Benefits of Micronization

Proven, dependable, and extremely versatile, micronization is still the most efficient, cost effective way for companies to achieve top quality particle size reduction results.

• Superior quality – Micronization can enhance  the solubility and bioavaibility of many compounds by increasing the dissolution rate and is the preferred process for many formulations including solid oral, topical creams, suspensions, and inhalation delivery

• Proven history – Micronization is a proven, viable process that has been used for decades

• Unparalleled versatility – Micronization is also proven to work well with a wide range of compounds and products

• Broad acceptance – Micronization is well understood by regulatory agencies

• Heat-free process – Due to the high air volume used during air jet milling, effectively no tempeature increase occurs

• Scalable process – Micronization enables optimization and control of particle size, from R&D through commercial scale

• Maximum efficiency – Micronization consistently produces high yields compared to alternate particle size reduction technologies

• Advanced processes – Micronization technologies and systems have benefited from years of continual improvement

• Potent compounds – Ability to micronize in containment.

Micronization Process

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 breakdown 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.

In-process samples of the micronized material are taken for particle size analysis. Based on the particle size results the milling parameters will be adjusted to achieve the established particle size specification. Upon completion of this process, the material is released as per specification.

Process Validation

Based upon solid regulatory, analytical, and manufacturing knowledge, 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. Support of the validation process will include protocol development and execution. Final reporting of this process will help carry your project into its commercial phase. Please see our Process Validation Information Sheet for additional suggested details.