IFPAC Cortona took place at the Centro Convengia Sant’Agostino in Citta Di Cortona, Italy, offering a relaxed setting in which delegates could discuss the latest innovations in the industry.
Martin Gadsby, Director of Optimal Industrial Automation, presented ‘The Practical Application of PAT to a Continuous Process using synTQ’, which detailed how to successfully implement the PAT platform in a range of varying production processes.
IFPAC is a global exhibition and forum which collects representatives of academia, industry and regulatory bodies to network and discuss developments in pharmaceutical and biotechnology processing. The FDA and the EMA were represented at the show, helping businesses to achieve industry harmonisation when implementing PAT.
Optimal’s synTQ V5 PAT software offers ‘end to end’ quality assurance of compounds during an entire production process via the utilisation of multivariate 3D models. By focussing on product quality attributes, control can be enabled through various stages of the production process via real-time feedback based on product quality attributes. Only products that attain the quality standards set out in the 3D model will make it to the packaging line, as the quality of each product is assessed holistically for the entire production process.
Due to this level of product quality assurance and control during production, the requirements for manual testing are dramatically reduced. Final products are tested throughout every stage of production to regulatory standards, so manufacturers of pharmaceutical products can achieve genuine real-time release to market. As manual testing typically greatly increases production times, the implementation of PAT using synTQ V5 offers a dynamic and reliable platform to get drugs to market faster than ever before. Such features have already seen synTQ V5 installed in production lines for many of the global pharmaceutical majors and on pilot plants across the globe.
Mr Gadsby offered his thoughts on the event: “We consistently attend IFPAC events, as they offer us a perfect forum for information sharing between delegates in relation to PAT. We can share our experiences in the implementation of synTQ including use-cases, and we can learn of new feature and function requirements. We regularly update synTQ V5 with features and functions, some of these arising as a result of these events. So as a business we feel it is vital to educate our potential users in how our technologies could work for them, while sharing our experiences and discoveries with industry, regulatory bodies and academia as a whole. Process Analytical Technology is relatively new for pharmaceuticals, but we are in the fortunate position to be able to offer potential users a stable platform with which to modernise their production processes and protect profit margins.”
“Potential and existing users attended the presentation, which was met with much enthusiasm. We were able to impart the benefits of synTQ, while also exploring a number of challenges that may be encountered when implementing the software. No production line is the same, but if we can give users guidance on successful PAT implementations, the uptake of the technology is only going to accelerate.”
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