In pharmaceutical factories, clean compressed air is a key factor to ensure the safety, stable quality and compliance with regulatory requirements. Its role runs through all aspects of drug production and is embodied in the following aspects:
1. prevent cross-contamination and ensure drug purity
- scenes of direct contact with drugs:
- raw material handling compressed air is used to transport powdered or granular raw materials (such as active ingredients, excipients). If it contains oil, water or particulate matter, it will pollute the raw materials and cause deviation of pharmaceutical composition.
- Preparation production in the process of tabletting, filling and packaging, compressed air directly contacts the surface or inner packaging of the drug, and clean air can avoid the attachment of oil, microorganisms or particles, which will affect the appearance and stability of the drug.
- sterile preparation such as injection, eye drops, etc., compressed air must meet the standard of aseptic and pyrogen-free, otherwise it may introduce microorganisms or endotoxin, causing the risk of infection in patients.
- Risk of cross-contamination:
- pharmaceutical companies usually produce a variety of drugs. If the cleanliness of the compressed air system is insufficient, oil or microorganisms may spread to different production lines through the air, resulting in drug odor, deterioration or reduced efficacy.
2. protect production equipment and extend service life
- pneumatic equipment relies on clean air:
- pneumatic valves, cylinders, agitators and other equipment are widely used in pharmaceutical factories. If the compressed air contains oil, water or particulate matter, it will accelerate the wear of the equipment, resulting in aging seals, stuck valves or scratched pistons, and increase the frequency of downtime and maintenance.
- For example, if the pneumatic valve is slow due to oil deposition, it may affect the accuracy of drug filling and cause inaccurate dosage.
- Avoid corrosive damage:
- if the moisture in the compressed air is not completely removed, it may condense into liquid water, mix with oil to form emulsion, corrode metal pipes and equipment, and shorten the life of the equipment.
3. compliance with regulatory requirements to ensure compliant production
- international Standards and Pharmacopoeia Specifications:
- ISO 8573-1: The International Organization for Standardization divides the quality of compressed air into Class 0-6. Pharmaceutical companies usually require Class 0 (no oil) or Class 1 (oil content ≤ 0.01 mg/m & sup3;) to meet the requirements of GMP (Good Manufacturing Practice).
- National Pharmacopoeia for example, the "Chinese Pharmacopoeia" and "United States Pharmacopoeia" clearly stipulate that the compressed air used for drug production must be oil-free, sterile, and pyrogen-free, and the content of particulate matter must be controlled at a very low level.
- Audit and Certification Requirements:
- pharmaceutical companies need to pass the FDA (U.S. Food and Drug Administration), EMA (European Drug Administration) and other agencies of the audit, clean compressed air is one of the focus of the audit. Failure to meet the standards may result in a product recall, production suspension or fine.
4. to ensure the safety and health of operators
- avoid inhaling harmful substances:
- if the compressed air contains oil mist or volatile organic compounds (VOCs), long-term inhalation by the operator may cause respiratory diseases or allergic reactions.
- Clean air can reduce the concentration of oil mist in the workshop and improve the working environment.
- Prevent explosion risk:
- some pharmaceutical raw materials (such as dust) may form explosive mixtures when mixed with air. If the compressed air contains oil, it may increase the risk of explosion. Clean air can reduce these risks.
5. to support specific process requirements
- aseptic environment maintenance:
- in the production of sterile preparations, compressed air needs to be treated through a sterilization filter (e. g. 0.2μm filter element) to ensure sterility and avoid microbial contamination.
- For example, equipment such as freeze dryers and filling machines rely on clean compressed air to maintain sterility.
- high precision control:
- some processes (such as cell culture, fermentation) require extremely high cleanliness of compressed air, and oil or particulate matter may inhibit the growth of microorganisms or damage the cell structure, affecting product quality.
6. Typical Application Scenario Example
| application Scenarios | compressed air quality requirements | potential risks (if not met) |
|---|
| raw material conveying | oil content ≤ 0.01 mg/m & sup3;, particulate matter ≤ 0.1μm | raw material pollution and composition deviation |
| tablet pressing process | oil-free, water-free, particulate matter ≤ 5μm | tablet surface oil spots, sticking and uneven hardness |
| filling process | sterile, pyrogen-free, oil content ≤ 0.001 mg/m & sup3; | microbial contamination, endotoxin exceeding standard |
| packing process | oil-free and dry (dew point ≤-40 ℃) | packaging materials adsorb oil and seal decrease |
| pneumatic equipment drive | oil content ≤ 0.1 mg/m & sup3;, moisture content ≤ 10ppm | equipment wear, slow action, downtime for maintenance |
7. solutions and recommendations
- choosing an oil-free compressed air system:
- oil-free screw air compressor or water-lubricated oil-free air compressor is preferred to eliminate oil pollution from the source.
- Avoid using the combination of oil and gas separator of oil injection screw machine, because the oil can not be completely removed.
- Multistage filtration and drying treatment:
- configure a pre-filter (to remove large particles), a precision filter (to remove tiny particles), an activated carbon filter (to adsorb oil mist), and a sterilization filter (to meet sterility requirements).
- Use a refrigeration dryer or an adsorption dryer to reduce the dew point of the compressed air to below -40°C to avoid moisture condensation.
- Regular inspection and verification:
- compressed air quality, including oil, particulate, moisture and microbiological content, shall be checked regularly in accordance with ISO 8573-1.
- Validation of compressed air systems for critical processes such as aseptic filling to ensure ongoing GMP compliance.
- Maintenance and training:
- establish a compressed air system maintenance plan, regularly replace the filter element and check the tightness.
- Operators are trained to emphasize the importance of clean compressed air and operational practices.
