the safety and reliability of compressed air in the pharmaceutical process. Pharmaceutical companies should strictly follow the relevant standards to ensure the quality and safety of drug production.