手持FTIR在制药清洁验证中表现优于全有机碳抹布
Isabella Jul-Jørgensen1,2, Krist V Gernaey1, Christian A Hundahl2
1Department of Chemical and Biochemical Engineering, Technical University of Denmark, Søltofts Plads 227, 2800 Kgs. Lyngby, Denmark. ibja@novonordisk.com.
The Analyst
|June 23, 2023
概括
本研究介绍了一种手持的富里埃转换IR (FTIR) 光谱模型,用于制药清洁验证. 该模型准确地确定设备是否干净,为传统方法提供更快的替代方案.
科学领域:
- 分析化学 分析化学
- 制药制造技术 制药制造技术
背景情况:
- 清洁验证在制药制造中至关重要,以防止交叉污染.
- 中红外 (IR) 光谱,特别是手持的富里埃变换IR (FTIR),提供了一个潜在的快速实时释放方法.
- 在制造业中实施FTIR面临挑战,特别是在不完全可追溯的多产品工厂.
研究的目的:
- 解决多产品制药厂清洁验证的模型开发挑战.
- 使用FTIR开发一个部分最小平方差分分析 (PLSDA) 模型,用于使用FTIR进行清洁/不清洁的确定.
- 为了评估模型的性能与总有机碳 (TOC) 测量.
主要方法:
- 使用来自人工样本的FTIR光谱数据开发PLSDA模型.
- 使用化学打印机为具有不同光谱特征的多种产品创建了人工样本.
- 模型校准使用了91个样本,验证使用了30个样本,包括表面粗度的变化.
主要成果:
- 开发的FTIR-PLSD模型有效地根据残留接受限值将样品分类为干净或不干净.
- 模型性能使用灵敏度,特异性和类错误指标进行评估.
- 根据采样错误,FTIR模型表现出与TOC扫描方法相似或更高的性能.
结论:
- 手持FTIR光谱为制药制造业的实际清洁验证提供了可行的解决方案.
- 开发的PLSDA模型提供了一种快速可靠的方法来评估设备的清洁性.
- 这种方法有可能简化制药生产中的实时释放过程.
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