I noted in yesterday’s post that two major industry conferences were happing this week—the pharmaceutical and biotech industry’s Interphex show and the oil and gas industry’s Offshore Technology Conference (OTC). I highlighted happenings from OTC in that post.
Today I’ll highlight an Interphex presentation, Incorporating PAT Methods into Production Recipes for Real Time Release, given by Emerson’s Chris Amstutz and David Rehbein of the Life Sciences industry team.
In a pharmQbD article, Real-Time Release: It’s Time for Action, Not Debate, the author noted:
RTR, on the other hand, was defined in the PAT [Process Analytical Technology] Guidance to facilitate product release based on the “combined process measurements and other test data gathered during the manufacturing process” which “can serve as the basis for real-time release of the final product,” demonstrating “that each batch conforms to established regulatory quality attributes.”
The author shared the need to optimize the supply chain:
As other industries have shown us, an agile supply chain can only exist in a just-in-time environment. In pharma, JIT is RTR.
David and Chris focused their presentation around the manual work instructions, where they connected to the automated process, and the testing procedures—online, offline, and at line. Think of a PAT method to measure a quality parameter such as moisture content. The PAT method would check for moisture level before the drying phase begins and check through this phase until the correct moisture level was reached.
They described the role of Syncade operations management software in providing the recipe authoring, recipe management, and recipe execution above the control system. PAT Data Management systems such as synTQ provide the PAT methods and orchestrations and the associated data management.
Their guidance was to treat the PAT methods like phases in the control system and sequence them with the recipe authoring tool. This allows the action to be performed without operator intervention—provided the design is such that it looks like what the operators would see if the method was performed manually. This automated approach also helps the RTR effort by having the PAT method results end up in the batch record like all the other analyses. Like process alarms, an alarm would occur if a problem occurs during the execution of the PAT method.
David and Chris described the recipe execution and workflow. The Recipe execution is initiated in Syncade. The PAT methods (synTQ Orchestrations) are launched based on built in recipe triggers and sequencing. Parameters are passed from Syncade to PAT Methods based on the method requirements. Real-time communication occurs between Syncade, DeltaV and PAT Method during the recipe’s execution. Finally, the PAT method completes and its collected details are incorporated into the executing recipe—the final batch record.
From a data collection perspective, recipes can be configured to auto-close based on successful completion of the PAT method. The recipe output can be auto-reported by the Syncade software to an enterprise resource planning (ERP) system. From the control system, materials can be transferred based on batch completion. The final batch record contains the details of the PAT method run and results and these batch records are auto archived by the Syncade software.
They also addressed considerations from a quality assurance perspective. These considerations included redefinition of acceptance criteria, expanded sample size, alarm/reporting strategy changes, starting material variability, comparability of alternate methods, and intermediates vs. “final” product release. These considerations can vary and require a collaborative planning and execution team to work through.
If you didn’t get a chance to catch their presentation, you can catch up with them through their links above or through the Life Sciences “Ask the Expert” page.
You can also join the Life Sciences track on the Emerson Exchange 365 online community to connect with other Life Science professionals and members of the Emerson Life Sciences team.