Environmentally Friendly Pharmaceutical Manufacturing Training Program

该项目是罗格斯大学化学与生物化学工程系和药学院共同努力建立的一个环境友好型制药培训项目。这种培训方案将对促进在药品生产中使用环境友好技术产生巨大影响。这样的计划是必要的，因为制药过程会产生大量本可避免的污染。更好的设计和控制过程将减少制药过程对环境的影响，也将导致降低药物成本；更可靠的药品生产和更具竞争力的美国制药业。本课程的目标是培养能够在制药操作中设计和实施成功的污染预防策略的专业人员。这些专业人员将需要扎实的化学工程基础知识；优化技术;现行良好生产规范（CGMP）指南；风险评估技术，管道末端处理策略，FDA和EPA法规，以及在制药过程中使用的单元操作。将通过一些活动提供这些领域的培训，包括：*多个学术单位的课程扩展菜单，*新课程组成部分包括全年的研讨会/讨论会议，重点介绍成功的污染预防方案*博士论文*另一个新课程组成部分包括有监督的教学经验*暑期在工业实习除了培训学生，这里提出的计划将导致建立一个有凝聚力和自我维持的环境友好型制药研究计划。这样的一个研究项目将产生新的技术来防止生产过程中的污染，并确保拟议的培训项目在NSF由GRT项目分配的资金期限之外的可行性。论文主题将涉及工业直接感兴趣的四个问题，并为预防污染提供了很高的潜力：a)由于固体混合和压实操作处理不当而导致的固体剂量制造过程失败。B)大规模生物反应过程的失败（由于饥饿、剪切破坏或混合不良）c)批量过程中缺乏时间表优化，在装载、卸载、排气、清洁等处理步骤中产生大量排放d)在反应和净化过程中能够防止有机溶剂排放的减排技术不足。已经制定了一项积极的少数民族征聘计划。少数族裔招聘活动包括，扩大已经建立的少数族裔本科生实习计划，作为少数族裔和女研究生的原位来源，在拥有大量少数族裔学生的大学报纸上开展广泛的广告活动，以及向美国每个化学工程系发送邮件活动。为了证明罗格斯大学对这个项目的承诺，罗格斯大学将提供三个五年的奖学金，以匹配国家科学基金会的贡献（其中一个奖学金将专门用于少数民族学生）。额外的匹配资源将从化学和生物化学工程系获得，并形成由其他联邦机构和工业界资助的正在进行的项目。预计这些匹配的资源将使我们能够显著扩大拟议培训计划所支持的学生人数。

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.