ABSTRACT

The pharmaceutical industry has not sufficiently utilized heat processing methods to reduce microorganism loads or inactivation of reactive components. Several methods are available to heat process product at a minimum cost without affecting product quality. As federal laws become more regulatory and stringent, the technology for creating and maintaining product control via heat pasteurization or sterilization has evolved to comply with regulations. Effective heat processing requires the knowledge and understanding of fluid flow and heat transfer. These, with proper process definition, engineering, equipment selection, and operational procedures are the critical basis for high-temperature short-time (HTST) processing of pharmaceuticals. The primary requirement in pharmaceutical heat processing involves the characteristics of fluid flow within circular pipes. HTST pasteurization is the most important operation in milk processing. There are two methods of heat processing: batch sterilization and continuous sterilization. In batch sterilization, the liquid is pumped into a storage/mixing vessel that is equipped with an agitator and a heating jacket or heating coils.