The pharmaceutical industry has very strict requirements on the quality level of compressed air, which needs to meet the core standards of oil-free, dry, dust-free and sterile. The specific requirements are as follows:
1. Core Standards Basis
compressed air quality standards for pharmaceutical use are based on the international standard ISO 8573-1:2010, the Chinese Pharmacopoeia, GMP (Good Manufacturing Practices) and industry best practices. These standards set clear limits for contaminants such as solid particles, moisture, oil and microorganisms in compressed air.
2. key control parameters
solid particle:
- the particle size should be less than or equal to 0.1 μm to meet the cleanliness requirements of GMP for sterile drug production environment.
- In the Class A clean area (high-risk operation area), such as the filling area, the control of particulate matter is more stringent.
Oil:
- chinese Pharmacopoeia and GMP require compressed air oil content ≤ 0.1 mg/m & sup3;.
- In some special scenarios or high standards, the oil content should be less than 0.01 mg/m & sup3;(surface area method) or less than 0.08 mg/m & sup3;(weight method).
- EU medical standards also require oil content ≤ 0.01 mg/m & sup3;.
Moisture (dew point):
- in conventional pharmaceutical processes, the dew point of compressed air should be less than -40°C.
- In high-risk processes or special sterilization scenarios, the dew point should be ≤-70°C.
- Dew point temperature is an important indicator to measure the moisture content in compressed air. Low dew point can prevent water vapor condensation from affecting the quality of drugs and production equipment.
Microorganisms:
- according to clean room standards, such as ISO 5 (100) clean area, the microbial limit is usually less than 1CFU/m & sup3;(colony forming unit per cubic meter).
- Microbial contamination may directly affect the quality and safety of drugs, so it needs to be strictly controlled.
3. Implementation Requirements
filtration and purification equipment:
- multi-stage filtration systems such as pre-coarse filter (3μm), precision filter (0.01 μm) and sterilization filter (0.22 μm) shall be provided.
- The oil mist separator shall achieve a removal efficiency of 0.01ppm.
- Sterile grade filters (0.22 μm) are used in processes that directly contact pharmaceutical products.
Piping and Materials:
- the part in contact with compressed air shall be made of 316L stainless steel and other corrosion resistant materials to avoid carbon steel corrosion pollution.
- The inner wall treatment shall be electropolished to Ra ≤ 0.4 μm to reduce particle shedding.
- Stainless steel pipes and carbon steel supports shall be padded with insulating materials to prevent potential difference corrosion.
Monitoring and verification:
- real-time monitoring equipment such as dew point meter and oil detector shall be installed to provide early warning for compressed air quality.
- Every 6 months for dew point, oil content, particle number testing, in line with ISO 12500 standards.
- 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.
System Design:
- oil-free air compressor adsorption dryer three-stage filtration combination, the end of the configuration of sterile filter.
- Add steam sterilization system, air blow 30 minutes after high temperature steam sterilization.
- The dew point of the dryer shall be 10 ℃ lower than the lowest ambient temperature to prevent freezing.
4. risk control and continuous improvement
risk Assessment:
- conduct regular risk assessment of compressed air system and update control measures.
- Dynamic monitoring of system status and product risks to ensure that compressed air quality continues to meet standards.
Continuous improvement:
- with the continuous advancement of technology and changes in market demand, pharmaceutical companies should continue to improve and optimize the production process.
- Adopt more advanced, efficient and environmentally friendly equipment and processes to improve drug quality and production efficiency.
