Environmentally Friendly Pharmaceutical Manufacturing Training Program

GER-9553387 Pedersen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的项目，旨在建立环境友好型制药制造培训计划。这样的培训计划将对推动环保技术在医药制造中的使用产生巨大影响。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，还将导致药品成本降低；生产的药品更可靠，美国制药业更具竞争力。该计划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；当前的良好制造规范(CGMP)指南；风险评估技术、管道末端处理策略、FDA和EPA法规，以及制药工艺中使用的单元操作。这些领域的培训将通过一系列活动进行，包括：*来自几个学术单位的扩展课程菜单，*由全年研讨会/讨论部分组成的新课程部分，重点介绍成功的污染预防方案*博士论文*另一个新课程部分，由监督教学经验组成*工业暑期实习除了培训学生外，这里建议的计划将导致建立一个连贯和自我维持的环境友好型药物制造研究计划。这样的研究计划将产生防止制造过程中污染的新技术，并确保拟议的培训计划在GRT计划分配的NSF资助期后的可行性。论文主题将解决四个与工业直接相关并具有很高污染预防潜力的问题：a)固体配料制造中的工艺故障，原因是固体混合和压实操作处理不当。B)大规模生物反应过程的失败(由于饥饿、剪切损伤或混合不良)c)批处理过程中缺乏调度优化，在加载、卸载、排气、清洗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族裔招募计划。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，该计划是少数族裔和女性研究生的就地来源，在有大量少数族裔学生的大学报纸上开展广泛的广告活动，以及针对美国每个化学工程系的邮寄活动。作为罗格斯大学致力于这一项目的证明，该大学将提供三项为期五年的奖学金，以匹配NSF的贡献(其中一项奖学金将专门为少数族裔学生提供)。额外的配套资源将从化学和生化工程部获得，并形成由其他联邦机构和行业资助的正在进行的项目。预计这些配套资源将使我们能够显著扩大拟议培训计划支持的学生数量。

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.