Steiner-Browne Marina, Karim Aramouni Nicolas Abdel, Mouras Rabah
Pharmaceutical Manufacturing Technology Centre (PMTC), Department of Chemical Sciences, Bernal Institute, University of Limerick, V94 T9XP, Limerick, Ireland.
Heliyon. 2024 Jul 16;10(15):e34679. doi: 10.1016/j.heliyon.2024.e34679. eCollection 2024 Aug 15.
The main purpose of this research was to develop an experimental film flow cleaning rig that can be combined with Process analytical technology (PAT) tools to reduce cleaning time and costs. Here, we show that the use of in-line UV-Vis was successful for real-time monitoring of the cleaning process of olanzapine as a challenging residue to clean. The cleaning process was found to be affected by the properties of the olanzapine soil, and the study showed the competing effects of mechanical lift-off and dissolution action with methanol as a solvent. However, The method is limited by the cleaning mechanisms, with the dissolution being the only mechanism that can be accurately quantified using an in-line UV-Vis PAT tool. This experimental approach can be used to optimize cleaning process conditions and solvent choices at the bench scale before deployment. The material of which the cleaning rig was printed limited the solvent that could be used for this study, and future modifications will include a more chemical-resistant material.
本研究的主要目的是开发一种实验性的薄膜流动清洗装置，该装置可与过程分析技术（PAT）工具相结合，以减少清洗时间和成本。在此，我们表明，在线紫外可见光谱法成功用于实时监测奥氮平的清洗过程，奥氮平是一种具有挑战性的残留污染物。研究发现，清洗过程受奥氮平污垢性质的影响，并且该研究表明了以甲醇作为溶剂时机械剥离和溶解作用的竞争效应。然而，该方法受清洗机制的限制，溶解是唯一可使用在线紫外可见光谱PAT工具准确定量的机制。这种实验方法可用于在实际应用前在实验室规模优化清洗工艺条件和溶剂选择。清洗装置所使用的打印材料限制了本研究中可使用的溶剂，未来的改进将包括使用更耐化学腐蚀的材料。
