(42a) Mixing-Related Manufacturing Problems in the Pharmaceutical Industry

Mixing of different fluids is an extremely common operation encountered in countless applications throughout the pharmaceutical industry. Many industrial processes require, or are greatly enhanced, by the rapid homogenization of miscible constituents (in single-phase systems) or the intimate contact between two or more distinct phases (in multiphase systems).

In this presentation, the results of several recent investigations conducted in Mixing Laboratory at NJIT are presented and discussed, with special emphasis on their pharmaceutical applications. Examples include the impact of mixing on processes such as impurity formation during chemical reactions, variation of crystal size during reactive precipitation, dissolution testing of pharmaceutical dosage forms using USP dissolution testing Apparatus II, simultaneous reactions in laboratory reactors, solid suspension in partially filled tanks, partially baffled, glass lined-type reactors used in pharmaceutical synthesis. The typical approach used in this work is based on the use of computational and predictive tools such as Computational Fluid Dynamics (CFD), population balances, and micromixing modeling, coupled with experimentation based on Laser-Doppler Velocimetry (LDV), particle size distribution analysis and other experimental techniques.

In all these cases, mixing can, and often does, play a critical role, which, if neglected, can result in unexpected process results during scale-up. The presentation will stress how a careful analysis of the mixing system and operating conditions can prevent unexpected problems upon process scale-up.