Experimental design of a film flow cleaning rig equipped with in-line process analytical technology (PAT) tool for real-time monitoring

被引:0
|
作者
Steiner-Browne, Marina [1 ]
Aramouni, Nicolas Abdel Karim [1 ]
Mouras, Rabah [1 ]
机构
[1] Univ Limerick, Dept Chem Sci, Bernal Inst, Pharmaceut Mfg Technol Ctr PMTC, Limerick V94 T9XP, Ireland
关键词
Cleaning; Rig; Monitoring; In-line; PAT; Spectroscopy; VERIFICATION; SURFACE; SPECTROSCOPY; CLEANLINESS;
D O I
10.1016/j.heliyon.2024.e34679
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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.
引用
收藏
页数:10
相关论文
共 50 条
  • [1] NIR spectroscopy as a process analytical technology (PAT) tool for on-line and real-time monitoring of an extraction process
    Wu, Yongjiang
    Jin, Ye
    Li, Yerui
    Sun, Di
    Liu, Xuesong
    Chen, Yong
    VIBRATIONAL SPECTROSCOPY, 2012, 58 : 109 - 118
  • [2] In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools
    De Beer, T. R. M.
    Vercruysse, P.
    Burggraeve, A.
    Quinten, T.
    Ouyang, J.
    Zhang, X.
    Vervaet, C.
    Remon, J. P.
    Baeyens, W. R. G.
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2009, 98 (09) : 3430 - 3446
  • [3] Raman spectroscopy as a process analytical technology (PAT) tool for the in-line monitoring and understanding of a powder blending process
    De Beer, T. R. M.
    Bodson, C.
    Dejaegher, B.
    Walczak, B.
    Vercruysse, P.
    Burggraeve, A.
    Lemos, A.
    Delattre, L.
    Heyden, Y. Vander
    Remon, J. P.
    Vervaete, C.
    Baeyens, W. R. G.
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2008, 48 (03) : 772 - 779
  • [4] Process analytical technology (PAT) as a versatile tool for real-time monitoring and kinetic evaluation of photocatalytic reactions
    Roessler, Martin
    Huth, Philipp U.
    Liauw, Marcel A.
    REACTION CHEMISTRY & ENGINEERING, 2020, 5 (10) : 1992 - 2002
  • [5] Application of process analytical technology (PAT) in real-time monitoring of pharmaceutical cleaning process: Unveiling the cleaning mechanisms governing the cleaning-in-place (CIP)
    Aramouni, Nicolas Abdel Karim
    Steiner-Browne, Marina
    Mouras, Rabah
    PROCESS SAFETY AND ENVIRONMENTAL PROTECTION, 2023, 177 : 212 - 222
  • [6] On-line UV-NIR spectroscopy as a process analytical technology (PAT) tool for on-line and real-time monitoring of the extraction process of Coptis Rhizome
    Dai, Xuezhi
    Song, Hang
    Liu, Wen
    Yao, Shun
    Wang, Gang
    RSC ADVANCES, 2016, 6 (12) : 10078 - 10085
  • [7] Water Proton Flow-NMR-A Novel Tool for Real-Time In-Line Process Monitoring in Biomanufacturing
    Taraban, Marc B.
    Briggs, Katharine T.
    Yu, Yihua Bruce
    BIOPHYSICAL JOURNAL, 2019, 116 (03) : 285A - 285A
  • [8] Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation
    Gendre, Claire
    Genty, Muriel
    Boiret, Mathieu
    Julien, Marc
    Meunier, Loic
    Lecoq, Olivier
    Baron, Michel
    Chaminade, Pierre
    Pean, Jean Manuel
    EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2011, 43 (04) : 244 - 250
  • [9] Quality-by-Design (QbD): An Integrated Process Analytical Technology (PAT) Approach for Real-Time Monitoring and Mapping the State of a Pharmaceutical Coprecipitation Process
    Wu, Huiquan
    Khan, Mansoor A.
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 99 (03) : 1516 - 1534
  • [10] PAT Implementation on a Mobile Continuous Pharmaceutical Manufacturing System: Real-Time Process Monitoring with In-Line FTIR and Raman Spectroscopy
    Miyai, Yuma
    Formosa, Anna
    Armstrong, Cameron
    Marquardt, Brian
    Rogers, Luke
    Roper, Thomas
    ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2021, 25 (12) : 2707 - 2717