Operationalizing Maintenance of Calibration Models Based on Near-Infrared Spectroscopy by Knowledge Integration

“…This size advantage leads to a third characteristic: namely, that the manufacturing space for continuous technology is smaller than that for batch technology. Fourth, the continuous technology requires PAT maintenance that costs man-hours . Finally, continuous technology needs some time (which can be several tens of minutes) until the machine operation is sufficiently stable.…”

Section: Methodsmentioning

confidence: 99%

“…Fourth, the continuous technology requires PAT maintenance that costs man-hours. 42 Finally, continuous technology needs some time (which can be several tens of minutes) until the machine operation is sufficiently stable. During this start-up operation, the precious materials are disposed.…”

Section: Methodsmentioning

confidence: 99%

Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing

Matsunami

Miyano

Arai

et al. 2018

Ind. Eng. Chem. Res.

Self Cite

View full text Add to dashboard Cite

This work presents a decision support method for the choice between batch and continuous technologies in solid drug product manufacturing based on the economic evaluation. The method consists of four steps: (I) modeling of operating costs, (II) evaluation, (III) sensitivity analysis, and (IV) interpretation, with iterations. For a given design situation, manufacturing processes are modeled and evaluated with consideration for the characteristics of the two technologies. The sensitivity of the input parameters is analyzed; after interpreting all results, the economically preferable technology is suggested. As a case study, the method was applied to a situation where a new product was in the late development stage, and one of the two technologies needs to be chosen. After executing the four steps, the comparison result of the net present cost was obtained as the decision support information.

show abstract

“…The total cost of ownership (development and maintenance) is not to be underestimated and has been recognized itself as an area of research by some academics . This is a particularly difficult aspect as the development of a model that would potentially require less maintenance will have to account for variations and disturbances not typically seen at the development scale.…”

Section: Introductionmentioning

confidence: 99%

Estimation of mass‐based composition in powder mixtures using Extended Iterative Optimization Technology (EIOT)

2018

View full text Add to dashboard Cite

The Extended Iterative Optimization Technology (EIOT) method is proposed as an extension to Muteki's [I&ECR 2013;52 (35):12258-12268] Iterative Optimization Technology to address deviations from Beer-Lambert's law in powders. The new method estimates the apparent spectrum for the pure species, rather than using the measured spectrum and augments Beer-Lambert's law with a bilinear term to capture the signature and strength of the nonchemical interferences. The proposed method has exhibited acceptable performance in spite of using a lean data set to estimate its parameters. The method provides robust and coherent estimates within the physical boundaries of the system and exhibits robustness to instrument transfer. The lean effort needed to build the EIOT method positions it as an attractive option in early stages of pharmaceutical drug product development. Its robustness to distinguish chemical from nonchemical signals implies a potential to lower the total cost of ownership for an EIOT-based solution in manufacturing.

show abstract

Operationalizing Maintenance of Calibration Models Based on Near-Infrared Spectroscopy by Knowledge Integration

Cited by 8 publications

References 35 publications

Multivariate Spectroscopic Method Lifecycle Management as Part of the Quality Management System

Multivariate Spectroscopic Method Lifecycle Management as Part of the Quality Management System

Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing

Estimation of mass‐based composition in powder mixtures using Extended Iterative Optimization Technology (EIOT)

Contact Info

Product

Resources

About