Our contract powder size reduction services are exclusively for the pharmaceutical industry. Micronizing (defined as particles smaller than 20µm) often enhances solubility and improves bioavailability, allowing you to optimize the formulation of your product and reduce the therapeutic dose. With a reproducible and controlled particle size of your active pharmaceutical ingredients and excipients, manufacturing of your finished dosage form could be improved.
The most commonly used pieces of equipment are tangential fluid energy mills or pancake mills. High-pressure air / gas is introduced causing particle-to-particle collision and micronization. Micron Technologies utilizes over 20 years' experience and a wide range of equipment to consistently produce particles in the 1 to 20 micron range.
We can process as little as 1g of material, through scale up to commercial volumes. Micron's expertise also extends into specialized milling technologies such as opposed jet micronization.
When the size specification for a powder does not require micronization, mechanical milling is ideal for achieving consistent particle sizes above 20 microns.
The safe handling of potent compounds is an increasing concern for the Pharmaceutical Industry; even more true when it comes to the micronization process which by nature, generates a lot of very fine dust. Micron Technologies, always leading this technology, invested into what is believed to be the very first glove box capable of containing a very large scale jet mill and micronize safely potent compounds with an OEL of less than 1µg/m3 at that scale.
During this year, this unit and its performance has been reviewed and approved by the FDA, the Korean FDA and the Japanese authorities; this allowed some of our customers to launch their new blockbusters into these markets. Our general approach of 100% cleaning verification by swabbing is applied to the containment as well and our customers can be sure that their product will be protected from any risk of cross contamination.
With classification mills, inert gas is injected through specially designed nozzles directly into the grinding chamber of the mill. Raw material is introduced into the mill. Size reduction is accomplished by collisions between particles.
Small particles are then swept towards the classifier, which rotates at high speeds above the grinding chamber. Material which is fine enough to pass through the classifier is collected as product. Oversized particles are recycled, by the classifier, back into the grinding chambers for further reduction.
Monitoring of particle size reduction is typically performed using laser diffraction. This technique can be relatively simple and fast, making such methods ideal for in-process testing.
Micron Technologies uses its knowledge and vast experience to develop reproducible and robust methods. In cases where particle size will be used as a release specification, thorough method development and validation studies are required. Method transfer studies must also be performed when using contract manufacturers. All these requirements can be serviced in the Micron Technologies Laboratory.
"Information regarding the comprehensive characterization of the physical and chemical properties of the drug substance should be included in the application. Important properties of the drug substance can include density, particle size distribution, particle morphology, solvates and hydrates, polymorphs, amorphous forms…"
Guidance for Industry, FDA, Centre for Drug Evaluation and Research.
Using a wide range of material characterization techniques, Micron can provide valuable information on the physical properties of a material.
Good Manufacturing Practice (GMP) is an integral part of every process at Micron Technologies. Compliance is expected in the areas of validation (for example particle size methods, computers and instrumentation), employee training and documentation. Each plant has a quality assurance group which oversees every facet of the business that could impact on quality. All internal documentation is fully reviewed and your product is only released after a full QA check. The equipment we use for your project is released by QA after a 100% cleaning verification programme.