Environmentally Friendly Pharmaceutical Manufacturing Training Program

环保药品制造培训计划

• 批准号: 9553387
• 负责人: Henrik Pedersen
• 金额: $ 67.5万
• 依托单位: Rutgers University New Brunswick
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-01 至 2001-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=9553387&HistoricalAwards=false
• 关键词: Environmentally; Friendly; Pharmaceutical; Manufacturing; Training

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.

格尔-9553387佩德森 该项目是罗格斯大学化学和生物化学工程系与药学院共同努力建立的一个环境友好型制药培训计划。这样的培训计划将对促进环保技术在制药制造中的使用产生巨大影响。 这样的计划是必要的，因为制药过程产生大量的可避免的污染。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，更可靠地生产药物和更具竞争力的美国制药业。这里提出的计划的目标是培养能够设计和实施成功的污染防治策略在制药操作的专业人员。这些专业人员将需要化学工程基础的扎实知识;优化技术;当前良好生产规范（CGMP）指南;风险评估技术，管道末端处理策略，FDA和EPA法规以及制药过程中采用的单元操作。这些领域的培训将通过一些活动进行，包括：* 提供多个学术单位的课程，* 新课程包括全年举办的研讨会/讨论会，重点介绍成功的污染预防方案 * 博士论文 * 另一个新课程包括督导教学经验 * 除了培训学生外，这里提出的计划将导致建立一个关于环保制药的有凝聚力和自我维持的研究计划。这样的研究计划将产生新的技术，以防止在制造过程中的污染，并确保他的可行性，拟议的培训计划超出了由GRT计划分配的NSF资金的期限。 论文主题将解决四个问题，是直接感兴趣的行业，并提供高潜力的污染防治：a）在固体剂量制造过程中的故障，由于处理不当的固体混合和压实操作。 B）大规模生物反应过程的失败（由于饥饿、剪切破坏或不良混合）c）在分批过程中缺乏进度优化，从诸如装载、卸载、排气、清洁等的处理步骤产生大量排放物。d）能够防止反应和纯化过程中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征聘计划。 少数民族招聘活动包括，除其他外，扩大已经建立的少数民族本科生实习计划，作为少数民族和女性研究生的就地来源，在大学报纸上广泛的广告活动，少数民族学生人数众多，以及针对美国每个化学工程系的邮寄活动。 为了证明罗格斯大学对这个项目的承诺，该大学将提供三个五年期的奖学金，以配合NSF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所支持的学生人数。