Utilising PAT in mainstream pharmaceutical production represents a new approach for several major US drug companies, so discussion between users and vendors at the recent synTQ user group meeting included some significant targets for change and correspondingly focused solutions
The two day event offered a chance for Optimal to unveil new features for synTQ V5.0
The synTQ software suite from Optimal is becoming the default process analytical technology (PAT) implementation platform for the industry — as seismic shifts in the way pharmaceutical and life science companies go about business are few and far between — the software suite is necessarily drawing a lot of attention.
How does PAT software work?
synTQ enables the production of pharmaceuticals (or other processed products such as chemicals or food), by accurately predicting product critical quality attributes during manufacture using non-destructive techniques that typically involve multivariate, univariate data acquisition and interpretation in real time.
The predicted quality values can then be used to control the process immediately to optimise product quality and production rates.
This is very different to traditional production where the process is controlled purely on measured process parameters (temperature, pressure, flowrate etc.), and not the product quality, until the process is complete.
Equally applicable to research and development work, continuous and batch production processes — synTQ has found wide ranging use in the pharmaceutical, chemical, food & beverage and life science industries.
The synTQ platform, in combination with encouragement from the Food and Drug Administration (FDA), is fuelling a paradigm shift away from typically slower batch orientated development and production cycles toward higher speed continuous processes.
Optimising the implementation and execution of a PAT orientated working methodology
Optimal synth User Group Meetings are significant because they focus on optimising the implementation and execution of a PAT orientated working methodology. The synTQ User Group Meeting in Maryland USA this April was particularly busy thanks to the maturing and widespread deployment of V5.0, which represented a big revision for the core platform and the graphical user interface (GUI).
There are many new features for synTQ V5.0, including a new real time MSPC viewer and user configurable Control Charts, that not only detect when your process is moving out of control, but can also take action to correct the situation.
Martin Gadsby, Director at Optimal Industrial Automation, said: "The aim of these user group events is to generate interaction and information sharing between synTQ users, and therefore highlight how synTQ is being used now, how it could be used in the future and how we need to further develop the product to achieve this.
There are substantial benefits for businesses who complete this changeover such as increased production capacity from the same manufacturing footprint, improved quality and consistency, reduced development and manufacturing costs as well as real-time release of manufactured product, which will shorten time to market.