Adverse events integrated approach

Several of the validated in vitro methods aim to be validated as full replacement methods to offer an alternative for in vivo test guideline method(s). However, for integrated testing strategies, validated mechanistic tools targeting key events in adverse outcome pathways are necessary to generate state-of-the-art alternative approaches to conventional toxicological test methods based on laboratory animals. 

In this work, we describe an approach to integrate multivariate statistical process monitoring and online HAZOP analysis for abnormal event management of batch processes. The framework consists of three main parts process monitoring and fault detection, automated online HAZOP analysis module and a coordinator. Multiway PCA is used for batch process monitoring and fault detection. When abnormal event is detected, signal-to-symbol transformation technique based on variable contribution is used to transfer quantitative sensor readings to qualitative states. Online HAZOP analysis is based on PHASuite, an automated HAZOP analysis tool, to identify the potential causes, adverse consequences and potential operator options for the identified abnormal event. 

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