Managing API raw material variability in a continuous manufacturing line – Prediction of process robustness

Stauffer, F. J.; Vanhoorne, Valérie; Pilcer, Gabrielle; Chavez, Pierre-François; Beer, Thomas De

doi:10.1016/j.ijpharm.2019.118525

Cited by 23 publications

(19 citation statements)

References 25 publications

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“…Other studies aimed at determining the granule moisture content by in-line near infrared (NIR) measurements in the ConsiGma-25 dryer [26,27]. In a recent study, Stauffer et al [28] highlighted the influence of wet granule properties on drying stability (i.e., air flow deviations). Their study emphasized the importance of granule properties prior to drying as an excess of fine particles accumulating on the surface of the drying filter resulted in an unstable drying process.…”

Section: Introductionmentioning

confidence: 99%

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

et al. 2021

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The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality. Understanding the size reduction of pharmaceutical granules before, during, and after the fluid bed drying process is, however, still lacking. A first major goal was to investigate the breakage and attrition phenomena during transport of wet and dry granules, the filling phase, and drying phase on a ConsiGma-25 system (C25). Pneumatic transport of the wet granules after TSG towards the dryer induced extensive breakage, whereas the turbulent filling and drying phase of the drying cells caused rather moderate breakage and attrition. Subsequently, the dry transfer line was responsible for additional extensive breakage and attrition. The second major goal was to compare the influence of drying air temperature and drying time on granule size and moisture content for granules processed with a commercial-scale ConsiGma-25 system and with the R&D-scale ConsiGma-1 (C1) system. Generally, the granule quality obtained after drying with C1 was not predictive for the C25, making it challenging during process development with the C1 to obtain representative granules for the C25.

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Section: Introductionmentioning

confidence: 99%

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

et al. 2021

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“…The most commonly used immediate release binders in twin screw wet granulation of drug-loaded formulations are cellulose derivatives such as hydroxypropylmethylcellulose (HPMC) [ 12 , 21 , 57 , 66 ] and hydroxypropylcellulose (HPC) [ 26 , 29 , 67 , 68 , 78 , 79 ] as well as synthetic polymers such as polyvinylpyrrolidone (PVP) [ 14 , 25 , 59 ]. Although cellulosic binders are also commonly used in batch manufacturing, they are not always the most suitable choice for twin screw granulation.…”

Section: Influence Of Raw Materials Propertiesmentioning

confidence: 99%

“…The third PC, dominated by surface energy, had no effect on granule quality attributes [ 78 ]. In a follow-up study, it was demonstrated that the API batch-to-batch variability could be mitigated by choosing an appropriate L/S ratio [ 79 ].…”

Section: Influence Of Raw Materials Propertiesmentioning

confidence: 99%

“…As most studies to date studied twin screw wet granulation as a stand-alone unit operation, it is essential that more data become available to evaluate the interaction between the characteristics of the wet granules leaving the barrel and subsequent downstream processing (drying, milling, tableting, and coating). Therefore, it is recommended to consider holistic approaches that integrate all relevant unit operations, similar to the studies of Stauffer et al and De Leersnyder et al [ 79 , 110 ].…”

Section: Recommendations and Research Opportunitiesmentioning

confidence: 99%

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Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

Portier

Vervaet

2021

Pharmaceutics

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Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in batch mode such as high shear granulation and fluid bed granulation, several equipment manufacturers have designed their own manufacturing setup. This has led to a steep increase in the research output in this field. However, most studies still focused on a single (often placebo) formulation, hence making it difficult to assess the general validity of the obtained results. Therefore, current review provides an overview of recent progress in the field of continuous twin screw wet granulation, with special focus on the importance of the formulation aspect and raw material properties. It gives practical guidance for novel and more experienced users of this technique and highlights some of the unmet needs that require further research.

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“…Aiming efficiency and productivity increase in manufacturing industry, several works imply context awareness, especially in flexible manufacturing systems, such as pharma industry [84]. An experimental application on shoe industry is given in [85] using ontology-based reasoning.…”

Section: Smart Resource Managementmentioning

confidence: 99%

Context Aware Control Systems: An Engineering Applications Perspective

et al. 2020

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Cyber-physical systems revolve around context awareness, empowering objective-oriented services, products and operations based on real data. Self-aware and self-control systems are core elements in the Industry 4.0 framework towards self-sustainable adaptive manufacturing and personalized services. This development is witnessed by the context-aware pervasive assistance to users and machines in decisions making process for optimizing product performance and economic yield. While integration of the virtual and the physical world entails smart sensors communication and complex data analytics, it relies on artificial intelligence tools to manage process operations. The objective of the article is to create awareness that systems & control community must address theoretical and practical aspects from a larger perspective. Context aware control is emerging as a natural solution to maximize the use of available sensing instrumentation and the relatively low cost data logging, i.e. an important source for extracting information, interpreting and using context information and adapt its functionality to the current context of use. This article presents a concise overview of applications where context aware systems and control methodologies are relevant in the seven societal challenges acknowledged by European policy-makers: Digital Society;

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Managing API raw material variability in a continuous manufacturing line – Prediction of process robustness

Cited by 23 publications

References 25 publications

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

Context Aware Control Systems: An Engineering Applications Perspective

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