Medical sterile airflow grinder

Medical sterile airflow grinder

Working Principle:

It is achieved by compressing air through freeze-drying and filtering, allowing clean air to enter the crushing chamber at supersonic speed through the crushing nozzle, making the material in a fluidized state. The accelerated material converges at the intersection of several nozzle jet streams, producing intense collisions, friction, and shear to achieve ultrafine particle crushing. The material enters the grading zone with the rising airflow, and due to the high-speed rotation of the grading wheel, the crushed particles are simultaneously subjected to the centrifugal force of the grading wheel and the centripetal force of the fan, achieving the screening effect. Particles that meet the fineness requirements enter the next collection step through the gap of the grading wheel, while particles that do not meet the requirements return to the crushing chamber for further crushing.

Typical application scenarios

1. Biopharmaceuticals: Aseptic ultrafine grinding of monoclonal antibodies, fusion proteins, and peptide raw materials for injection freeze-dried powders and microsphere formulations to ensure activity and dispersibility.

2. Chemical drugs: Micronization of sterile raw materials such as antibiotics and anti-tumor drugs to improve dissolution rate, suitable for the production of oral solid preparations and inhalants.

3. Vaccines and adjuvants: Aseptic pulverization of vaccine antigens and adjuvants to meet the requirements of GAOendSterility and activity requirements for injections.

4. Aseptic preparations of traditional Chinese medicine: low-temperature crushing of traditional Chinese medicine extract powder and sterile extract, retaining effective ingredients, suitable for the research and production of sterile traditional Chinese medicine injections.

Key points of operation and maintenance

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

2. Parameter optimization: intake pressure 0.6-1.2 MPa, grading wheel speed adjusted with target particle size; Aseptic materials are fed continuously to reduce the risk of batch cross contamination.

3. Aseptic 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 to ensure crushing efficiency and sterility; Key components are regularly replaced and recorded.

Equipment Selection Table for Medical Aseptic Airflow Grinder: