What is Micronization?
Summary: Particle size reduction is achieved through the use of fluid energy jet mills. The material is drawn into a confined, circular chamber by way of pressurized nitrogen gas or compressed air. The powder gets suspended in a high velocity fluid stream in the milling chamber. The mill operates on the principle of impact and attrition due to the high velocity collisions between particles suspended within the nitrogen gas or compressed air stream, causing them to break down into smaller particles. Centrifugal force causes large, heavy particles to separate from smaller and lighter particles. The smaller particles are carried in the fluid stream towards the center of the milling chamber, where they are discharged into a collection bag. Larger particles remain in the milling chamber where they recirculate, causing them to breakdown. Operational parameters are monitored throughout the process and are documented in the batch record.
Based upon solid regulatory, analytical, and manufacturing knowledge, Catalent Micron Technologies will work with you to develop a validation plan which meets your needs. Our staff will provide robust and efficient validation services which comply with cGMP guidelines.