How to choose oil-free screw air compressor for pharmaceutical production
Pharmaceutical production industry background
The pharmaceutical production industry has extremely strict requirements for the cleanliness of compressed air, involving key links such as aseptic filling, freeze-drying process, and oxygen supply in fermentation tanks. According to the GMP requirements of the pharmaceutical industry for clean areas for drug production, the oil content of compressed air must be <0.01mg/m³, the dust content must be ≤0.01μm, and the dew point must be stable at-20℃ (PDP). Even trace amounts of oil or microbial contamination may lead to deterioration of drugs, batch scrapping, and even medical accidents. The oil-free screw air compressor has passed the German Tüv “0” oil-free certification and has become a necessary equipment to pass the FDA 21 CFR Part 11 electronic record compliance review.
Why does pharmaceutical production need oil-free screw air compressors?
- drug safety：
Oil residue will cause visible foreign matter in the injection to exceed the standard, violating the General Chapter 0904 standard of China Pharmacopoeia. - process stability：
The dew point control accuracy of ±1℃ meets the requirements of the freeze-drying process for water activity (Aw≤0.25). - Certification compliance：
It has passed the US FDA filing and the EU CE certification, and supports sterile workshops to pass the ISO 13485 medical device quality management system certification. - microbial control：
The total number of compressed air colonies is ≤1CFU/m³ (verified by product quality and safety certification certificate).
Shanghai Granklin Group’s oil-free screw air compressor adopts oil-free compression technology that meets international standards to ensure continuous operation in Class A clean areas.
Selection of core parameters for pharmaceutical production
According to ISO 8573-1:2010 Class 0 and GMP standards, the following parameters need to be verified:
- oil content:<0.01mg/m³ (German Tüv “0” oil-free certification is required).
- dew point control:-20℃ (PDP) ±2℃ (requires environmental management system certification support).
- exhaust pressure: 0.8MPa±0.5%(required to be verified by quality management system certification certificate).
- on-line sterilization: The high temperature steam sterilization module (121℃/30min) complies with the ASME BPE-2019 Bioprocess Equipment Standard.
The oil-free screw air compressor has passed 316L stainless steel all-welded pipelines and combined with occupational health and safety management system certification to eliminate cross-contamination risks.
Potential risks of not using oil-free screw air compressors
If traditional oil lubrication equipment is used, it may cause:
- Batch scrapping: Oil pollution caused visible foreign matters in the freeze-dried powder injection to exceed the standard, and the loss in a single batch exceeded 20 million yuan.
- Certification revocation: The EU GMP audit found that the oil content of compressed air exceeded the standard and the export qualification was cancelled.
- equipment corrosion: Acidic substances produced by lubricating oil oxidation accelerate pitting corrosion of 316L stainless steel pipes.
- legal accountability: Violations of FDA cGMP requirements face product recalls and administrative penalties.
By comparing the ISO 8573-1:2010 standard with traditional equipment parameters (oil content ≥0.1mg/m³), the necessity of oilless screw technology can be clarified.
Economic benefits of using oil-free screw air compressors
- Reduce quality costs: The drug pass rate will increase by 3%-5%, and the annual scrapping cost will be reduced by 15 million yuan.
- energy-saving benefit: Permanent magnet frequency conversion technology saves annual electricity bills by more than 450,000 yuan (250kW model).
- maintenance costs: The oil-free design extends the filter element replacement cycle to 8000 hours and reduces annual maintenance costs by 60%.
- Carbon tax optimization: In line with the EU Carbon Border Regulation Mechanism (CBAM), export tariffs are reduced by 5%-8%.
Comparison of oil-free screw air compressor versus oil-containing compressor in pharmaceutical production
| parameters | Oil-free screw air compressor | Traditional oil lubrication equipment |
|---|---|---|
| oil content | <0.01mg/m³ (Tüv certification) | ≥0.1mg/m³ (three-level filtration required) |
| Dew point control accuracy | ±1℃ (intelligent humidity module) | ±5℃ (mechanical adjustment error) |
| microbial control | ≤1CFU/m³ (online monitoring) | ≥100CFU/m³ (high risk of contamination) |
| Average annual maintenance cost | 80,000 – 120,000 yuan (no consumables design) | 300,000 – 500,000 yuan (oil-containing filter replacement) |
| equipment life | 15-20 Year (fully enclosed structure) | 6-10 Year (caused by oil pollution corrosion) |
| compliance of | Passed 8 certifications including CE/Tüv/EU GMP | Only meets basic security certification |
summary
Choosing oil-free screw air compressors for pharmaceutical production is the core decision to ensure drug safety and production compliance. By strictly adhering to the ISO 8573-1:2010 standard and German Tüv “0” certification, such equipment eliminates the risk of oil pollution and improves international market access. Leading manufacturers such as Shanghai Granklin Group use innovative technologies to promote industrial upgrading and provide global pharmaceutical companies with clean compressed air solutions that meet PIC/S GMP requirements.