scholarly journals Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation

Processes ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1502
Author(s):  
Kensaku Matsunami ◽  
Alexander Ryckaert ◽  
Michiel Peeters ◽  
Sara Badr ◽  
Hirokazu Sugiyama ◽  
...  
Keyword(s):  
Process Parameters ◽  
Economic Assessment ◽  
Product Yield ◽  
Granule Size ◽  
Wet Granulation ◽  
Continuous Manufacturing ◽  
Optimal Point ◽  
Solid Ratio ◽  
Start Up ◽  
The Impact

Toward further implementation of continuous tablet manufacturing, one key issue is the time needed for start-up operation because it could lead to lower product yield and reduced economic performance. The behavior of the start-up operation is not well understood; moreover, the definition of the start-up time is still unclear. This work investigates the effects of process parameters on the start-up operation in continuous wet granulation, which is a critical unit operation in solid drug manufacturing. The profiles of torque and granule size distribution were monitored and measured for the first hour of operation, including the start-up phase. We analyzed the impact of process parameters based on design of experiments and performed an economic assessment to see the effects of the start-up operation. The torque profiles indicated that liquid-to-solid ratio and screw speed would affect the start-up operation, whereas different start-up behavior resulted in different granule size. Depending on the indicator used to define the start-up operation, the economic optimal point was significantly different. The results of this study stress that the start-up time differs according to the process parameters and used definition, e.g., indicators and criteria. This aspect should be considered for the further study and regulation of continuous manufacturing.

scholarly journals Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 210
Author(s):  
Lise Vandevivere ◽  
Maxine Vangampelaere ◽  
Christoph Portier ◽  
Cedrine de Backere ◽  
Olaf Häusler ◽  
...  
Keyword(s):  
Dissolution Kinetics ◽  
Wet Granulation ◽  
Continuous Manufacturing ◽  
Formulation Development ◽  
Granulation Process ◽  
Low Viscosity ◽  
Twin Screw ◽  
Poorly Soluble ◽  
Selection For ◽  
The Impact

The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.

scholarly journals Control Strategy for Process Development of High-Shear Wet Granulation and Roller Compaction to Prepare a Combination Drug Using Integrated Quality by Design

Pharmaceutics ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 80
Author(s):  
Ji Yeon Kim ◽  
Myung Hee Chun ◽  
Du Hyung Choi
Keyword(s):  
Process Parameters ◽  
Control Strategy ◽  
Quality By Design ◽  
Quality Attributes ◽  
Granule Size ◽  
Wet Granulation ◽  
Roller Compaction ◽  
High Shear ◽  
Intrinsic Dissolution ◽  
High Shear Wet Granulation

In this study, we developed a control strategy for a drug product prepared by high-shear wet granulation and roller compaction using integrated quality by design (QbD). During the first and second stages, we optimized the process parameters through the design of experiments and identified the intermediate quality attributes (IQAs) and critical quality attributes (CQAs) relationship, respectively. In the first stage, we conducted an initial risk assessment by selecting critical process parameters with high impact on IQAs and CQAs and confirmed the correlation between control and response factors. Additionally, we performed Monte Carlo simulations by optimizing the process parameters to deriving and building a robust design space. In the second stage, we identified the IQAs and CQAs relationship for the control strategy, using multivariate analysis (MVA). Based on MVA, in the metformin layer, dissolution at 1 h was significantly correlated with intrinsic dissolution rate and granule size, and dissolution at 3 h was significantly correlated with bulk density and granule size. In dapagliflozin layer, dissolution at 10 min and 15 min was significantly correlated with granule size. Our results suggest that the desired drug quality may result through IQAs monitoring during the process and that the integrated QbD approach utilizing MVA can be used to develop a control strategy for producing high-quality drug products.

Clients' Expectations on Audit Judgments: A Note

2004 ◽  
Vol 16 (1) ◽  
pp. 63-74 ◽  
Author(s):  
Venkataraman M. Iyer ◽  
Dasaratha V. Rama
Keyword(s):  
Audit Quality ◽  
Financial Statements ◽  
Early Years ◽  
Relative Power ◽  
Client Perceptions ◽  
Audit Firm ◽  
Auditor Tenure ◽  
Start Up ◽  
Nonaudit Services ◽  
The Impact

Audited financial statements can be viewed as the product of negotiations between a company's management and its auditor. Relative power of these two parties is a major factor that determines the outcome of the negotiation. This study examines the impact of auditor tenure, importance of a client to an audit partner, nonaudit purchases, and prior audit firm experience of client personnel on client perceptions about their ability to persuade the auditor in the context of an accounting disagreement. We obtained responses to a survey from 124 CPAs in industry who are employed as CEOs, CFOs, controllers, or treasurers. Our results indicate that respondents from companies with short auditor tenures were somewhat more likely to indicate that they could persuade the auditor to accept their (client's) position in case of a disagreement. This finding is consistent with the argument that auditors are susceptible to influence in the early years as they are still in the process of recouping start-up costs, but is not consistent with concerns expressed by legislators and others that long auditor tenures will adversely affect audit quality. Respondents who believed their business was more important for the audit partner were also more likely to believe that they could persuade the auditor. However, the purchase of nonaudit services and prior audit experience were not related to client's perceptions about their ability to persuade the auditor.

scholarly journals Effects of Process Parameters on the Color Quality of Anthocyanin-Based Colorants from Conventional and Microwave-Assisted Aqueous Extraction of Sweet Potato (Ipomoea batatas L.) Leaf Varieties

