Particle size reduction is an important engineering step for many materials, helping to improve bioavailability and achieve certain specifications. The micronization and/or milling process generates a more consistent particle size distribution, thereby enhancing pharmaceutical formulations. To satisfy cGMP guidelines and deliver results, scientists should look for particle size reduction services that use specialized equipment, while offering support for customized protocol development, validation, execution and reporting.
Uniform Particle Size Reduction
Effective particle size reduction requires an understanding of many material characteristics, including particle size distribution, hardness and flowabilty. Certain formulations may also require specialized protocols based on the potency of the active ingredients. Catalent works to understand the requirements of your formulations, with robust particle size testing and analyses. This knowledge is then passed to you as part of a final project report.
How it Works: Jet Mill Patricle Size Reduction Techniques
Catalent’s particle size reduction services are accomplished through the use of fluid energy jet mills. This type of mill operates on the principles of impact and attrition, generating high velocity collisions between particles that are suspended in a nitrogen gas or compressed air stream. The resulting impact causes the particles to break down into smaller fragments. Centrifugal forces in the jet mill cause 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 unit. Larger particles remain in the milling chamber where they recirculate, causing them to breakdown, creating a consistent particle size distribution. The mechanics of the jet mill remove the need for any grinding media, which could negatively impact the formulation.
In-Process Particle Size Analysis
Operational parameters are monitored throughout the particle size reduction process to help adjust and improve the milling or micronization parameters. In-process samples are removed during the course of the micronization process and are analyzed to ensure that the micronization process is delivering the targeted specification. Based on these measurements the milling conditions are adjusted to generate micronized material with an acceptable micron size. Upon completion of this process, the material is released as per specification. All projects are accompanied by a comprehensive batch record and particle size results from the in-process analysis.
Process Validation Design for Particle Size Reduction
Catalent Micron Technologies understands the challenges in technology transfer and lean manufacturing and will provide expertise in milling/micronization to assist our clients with their Quality by Design (QbD) initiatives. We develop screening and optimization Design of Experiment (DOE) protocols and conduct well-defined milling/micronization runs. We also provide insightful risk assessment to custom develop the optimal design space for our client’s product. Our QbD offerings are part of a dedicated approach to customer support, to fuel continuous process improvements, cost savings, and regulatory flexibility.
Based upon solid regulatory, analytical, and manufacturing knowledge, Catalent Micron Technologies works with you to develop a validation plan tailored to your needs. Our robust and efficient validation services comply with cGMP guidelines. Support of the validation process also includes protocol development and execution. Final reporting of this process will help carry your project into its commercial phase.