Gmp requires high pressure nitrogen and compressed air pressure requirements
According to GMP (Good Manufacturing Practice) and relevant pharmaceutical industry standards, the pressure requirements for high-pressure nitrogen and compressed air need to be comprehensively determined based on specific application scenarios and equipment performance. The following are detailed answers based on authoritative data and industry practice:
1. High pressure nitrogen pressure requirements
- General industrial applications：
The high pressure nitrogen pressure range is usually 1000-3000 psi(approximately 68.94-206.84 bar), suitable for pneumatic tools, nitrogen springs, chemical reaction inert protection and other scenarios. This range has been safety-verified and balances process requirements with operational safety. - Specific scenarios in the pharmaceutical industry：
- In the nitrogen system pressure reducing device, the inlet pressure is ≤15 MPa, and the outlet pressure is ≤1.6 MPa. The final pipeline pressure needs to be adjusted to 0.6 MPa and remain stable.
- When leaking the pipeline, it is necessary to test the pressure to 0.6 MPa, and maintain the pressure for 8 hours.
2. Compressed air pressure requirements
- General Standards for the Pharmaceutical Industry：
The compressed air pressure range is usually 0.4-0.8 MPa(4-8 bar), depending on the application scenario:- Medical and health use: The output air pressure of the air compressor needs to be controlled at 0.7-0.8 MPaEnsure the flow rate and purity of medical gases.
- Ward/operating room: The operating pressure is low, generally 0.4-0.5 MPa。
- Oral Treatment Center: Due to the large instantaneous demand, the pressure range can be 0.5-0.8 MPa。
- Special requirements for pharmaceutical processes：
- Biological fermentation, cell culture: Purified air or nitrogen is required, and the pressure is usually controlled to 0.6 MPa。
- Instrument air supply system: Pressure of pneumatic instrument power source is 0.5-0.7 MPa, the maximum shall not exceed 0.9 MPa.
3. GMP core specifications and quality control
- pressure stability：
- The compressed air system needs to be equipped with an air storage tank (the recommended capacity is 20%-30% of the air compressor exhaust volume) to reduce pressure fluctuations.
- The range of pressure fluctuations needs to be controlled within ±0.1 MPa Within, avoid equipment misoperation or reduction in processing accuracy.
- Gas Quality Standards：
- oil content: ≤0.1 mg/m³ (some scenarios require ≤0.01 mg/m³).
- cleanliness: The particle size of solid particles is ≤0.1 μm, and the microbial content must meet medical standards.
- humidity: It is recommended to control it below 50% to prevent adverse effects on drugs or equipment.
4. Safety operation and compliance recommendations
- equipment selection：
- Select the air compressor according to the total air consumption and pressure requirements, and reserve a margin of 10%-20%.
- Priority is given to oil-free lubricated air compressors to avoid the risk of oil pollution.
- periodic verification：
- Check the pressure gauge and drain valve daily; check the accuracy of the pressure gauge quarterly.
- Comprehensive gas quality testing is carried out every year, including indicators such as oil content, cleanliness, and humidity.
- emergency plan：
- Set a pressure abnormality alarm threshold (such as an alarm when the compressed air pressure is lower than 0.4 MPa or higher than 0.8 MPa).
- Formulate emergency response procedures in case of sudden pressure drop or equipment failure to ensure production safety.
example：
A biopharmaceutical workshop uses high-pressure nitrogen to protect the reaction vessel, and its pressure system is set to: the outlet pressure of the nitrogen cylinder is 1.6 MPa, which is reduced to 0.6 MPa through a pressure reducing valve for equipment use. At the same time, the pressure of the compressed air system in the workshop is set to 0.7 MPa, and it is equipped with a 3 m³ air storage tank and a freeze dryer to ensure that the gas quality meets the standard and the pressure is stable.
