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Exploring the advantages of PAT for pharmaceutical cleaning in Ireland

4 May 2016  •  Author(s): Adeyinka Aina, University of Nottingham / Manuel Kuhs, Bernal Powder Engineering Research Group / Shaza Darwish, University of Limerick / Chris Edlin, Pharmaceutical Technology Manufacturing Centre

Process analytical technology (PAT) and its applications have been used in various industrial processes for a long time. It originates from the last century where its first application was in Germany after World War II within the chemical and petrochemical industry1. Following this, it was implemented and refined in different industries worldwide – for example in refineries and petrochemical plants – until it became an integral part of process control. However, it is considered a young technology in pharmaceutical manufacturing where the processes have always been restricted to conventional approaches. This forces many limitations on product quality monitoring since the control relies mainly on collected samples being tested off-line in a laboratory.

Exploring the advantages of PAT for pharmaceutical cleaning in Ireland

In order to support novelty in production, the United States Food and Drug Administration (FDA) started an initiative and set guidance in 2004 to describe PAT, its scientific scope and framework. PAT was defined as a “system for designing, analysing and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality”2. This regulatory scope fits into the broader Quality by Design (QbD) concept which requires the quality of a product to be designed in advance and not merely tested retrospectively. PAT’s main framework is to enhance understanding and control the manufacturing process to facilitate the implementation of QbD. Consequently, the effectiveness of a process can be improved using PAT tools, such as process analysers, process control tools and multivariate tools. This allows for an improved study of the effect of critical sources of variabilities on the product quality in real time, as well as providing a good insight on how to manage the effect of product composition and other factors on quality (multivariate) as opposed to traditional univariate trend analysis2-4.

The advantages of PAT as an industrial monitoring tool cannot be over-emphasised; it is rapid and non-destructive and imparts more understanding into a process, thus engendering greater confidence in the quality of the end product5-6. Furthermore, when PAT is deployed the need to develop chemometric models for both qualitative and quantitative testing are not commonly required as, compared with data analysis during process development, the more important aspect is the capability to monitor the underlying process in situ or in near real time7.

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