Use of Compressed Air in Pharmaceutical Production Workshop

Compressed air plays a vital role in the pharmaceutical production workshop. Its use is extensive and strict, which is directly related to the quality, safety and production efficiency of drugs. The following are the core uses and key requirements of compressed air in pharmaceutical production workshops:

1. core use

1. process links of direct contact with drugs
   • aseptic Filling and Packaging compressed air is used to drive equipment such as filling machines and sealing machines to ensure that drugs (such as injections and oral liquids) are accurately filled and sealed in an aseptic environment. For example, in vaccine production, high-pressure oil-free compressed air pushes the piston to complete the filling of vaccine bottles to avoid microbial contamination.
   • Powder material treatment in the production of tablets and capsules, compressed air is used for conveying, mixing, drying and blowing of powder materials. For example, the powder is transported to the granulator by air flow, or the inside of the equipment is cleaned with compressed air to prevent cross-contamination.
   • Spray Drying and Coating: Compressed air is used as the power source to drive the atomizer in the spray drying tower to disperse the liquid medicine into tiny droplets and dry it into powder. At the same time, it is used to evenly spray the drug layer in the coating process.
2. Device Driver and Automation Control
   • pneumatic equipment power: Compressed air provides power for pneumatic valves, cylinders, agitators and other equipment to realize automatic operation. For example, in the extraction tank, compressed air drives the rotation of the stirring paddle to accelerate the extraction of active ingredients.
   • Cleaning and purging: Used to clean the surface of the equipment, the inside of the pipeline or the working area, and remove residue or dust. For example, use compressed air to purge the needle of the filling machine to prevent contamination caused by liquid medicine residue.
3. Environmental Control and Maintenance
   • aseptic environment maintenance in clean rooms (such as Class A and Class B clean areas), compressed air is maintained at positive pressure through the air purification system to prevent external pollution from invading and ensure compliance with GMP (Good Manufacturing Practice) requirements.
   • barometric balance: In a closed production environment, compressed air is used to balance the air pressure to avoid equipment damage due to pressure differences or affect process stability.
4. Laboratory and R & D Support
   • experimental instrument gas: Provide high-purity compressed air for gas chromatograph, liquid chromatograph and other analytical instruments to ensure the accuracy of experimental results.
   • reactor agitation: In drug research and development, compressed air drives the agitator in the reactor to promote uniform mixing of drugs and stable reaction.

2. Key Requirements

1. air Quality Standards
   • oil-free requirements oil-free air compressor (such as water-lubricated oil-free screw air compressor) must be used, or oil content must be reduced to a very low level (≤ 0.01 mg/m & sup3;) through precision filters (such as activated carbon filters and oil removal filters) to avoid oil contamination of drugs.
   • high purity gas compressed air shall comply with ISO 8573-1, with solid particles, moisture and oil content of Class 0 (highest cleanliness level) or Class 1 to meet aseptic production requirements.
   • microbial control: Ensure that the content of microorganisms (such as bacteria and fungi) in the compressed air meets GMP requirements by steam sterilization or chemical disinfection.
2. Equipment stability and reliability
   • intelligent control: The air compressor shall be equipped with abnormal pressure/temperature alarm and automatic shutdown protection function to reduce human intervention and failure risk.
   • Long life design: Choose models with a regular service life of more than 15000 hours to reduce maintenance costs.
   • standby redundancy: In key production links, it is recommended to use two air compressors to operate in parallel, one as the main use and the other as a backup to ensure the continuity of gas supply.
3. piping system design
   • material Selection stainless steel (such as 316L) and other corrosion-resistant materials shall be used for pipelines and gas storage tanks in contact with drugs to avoid metal ion pollution caused by potential difference corrosion.
   • Check valve and drain valve: Install a check valve at the outlet of the air compressor to prevent gas backflow, and install an automatic drain valve at the low point of the pipeline to drain the condensed water.
   • Clean piping the pipeline installation shall comply with GMP requirements, such as sanitary clamp connection, polishing treatment, etc., to reduce the risk of dead angle and microbial breeding.
4. Compliance and Certification
   • regulatory Compliance air compressor and supporting equipment to comply with FDA, GMP, ISO 13485 and other medical industry standards, and through the CFDA (State Drug Administration) certification.
   • Periodic verification compressed air system should be verified regularly (e. g. once every six months), including air quality inspection, equipment performance test, etc., to ensure continuous compliance with production requirements.

3. typical application cases

1. sterile injection production
   • scene: On the injection filling line, compressed air drives the needle of the filling machine to move up and down to complete the filling of the liquid medicine, and at the same time is used to purge the residual liquid medicine on the surface of the needle.
   • Requirements: Compressed air needs to undergo three-stage filtration (dust removal, water removal, oil removal) and sterilization to ensure sterility.
2. Tablet production
   • scene: In the tablet press, compressed air is used to purge the powder residue on the surface of the mold and prevent surface defects of the tablet (such as lobing and sticking).
   • Requirements: The compressed air pressure should be stable (usually 0.4-0.6MPa) to avoid pressure fluctuations affecting the quality of tablets.
3. Freeze-dried powder injection production
   • scene: In the freeze dryer, compressed air is used to open the door after breaking the vacuum, and to clean the residual liquid on the surface of the freeze-drying tray.
   • Requirements: Compressed air should be oil-free and water-free to avoid pollution of freeze-dried powder.

4. Summary

compressed air is the "life gas source" of the pharmaceutical production workshop, and its use runs through the whole chain of pharmaceutical production (from raw material processing to finished product packaging). In order to ensure the quality and safety of drugs, the following conditions must be strictly met:

1. air quality oil-free, high purity, sterile;
2. equipment reliability: Stable operation, standby redundancy;
3. pipeline design: Corrosion resistance, easy to clean, no dead angle;
4. compliance Verification: Compliance with regulatory requirements, regular testing.

Through the scientific configuration of compressed air system, the stability, efficiency and compliance of drug production can be significantly improved, and safe and effective drugs can be provided to patients.