Implementation of a Fully Integrated Continuous Manufacturing Line for Direct Compression and Coating at a Commercial Pharmaceutical Facility - Part 1: Operational Considerations and Control Strategy.

[1]  J. G. Rosas,et al.  Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility - Part 2: PAT and RTD results for normal operational conditions batches. , 2023, International journal of pharmaceutics.

[2]  M. Metzger,et al.  Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous Manufacturing Drug Product Pharmaceutical Process , 2022, Pharmaceutics.

[3]  Robert Meyer,et al.  A very boring 120 h: 15 million tablets under a continuous state of control , 2021 .

[4]  Ivan Macuzic,et al.  Early management of human factors in lean industrial systems , 2019, Safety Science.

[5]  R. T. Haslam,et al.  Why We Need Continuous Pharmaceutical Manufacturing and How to Make it Happen: A Summary of Thoughts from the International Symposium on Continuous Manufacturing. , 2019, Journal of pharmaceutical sciences.

[6]  Jenny M. Vargas,et al.  Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. , 2018, International journal of pharmaceutics.

[7]  Bernhardt L Trout,et al.  Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals. , 2017, Journal of pharmaceutical sciences.

[8]  Lawrence X. Yu,et al.  Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production , 2015, Journal of Pharmaceutical Innovation.

[9]  Marianthi G. Ierapetritou,et al.  A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process , 2014, Comput. Chem. Eng..

[10]  James M. B. Evans,et al.  End-to-end continuous manufacturing of pharmaceuticals: integrated synthesis, purification, and final dosage formation. , 2013, Angewandte Chemie.

[11]  Fernando J. Muzzio,et al.  Characterizing continuous powder mixing using residence time distribution , 2011 .

[12]  T. Melton,et al.  The Benefits of Lean Manufacturing: What Lean Thinking has to Offer the Process Industries , 2005 .

[13]  Martin D. Johnson,et al.  Annual Review of Chemical and Biomolecular Engineering Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing , 2018 .