Newest PharmaSuite MES Adds In-Process Control Capabilities to Streamline Quality Monitoring
Electronically modelled and defined in the MES, IPC activities help improve product quality and minimise human error
In-process control (IPC) checks are essential in the highly regulated life sciences industry. However, manually conducting IPC checks can introduce human error, while standalone IPC systems are difficult to integrate with electronic batch records. Rockwell Automation has added new recipe modelling 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.
“This latest version of PharmaSuite software further extends pharmaceutical manufacturers’ IPC capabilities,” said Martin Dittmer, PharmaSuite product manager, Rockwell Automation. “IPC quality checks that previously were the sole responsibility of an operator can now be easily defined and modelled into the recipe up front in the MES, providing instructions, data collection and alerts to ensure these activities are carried out.”
Throughout the design process, the building block library within the PharmaSuite recipe designer allows programmers to re-use and maintain modelled 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 time frame 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.
Added Work-Flow Flexibility
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.
Typically when using other systems, an operator must manually create and attach new paper documentation for any additional work flow. However, this process can be time consuming and riskier due to human error. Pre-defined work flows can be created up front in PharmaSuite v6.0 software, and then 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 introduced in PharmaSuite v6.0 software offer greater MES flexibility, enabling operators to abort and re-activate a production process. These new capabilities eliminate the time, cost and effort of completely re-starting 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.
Rockwell Automation Ltd
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