scholarly journals Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1033
Author(s):  
Raghu V. G. Peddapatla ◽  
Gerard Sheridan ◽  
Conor Slevin ◽  
Shrikant Swaminathan ◽  
Ivan Browning ◽  
...  
Keyword(s):  
Process Model ◽  
Model Development ◽  
Processing Parameters ◽  
Pilot Scale ◽  
Direct Compression ◽  
Processing Conditions ◽  
Flow Properties ◽  
Production Scale ◽  
Optimum Processing ◽  
Relative Standard

Optimizing processing conditions to achieve a critical quality attribute (CQA) is an integral part of pharmaceutical quality by design (QbD). It identifies combinations of material and processing parameters ensuring that processing conditions achieve a targeted CQA. Optimum processing conditions are formulation and equipment-dependent. Therefore, it is challenging to translate a process design between formulations, pilot-scale and production-scale equipment. In this study, an empirical model was developed to determine optimum processing conditions for direct compression formulations with varying flow properties, across pilot- and production-scale tablet presses. The CQA of interest was tablet weight variability, expressed as percentage relative standard deviation. An experimental design was executed for three model placebo blends with varying flow properties. These blends were compacted on one pilot-scale and two production-scale presses. The process model developed enabled the optimization of processing parameters for each formulation, on each press, with respect to a target tablet weight variability of <1%RSD. The model developed was successfully validated using data for additional placebo and active formulations. Validation formulations were benchmarked to formulations used for model development, employing permeability index values to indicate blend flow.

scholarly journals New Scale-up Technologies for Hydrogenation Reactions in Multipurpose Pharmaceutical Production Plants

2021 ◽  
Vol 75 (11) ◽  
pp. 948-956
Author(s):  
Thierry Furrer ◽  
Benedikt Müller ◽  
Christoph Hasler ◽  
Bernhard Berger ◽  
Michael K. Levis ◽  
...  
Keyword(s):  
Heat Transfer ◽  
Process Model ◽  
Scale Up ◽  
Pilot Scale ◽  
Hydrogenation Reaction ◽  
Production Scale ◽  
Hydrogenation Reactions ◽  
Scale Down ◽  
Physical And Chemical ◽  
Scale Reactor

The classical scale-up approach for hydrogenation reaction processes usually includes numerous laboratory- and pilot-scale experiments. With a novel scale-up strategy, a significant number of these experiments may be replaced by modern computational simulations in combination with scale-down experiments. With only a few laboratory-scale experiments and information about the production-scale reactor, a chemical process model is developed. This computational model can be used to simulate the production-scale process with a range of different process parameters. Those simulations are then validated by only a few experiments in an advanced scale-down reactor. The scale-down reactor has to be geometrically identical to the corresponding production-scale reactor and should show a similar mass transfer behaviour. Closest similarity in terms of heat transfer behaviour is ensured by a sophisticated 3D-printed heating/cooling finger, offering the same heat exchange area per volume and overall heat-transfer coefficient as in production-scale. The proposed scale-up strategy and the custom-designed scale-down reactor will be tested by proof of concept with model reactions. Those results will be described in a future publication. This project is an excellent example of a collaboration between academia and industry, which was funded by the Aargau Research Fund. The interest of academia is to study and understand all physical and chemical processes involved, whereas industry is interested in generating a robust and simple to use tool to improve scale-up and make reliable predictions.

Upscaling of foam forming technology for pilot scale

TAPPI Journal ◽  
2019 ◽  
Vol 18 (8) ◽  
Author(s):  
JANI LEHMONEN ◽  
TIMO RANTANEN ◽  
KARITA KINNUNEN-RAUDASKOSKI
Keyword(s):  
Production Efficiency ◽  
Strength Loss ◽  
Pilot Scale ◽  
Foam Density ◽  
Forming Process ◽  
Production Scale ◽  
Forming Technology ◽  
Wet Pressing ◽  
Foam Forming ◽  
Board Industry

The need for production cost savings and changes in the global paper and board industry during recent years have been constants. Changes in the global paper and board industry during past years have increased the need for more cost-efficient processes and production technologies. It is known that in paper and board production, foam typically leads to problems in the process rather than improvements in production efficiency. Foam forming technology, where foam is used as a carrier phase and a flowing medium, exploits the properties of dispersive foam. In this study, the possibility of applying foam forming technology to paper applications was investigated using a pilot scale paper forming environment modified for foam forming from conventional water forming. According to the results, the shape of jet-to-wire ratios was the same in both forming methods, but in the case of foam forming, the achieved scale of jet-to-wire ratio and MD/CD-ratio were wider and not behaving sensitively to shear changes in the forming section as a water forming process would. This kind of behavior would be beneficial when upscaling foam technology to the production scale. The dryness results after the forming section indicated the improvement in dewatering, especially when foam density was at the lowest level (i.e., air content was at the highest level). In addition, the dryness results after the pressing section indicated a faster increase in the dryness level as a function of foam density, with all density levels compared to the corresponding water formed sheets. According to the study, the bonding level of water- and foam-laid structures were at the same level when the highest wet pressing value was applied. The results of the study show that the strength loss often associated with foam forming can be compensated for successfully through wet pressing.

