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Continuous production and synTQ V5.0 at Interphex Japan 2016

14 October 2016

Optimal Industrial Automation Ltdvisit website

 

Optimal Industrial Automation has reported even more positivity in the wake of Interphex Japan 2016 with regards to the latest trend in pharmaceutical manufacturing – continuous production. The wide ranging benefits of continuous production promises a paradigm shift in pharmaceuticals manufacturing – with a number of the global majors reporting drastically reduced development and production times by utilising Process Analytical Technology systems such as Optimal’s synTQ V5.

Undoubtedly one of the most anticipated topics of conversation at this year’s show, Optimal joined a number of pioneers in the field to showcase the tangible advantages that Process Analytical Technology (PAT) platforms can offer to realise continuous production and how the business has tackled the challenges of implementation.

Optimal conducted a seminar entitled ‘Advanced Control for Continuous Manufacturing Process’ at the exhibition, in which the company introduced its advanced PAT systems to attendees. PAT experts from Optimal were on hand to offer guidance and answer questions on synTQ and its application for pharmaceutical, chemical, food and beverage production processes. Response from attendees was overwhelmingly positive, with the real-time product quality prediction and control capabilities of the software of particular interest.

Following soon after a successful Interphex New York in April, Optimal showcased new updates for existing users, while also demonstrating the flexibility and features it provides to new users. Optimal is in continued contact with operators in the global pharmaceutical industry, and is continually upgrading and improving the software as per the application challenges of their customers. As Process Analytical Technology cannot be applied uniformly across differing applications, Optimal has been committed to ensuring ease of integration for its clients, while also transmitting the experience gained to the industry as a whole.

While continuous manufacturing is the norm for many typical industrial production processes, the complexities of production together with the need for continuous quality assurance throughout the process, has made the application to drug manufacture, historically at least, problematic.

However, synTQ V5 offers users holistic ‘end to end’ quality assurance for the whole process and the possibilities of closed loop control based on product quality attributes. Thus the product quality is measured and controlled throughout the process, and this ensures that only product that meets the quality specifications for the whole of the process is accepted and passed for packing. Such methodology removes the need for manual, multiple end-of-unit operation testing and lengthy ‘end-of-batch’ testing of final product – enabling manufacturers of pharmaceuticals to achieve real-time release.

FDA guidance

synTQ V5 is suitable for large and small molecule production as well as batch production processes, offering similar reductions in time to market for a large range of products. With the Food and Drug Administration (FDA) offering support and guidance for PAT technology, global majors reporting huge benefits in actual production plants and the continued importance of ensuring medicine reaches market as quickly as possible – it is clear such technology is revolutionising the industry.

Martin Gadsby, Director of Optimal Industrial Automation comments: “Events such as this provide the perfect forum to showcase our continued commitment to development of synTQ. We want to stress that this is not a software that is suited to just continuous manufacture of a certain final product, but rather an adaptable framework that can be applied to all levels of any life sciences production cycle from lab to line. We have achieved this adaptability thanks to the continued adoption of synTQ by pharmaceutical manufacturers, so we can continue adding features and updates to what is an already proven and dynamic PAT solution.”

For more information about Optimal Industrial Automation and synTQ V5 visit www.optimal-ltd.co.uk.

 
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