Procurement of One (1) each Ceramic Triple Roller Mill System

The FDA Division of Product Quality Research (DPQR) conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to conduct research on assessing the performance, quality, and safety of semisolid topical drug products. These studies are critical in assessing the quality of intermediate and marketed drug products. To support this function, DPQR is requesting the acquisition of one (1) EXAKT 80S Plus w/ Al2O3 Ceramic Triple Roller or equal. This Roller mill will be used to comminute the dispersed powder particles in semisolid topical drug products for understanding effects of formulation and processing parameters on the quality attributes of these drug products. This instrument and these studies will provide valuable information regarding safety and quality of semisolid topical drug products and support CDER’s mission critical missions. The Ceramic Triple Roller system is suited for processing high viscosity topical creams, ointments, and gels with dispersed powders. It works on the principle of high viscosity powder dispersion with the capability to achieve narrow particle size distribution, deaeration of semisolid matrix and wetting of dispersed particles. It is required to conduct research on assessing the performance, quality and safety of semisolid topical drug products. The system will be used to carry out mixing processes to incorporate various excipients into highly viscous topical products.