Manufacturing Execution System Adds In-Process Control for Quality Monitoring

In-process control (IPC) checks are essential in the highly regulated life sciences industry. Manually conducting IPC checks can introduce human error, and standalone IPC systems are difficult to integrate with electronic batch records, noted Rockwell Automation in a press release. The company added new recipe modeling capabilities to its Rockwell Software PharmaSuite v6.0 manufacturing execution system (MES) to help streamline these crucial activities into the larger production and packaging processes.

“IPC quality checks that previously were the sole responsibility of an operator can now be easily defined and modeled into the recipe up front in the MES, providing instructions, data collection, and alerts to ensure these activities are carried out,” explained said Martin Dittmer, PharmaSuite product manager, Rockwell Automation, in the press release.

Throughout the design process, the building block library within the PharmaSuite recipe designer allows programmers to re-use and maintain modeled IPC checks across multiple recipes. Within a running program, escalation management helps monitor, control, and log the timely execution of IPC checks through an escalating series of documented alerts. For example, a quality check that must be conducted within a five-minute timeframe every 30 minutes will first alert the operator when the five-minute window arrives. A warning is provided if the activity is not completed after a set time. The activity data, including any exceptions or deviations, is recorded and logged in the batch record for the quality assurance team to review and take action on, if necessary.

PharmaSuite v6.0 software also incorporates new work-flow integration capabilities, allowing executed work-flow information to be appended and tracked as part of the electronic batch record, rather than manually creating and attaching paper documentation. Predefined work flows can be created up front in the software, and operators can select, execute, and document the work flow as needed during production. This also provides a new level of flexibility on the plant floor, creating an opportunity to streamline the content of master recipes. Additionally, new re-work capabilities offer greater MES flexibility, enabling operators to abort and reactivate a production process. These new capabilities eliminate the time, cost, and effort of completely restarting an order from the beginning should an unexpected issue arise, while also ensuring the re-work activities are carried out in a controlled and documented fashion.

Source: Rockwell Automation