Ultra fine airflow pulverizer for active pharmaceutical ingredients

Ultra fine airflow pulverizer for active pharmaceutical ingredients

Core working principle

1. Power and Low Temperature: Compressed clean air/nitrogen is dried, filtered, and accelerated to supersonic speeds of 2-3 Mach through Laval nozzles. The airflow expands to produce Joule Thomson effect, and the temperature of the crushing chamber is stabilized at 5-25 ℃ to avoid thermal degradation of thermosensitive raw materials.

2. Self grinding and crushing: The material is carried by the airflow and is "hit by the material" at the intersection of multiple nozzles in the crushing chamber. It is crushed through particle collision, friction, and shear without mechanical contact pollution; A fully enclosed system eliminates external cross contamination.

3. Accurate grading: Equipped with a built-in turbine grading wheel (speed 3000-15000 r/min) for dynamic screening, qualified fine powder is efficiently collected by a cyclone separator+pulse dust collector, and coarse particles are returned to the crushing area for cyclic processing, with a grading efficiency greater than 95%.

4. Inert protection: supports nitrogen closed-loop circulation, suitable for easily oxidizable, flammable and explosive raw materials (such as anti-tumor drugs, peptides), to prevent oxidation deterioration and safety risks.

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Typical application scenarios

1. Chemical raw materials: Micronization of antibiotics, anti-tumor drugs, and insoluble APIs to improve dissolution rate, suitable for the production of oral solid preparations, injections, and inhalants.

2. Biological raw materials: low-temperature ultrafine grinding of monoclonal antibodies, peptides, and enzyme preparations to ensure activity and purity, used for the research and production of freeze-dried powders and microsphere preparations.

3. Chinese herbal raw materials: low-temperature crushing of Chinese herbal extract powder and sterile extract, retaining effective ingredients, suitable for the production of Chinese herbal sterile preparations and high-end health products.

4. Micronization of excipients: Ultra fine processing of medicinal excipients such as lactose and mannitol to meet the requirements for mixing uniformity and dispersion of the formulation

Key points of operation and maintenance

1. Pre treatment: The moisture content of the raw material should be ≤ 3% to avoid sticking to the cavity; Before feeding, sterile filtration is carried out to ensure the initial purity of the raw materials; Priority should be given to nitrogen protection mode for easily oxidizable materials.

2. Parameter optimization: Adjust the intake pressure and grading wheel speed based on the characteristics of the raw material (hardness, thermal sensitivity); Batch production adopts continuous feeding to reduce batch cross contamination.

3. Cleaning validation: CIP cleaning after each batch, regular SIP sterilization (121 ℃, 30 min), retention of cleaning/sterilization records, in compliance with GMP data traceability requirements.

4. Equipment maintenance: Regularly check nozzle wear, grading wheel dynamic balance, and seal integrity. Key components (nozzles, grading wheels) are replaced regularly and recorded to ensure crushing efficiency and purity.

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6. Key performance advantages:

7. High grading accuracy: It can accurately control the particle size range of the finished powder, with small particle size deviation, and can meet the strict requirements of high-end new materials.

8. Strong adaptability: It can handle powders of different shapes such as spherical, sheet-like, and fibrous, and can be linked with equipment such as crushers and mixers to form an automated powder processing production line.

9. Good environmental friendliness: The closed type model can effectively prevent dust leakage, and with the dust removal system, it can achieve dust discharge, which meets environmental standards.

10. Flexible operation: By adjusting parameters such as the speed of the grading wheel, feed rate, and induced draft air volume, the particle size specifications of the finished powder can be quickly adjusted to meet the grading requirements of multiple types of materials.

Equipment selection table for ultrafine airflow pulverizer of raw materials: