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Olena Gligorich
Olena brings over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable...
https://cmkc.usp.org/members/2480
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Compact NMR Spectroscopy for Automated Continuous-Flow Production of Chemicals and Pharmaceuticals (On-Demand)
| Contributor(s):: Klas Meyer
Chemical companies are under constant pressure to improve productivity while cutting costs. Flexible and modular chemical plants can produce high-quality products using multi-purpose equipment with short downtimes, reducing time to market for new products. Intensified continuous production...
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MOOC I Control Strategy - Process Control
| Contributor(s):: RCPE
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MOOC I Control Strategy - Examples
| Contributor(s):: RCPE
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MOOC I Control Strategy - Introduction
| Contributor(s):: RCPE
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MOOC I Control Strategy - Quality Control
| Contributor(s):: RCPE
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Xiao-Dong Wu
https://cmkc.usp.org/members/1169
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Videometric mass flow control: A new method for real-time measurement and feedback control of powder micro-feeding based on image analysis
| Contributor(s):: Madarasz, L, Kote, AGyurkes, M, Farkas, A, Hambalko, B, Pataki, H, Fulop, G, Marosi, G, Lengyel, L, Casian, T, Csorba, K, Nagy, ZK
The present paper reports the first monitoring and control of ultra-low dose powder feeding using a camera image-based mass flow measurement system. Caffeine was fed via a single-screw microfeeder as a model active pharmaceutical ingredient (API). The mass, mass flow and sizes of the particles...
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Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen
| Contributor(s):: Clive Badman, Charles L.Cooney, Alastair Florence, Konstantin Konstantinov, Markus Krumme, Salvatore Mascia, Moheb Nasr, Bernhardt L. Trout
We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.
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The use of rheology to elucidate the granulation mechanisms of a miscible and immiscible system during continuous twin-screw melt granulation
| Contributor(s):: Monteyne, Tinne, Heeze, Liza, Mortier, Severine Therese F. C., Oldorp, Klaus, Nopens, Ingmar, Remon, Jean-Paul, Vervaet, Chris, De Beer, Thomas
Twin-screw hot melt granulation (TS HMG) is a valuable, but still unexplored alternative to granulate temperature and moisture sensitive drugs in a continuous way. Recently, the material behavior of an immiscible drug-binder blend during TS HMG was unraveled by using a rheometer and differential...
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The effects of unintentional and intentional process disturbances on tablet quality during long continuous manufacturing runs
| Contributor(s):: Taipale-Kovalainen, Krista, Karttunen, Anssi-Pekka, Niinikoski, Hannes, Ketolainen, Jarkko, Korhonen, Ossi
Several kinds of process disturbances can occur during (continuous) tablet manufacturing, i.e. unintentional or intentional disturbances. Long run-time continuous manufacturing studies are used to investigate the effects of intentional and unintentional deviations. In this study, the horizontal...
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The Application of an Automated Control Strategy for an Integrated Continuous Pharmaceutical Pilot Plant
| Contributor(s):: Lakerveld, R, Benyahia, BHeider, PL, Zhang, HT, Wolfe, A, Testa, CJ, Ogden, S, Hersey, DR, Mascia, S, Evans, JMB, Braatz, RD, Barton, PI
Continuous manufacturing offers potential opportunities for the improved manufacturing of pharmaceutical products. A key challenge is the development of an appropriate control strategy. The experimental application of an automated control strategy is presented for an end-to-end continuous...
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Tableting model assessment of porosity and tensile strength using a continuous wet granulation route
| Contributor(s):: Wang, Li Ge, Omar, Chalak, Li, Jianfeng, Mitchell, Niall, Bellinghausen, Stefan, Barrasso, Dana, Salman, Agba, Slade, David
This paper presents a comprehensive assessment of the most widely used tablet compaction models in a continuous wet granulation tableting process. The porosity models, tensile strength models and lubricant models are reviewed from the literature and classified based on their formulations i.e....
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Simulation-Based Design of an Efficient Control System for the Continuous Purification and Processing of Active Pharmaceutical Ingredients
| Contributor(s):: Sen, M, Singh, R, Ramachandran, R
In this study, an efficient system-wide controlsystem has been designed for the integrated continuous purification and processing of the active pharmaceutical ingredient (API). The control strategy is based on the regulatory PID controller which is most widely used in the manufacturing industry...
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Sample Mass Estimate for the Use of Near-Infrared and Raman Spectroscopy to Monitor Content Uniformity in a Tablet Press Feed Frame of a Drug Product Continuous Manufacturing Process
| Contributor(s):: Hetrick, Evan, Castillo, Ismael, Rehrla, Jakob, Sagmeistera, Peter, Lebl, René, Kruisza, Julia, Celikovic, Selma, Sipek, Martin, Williams, Myers, David P
Recently, feed frame-based process analytical technology measurements used to assure product quality during continuous manufacturing processes have received significant attention. These measurements are able to accurately determine uniformity of the powder blend before compression, and in these...
