Environmentally Friendly Pharmaceutical Manufacturing Training Program

GER-9553387 Pedersen This project is a joint effort of the Department of Chemical and Biochemical Engineering and the School of Pharmacy at Rutgers University to establish an environmentally Friendly Pharmaceutical Manufacturing Training Program. Such a training program will have a huge impact on promoting the use of environmentally friendly technology in pharmaceutical manufacturing. Such a program is needed because pharmaceutical processes generate large amounts of avoidable pollution. Better designed and controlled processes would decrease the impact on the environment of pharmaceutical processes, and would also result in reduced cost of drugs; more reliably produced drugs and a more competitive US pharmaceutical industry. The objective of the program proposed here is to train professional capable of designing and implementing successful pollution prevention strategies in pharmaceutical operation. These professionals will require solid knowledge of chemical engineering fundamental; optimization techniques; Current Good Manufacturing Practice (CGMP) guidelines; risk assessment techniques, end-of-pipe treatment strategies, FDA and EPA regulations, and unit operations employed in pharmaceutical processes. Training in these areas will be imparted through a number of activities, including: * an extended menu of courses from several academic units, * a new curriculum component consisting of a year-round seminar/discussion session highlighting successful pollution prevention scenarios * a PhD dissertation * another new curriculum component consisting of a supervised teaching experience * a summer internship in industry In addition to training students, the program proposed here will lead to the establishment of a cohesive and self-sustaining research program on environmentally friendly pharmaceutical manufacturing. Such a research program will generate new technologies for preventing pollution in manufacturing processes, and ensure t he viability of the proposed training program beyond the period of NSF funding allocated by the GRT program. Dissertation topics will address four problems that are of direct interest to industry and that offer high potential for pollution prevention: a) process failures in solid dosage manufacturing due to inadequate handling of solid blending and compaction operations. b) failure of large scale bioreactive processes (due to starvation, shear damage, or poor mixing ) c) lack of schedule optimization in batch processes, generating a large amount of emissions from processing steps such as loading, unloading, venting, cleaning, etc. d) inadequate abatement techniques capable of preventing emission of organic solvents in reactive and purification processes. An aggressive plan for minority recruitment has been formulated. Minority recruitment activities include, among others, expansion of an already established minority undergraduate internship program, which serves as an in situ source of minority and female graduate students, an extensive advertisement campaign in college newspapers with large populations of minority students, and a mailing campaign directed to every Chemical Engineering department in the US. As proof of Rutgers' commitment to this project, the University will provide three five-year fellowships to match NSF's contribution (one of these fellowships will be earmarked for a minority student). Additional matching resources will be obtained from the Department of Chemical and Biochemical Engineering and form ongoing projects funded by other federal agencies and by industry. It is anticipated that these matching resources will allow us to significantly expand the number of students supported by the proposed training program.