Case Studies

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Optimal delivers complete PAT software and hardware solution for continuous pharmaceutical production

Bristol, UK based Optimal Industrial Automation is just completing the design, construction and installation of a complete Process Analytical Technologies based control system, built to manage a pharmaceutical customer’s continuous manufacturing line, it delivers a huge increase in production efficiency, including regulatory compliance.

The new system builds on Optimal’s 26 years of systems integration experience in the pharmaceutical sector and makes use of the company’s latest synTQ® PAT implementation management software.

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PAT & synTQ for API Production

A leading pharmaceutical manufacturer installed synTQ® for use on a reactor system that was producing an API product using an exothermic reaction. The existing process cannot determine the status of the critical to quality attributes until the end of the process, and the quality verification process at the end of production resulted in a great deal of waste.

A leading pharmaceutical manufacturer installed synTQ® for use on a reactor system that was producing an API product using an exothermic reaction. The existing process cannot determine the status of the critical to quality attributes until the end of the process, and the quality verification process at the end of production resulted in a great deal of waste.

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PAT & synTQ for Product Development

A leading pharmaceutical manufacturer installed synTQ® for use in their development facility in order to help them gain process understanding of their raw material production process, develop process models and in turn control models.

Their intention is that in due course the product will be used on the full-scale plant. synTQ® is being used in combination with a Grams multivariate analysis package and suitable instruments, and our understanding is that the development of the models is progressing very well and the client is gaining valuable process understanding.

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PAT & synTQ for Fluidised Bed Dryer Control

A leading pharmaceutical manufacturer installed synTQ® for use on a fluidised bed drier to see if positive gains could be made in terms of process understanding and in terms of reducing processing time by using real time temperature control to suit the real time status of the critical to quality attributes and real time end point control.

synTQ® was used in combination with multivariate analysis products from Umetrics and a suitable instrument, and after building the process models and gaining process understanding the client was able to determine in real time the drying phases that were occurring in the drier.

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