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RTD modeling of a continuous dry granulation process for process control and materials diversion
| Contributor(s):: Kruisz, Julia, Rehrl, Jakob, Sacher, Stephan, Aigner, Isabella, Horn, Martin, Khinast, Johannes G., Krumme, Markus
Disturbance propagation during continuous manufacturing processes can be predicted by evaluating the residence time distribution (RTD) of the specific unit operations. In this work, a dry granulation process was modelled and four scenarios of feeding events were simulated. We performed...
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Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies
| Contributor(s):: Chopda, Viki, Gyorgypal, Aron Yang, Ou Singh, Ravendra Ramachandran, Rohit Zhang, Haoran Tsilomelekis, George Chundawat, Shishir PS, Ierapetritou, Marianthi G
Continuous bioprocessing is significantly changing the biological drugs (or biologics) manufacturing landscape by potentially improving product quality, process stability, and overall profitability, as was similarly seen during the adoption of advanced manufacturing processes for small molecule...
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Real-time monitoring of particle size distribution in a continuous granulation and drying process by near infrared spectroscopy
| Contributor(s):: Pauli, V, Roggo, YKleinebudde, P, Krumme, M
In continuous granulation, it can be important to control granules particle size distribution (PSD), as it may affect final product quality. Near infrared spectroscopy (NIRS) is already a routine analytical procedure within pharmaceutical continuous manufacturing for the in-line analysis of...
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Process monitoring and evaluation of a continuous pharmaceutical twin-screw granulation and drying process using multivariate data analysis
| Contributor(s):: Silva, A. F., Vercruysse, J., Vervaet, C., Remon, J. P., Lopes, J. A., De Beer, T., Sarraguca, M. C.
The present study aims at acquiring an in-depth process knowledge about a twin-screw granulation and fluid bed drying process performed on the commercially available continuous line. Batch Statistical Process Monitoring (BSPM) principles are used to describe and monitor the variables with a...
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Predictive Model-Based Process Start-Up in Pharmaceutical Continuous Granulation and Drying
| Contributor(s):: Pauli, Victoria, Kleinebudde, Peter, Krumme, Markus
Continuous manufacturing (CM) is a promising strategy to achieve various benefits in the context of quality, flexibility, safety and cost in pharmaceutical production. One of the main technical challenges of CM is that the process needs to handle transient conditions such as the start-up phase...
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Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets
| Contributor(s):: Shi, Guolin, Lin, Longfei, Liu, Yuling, Chen, Gongsen, Luo, Yuting, Wu, Yanqiu, Li, Hui
The tablet manufacturing process is a complex system, especially in continuous manufacturing (CM). It includes multiple unit operations, such as mixing, granulation, and tableting. In tablet manufacturing, critical quality attributes are influenced by multiple factorial relationships between...
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Pharmaceutical crystallisation processes from batch to continuous operation using MSMPR stages: Modelling, design, and control
| Contributor(s):: Su, Qinglin, Nagy, Zoltan K., Rielly, Chris D.
In pharmaceuticals manufacturing, the conversion of conventional batch crystallisations to continuous mode has the potential for intensified, compact operation and more consistent production via quality-by-design. A pragmatic conversion approach is to utilise existing stirred tank batch...
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Orthogonal Redundant Monitoring of a New Continuous Fluid-Bed Dryer for Pharmaceutical Processing by Means of Mass and Energy Balance Calculations and Spectroscopic Techniques
| Contributor(s):: Pauli, Victoria, Elbaz, Frantz, Kleinebudde, Peter, Krumme, Markus
In line with the ongoing shift from batch to continuous pharmaceutical production of solid oral dosage forms, a novel continuous fluid-bed dryer was developed. The forced feed nature of the Glatt GPCG2 CM fluid-bed dryer allows continuous, first-in-first-out drying of wet granulate materials...
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On-Demand Continuous Manufacturing of Ciprofloxacin in Portable Plug-and-Play Factories: Implementation and in Situ Control of Downstream Production
| Contributor(s):: Capellades, Gerard, Neurohr, Clemence Briggs, Naomi Rapp, Kersten, Hammersmith, Gregory, Brancazio, David, Derksen, Bridget, Myerson, Allan S.
Traditional pharmaceutical manufacturing operates around a supply chain that is subject to complex logistics and is vulnerable to spikes in demand and interruptions. In this context, continuous pharmaceutical manufacturing in portable, refrigerator-sized factories is a promising solution with...
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New approach to optimizing risk management of the sticking problem using scale-independent critical material attributes and the quantitative process parameter
| Contributor(s):: Ando, Hirotaka, Hara, Yuko, Sato, Kazunari, Dohi, Masafumi, Hakomori, Tadashi, Yonemochi, Etsuo
In pharmaceutical manufacturing of solid formulations, blending with a lubricant is a key process in preventing sticking during compression. Sticking not only results in tablets with a disfigured appearance but also brings about the interruption of continuous operations. The aim of our study was...