The quality standards of compressed air for pharmaceutical use are very strict to ensure the safety and reliability of the pharmaceutical production process. The following is a detailed summary of the quality standards for compressed air for pharmaceutical use:
main standard indicators of 1.
Cleanliness
- solid particle: Compressed air for pharmaceutical use shall not contain impurities, dust and other pollutants. The particle size of solid particles should be less than or equal to 0.1 microns to meet the cleanliness requirements of GMP for sterile drug production environment.
- Oil: There shall be no impurities such as oil in the compressed air. Chinese Pharmacopoeia and GMP require compressed air oil content ≤ 0.1 mg/m & sup3;. 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 Annex C.
Humidity
- relative humidity the relative humidity of compressed air for pharmaceutical use should be maintained between 40% and 60%.
- dew point: Dew point of compressed air shall be lower than -40 ℃. According to the provisions of GB/T13277.1-2023 Compressed Air Part 1: Pollutant Purification Level, the dew point temperature of Class 1 compressed air shall be ≤-70 ℃.
Microbial limit
- number of microorganisms: There should be no obvious microbial contamination in compressed air for pharmaceutical use. Microbial limit standards usually require less than 1 CFU/m & sup3;(colony forming units per cubic meter).
Other Requirements
- no odor: Compressed air for pharmaceutical use should have no peculiar smell.
- gas composition: 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;.
- SPECIFIC REQUIREMENTS: Depending on the specific application, there may be other specific requirements, such as pressure, flow, temperature, etc.
2. detection and monitoring
detection method
- gas detection tube: Detect specific pollutants in compressed air through specific chemical reactions.
- Professional instrument testing: Use advanced detection instruments, such as dew point meter, dust particle counter, buoyant bacteria sampler, etc., to accurately measure moisture, particles, microorganisms, etc. in compressed air.
Monitoring frequency
- newly installed system: The inspection period of the newly installed system can be set at 3 months.
- mature system: The mature system can be extended to 6 months to 1 year for testing. The specific inspection cycle should be determined according to the system verification results and product risks.
3. quality control measures
clear standards
- development of standards pharmaceutical companies should clarify the compressed air quality requirements and corresponding control measures in each link.
- Staff training: Strengthen staff training to ensure that employees are familiar with and master the relevant requirements and operating procedures.
Purification equipment
- filters and purification equipment in order to remove 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.
- real-time monitoring: Real-time monitoring of compressed air quality indicators, once found abnormal conditions, should take appropriate measures in a timely manner.
Continuous improvement
- optimize process flow pharmaceutical companies should continuously improve and optimize the production process, and fully consider the requirements of compressed air quality standards in the improvement process.
- Adopt advanced equipment: Adopt more advanced, efficient and environmentally friendly equipment and processes to improve drug quality and production efficiency.
4. Summary
the quality standard of compressed air for pharmaceutical use covers many aspects to ensure the safety and reliability of compressed air in the pharmaceutical process. Pharmaceutical companies should strictly follow the relevant standards and strengthen quality management and monitoring to ensure the quality and safety of drug production.
