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.
机构:
Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Ralbovsky, Nicole M.
Dixit, Gunjan
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Dixit, Gunjan
Lomont, Justin P.
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Lomont, Justin P.
Desai, Jay
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Desai, Jay
Butu, Cristina
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Butu, Cristina
Saha-Shah, Anumita
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Saha-Shah, Anumita
Costello, Emily
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Costello, Emily
Lukens, Janelle
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Lukens, Janelle
Mazur, Michael
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Merck & Co Inc, Global Vaccines & Biol Commercializat, MMD, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Mazur, Michael
Mchugh, Patrick M.
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Mchugh, Patrick M.
Barrientos, Rodell C.
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Barrientos, Rodell C.
Semple, Andrew
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Semple, Andrew
Hughes, Gregory J.
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Hughes, Gregory J.
Chmielowski, Rebecca
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Chmielowski, Rebecca
Wang, Sheng-Ching
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Wang, Sheng-Ching
Patel, Bhumit A.
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Merck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA
Patel, Bhumit A.
Smith, Joseph P.
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Merck & Co Inc, Proc Res & Dev, MRL, West Point, PA 19486 USAMerck & Co Inc, Analyt Res & Dev, MRL, West Point, PA 19486 USA