Can oil air compressors be used in the pharmaceutical system?
Technical compliance statement on the use of oily air compressors in the pharmaceutical system
In the pharmaceutical production system, compressed air is a key utility medium, and its quality standards are directly related to drug safety and process compliance. After systematic evaluation, the relevant technical requirements are now explained as follows:
1. Quality standard requirements
According to the general specifications of the pharmaceutical industry, the compressed air required in the production processes that directly contact drugs (such as liquid preparation, sub-packaging, filling, etc.) must meet:
- Oil content ≤0.01mg/m³ (ISO 8573-1 Level 1 standard)
- Particulate matter ≤0.1μm (Class 1 cleanliness)
- Microbial load ≤1CFU/m³
Oiled air compressors use lubricating oil to lubricate mechanical components, which poses a risk of oil migration and is difficult to stably meet the above cleanliness requirements. In principle, they are not suitable for production scenarios in direct contact with drugs.
2. Technical alternatives
The following oil-free solutions are recommended:
- Oil-free dry screw technology: Through special coating and sealing design, zero-lubricant use is achieved
- Water-lubricated oil-free technology: Use purified water as the working medium to completely eliminate the risk of oil pollution
- Membrane air drying technology: Used in combination with oil-free compressor to simultaneously remove oil and bacteria
3. Special scenario assessment
For auxiliary systems that are not in direct contact with drugs (such as factory pneumatic control, equipment cleaning, etc.), if oil-containing air compressors need to be used, they must meet:
- Equipped with a three-stage precision filtration system (activated carbon filtration + coalescence filtration + sterilization filtration)
- Establish an online oil monitoring device (real-time display of oil content)
- Develop a strict periodic testing plan (at least once a week)
- Implement change control procedures and any process adjustments require approval from quality department
4. Compliance recommendations
It is recommended that pharmaceutical companies establish a hierarchical management system for compressed air systems:
- Oil-free technology must be used in critical areas (Class A/B clean areas)
- Risk assessment reports need to be completed when oil-containing technology is used in non-critical areas (C/D clean areas)
- Conduct regular compressed air quality audits (at least once a year)
- Maintain complete system verification documents (including DQ/IQ/OQ/PQ)
When companies choose compressed air solutions, they should give priority to oil-free technology routes to minimize product quality risks. If oily technology is needed, a sound pollution prevention and control system must be established to ensure that the entire process meets the requirements of good drug production management regulations.
