Can pharmaceutical companies use micro-oil air compressors for process compressed air?

Compliance analysis of using micro-oil air compressors for process compressed air in pharmaceutical factories

Pharmaceutical production has extremely strict quality requirements for compressed air, and requires comprehensive evaluation from three dimensions: pollution control, regulatory compliance, and process adaptability. The following is a professional analysis based on industry norms and technical practices:

1. Quality risks of drug production

1. Oil pollution risk
   Micro-oil air compressors use lubricating oil to achieve bearing lubrication and sealing, but oil carryover may occur during operation. Experimental data shows that even under ideal operating conditions, the oil content of its exhaust gas may still reach 0.01-0.1mg/m³. Such oils may enter the process in the form of aerosols or vapors, posing the following risks:

• Drug contamination: Oil reacts chemically with pharmaceutical ingredients, resulting in degradation of active ingredients or the production of unknown impurities.
• equipment corrosion: Oil deposits on the inner wall of the pipeline, breeding microorganisms and forming biofilms, increasing the risk of pollution to the process system.
• product recall: In the production of sterile preparations, oil pollution may trigger microbial limits to exceed the standard, resulting in the scrapping of the entire batch of products.

2. Particulate matter control challenges
   Micro-oil air compressors need to be equipped with a multi-stage filtration system to reduce the oil content, but the filter poses a risk of penetration. For example, if the front-end filtration efficiency is insufficient, the back-end precision filter may fail prematurely due to excessive load, resulting in a breakthrough of particulate matter.

2. Requirements of regulations and industry norms

1. International standard constraints
   According to the ISO 8573 “Compressed Air” standard, compressed air for pharmaceutical production must meet:

• oil content: ≤0.01mg/m³ (Class 1 level), while micro-oil air compressors are difficult to meet the standard stably.
• particulate matter: ≤0.1μm particle size (Class 1 level), which needs to be achieved through a high-efficiency filter.

2. Drug regulatory requirements
   China GMP Appendix “Sterile Drugs” clearly requires:

• Compressed air that comes into direct contact with medicines requires sterilization and filtration, and filter integrity needs to be tested regularly.
• Compressed air used for the production of non-sterile drugs needs to control microbial load and prevent cross-contamination.

3. Process adaptability analysis

1. High-risk processes are prohibited
   The use of micro-oil air compressors is strictly prohibited in the following scenarios:

• sterile drug product manufacturing: For injections and lyophilized powder injections, oil may destroy the sterile barrier.
• Inhalation preparation production: Oil may deposit on the surface of aerosolized particles, affecting the delivered dose.
• Fermentation of biological products: Oil inhibits microbial metabolism, resulting in a decrease in fermentation efficiency.

2. Use caution in low-risk processes
   If you need to use a micro-oil air compressor in the following scenarios, you need to meet:

• Equipped with a three-stage filtration system (front-end oil removal + mid-end dust removal + terminal sterilization).
• Install an online oil content detector to monitor oil content in real time.
• Filter integrity testing and compressed air quality audit are conducted annually.

4. Alternatives and technical paths

1. oil-free air compressor
   Use water-lubricated or oil-free screw technology to eliminate the risk of oil contamination at the source. Such equipment has achieved:

• The oil content is ≤0.003mg/m³, which is much lower than that of micro-oil models.
• Maintenance costs are reduced by 30%, as there is no need to replace the oil filter.

2. Modification of micro-oil air compressor
   If micro-oil equipment is installed, it can be downgraded to use using the following measures:

• Add an activated carbon adsorption device to remove gaseous oil.
• Shorten the filter replacement cycle to ensure that the filtration efficiency is ≥99.999%.
• Establish a compressed air quality monitoring plan and conduct quarterly sampling and testing.

conclusion
Pharmaceutical factory process compressed airUnsuitable for using micro-oil air compressors, especially in high-risk processes that come into direct contact with drugs. If it needs to be used for special reasons, the risks must be controlled within acceptable ranges through multiple filtering, online monitoring, regular audits and other measures. It is recommended to give priority to oil-free air compressors and be equipped with high-efficiency purification systems to ensure drug quality and patient safety.