PAT用于监测固体口服剂型的连续制造中的控制状态
Nathaly A Movilla-Meza1, Dhavalkumar S Patel1, Rafael Méndez2
1Department of Chemistry, University of Puerto Rico at Mayaguez, PO Box 9000, Mayaguez, Puerto Rico, 00681, USA.
过程分析技术 (PAT) 确保了制药制造的控制. 近红外光谱检测在连续制造过程中药物度,提高产品质量和工艺可靠性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 过程分析技术
- 频谱学是一种光谱学.
背景情况:
- 过程分析技术 (PAT) 对于维持制药制造中的控制至关重要.
- 连续制造具有优势,但需要严格的监控.
- 近红外光谱 (NIRS) 是实时分析的关键PAT工具.
研究的目的:
- 审查关于在连续制药制造中PAT实施的研究.
- 评估NIRS用于药物度监测的性能.
- 突出提高PAT有效性和流程理解的方法.
主要方法:
- 审查连续制造研究 (长达120小时).
- 接近红外光谱的应用用于药物度的确定.
- 分析方法的验证 (准确性,精度,线性,稳定性).
- 使用居住时间分布和变形图分析.
主要成果:
- 尼尔斯有效监测药物度和产品规格.
- 可重复性研究对于方法性能至关重要.
- 从各种采样地点进行实时监测是可行的.
- 通过PAT和建模,可以检测和转移不合格材料.
结论:
- PAT,特别是NIRS,提高了持续的制造控制和可靠性.
- 变形图分析区分了过程的变化和错误.
- 通过PAT实施,可以获得更好的流程理解和产品质量.
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