Optimization of Microcrystalline Cellulose PH 101, Lactose, and Kollidon® K 30 To Obtain Co-Processed Excipient Through Spray Drying

2017 ◽  
Vol 7 (2) ◽  
Author(s):  
Kusuma P. ◽  
Syukri Y ◽  
Sholehuddin F. ◽  
Fazzri N. ◽  
Romdhonah . ◽  
...  
Keyword(s):  
Spray Drying ◽  
Microcrystalline Cellulose ◽  
Chemical Change ◽  
Direct Compression ◽  
Flow Properties ◽  
Scanning Calorimetry ◽  
Compression Process ◽  
Infrared Spectrophotometer ◽  
Physical Mixtures ◽  
Spray Dried

The most efficient tablet processing method is direct compression. For this method, the filler-binder can be made by coprocessing via spray drying method. The purpose of this study was to investigate the effect of spray dried co-processing on microcrystalline cellulose (MCC) PH 101, lactose and Kollidon® K 30 as well as to define the optimum proportions. Spray dried MCC PH 101, lactose, and Kollidon® K 30 were varied in 13 different mixture design proportions to obtain compact, free-flowing filler-binder co-processed excipients (CPE). Compactibility and flow properties became the key parameters to determine the optimum proportions of CPE that would be compared to their physical mixtures. The result showed that the optimum proportion of CPE had better compactibility and flow properties than the physical mixtures. The optimum CPE, consisting of only MCC PH 101 and Kollidon® K 30 without lactose, that were characterized using infrared spectrophotometer, differential scanning calorimetry (DSC), X-ray diffraction (XRD), and scanning electron microscope (SEM) indicated no chemical change therein. Therefore, this study showed that spray dried MCC PH 101, lactose and Kollidon® K 30 could be one of the filler-binder alternatives for direct compression process.

Interaction Process Model – ESM Quality Model Development Tool

2020 ◽  
Vol 25 (1) ◽  
pp. 10-17
Author(s):  
B.V. Boytsov ◽  
◽  
G.S. Zhetessova ◽  
M.K. Ibatov ◽  
◽  
...  
Keyword(s):  
Process Model ◽  
Swot Analysis ◽  
Statistical Data ◽  
Model Development ◽  
Interaction Process ◽  
Educational Process ◽  
Quality Model ◽  
Development Tool ◽  
The Republic ◽  
Education Science

The article discusses the methodology and provides the results of a multivariate SWOT analysis for a scientific and manufacturing educational process based on a set of regulatory and strategic documents, statistical data of the Republic of Kazakhstan; The main conclusions and description of the generated matrices for the subjects of interaction within the hierarchical triangle «Education – Science – Manufacturing (ESM)» are given.

scholarly journals Binary Self-Assembly of Nanocolloidal Arrays using Concurrent and Sequential Spin Coating Techniques

Materials ◽  
2021 ◽  
Vol 14 (2) ◽  
pp. 274
Author(s):  
Shih-Jyun Shen ◽  
Demei Lee ◽  
Yu-Chen Wu ◽  
Shih-Jung Liu
Keyword(s):  
Silicon Substrate ◽  
Self Assembly ◽  
Spin Coating ◽  
Processing Parameters ◽  
The Self ◽  
Silicon Substrates ◽  
Processing Conditions ◽  
Polystyrene Spheres ◽  
Optimal Processing ◽  
Spin Coater

This paper reports the binary colloid assembly of nanospheres using spin coating techniques. Polystyrene spheres with sizes of 900 and 100 nm were assembled on top of silicon substrates utilizing a spin coater. Two different spin coating processes, namely concurrent and sequential coatings, were employed. For the concurrent spin coating, 900 and 100 nm colloidal nanospheres of latex were first mixed and then simultaneously spin coated onto the silicon substrate. On the other hand, the sequential coating process first created a monolayer of a 900 nm nanosphere array on the silicon substrate, followed by the spin coating of another layer of a 100 nm colloidal array on top of the 900 nm array. The influence of the processing parameters, including the type of surfactant, spin speed, and spin time, on the self-assembly of the binary colloidal array were explored. The empirical outcomes show that by employing the optimal processing conditions, binary colloidal arrays can be achieved by both the concurrent and sequential spin coating processes.

Toward Metamodels for Composable and Reusable Additive Manufacturing Process Models

2014 ◽  
Vol 136 (6) ◽  
Author(s):  
Paul Witherell ◽  
Shaw Feng ◽  
Timothy W. Simpson ◽  
David B. Saint John ◽  
Pan Michaleris ◽  
...  
Keyword(s):  
Additive Manufacturing ◽  
Metal Powder ◽  
Manufacturing Process ◽  
Process Model ◽  
Model Development ◽  
Process Models ◽  
Powder Bed Fusion ◽  
Powder Bed ◽  
Future Work ◽  
Am Processes

In this paper, we advocate for a more harmonized approach to model development for additive manufacturing (AM) processes, through classification and metamodeling that will support AM process model composability, reusability, and integration. We review several types of AM process models and use the direct metal powder bed fusion AM process to provide illustrative examples of the proposed classification and metamodel approach. We describe how a coordinated approach can be used to extend modeling capabilities by promoting model composability. As part of future work, a framework is envisioned to realize a more coherent strategy for model development and deployment.

Ball Grid Array Thermomechanical Response During Reflow Assembly

1996 ◽  
Vol 118 (4) ◽  
pp. 214-222 ◽  
Author(s):  
T. E. Voth ◽  
T. L. Bergman
Keyword(s):  
Process Model ◽  
Experimental Studies ◽  
Ball Grid Array ◽  
Mechanical Processing ◽  
Processing Conditions ◽  
System Behavior ◽  
Reflow Soldering ◽  
Thermomechanical Response ◽  
Model Predictions ◽  
Representative System

The thermomechanical response of ball-grid array assemblies during reflow soldering is considered here. Experiments are performed to investigate the thermomechanical response of a representative system and the results are used to validate a numerical model of system behavior. The conclusions drawn from the experimental studies are used to guide development of a process model capable of describing more realistic BGA soldering scenarios. Process model predictions illustrate the system’s thermomechanical response to thermal and mechanical processing conditions, as well as component properties. High thermal conductivity assemblies show the greatest sensitivity to mechanical loading conditions.

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