During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process deve...

Purpose – The purpose of this research is to contrast manufacturing and service sector supply chains in order to develop an audit methodology capable of providing objective, cross-sector comparisons of supply chain integration performance. Design/Methodology/approach – A robust, site-based multi-method supply chain diagnostic for detecting manufacturing supply chain system uncertainty (QSAM) wa...

Using a patented matrix formulation, a Discrete Event (DE) controller is designed for a manufacturing cell. The DE controller can directly be implemented from standard manufacturing tools such as the Bill of Materials or the assembly tree. The matrices also make it straightforward to actually implement the DE controller for sequencing the jobs and assigning the resources. We use virtual places ...

Globalization of business and competitiveness in manufacturing has forced companies to improve their manufacturing facilities to respond to market requirements. Machine tool evaluation involves an essential decision using imprecise and vague information, and plays a major role to improve the productivity and flexibility in manufacturing. The aim of this study is to present an integrated approac...

In response to fast-growing and rapidly-changing markets, launching new products faster than competitors cannot only assist firms in acquiring larger market share but also reducing development lead time, significantly. However, owing to its intrinsically uncertain properties of managing NPD (new product development), manufacturing companies often struggle with the dilemma of increasing product ...

Properties and serviceability of additively manufactured components are affected by their geometry, microstructure and defects. These important attributes are now optimized by trial and error because the essential process variables cannot currently be selected from scientific principles. A recourse is to build and rigorously validate a digital twin of the additive manufacturing process that can...

Emulsions are widely used for pharmaceutical, food, and cosmetic applications. To guarantee that their critical quality attributes meet specifications, it is desirable to monitor the emulsion manufacturing process. However, finding of a suitable process analyzer has so far remained challenging. This article introduces diffusing wave spectroscopy (DWS) as an at-line technique to follow the manuf...

This paper describes a procedure to merge two STEP/AP EXPRESS schemata, using automated methods to assist the merging process. The desire to integrate or merge two schemata or ontologies is very common today (for example, it may be necessary to integrate two models describing car manufacturing from two different car manufacturing companies who just merged and need a common car manufacturing mod...

The worldwide competitive economy, the increase in sustainable issue and investment of new production line is demanding companies to choose the right machine from the available ones. An improper selection can negatively affect the overall performance of the manufacturing system like productivity, quality, cost and company’s responsive manufacturing capabilities. Thus, selecting the right machin...

It is a common practice in biotherapeutic manufacturing to define a fixed-volume feed strategy for nutrient feeds, based on historical cell demand. However, once the feed volumes are defined, they are inflexible to batch-to-batch variations in cell growth and physiology and can lead to inconsistent productivity and product quality. In an effort to control critical quality attributes and to appl...