tive supplier’s software products, offering faster drug development within a PAT framework. The respective software products are highly symbiotic and are designed to deliver a simplified route to increasing production efficiency and accuracy in complex, data heavy, process applications – typified by commercial pharmaceutical manufacturing.
SynTQ® from Optimal and The Unscrambler® X from CAMO Software have both been developed independently, but very much in the same vein. Having worked together on several projects, the products can now be fully integrated into an R&D or production environment, bringing out the best in both packages. The result for end users is a powerful model development, data management and production management solution that will transfer easily from the lab to the production floor, while retaining its accuracy, flexibility and regulatory compliant nature.
What is driving the need for these two software solutions?
As manufacturing processes in the food, chemical and life science industries evolve with the introduction of smart sensors, new testing procedures and data analysis techniques, these advances have brought a huge increase in the amount of data being generated throughout the production cycle. In-turn the requirement to manage this data in a more efficient way has led to the adoption of increasingly powerful software products.
The design, development and test process is also becoming far more integrated into manufacturing so it is essential that the software packages also become more integrated, in order to simplify use for the operator and reveal previously hidden information. This is the core benefit of the closer CAMO and Optimal cooperation, as both Multivariate Analysis and PAT Data Management software tools are vital components of a successful and compliant PAT implementation.
Moving away from a batch orientated production regime that has to be halted for quality checks to be made and towards a more continuous in-process solution requires powerful software, especially when regulatory compliance demands strict quality standards, data storage tracking and traceability.
The essential interrelation between multivariate data analysis and PAT
A key mechanism in achieving this transition is the implementation of Process Analytical Technology (PAT). Part of a PAT process necessitates the definition of your product’s Critical Quality Attributes (CQAs), these attributes being essential to the quality and efficacy of your product. By measuring and controlling the process to optimise these CQAs the manufacturer can produce a finished product of consistent and enhanced quality, while also reducing costs and waste.
In order to measure these CQAs in real-time two software components are required – a PAT Data Manager such as synTQ® from Optimal and a multivariate data analysis package such as The Unscrambler® X from CAMO. synTQ® is used to configure, run in real-time and coordinate all the spectral instruments demanded by your process. It also stores all the gathered data for regulatory purposes and passes the data on to The Unscrambler® X for multivariate model building.
When the models are built, users can then run them in real-time within the synTQ® environment combined with CAMO’s Process Pulse software or analytical engines. Users can then improve their process understanding by carrying out experiments where input parameters are varied and the resulting changes in CQAs are predicted in real time. Armed with process understanding and using the facilities in both packages, users can then develop and run Control Models using synTQ®, ultimately enabling closed loop feedback and feed-forward control.
Multivariate analysis is a familiar part of R&D processes, but now, when linked closely with PAT Data Management software, it can more readily be used in the production and manufacturing process. CAMO is a market leader in multivariate analysis software, designed to generate a simplified picture of the interactions between all the variables in the production process. Optimal Industrial Automation is a market leader with their synTQ® PAT Data Management product and has more than 26 years experience in the automation and optimisation of manufacturing systems within the food, chemical, pharmaceutical and life science industries.
Proving the benefits
It would seem almost inevitable that these two market leaders should closely collaborate to produce a tightly integrated package that will deliver all of the benefits attributed to implementing PAT. The ability to reduce product variability and also reduce production cycle times are achieved by running the process more efficiently. By using closed loop control based on process understanding and continuous quality assurance techniques as demanded by true PAT, not only is the product quality optimised but also wastage of expensive raw materials can be reduced as well as preventing the rejection of batches.
By introducing a PAT Data Management system such as synTQ® and combining it with multivariate software from CAMO, manufacturers are able to reduce the overall cost of production, improve the quality of the final product and customer confidence in that product. All of this can be achieved while also meeting FDA and other regulatory guidelines – an issue that will become increasingly difficult in the future if a manufacturer does not implement PAT in some form or other.
Further information on Optimal’s synTQ® can be found here.
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