Application of Compressed Air in Biopharmaceutical

In the field of biopharmaceuticals, compressed air is the core element to ensure drug quality and production safety. Its application runs through key links such as fermentation, packaging, transportation, automatic control and experimental research, and has extremely high requirements for air quality. The following is a description of the application scenario and quality requirements:

1. core application scenarios

1. fermentation process
   in the production of citric acid, antibiotics, etc., compressed air provides oxygen to the bacteria. At this time, even a trace amount of oil will kill active bacteria, resulting in product grade degradation or pollution. For example, antibiotic fermentation requires completely oil-free air, otherwise it may cause strain variation and affect drug efficacy.

2. Packaging and Bottling

   • liquid preparation compressed air drives the filling machine to ensure accurate filling of the liquid medicine while avoiding oil contamination of the liquid.
   • solid preparation it is used for dedusting, coating, blister packaging and bottling of tablets. Oil-free air is required to prevent oil pollution on the surface of tablets and affect solubility or stability.
   • Printing and marking pneumatic printers rely on compressed air and require clean air to avoid ink contamination.

3. Material conveying

   • powder conveying: Transfer of raw materials from one process to another through a pneumatic conveying system, such as from a granulator to a filling machine. Oil-free air prevents powder from clumping or adsorbing oil, ensuring formulation accuracy.
   • Liquid pressure feeding: In the preparation of liquid medicine, compressed air provides pressure to push the liquid to the reaction kettle or storage tank, and the water content needs to be controlled to avoid microbial growth.

4. automated production process

   • pneumatic component drive cylinders, control valves, etc. rely on compressed air for precise action, and if the exhaust gas contains oil, it will pollute the production space and thus the final product.
   • Instrumentation and Control pneumatic instruments (such as pressure sensors and flow meters) need oil-free air to ensure accurate readings and avoid equipment failure due to oil blockage.

5. experiment and research

   • laboratory equipment gas supply: Precision instruments such as gas chromatographs and mass spectrometers require high-purity compressed air as carrier gas or auxiliary gas to ensure the reliability of experimental results.
   • Pneumatic tools such as pneumatic needles, sprayers, etc., used for sample processing or preparation spraying, requiring air-free oil to avoid cross-contamination.

2. Quality Requirements and Standards

1. oil content
   • core Requirements: It must be grade 0 oil-free air (oil content ≤ 0.01 mg/m & sup3;), I .e. oil droplets, suspended oil mist and oil vapor must be completely removed.
   • Basis GMP (good manufacturing practice) clearly stipulates that the compressed air in direct contact with drugs should be purified to meet the production requirements.
2. Moisture content
   • core Requirements: The pressure dew point should be controlled between -20 ℃ and -40 ℃ to ensure that there is no liquid water in the air.
   • Impact: Water will accelerate the growth of bacteria, leading to moisture absorption and deterioration of drugs, and corrosion of pipeline valves, shortening the life of equipment.
3. Dust particle content
   • core Requirements solid particles (such as dust and metal debris) need to be controlled at a very low level, usually requiring the number of 0.5μm particles ≤ 100 (I .e. ≤ 1 0.5μm particle per cubic meter of air).
   • Basis refer to the microbial control index of 100 grade biological clean room to ensure the sterility of drugs.
4. Content of biological particles
   • core Requirements: Microorganisms (such as bacteria, fungi) need to reach ≤ 1CFU/m & sup3;(colony forming unit/cubic meter), that is, the possibility of detecting viable bacteria is extremely small.
   • Impact microbial contamination can cause deterioration of drugs and even cause infection in patients, so it needs to be completely removed by high-efficiency filters (such as 0.01μm pore size).
5. No odor
   • core Requirements: Compressed air should have no peculiar smell to avoid irritating smell caused by oil or impurities, which will affect drug safety or patient acceptance.

Key Points of 3. System Design and Maintenance

1. drying and purification equipment
   • dryer refrigeration type (dew point ≥ 3 ℃) or adsorption type (dew point <3 ℃) dryer shall be selected according to the pressure dew point, and joint operation shall be carried out when necessary.
   • Filter multi-stage filtration system, including pre-filter (5μm), precision filter (1μm, 0.1 μm), activated carbon filter (0.01 μm), etc., to ensure the removal of particles, oil and microorganisms step by step.
2. Gas tank and balance tank
   • role: Buffer gas fluctuation to avoid filter damage caused by pressure drop and stabilize gas supply pressure.
   • Material use stainless steel (such as 316L) to prevent corrosion, and configure a respirator to maintain pressure balance in the tank.
3. Piping and Valves
   • material: All made of stainless steel (316L), welding using argon arc welding to reduce weld contamination.
   • Layout: Overhead laying, reduce contact with the ground, avoid dust accumulation; clean area open pipe, riser and valve need to minimize, in order to reduce the risk of pollution.
4. Monitoring and maintenance
   • online monitoring: Use dew point meter, laser particle counter, oil content detector and other equipment to monitor the quality of compressed air in real time.
   • Regular maintenance replace the filter element and desiccant every 3-6 months, and check the pipeline tightness every 1-2 years to ensure the continuous and stable operation of the system.