New Quadro® HV0 Pharmaceutical Lab Wet Mill
Crystallization Wet Milling and Particle Size Reduction Technology
The new Quadro® HV0 optimizes pharmaceutical research and development wet milling downstream to an API crystallization process to efficiently reduce crystal size and produce a narrow particle size distribution for a wide range of pharmaceutical products and suspensions. Our unique high velocity (HV) wet milling technology displaces traditional ball milling with a more energy efficient and sanitary solution. Pharmaceutical product development and manufacturing of small molecule drugs can now be undertaken from formulation development, to pilot and production processing with a single series of precisely scalable wet milling technology.
High Value Alternative to Ball Milling a Pharmaceutical API
The HV-Wet Mill defines new limits in high shear wet milling and closes the gap between traditional rotor-stator mixers and ball milling technology. The unique high velocity mill speeds and tooling design of the HV Series creates an exponential increase in available high shear wet milling energy, and at a maximum speed of 70m/s, the HV produces more than 55x the wet milling energy of a conventional rotor-stator mill. Crystallization and subsequent particle size distribution control in the micronization of small molecule drugs can now be accomplished without the use of difficult-to-clean and time consuming media milling techniques (i.e. ball mills, bead mills and other media grinding mills).
Formulation Development and Tested Pharmaceutical Products
Recent pharmaceutical development testing on crystal size reduction performance by a Top-10 pharmaceutical company has shown the HV0 to generally produce a mean particle size distribution approximately 60% smaller than other conventional wet milling technologies. The new HV-Series wet milling technology was found to greatly broaden capabilities in downstream crystallization particle size control, offering a new alternative to dry milling (i.e. pin mill and jet mills) when working with pharmaceutical products involving crystal size reduction in the 10 micron range, compared to a practical limit of 30-65 micron with traditional wet milling technologies.
Particle Size Control in a Crystallization Process
It is commonly accepted that dry milling is required to attain or normalize the desired particle size distribution of small molecule drugs after a crystallization process. However, traditional dry milling techniques such as pin mills have come under increased scrutiny due to an increasing potential for creating downstream issues, especially when working with extremely potent drugs. The issues assoicated with dry milling include safety and cost of containment (both worker exposure and dust explosion hazards), in addition to productivity issues (i.e. time and yield loss), and at times a break down of physical properties.
Wet milling offers a solution to many of these challenges, with the avoidance of dust formation during milling, superior yield recovery with active pharmaceutical products remaining in the closed system, and improved heat dissipation due to the fluid carrier phase.
Historically the practical lower particle size limit in crystallization processing using a traditional wet mill is often a mean crystal size of greater than 30 microns. However, with the development of the HV0-Wet Mill, pharmaceutical product development teams can now apply a wet milling technology in their formulation development that offers precision scalability to full scale pharmaceutical manufacturing, with the capability to work in the 10 micron crystal range.
For more information, please contact us at (519) 884-9660 or email
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