Pharmaceutical companies use compressed air in multiple production processes and auxiliary systems, with a wide range of applications and strict air quality requirements to ensure the safety, effectiveness and compliance of pharmaceutical production. The following are typical cases and specific requirements for the use of compressed air in pharmaceutical plants:
main Scenarios of Compressed Air Used in 1. Pharmaceutical Factory
- pharmaceutical Device Driver
- pneumatic control compressed air is used to drive valves, pistons, cylinders and other pneumatic components to control the automatic operation of pharmaceutical equipment (such as filling machines, tablet presses, packaging machines, etc.).
- Material conveying: Through compressed air, powder or granular raw materials (such as pharmaceutical powder, auxiliary materials) are transported to the reactor, mixer or tablet press to achieve pollution-free and efficient material transfer.
- Cleaning and purging: Purge the inside of the equipment, pipes or containers with compressed air to remove residues or foreign objects and ensure the cleanliness of the production environment.
- Process Support
- fermentation and culture: In biopharmaceuticals, compressed air is used to pass sterile air into the fermentation tank to provide oxygen for microorganism or cell culture while maintaining a stable pressure in the tank.
- spray drying compressed air is used as the atomization medium to atomize the liquid medicine into tiny particles, which is convenient for drying into powdered preparations (such as antibiotics, vitamins, etc.).
- Aerodynamic Mixing: In the mixing process, compressed air drives a stirrer or vibrator to ensure that the raw materials are evenly mixed.
- Packaging and repackaging
- pneumatic filling compressed air drives the piston of the filling machine to accurately control the filling volume of drugs (e. g. filling of capsules and ampoules).
- Labeling and coding: Use compressed air to drive the labeling machine or inkjet printer to ensure that the label is firmly adhered and the inkjet code is clear.
- Packaging Sealing: Compressed air is used in pneumatic sealing machines to ensure that packaging containers (such as bottles and bags) are tightly sealed to prevent drugs from moisture or contamination.
- Laboratory and Quality Control
- instrument operation compressed air provides a gas source for laboratory equipment (such as gas chromatograph and liquid chromatograph) to drive the detection and analysis process.
- Sample processing: Use compressed air to dry the sample or assist in filtration to improve detection efficiency.
- Cleaning verification: During the cleaning verification process, compressed air is used to purge the inside of the equipment to confirm that there is no residue.
- Utilities Support
- air conditioning system compressed air drives pneumatic valves to adjust the temperature, humidity and pressure difference in the clean room to maintain a stable production environment.
- Vacuum system: Compressed air drives the vacuum pump to provide power for the vacuum process (such as freeze dryer).
- Fire protection system some pharmaceutical factories use compressed air to drive fire fighting equipment (such as pneumatic fire monitor) to ensure emergency response capability.
Quality Requirements for Compressed Air in 2. Pharmaceutical Factory
pharmaceutical companies have extremely strict quality requirements for compressed air and must meet the requirements. ISO 8573-1(International Compressed Air Quality Rating Standard), and classified according to specific purposes:
- sterility requirements (critical process)
- application Scenarios fermentation tank ventilation, aseptic filling, direct contact with the drug process.
- Quality Standards:
- oil content: ≤ 0.01 mg/m & sup3;(oil-free air compressor is required).
- Dust content: ≤ 0.1 μm particulate matter, quantity ≤ 10/m & sup3;.
- Microorganisms sterile (processed by high efficiency filter or steam sterilization).
- Pressure dew point: ≤-40 ℃ (to prevent condensate water pollution).
- General industrial requirements (non-direct contact)
- application Scenarios equipment drive, material conveying, cleaning and purging, etc.
- Quality Standards:
- oil content: ≤ 0.1 mg/m & sup3;.
- Dust content: ≤ 1μm particulate matter, quantity ≤ 100/m & sup3;.
- Pressure dew point: ≤ 3 ℃ (to prevent pipeline corrosion).
Design Points of Compressed Air System in 3. Pharmaceutical Factory
- oil-free air compressor: The key process must use oil-free air compressor (such as centrifugal or water-lubricated oil-free screw type) to avoid lubricating oil contamination of drugs.
- multistage filtration: Configure pre-filter, precision filter and activated carbon filter to gradually remove particles, oil and odor.
- Drying equipment: Adopt adsorption dryer (such as non-thermal regeneration or micro-thermal regeneration dryer) to ensure that the pressure dew point reaches the standard.
- Sterilization treatment: Steam sterilization or ozone sterilization of compressed air pipes in direct contact with drugs.
- Monitoring and verification: Install online monitoring instruments (such as dew point meter, particle counter), and conduct regular quality verification to ensure compliance with GMP requirements.
4. typical cases
- antibiotic production: Fermentation tank ventilation needs to use sterile compressed air to prevent bacteria contamination.
- lyophilized preparation: Compressed air drives the vacuum pump to ensure a stable lyophilization process.
- inhalation preparation: The filling machine needs to use high cleanliness compressed air to prevent particles from entering the drug.