Proceedings ◽  
2020 ◽  
Vol 70 (1) ◽  
pp. 103
Author(s):  
Jin Mark D. G. Pagulayan ◽  
Aprille Suzette V. Mendoza ◽  
Fredelyn S. Gascon ◽  
Jan Carlo C. Aningat ◽  
Abigail S. Rustia ◽  
...  
Keyword(s):  
Sweet Potato ◽  
Process Parameters ◽  
Ipomoea Batatas ◽  
Extraction Methods ◽  
Aqueous Extraction ◽  
Potato Leaf ◽  
Microwave Assisted ◽  
Color Quality ◽  
The Impact

The study aimed to evaluate the effects of process parameters (time and raw material weight (RMW)) of conventional (boiling for 10–45 min) and microwave-assisted (2–8 min) aqueous extraction on the color quality (i.e., lightness (L*), chroma (C*), and hue (H°) of anthocyanin –based colorants of red and Inubi sweet potato (Ipomoea batatas L.) leaves. Using response surface methodology, it was found that RMW and boiling time (BT) and microwave time (MT) generally had a significant (p < 0.05) effect on the color quality of the extract from both extraction methods. The effects were found to vary depending on the extraction method and variety of the leaves used. Both extraction methods produced a brown to brick-red extract from the Inubi variety that turned red-violet to pink when acidified. The red sweet potato leaves produced a deep violet colored extract that also turned red-violet when acidified. It is recommended that the anthocyanin content of the extracts be measured to validate the impact of the methods on the active agent. Nevertheless, the outcomes in this study may serve as baseline data for further studies on the potential of sweet potato leaf colorants (SPLC) as a colorant with functional properties.

The Impact of Ball Milling Process Parameters on the Preparation of Nano Silicon Powder

2021 ◽  
Vol 217 (1) ◽  
pp. 255-264
Author(s):  
Xiaomeng Zhu ◽  
Xiaolan Cai ◽  
Shuang Zhang ◽  
Lei Wang ◽  
Xudong Cui
Keyword(s):  
Ball Milling ◽  
Process Parameters ◽  
Silicon Powder ◽  
Milling Process ◽  
Ball Milling Process ◽  
Nano Silicon ◽  
The Impact

scholarly journals A FEM-Based 2D Model for Simulation and Qualitative Assessment of Shot-Peening Processes

Materials ◽  
2021 ◽  
Vol 14 (11) ◽  
pp. 2784
Author(s):  
Georgios Maliaris ◽  
Christos Gakias ◽  
Michail Malikoutsakis ◽  
Georgios Savaidis
Keyword(s):  
Process Parameters ◽  
Material Properties ◽  
Shot Peening ◽  
Qualitative Assessment ◽  
Experimental Investigations ◽  
Elastoplastic Material ◽  
Size Distributions ◽  
User Friendly ◽  
The Impact ◽  
2D Model

Shot peening is one of the most favored surface treatment processes mostly applied on large-scale engineering components to enhance their fatigue performance. Due to the stochastic nature and the mutual interactions of process parameters and the partially contradictory effects caused on the component’s surface (increase in residual stress, work-hardening, and increase in roughness), there is demand for capable and user-friendly simulation models to support the responsible engineers in developing optimal shot-peening processes. The present paper contains a user-friendly Finite Element Method-based 2D model covering all major process parameters. Its novelty and scientific breakthrough lie in its capability to consider various size distributions and elastoplastic material properties of the shots. Therewith, the model is capable to provide insight into the influence of every individual process parameter and their interactions. Despite certain restrictions arising from its 2D nature, the model can be accurately applied for qualitative or comparative studies and processes’ assessments to select the most promising one(s) for the further experimental investigations. The model is applied to a high-strength steel grade used for automotive leaf springs considering real shot size distributions. The results reveal that the increase in shot velocity and the impact angle increase the extent of the residual stresses but also the surface roughness. The usage of elastoplastic material properties for the shots has been proved crucial to obtain physically reasonable results regarding the component’s behavior.

scholarly journals Electrochemical synthesis of biobased polymers and polymer building blocks from vanillin

RSC Advances ◽  
2021 ◽  
Vol 11 (15) ◽  
pp. 8970-8985
Author(s):  
Robin Kunkel ◽  
Volkmar M. Schmidt ◽  
Carsten Cremers ◽  
Dominik Müller ◽  
Detlef Schmiedl ◽  
...  
Keyword(s):  
Process Parameters ◽  
Current Density ◽  
Electrode Material ◽  
Electrochemical Synthesis ◽  
Building Blocks ◽  
Biobased Polymers ◽  
The Impact

Hydrovanilloin and polyvanillin were synthesized electrochemically investigating the impact of process parameters such as electrode material, charge and current density.

scholarly journals The influence of cronyism on entrepreneurial resource acquisition

2021 ◽  
Author(s):  
Junfan Yu ◽  
Saskia De Klerk ◽  
Michael Hess
Keyword(s):  
Community Involvement ◽  
Private Property ◽  
Resource Acquisition ◽  
Property Development ◽  
Network Utilization ◽  
Start Up ◽  
Entrepreneurial Strategies ◽  
Staged Model ◽  
The Impact

AbstractThis research focuses on how entrepreneurs utilize cronyism to acquire resources. A case study method allowed us to explore three firms in the private property development industry in China. These firms uniquely cultivated cronyism and achieved distinctly different outcomes. Our findings highlight Chinese entrepreneurs in start-up ventures and later-stage enterprises employ cronyism. The underlying rationale for using cronyism have common and heterogeneous motivations. The similarity and distinguishing rationale also apply to the impact of cronyism. We also find two contingency working mechanisms for cronyism: entrepreneurial characteristics and a staged model for cronyism. With the firm’s growth, cronyism remains important, but firms with more community involvement outperform others. This research contributes to the theory on strategic network utilization for resource acquisition during entrepreneurial development stages. We investigate how entrepreneurial strategies can assist in adapting to the “rules of the game” while utilizing resources within the set contextual constraints.

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