ESI-IMS for Rapid On-site Cleaning Validation in Pharmaceutical Manufacturing

用于制药制造中快速现场清洁验证的 ESI-IMS

• 批准号: 7536634
• 负责人: Ching Wu
• 金额: $ 10万
• 依托单位: EXCELLIMS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-20 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7536634
• 关键词: ESI; IMS; Rapid; site; Cleaning

DESCRIPTION (provided by applicant): An electrospray ionization ion mobility spectrometer (ESI-IMS) is proposed to be used as an innovative process analytical technology (PAT) to overcome the limitations of current cleaning validation systems for pharmaceutical manufacturing and quality assurance. With its sensitivity, speed and portability, IMS has already been used in trace chemical detection that includes cleaning validation applications in pharmaceutical manufacturing processes. However, current commercially available IMS systems have significant limitations in quantitative measurements and in the ability to analyze non-volatile organic and biological samples. In this project, an IMS is proposed to be interfaced to a novel electrospray ionization source for on-site analysis of both small molecule and biological pharmaceuticals. The new system will accept samples either directly from a swab or extracted sample solution. As these samples are introduced into the IMS, the targeted analytes are ionized, separated, and quantitatively detected within seconds. More importantly, the new IMS system allows detection of low charge affinity compounds and provides quantitative information of targeted active ingredients and other substance of interests. This on-site analytical technology can significantly reduce manufacturing down time and associated costs in the pharmaceutical manufacturing industry. PUBLIC HEALTH RELEVANCE: The proposed electrospray ionization ion mobility spectrometry (ESI-IMS) based cleaning validation technology is consistent with FDA's Process Analytical Technology (PAT) initiative, the goal of which is to improve efficiency in pharmaceutical manufacturing and quality assurance. This on-site analytical technology can significantly reduce manufacturing down time and associated costs in pharmaceutical manufacturing industry, and could help lead to lower pharmaceutical costs to the public. Compared to existing IMS based cleaning validation methods, the proposed innovative IMS device fundamentally improves ion mobility spectrometry performance and enables direct introduction of swabbed samples, superior quantitative measurements, and the analysis of non-volatile and biological samples.

描述（由申请人提供）：拟将电喷雾电离离子迁移谱仪（ESI-IMS）用作创新工艺分析技术（PAT），以克服当前用于药品生产和质量保证的清洁验证系统的局限性。凭借其灵敏度、速度和便携性，IMS已被用于痕量化学品检测，包括制药工艺中的清洁验证应用。然而，目前市售的IMS系统在定量测量和分析非挥发性有机和生物样品的能力方面具有显著的局限性。在这个项目中，IMS被提议连接到一个新的电喷雾电离源，用于小分子和生物药物的现场分析。新系统将接受直接来自拭子或提取样品溶液的样品。当这些样品被引入IMS时，目标分析物在几秒钟内被电离、分离和定量检测。更重要的是，新的IMS系统可以检测低电荷亲和力化合物，并提供目标活性成分和其他感兴趣物质的定量信息。这种现场分析技术可以显著减少制药行业的生产停机时间和相关成本。 公共卫生关系：拟议的基于电喷雾电离离子迁移谱（ESI-IMS）的清洁验证技术与FDA的过程分析技术（PAT）计划一致，其目标是提高药品制造和质量保证的效率。这种现场分析技术可以显着减少制药行业的生产停机时间和相关成本，并有助于降低公众的制药成本。与现有的基于IMS的清洁验证方法相比，所提出的创新IMS设备从根本上提高了离子迁移谱性能，并能够直接引入擦拭样品、进行上级定量测量以及分析非挥发性和生物样品。