@Air Compressor
2025-04-15
Compressed air inspection standards pharmaceutical companies
The pharmaceutical industry has strict standards for the quality of compressed air. The following arePurpose, inspection standards, special system requirementsDetailed analysis is carried out in three aspects:
1. The main uses of compressed air in the pharmaceutical industry
- device driver
- Power source for pneumatic valves, pneumatic pumps, agitators, conveyor belts and other equipment.
- automation control
- Drive pneumatic sensors and actuators to ensure precise control of the production process.
- Creation of sterile environment
- Through filtration and sterilization treatment, sterile air is provided for the clean room to prevent microbial pollution.
- Material handling and transportation
- Promote the flow of raw materials and intermediates in pipelines to achieve efficient mixing and transportation.
- Equipment cleaning and purging
- Remove residue on the surface of equipment to avoid cross-contamination.
- Experiments and testing
- Provide carrier gas for gas chromatographs, mass spectrometers and other equipment.
2. Pharmaceutical industry compressed air inspection standards
basisISO 8573-1andGMPNormative, the core indicators are as follows:
| indicators | standard requirements | Detection Tools |
|---|---|---|
| particulate matter | ≤0.1μm (level 1), ≤2000 pieces per cubic meter (0.1-0.5μm) | dust particle counter |
| oil content | ≤0.01mg/m³ (surface area method) or ≤0.08mg/m³ (weight method) | Oil content detector |
| water content | Dew point ≤-70℃ (Level 1) | dew point hygrometer |
| microbial | ≤1CFU/m³ (Class A clean area) | purification plant Su Su |
| gas composition | CO≤5mg/m³, no odor | gas detection tube |
| relative humidity | 40%-60% | temperature and humidity sensor |
detection frequency：
- New system: Tested every 3 months.
- Mature systems: Tested every 6-12 months (adjusted for risk).
3. Special requirements for compressed air systems for pharmaceutical companies
- equipment selection
- oil free compressor: Avoid lubricating oil contamination (such as screw-type or piston-type oilless models).
- drying system: Refrigeration + adsorption dryers are connected in series to ensure that the dew point is stable ≤-70℃.
- filtration system: Three-stage filtration (pre-stage + precision + sterilization), terminal accuracy ≤0.01μm.
- Piping and Materials
- 316L Stainless Steel: Electrolytic polishing of the inner wall to prevent rust and falling off.
- No dead angle design: Reduce pipe elbows to avoid retention of pollutants.
- operation management
- real-time monitoring: Online monitoring of dew point, oil content, and microorganisms.
- periodic verification: Conduct annual quality review and optimize control parameters.
- redundancy design: The standby air compressor is started for 4 hours every month to prevent internal corrosion.
- compliance requirements
- Comply with ISO 8573-1 Class 0: No dust, no oil, and no water.
- GMP compliance: Establish a complete quality risk management file that is traceable throughout the cycle.
4. Common problems and handling
- Dew point exceeds standard: Check the dryer heating rod and regeneration air flow rate.
- microbial contamination: Soak the pipes in 75% alcohol for 2 hours, rinse with purified water and then sterilize.
- oil residue: Replace the activated carbon filter and check whether the seals are burnt.
conclusion: Pharmaceutical companies ‘compressed air systems need to be controlled throughout the entire process from design, installation to operation to ensure compliance with ISO 8573 and GMP standards to ensure the safety and quality of drug production.