Reliability modelling and verification of manufacturing processes based on process knowledge management

Reliability modelling and verification is indispensable in modern manufacturing, especially for product development risk reduction. Based on the discussion of the deficiencies of traditional reliability modelling methods for process reliability, a novel modelling method is presented herein that draws upon a knowledge network of process scenarios based on the analytic network process (ANP). An integration framework of manufacturing process reliability and product quality is presented together with a product development and reliability verification process. According to the roles of key characteristics (KCs) in manufacturing processes, KCs are organised into four clusters, that is, product KCs, material KCs, operation KCs and equipment KCs, which represent the process knowledge network of manufacturing processes. A mathematical model and algorithm is developed for calculating the reliability requirements of KCs with respect to different manufacturing process scenarios. A case study on valve-sleeve component manufacturing is provided as an application example of the new reliability modelling and verification procedure. This methodology is applied in the valve-sleeve component manufacturing processes to manage and deploy production resources.

Physiologically based pharmacokinetic modelling in drug delivery

The application of pharmacokinetic modelling within the drug development field essentially allows one to develop a quantitative description of the temporal behaviour of a compound of interest at a tissue/organ level, by identifying and defining relationships between a dose of a drug and dependent variables. In order to understand and characterise the pharmacokinetics of a drug, it is often helpful to employ pharmacokinetic modelling using empirical or mechanistic approaches. Pharmacokinetic models can be developed within mathematical and statistical commercial software such as MATLAB using traditional mathematical and computation coding, or by using the Simbiology Toolbox available within MATLAB for a graphical user interface approach to developing pharmacokinetic (PBPK) models. For formulations dosed orally, a prerequisite for clinical activity is the entry of the drug into the systemic circulation.